LIST OF RENEWAL APPLICATION OF YEAR 2018 DEFERRED BY ... of Deferred cases of renewal... · Colistin Sulphate …. 3gm Renewal granted in rd Meeting 53. 046678 Lincofas-44 Powder

LIST OF RENEWAL APPLICATION OF YEAR 2018

DEFERRED BY REGISTRATION BOARD FOR THE

RECTIFICATION OF SHORTCOMINGS

Disclaimer: The instant list pertains to the renewal applications of registered drugs submitted in

2018, which were considered and deferred in various meetings of Registration Board. These

renewal applications have been evaluated as per requirements of Form-5B and SOP as

approved by Registration Board for this purpose. The shortcomings/ deficiencies have already

been communicated to the applicants for completion of their renewal applications. Applicants

are hereby advised to rectify shortcomings/ deficiencies as communicated earlier for further

consideration of Registration Board.

Deferred Cases of 281st Meeting of Registration Board (RRR-Section)

Sr.

No

.

Registratio

n No.

Product Name Decision

M/s. Neomedix

1. 023102 Agapurin-Retard 400mg Tablet

Each tablet contains:-

Pentoxifyline …. 400mg

Deferred the cases of product at Sr.

No.12 regarding confirmation of

status of registration by the firm.

M/s. Westmont Pharmaceuticals Industry, Gujar Khan

2. 048186 Sulf Amprol Oral Water Soluble Powder

Each gm contains:-

Amprolium HCl….166mg

Sulphaquinoxaline Sodium…166mg

Colistin Sulphate…500 I.U.

Vitamin K3….50mg

Vitamin A…..5000I.U.

Deferred the cases of products at Sr.

No.02-30 regarding confirmation of

Licensing Status from Licensing

Division.

3. 048187 Benzomont Oral powder

Each 1000gm contains:-

Sodium Benzoate…100g

Ethanol-bi-amino-phosphoric acid…100gm

Vitamin A…10MIU

Vitamin K3…1000mg

Vitamin E…2500mg

4. 048188 Coccimont Water Soluble Powder


Sulphamerzine Sodium….200gm

Sulphaquinoxinaline sodium…25gm

5. 048190 Flushmont Water Soluble Powder

Each gm contains:-

Hexamethylene tetramine…955.0mg

Vitamin B2 (Riboflavin Sodium

Phosphate)…10.00mg

Calcium Pantothenate ….05.00mg

Nicotinamide…25.00mg

6. 048191 Salicorb Oral Powder


Salicylic acid….200gm

Ascorbic Acid…600gm

Potassium Chloride….2gm

Sodium Chloride…10gm

7. 048192 Tylo-CD Water Soluble Powder

Each gm contains:-

Tylosine tartrate…100mg

Doxycycline HCl…200mg

Colistin Sulphate…20,000IU

8. 048193 Zerocox Water Soluble Powder


Amprolium HCl…20gm

Ethopobate…01gm

Sulfadimidine Na…22.5gm

9. 048194 Albamont Oral Suspension

Each 100ml contains:-

Albendazole….7.5%

Cobalt Sulphate…0.075%

Sodium Selenite…0.035%

10. 048195 Levol Oral Suspension


Levamisol…1.5%Oxclozaide…3%

Cobalt Sulphate…0.167%


11. 048196 Darvimont Water Soluble Powder


Diaveridine….50gm

Sulphaquinoxaline…200gm

Vitamin A…2.50gm

Vitamin K…05gm

12. 048199 Oxamont Oral Suspension


Oxfendazole…22.65gm

13. 048200 Oxanide Oral Suspension


Oxyclozanide…7%

Oxfendazole…3%

14. 049557 Coliclor-N Water Soluble


Neomycin Sulphate…70gm

Colistin Sulphate….4gm

Chlortetracycline HCl…80gm

15. 053931 Colimont Powder


Colistin Sulphate…400MIUMethyl

Paraben…1.5gm

Propyl Paraben…1gm

Dextrose q.s. to produce…100gm

16. 058933 Coccivet Powder

Each Kg contains:-

Furosemide…20gm

Manganese Sulphate…6gm


Potassium Chloride….10gm

17. 058934 Coltin 550 Powder


Colistin Sulphate…550 MIU

18. 058936 Anrox Plus 10% Oral Liquid

Each ml contains:-

Enrofloxacin….10gm

19. 063742 Bromomont Oral Liquid


Bromhexine….

20. 063743 Liver fit Oral Suspension


Silymarin (Milk Thistle)..2100mg

Vitamin E….15000mg

21. 063744 Albawest 2.5% Oral Suspension


Albendazole ….2.5%

22. 063745 AB-Triclamont CS Oral Suspension


Triclabendazole…3.75%Albendazole…2.5%

Cobalt Chloride…0.1%


23. 063746 Enbro-20 Liquid


Enrofloxacin…20gm

Bromhexine…5gm

24. 063747 Ampronil-50 Oral


Oxytetracycline HCl…30%Florfenicol…30%

25. 063748 Normethaprim Oral Liquid

Each Litre contains:-

Norfloxacin…7%Sulfamethoxypyramethazin

e..10%Trimethoprim….2%

26. 063749 Ascirex Plus Oral Powder

Each Kg contains:-

Furosemide..30gm

Vitamin A…10MIU

Vitamin K3…1000mg

Vitamin E…2500mg

27. 063750 Toltrazic Oral Liquid



Toltrazuril…2.5gm

28. 063751 Oxcosel Suspension

Each ml contains:-

Oxfendazole…22.65mg

Cobalt Sulphate….3.82mg

Selenium…0.35mg

29. 063752 Gumbosol Powder


Ammonium Chloride..30gm

Sorbitol…5gm

DI-Methionine…10gm

Vitamin A…15,00,00IU

Vitamin C…10gm

Acetyl Salicylic Acid….10gm

30. 063753 Myco-TD 20/40 Oral Powder


Doxycycline…40gm

Tylosin Tartrate…20gm

M/s. Libra (Pvt) Ltd., Peshawar

31. 025478 Chixicol Syrup

Each 5ml contains:-

Promethazine HCI …. 1.5mg

Pholcodine …. 1.5mg

Registration Board decided to defer

the case for opinion from Legal

Affair Division.

Deferred Cases of 282nd Meeting of Registration Board (RRR-Section)

Sr.

No.

Registration

No.

Product Name Decision Remarks

i) M/s. Tagma Pharma(Pvt) Ltd., Lahore

1. 074270 Zasan Tablet 5mg


Olanzapine …. 5mg

Registration Board

deferred the case of above

mentioned products for

the confirmation of their

status in the Reference

Regulatory Agencies

approved by the Board in

275th meeting.

Renewal granted in

283rd Meeting

2. 074271 Zasan Tablet 10mg


Olanzapine …. 10mg

Renewal granted in

283rd Meeting

Fynk Pharmaceuticals, Lahore

3. 049012 Caveron Tablet 50


Diclofenac Potassium ….

50mg

Registration Board





Regulatory Agencies


275th meeting.

Renewal granted in

283rd Meeting

4. 049013 Caveron Tablet 75


Diclofenac Potassium ….

75mg

Renewal granted in

283rd Meeting

5. 049014 Feroos Tablet


Ferrous Fumarate …. 150mg

Folic Acid …. 0.5mg

Renewal granted in

283rd Meeting

6. 49015 Voveron Tablet


Diclofenac Sodium..50mg

Renewal granted in

283rd Meeting

7. 049016 No-UL Tablet


amotidine …. 40mg

Renewal granted in

283rd Meeting

8. 049017 Nazdac Tablet


Ranitidine …. 150mg

Renewal granted in

283rd Meeting

9. 049018 Qilium Tablet


Domperidone …. 10mg

Renewal granted in

283rd Meeting

10. 049019 Paigone Extra Tablet


Paracetamol …. 500mg

Caffeine …. 65mg

11. 049020 Rox-S Tablet


Naproxen …. 500mg

Renewal granted in

283rd Meeting

12. 049021 FYNKARD Tablet


Metoprolol Tartarate ….

Renewal granted in

283rd Meeting

25mg

13. 049022 Leve-Cit Tablet


Levocetirizine

Dihydrochloride …. 5mg

Renewal granted in

283rd Meeting

14. 049023 Macifar-F Tablet


Iron III Hydroxide

Polymaltose Complex ….

100mg


Renewal granted in

283rd Meeting

15. 049024 Egix Tablet


Cetirizine 2HCI …. 10mg

16. 049025 Becomin Tablet


Mecobalamin …. 500mcg

Renewal granted in

283rd Meeting

EG Pharmaceuticals. Islamabad

17. 075130 Neuromin 500mcg Tablet



Registration Board





Regulatory Agencies


275th meeting.

Renewal granted in

283rd Meeting

18. 075131 Ficx 400mg

Capsule

Each Capsule Contains:-

Cefixime as Trihydrate ….

400mg

Renewal granted in

283rd Meeting

19. 075132 Selovef 500mg

Capsule


Cephradine …. 500mg

Renewal granted in

283rd Meeting

20. 075133 Cobix 100mg

Capsule


Celecoxib …. 100mg

Renewal granted in

283rd Meeting

21. 075134 Tropiset 5mg

Capsule


Tropisetrone as HCI …. 5mg

Renewal granted in

283rd Meeting


Injection

Each 5ml contains:-


Renewal granted in

283rd Meeting

23. 075136 Xtramol Injection

Each 2ml ampoule contains:-


Lidocaine HCI …. 20mg

Renewal granted in

283rd Meeting

24. 075137 Doctofer 100mg

Injection


Renewal granted in

283rd Meeting

Iron as Iron Sucrose ….

100mg

25. 075138 Arteg Injection 80mg


Artemether …. 80mg

26. 075139 Tranex 500mg

Injection

Each 5ml contains:-

Tranexamic Acid …. 500mg

Renewal granted in

283rd Meeting

27. 075140 Axepime 500mg

Injection

Each vial contains:-

Cefepime as HCI with

Larginine …. 500mg

Renewal granted in

283rd Meeting

28. 075141 Axepime 1gm

Injection


Cefepime as HCI with

Larginine …. 1gm

Renewal granted in

283rd Meeting

29. 075142 Cefabest Injection 250MG


Cefotaxime as Sodium ….

250mg

Renewal granted in

283rd Meeting

30. 075143 Cefabest Injection 500mg


Cefotaxime as Sodium ….

500mg

Renewal granted in

283rd Meeting

Siza International (Pvt) Ltd Lahore

31. 021846 Megavit Injection

Each 3ml contains:-

Thiamine HCI …. 100mg

Pyridoxine HCI…100mg

Cyanocobalamine

………1000mcg

Registration Board





Regulatory Agencies


275th meeting.

32. 030291 Obramycin Injection 20mg

Each ml contains:-

Tobramycin as tobramycin

Sulfate. 20mg


Each ml contains:-


Sulfate..80mg

34. 030293 Bikil Injection 250mg

Each 2ml contains:-

Amikacin Sulfate 275mg

eq. to Amikacin..250mg


Each 2ml contains:-


eq. to Amikacin…500mg


Each 2ml contains:-


eq. to Amikacin 1000mg

37. 030296 Sauran 1000mg

Injection

Each 4ml contains:-

Citicoline …. 1000mg

38. 030297 Sauran 250mg

Injection

Each 2ml contains:-


Renewal granted in

283rd Meeting

39. 049114 Ordex Tablet 100mg

Each Film coated tablet

contains:-

Cefpodoxime …. 100mg

Renewal granted in

283rd Meeting

40. 049115 Kwicef Capsule 500mg

Each capsule contains:-

Cefadroxil …. 500mg

Renewal granted in

283rd Meeting




42. 049117 Kwicef Suspension 125mg

Each 5ml contains:-


Renewal granted in

283rd Meeting

43. 049118 Kwicef Suspension 250mg

Each 5ml contains:-


Renewal granted in

283rd Meeting

44. 049119 Solvein I.V Infusion


Sodium Lactate…. 0.320g

Potassium Chloride ….

0.040g Sodium Chloride.

0.600g Calcium Chloride

Dihydrate …. 0.027g water

for injection q.s to 100ml

45. 049120 Cefvox Dry Suspension

Each 5ml contains:-

Cefdinir …. 50mg

46. 049121 Cefvox Capsule 100mg


Cefdinir …. 100mg

Atzan Pharmaceuticals, Sargodha

47. 049739 Komicoccin Solution

Each liter contains:-

Teltrazuril (martindale) ….

25gm

Manufactured by M/s.

Registration Board




Renewal granted in

283rd Meeting

Komipharm International

Co., Ltd., Korea.


Regulatory Agencies


275th meeting.

Ethical Lboratories (Pvt) Ltd, Lahore

48. 006627 Vesochlor Eye Drops


Chloramphenicol USP ….

500mg

Registration Board





Regulatory Agencies


275th meeting.

Renewal granted in

283rd Meeting

49. 006629 Doxachlor eye Drops 0.5%


Chloramphenicol..0.5gm

Dexamethasone Sodium

Phosphate …. 0.1gm

50. 006628 Chloramphenicol Ear Drops


Chloramphenicol Levo USP

…. 1gm

Intervac (Pvt)Ltd, Lahore (Veterinary Products)

51. 046676 K-Fas Powder


Menadion Sodium Bisulfite

(Vit K-3)..12.5gm

Registration Board





Regulatory Agencies


275th meeting.

Renewal granted in

283rd Meeting

52. 046677 Biocol-TD Powder


Tylosin Tartrate …. 10gm

Doxycycline HCI..20gm

Bromhexine …. 10gm

Colistin Sulphate …. 3gm

Renewal granted in

283rd Meeting

53. 046678 Lincofas-44 Powder

Each Kg contains:-

Lincomycin HCI...4.4GM

Renewal granted in

283rd Meeting

54. 046679 Biofas CRD W.S.P


Spiramycin Adipate Vet …..

8,000,000 I.U

Oxytetracyline HCI ….

6000mg

Bromhexine HCI..150mg

Renewal granted in

283rd Meeting

55. 046680 Enrodine Oral Solution


Enrofloxacin HCI …. 10gm

Amantadine HCI …. 4gm

Renewal granted in

283rd Meeting

56. 046681 Enrofas 20% Oral Solution


Enrofloxacin …. 20gm

Renewal granted in

283rd Meeting

57. 046682 Tylodox-C Powder

Each Kg contains:- Renewal granted in

Tylosin Tartrate..140gm

Doxycycline HCI..160gm

Colistin Sulphate …. 1200

M.I.U

283rd Meeting

58. 046883 Amidiofas Powder


Amprolium HCI…. 20gm

Furaltadone HCI…. 20gm

Renewal granted in

283rd Meeting

59. 046884 Vita Tox Powder

Each Kg contains:-

Vitamin A …. 10000000 I.U

Vitamin E..2500mg

Vitamin K-3 …. 1000mg

Vitamin C …. 2500mg

Sodium Benzoate..500gm

Ethanol beta-amino

Phosphoric acid…100gm

Renewal granted in

283rd Meeting

60. 016723 Zeohydramine Cough Syrup

Each 5ml contains:-

Ammonium Chloride ….

100mg

Ephedrine HCI …. 7mg

Diphenhydramine HCI ….

8mg

Renewal granted in

283rd Meeting

M/s Zanctok Pharmaceuticals, Hyderabad

61. 029762 Painogin Tablet 50mg


Diclofenac Sodium …. 50mg

Registration Board





Regulatory Agencies


275th

meeting.*(Approved in

283rd Meeting)

Renewal granted in

283rd Meeting

62. 029763 Rancidine Tablet 150mg


Ranitidine as HCI..150mg

Registration Board





Regulatory Agencies


275th meeting.

Espoir Pharmaceuticals, Karachi

63. 073783 Ainis 100mg Tablet


Aceclofenac as Sodium ….

100mg

Registration Board





Regulatory Agencies


275th meeting.

64. 073782 Haito 10mg Tablet


Domperidone maleate eq. to

Domperidone …. 10mg

Renewal granted in

283rd Meeting

65. 073784 Pulsar 100mg

Capsule


Gabapentin …. 100mg

Renewal granted in

283rd Meeting

66. 073785 Pulsar 300mg

Capsule


Gabapentin …. 300mg

Renewal granted in

283rd Meeting

Bryon Pharmaceuticals (Pvt) Ltd, Peshawar

67. 029994 Zeclorin 250mg Tablet


Clarithromycin . 250mg

Registration Board





Regulatory Agencies


275th meeting.

68. 029995 Nobillium 1mg Tablet


Risperidone …. 1mg







71. 049090 Minacid Suspension 50mg

Each 5ml contains:-

Mefenamic Acid …50mg

72. 049091 Alben Suspension 200mg

Each 5ml contains:-

Albendazole …200mg

Renewal granted in

283rd Meeting

73. 049092 Flectin Syrup 20mg

Each 5ml contains:-

Fluoxetine HCI... 20mg

Renewal granted in

283rd Meeting

74. 049093 Gynosafe Vaginal Cream

Each tube contains:-

Clotrimazole …. 10%

Renewal granted in

283rd Meeting

75. 049094 Cobvit Tablet


Mecobalamin… 500mcg

Renewal granted in

283rd Meeting

76. 049096 Tagozer Tablet 30mg


Pioglitazone as HCI ….

30mg

Renewal granted in

283rd Meeting




45mg

Renewal granted in

283rd Meeting




15mg

Renewal granted in

283rd Meeting

79. 049154 Sopral Plus 5mg Tablet


Bisoprolol Fumarate ….5mg

Hydrochlorothiazide ….

6.25mg

80. 075576 Azibect 500 Capsule


Azithromycin …. 500mg

Unison Chemical Works, Lahore

81. 029701 Macdafin Tablet



Registration Board





Regulatory Agencies


275th meeting.

82. 029702 Unicough Syrup

Each 5ml contains:-


100mg

Sodium Citrate …. 58mg

Chlorpheniramine Maleate

…. 2mg

Menthol …. 1mg

83. 029703 GD-Cid Tablet


Famotidine …. 40mg

84. 029704 Fai-Cam Dispersible Tablet


Piroxicam …. 20mg

Renewal granted in

283rd Meeting

85. 030065 Dinopen 50 Tablet



Renewal granted in

283rd Meeting

86. 030066 Hirazine Tablet



Renewal granted in

283rd Meeting

Pakistan Pharmaceutical Products (Pvt) Ltd., Karachi.

87. 009318 Ulcedine Syrup 200mg/5ml

Each 5ml contains:-

Cimetidine …. 200mg

Registration Board





Regulatory Agencies

88. 013900 Famdin Tab

Each film coated tablet

contains:-


89. 009450 Rifapee Tablet


Rifampicin …. 450mg


275th meeting.

90. 009301 Rifapee Suspension

Each 5ml contains:-


Standpharma Pakistan (Pvt) Ltd., Lahore.

91. 020950 Motaar SR Tablet 100mg


Diclofenac Sodium ….

100mg

Registration Board





Regulatory Agencies


275th meeting.

92. 020951 Lorel Syrup

Each 5ml contains:-

Loratadine …. 5mg

93. 020953 Dopnil Tablet


Cetrizine …. 10mg

94. 020955 Curitol Infusion


Ofloxacin HCI …. 220mg

95. 020956 Resque Capsule



96. 020957 Resque Dry Suspension

Each 5ml contains:-


97. 074296 Dopez 10mg Tablet


Donepezil HCl …10mg

98. 074297 Mintride 2 Tablet


Metformin as HCI ….

500mg

Glimepiride …. 2mg



Metformin as HCI.500mg


100. 074299 Zuphen Injection 200mg

Each 1ml contains:-

ZuclopenthixolAcetate ….

200mg


Each 1ml contains:-

Zuclopenthixol Acetate ….

50mg

Nawan Laboratories (Pvt) Ltd., Lahore. (Veterinary Products)

102. 020804 Colimox Injection


Amoxycillin trihydrate eq. to

Amoxycillin..10gm

Colistin as Colistin sulphate

…. 25 M.I.U.

( VET.product)

Registration Board





Regulatory Agencies


275th meeting.

Renewal granted in

283rd Meeting

103. 020803 Encure-10 Injection



104. 020799 Encure-20 Solution



Renewal granted in

283rd Meeting

105. 020802 Wormec Injection


Ivermectin …. 1gm

Renewal granted in

283rd Meeting

106. 020801 Trimodin -48 Injection


Trimethoprim …. 8gm

Sulphadiazine …. 40gm

Renewal granted in

283rd Meeting

107. 020800 Nawacin LA Injection


Oxytetracycline Dihydrate

eq. to 20gm

Oxytetracycline base

Renewal granted in

283rd Meeting

PharmEvo (Private) Ltd., Karachi

108. 073761 Olsarb-A 5/20mg

TabletAmlodipine as

Besylate …. 5mg

Olmesartan medoxomil ….

20mg

Registration Board





Regulatory Agencies


275th meeting.

Renewal granted in

283rd Meeting

109. 073762 Telsarta-A 5/80mg Tablet


Amlodipine as Besylate ….

5mg

Telmisartan …. 80mg

Renewal granted in

283rd Meeting




5mg


Renewal granted in

283rd Meeting

111. 073764 Olsarb-D 20/12.5mg Tablet


Olmesartan Medoxomil ….

20mg


Renewal granted in

283rd Meeting

12.5mg

112. 073765 Olsarb-A 5/40mg Tablet



5mg

Olmesartan medoxomil ….

40mg

Renewal granted in

283rd Meeting

113. 073766 Olsarb-D 40/12.5mg Tablet


Olmesartan Medoxomil ….

40mg


12.5mg

Renewal granted in

283rd Meeting




10mg


Renewal granted in

283rd Meeting




10mg


Renewal granted in

283rd Meeting

116. 073769 Arbi 150mg Tablet


Irbesartan …. 150mg

Renewal granted in

283rd Meeting

117. 073770 Arbi 300mg Tablet



Renewal granted in

283rd Meeting

118. 073771 Arbi-D 300/12.5mg Tablet




12.5mg

Renewal granted in

283rd Meeting

119. 073772 Arbi-D 150/12.5mg Tablet




12.5mg

Renewal granted in

283rd Meeting

Opal Laboratories ( Pvt) Ltd, Karachi.

120. 073705 Perc Tablet


Betahistine Dihdrochloride

…. 16mg

Registration Board





Regulatory Agencies


275th meeting.

121. 073706 Prosec70mg/30mlSuspension


Secnidazole …. 750mg

122. 073707 Damor 50mg Tablet

Each tablet contains:- Renewal granted in

Tramadol HCI….50mg 283rd Meeting

123. 073708 Malther DS Dry Suspension

Each 5ml contains:-


Lumefantrine ….180mg

124. 073709 Draza 40mg Tablet


Drotaverine HCI …. 40mg

Saturn Pharmaceutical (Pvt) Ltd., Lahore.

125. 074228 Cynosat Injection

Each ml contains:-

Cyanocobalamine ….

500mcg

Registration Board





Regulatory Agencies


275th meeting.

126. 074229 Vitamin D3 Injection

Each ml contains:-

Vitamin D3 …. 200,000 I.U.

Renewal granted in

283rd Meeting

127. 074230 Lignocaine Injection


Lignocaine HCI …. 2%

Adrenaline …. 1:80,000

128. 074231 Arisat Injection

Each 2ml contains:-

Pheniramine Maleate ….

25mg

Macter International Limited, Karachi.

129. 073704 Adalin Sugar Free Syrup

Each 5ml contains:-

Aminophylline …. 32mg


8mg


30mg

Menthol …. 0.98mg

Registration Board





Regulatory Agencies


275th meeting.

130. 073632 Tacip 4.5gm

Injection


Piperacillin as Sodium ….

4gm

Tazobactum as Sodium ….

500mg

131. 073631 Tacip 3.37gm



3gm


375mg

132. 003260 Dimeco Suspension

Each 5ml contains:-

Aluminium Hydroixde Gel

… 215mg

Magnesium Hydroxide …

80mg

Simethicone … 25mg

133. 003249 Digel Suspension

Each 5ml contains:-

Aluminium Hydroixde

Gel…. 5.19mg

Magnesium Hydroxide ….

85mg

134. 003253 Paramac 120mg

Suspension

Each 5ml contains:-


135. 013856 Ciproquine Tablet


Ciprofloxacin as HCI ….

250mg

136. 013855 Oflamac Tablet


Ofloxacin …. 200mg

137. 013854 Co-Amoxi Suspension

156.25mg

Each 5ml contains:-

Amoxycillin Trihydrate eq.

to 125mg

Amoxycillin base.Clavulanic

acid as Potassium Salt ….

31.25mg

138. 013853 Co-Amoxi Tablet 375mg


Amoxycillin Trihydrate eq.

to 250mg

Amoxycillin base.Clavulanic


125mg

139. 013849 Bismol Suspension 88mg

Each 5ml contains:-

Bismuth sub-salicylate ….

88mg

Renewal granted in

283rd Meeting

140. 013846 Bismol Tablet 265mg



265mg

141. 073710 Clatica 3.5gm

Injection


Ticarcillin as disodium ….

3gm

Clavulanic acid as Potassium

Salt …. 200mg

Danas Pharmaceuticals (Pvt) Ltd., Islamabad.

142. 075205 Norden Tablet



Orphenadrine Citrate ….

35mg

Registration Board





Regulatory Agencies


275th meeting.

Renewal granted in

283rd Meeting

143. 075206 Iwill Injection

Each ml contains:-


22.7mg

Deferred Cases of 283rd Meeting of Registration Board (RRR-Section)

Sr.

No.

Registration

No.


Fynk Pharmaceuticals, Lahore.

1. 049019 Paigone Extra Tablet



Caffeine …. 65mg

(Fynk’s Specs)

Registration Board deferred the product for

submission of pharmacopeial specifications.

*(049019 already deferred in 282nd

Meeting)

2. 049024 Egix Tablet



Fynk Specs




Meeting)

M/s EG Pharmaceuticals. Islamabad.

3. 075138 Arteg Injection 80mg



(EG Specs)




Meeting)

M/s Siza International (Pvt) Ltd Lahore

4. 021846 Megavit Injection

Each 3ml contains:-

Thiamine HCl … 100mg

Pyridoxine HCl … 100mg

Cyanocobalamine …

1000mcg

Registration Board deferred the case for

clarification from firm regarding their

dosage form i.e. vial/ ampoule as the same

is not mentioned on the initial registration

letter. *(Deferred in 282nd Meeting)


Each ml contains:-

Tobramycin (as Tobramycin

Sulfate) …20mg

(1ml)


following clarification:Product is approved

as 10mg/ml in 2ml vial in reference

agencies (USFDA).The dosage form of the

product is also not mentioned on the

registration letter whether it is vial/

ampoule.Finished product specifications as

the formulation is pharmacopeial.Details

regarding the last production batch are not

submitted.*(Deferred in 282nd Meeting)


Each 2ml contains:-


Sulfate …. 80mg

(2ml)


clarification from firm regarding their

dosage form i.e. vial/ ampoule as the same

is not mentioned on the initial registration

letter. Moreover finished product

specifications are also required as the

product is pharmacopeial. *(Deferred in

282nd Meeting)


Each 2ml contains:-


eq. to Amikacin …. 250mg

(2ml)


following clarification:i. Formulation is

approved as 50mg/ml and 250mg/ml

injection in USFDA and 250mg/ml vial in

MHRA.ii. The dosage form of the

product is not mentioned on the registration

letter whether vial/ ampoule. iii. Finished

product specifications are also required as

the product is pharmacopeial. *(Deferred in

282nd Meeting)


Each 2ml contains:-



(2ml)


following clarification:i. The dosage form of

the product is not mentioned on the

registration letter whether vial/ ampoule. ii.

Finished product specifications are

also required as the product is

pharmacopeial. *(Deferred in 282nd

Meeting)

9. 049119 Solvein I.V Infusion


Sodium Lactate …. 0.320g

Potassium Chloride ….

0.040g Sodium Chloride

…. 0.600g Calcium

Chloride Dihydrate ….

0.027g water for injection

q.s to 100ml(Siza Specs)


following:i. Verification of installation

of TOC analyser and Liquid Particle

Counter by area FID.ii. Latest GMP

inspection report.iii. Clarification for

manufacturer specifications however the

formulation is pharmacopeial. *(Deferred in

282nd Meeting)


10. 029763 Rancidine Tablet 150mg


Ranitidine as HCI …. 150mg



*(Deferred in 282nd Meeting)

M/s Espoir Pharmaceuticals, Karachi

11. 073783 Ainis 100mg Tablet


Aceclofenac as Sodium ….

100mg

(BP Specifications)

Deferred for submission of copy of BP

monograph for finished product specs.


M/s Bryon Pharmaceuticals Pvt Limited, Peshawar

12. 029994 Zeclorin 250mg Tablet Registration Board deferred the product for


Clarithromycin …. 250mg





















16. 049154 Sopral Plus 5mg Tablet


Bisoprolol Fumarate ….5mg


6.25mg

(Bryon Specs)





17. 029701 Macdafin Tablet



Deferred for following:Finished product

specifications.Description of

tablet.*(Deferred in 282nd Meeting)

18. 029703 GD-Cid Tablet




specifications.Description of

tablet.*(Deferred in 282nd Meeting)

19. 030066 Hirazine Tablet




specifications.Description of tablet.


M/s Pakistan Pharmaceutical Products (Pvt) Ltd., Karachi.

20. 009318 Ulcedine Syrup 200mg/5ml

Each 5ml contains:-

Cimetidine …. 200mg




21. 013900 Famdin Tab

Each film coated tablet

contains:-





22. 009450 Rifapee Tablet






23. 009301 Rifapee Suspension

Each 5ml contains:-





M/s Standpharm Pakistan (Pvt) Ltd., Lahore.

24. 020950 Motaar SR Tablet 100mg


Diclofenac Sodium ….

100mg

Deferred for clarification of

following:Description of

tablet.Pharmacopeial

specifications.*(Deferred in 282nd

Meeting)

25. 020951 Lorel Syrup

Each 5ml contains:-

Loratadine …. 5mg




26. 020953 Dopnil Tablet


Cetirizine …. 10mg



tablet.Pharmacopeial specifications.Label

claim as per salt form.*(Deferred in 282nd

Meeting)

27. 020956 Resque Capsule




following:Pharmacopeial

specifications.Label claim as per salt

form.*(Deferred in 282nd Meeting)

28. 020957 Resque Dry Suspension

Each 5ml contains:-



following:Pharmacopeial

specifications.Label claim as per salt

form. *(Deferred in 282nd Meeting)

29. 074296 Dopez 10mg Tablet


Donepezil HCl …10mg

(Standpharm Specs)



tablet.Pharmacopeial specifications.



Each 1ml contains:-

Zuclopenthixol Acetate ….

50mg

(Standpharm Specs)

Deferred for following:i. Pharmacopeial

specificationsii. Dosage form of the product

is not mentioned in the initial letter whether

vial/ ampoule.*(Deferred in 282nd Meeting)

M/s Opal Laboratories (Pvt) Ltd, Karachi.

31. 073705 Perc Tablet


Betahistine Dihdrochloride

…. 16mg

(Manufacturer Specs)




32. 073708 Malther DS Dry Suspension

Each 5ml contains:-


Lumefantrine ….180mg





M/s Macter International Limited, Karachi.

33. 073632 Tacip 4.5gm

Injection



4gm


500mg


Deferred for clarification regarding

manufacturing facility for penicillin.


34. 073631 Tacip 3.37gm

Injection






3gm


375mg


35. 003253 Paramac 120mg

Suspension

Each 5ml contains:-





36. 013856 Ciproquine Tablet


Ciprofloxacin as HCI ….

250mg




37. 013855 Oflamac Tablet






38. 013854 Co-Amoxi Suspension

156.25mg

Each 5ml contains:-

Amoxicillin Trihydrate eq. to

125mgAmoxycillin

base.Clavulanic acid as

Potassium Salt …. 31.25mg




39. 013853 Co-Amoxi Tablet 375mg


Amoxicillin Trihydrate eq. to

250mg

Amoxicillin base.Clavulanic


125mg




40. 073710 Clatica 3.5gm

Injection



3gm


Salt …. 200mg




Fynk Pharmaceuticals, Lahore.

41. 049013 Caveron Tablet 75mg


Diclofenac Potassium …

75mg

(BP)

Registration Board deferred for further

deliberations.*(049013 already deferred in

282nd Meeting)



Metoprolol …. 25mg

(BP)



Capsule



deliberations.*(all Deferred in 282nd

Meeting)


(EG Specs)




Lidocaine HCI…20mg

(EG Specs)


Each 2ml contains:-



46. 030296 Sauran 1000mg

Injection

Each 4ml contains:-





(USP)


Each 5ml contains:-

Cefdinir …. 50mg

(Siza Specs)



Cefdinir …. 100mg

(Siza Specs)

M/s Ethical Laboratories (Pvt) Ltd, Lahore

50. 006629 Doxachlor Eye Drops 0.5%


Chloramphenicol …. 0.5gm

Dexamethasone Sodium

Phosphate …. 0.1gm


deliberations. *(Both Deferred in 282nd

Meeting)



Chloramphenicol Levo USP

…. 1gm



Each 5ml contains:-


100mg



8mg


deliberations. *(Deferred in 282nd Meeting)


53. 049090 Minacid Suspension 50mg

Each 5ml contains:-

Mefenamic Acid …. 50mg


deliberations. *(both Deferred in 282nd

Meeting)

(B.P)

54. 075576 Azibect 500 Capsule



(Bryon Specs)



Each 5ml contains:-


100mg



…. 2mg

Menthol …. 1mg


deliberations.*(Deferred in 282nd Meeting)


56. 020955 Curitol Infusion


Ofloxacin HCI …. 220mg


deliberations. *(all Deferred in 282nd

Meeting)




500mg


(Standpharm Specs)




500mg


(Standpharm Specs)


Each 1ml contains:-

ZuclopenthixolAcetate ….

200mg







deliberations.*(both Deferred in 282nd

Meeting)



Drotaverine HCI …. 40mg


M/s Saturn Pharmaceutical (Pvt) Ltd., Lahore.


Each ml contains:-

Cyanocobalamine ….

500mcg(Saturn Spec’s)


deliberations.*(all Deferred in 282nd

Meeting)



Lignocaine HCI …. 2%

Adrenaline ….

1:80,000(Saturn Specs)


Each 2ml contains:-


25mg

M/s Macter International Limited, Karachi


Each 5ml contains:-



8mg


30mg

Menthol …. 0.98mg



deliberations. *(all Deferred in 282nd

Meeting)


Each 5ml contains:-

Aluminum Hydroxide Gel …

215mg

Magnesium Hydroxide …

80mg



Each 5ml contains:-

Aluminum Hydroxide Gel….

5.19mg

Magnesium Hydroxide ….

85mg




265mg

69. 073710 Clatica 3.5gm

Injection



3gm


Salt …. 200mg

Danas Pharmaceuticals (Pvt) Ltd., Islamabad.


Each ml contains:-


22.7mg


deliberations.*(Deferred in 282nd Meeting)

M/s. Otsuka Pakistan Limited, Karachi.

71. 045744 Abilify Tablet



deliberation.

Aripiprazole … 10mg

72. 045745 Abilify Tablet


Aripiprazole … 15mg

Deferred Cases of 284th Meeting of Registration Board (RRR-Section)

Sr. No. Registration

No.


M/s Fynk Pharmaceuticals, Lahore.

1. 049013 Caveron Tablet 75mg


Diclofenac Potassium

…………….75mg

(BP)

Registration Board deferred the

case for further delibration on the

matter.*(both already deferred in

282nd and 283rd Meeting)



Metoprolol …. 25mg

(BP)



Capsule


Tropisetrone as HCI ……. …. 5mg

(EG Specs)



matter.*(both already deferred in



Each 2ml ampoule

contain:Paracetamol …. 300mg

Lidocaine HCI …. 20mg

(EG Specs)

M/s Siza International (Pvt) Ltd Lahore


Each 2ml contain: Amikacin Sulfate

1100mg

equivalent to Amikacin

……….…1000mg



matter.*(049116, 30295, 030296,

049120, 049121 already deferred in


6. 030296 Sauran 1000mg

Injection

Each 4ml contains:-





(USP)


Each 5ml contains:-

Cefdinir …. 50mg

(Siza Specs)



Cefdinir …. 100mg

(Siza Specs)

M/s Ethical Laboratories (Pvt) Ltd, Lahore

10. 006629 Doxachlor Eye Drops 0.5% Registration Board deferred the


Chloramphenicol…0.5gm

Dexamethasone Sodium Phosphate

…. 0.1gm


matter.*(Both Deferred in 282nd and

283rd Meeting)



Chloramphenicol Levo USP …. 1gm



Each 5ml contains:-

Ammonium Chloride ……. ….

100mg


Diphenhydramine HCI …. 8mg



matter.*(Deferred in 282nd and 283rd

Meeting)


13. 049090 Minacid Suspension50mg

Each 5ml contains:-

Mefenamic Acid…50mg

(B.P)



matter.*(both Deferred in 282nd and

283rd Meeting) 14. 075576 Azibect 500 Capsule



(Bryon Specs)

M/s Unison Chemical Works, Lahore.


Each 5ml contains:-

Ammonium Chloride ……. ….

100mg


Chlorpheniramine Maleate …. 2mg

Menthol …. 1mg



matter.*(Deferred in 282nd and 283rd

Meeting)


020955 Curitol Infusion


Ofloxacin HCI…220mg



matter. *(020955, 074297,

074298, 074299 Deffered in 282nd

and 283rd Meeting)



Metformin as HCI..500mg


(Standpharm Specs)



Metformin as HCI..500mg


(Standpharm Specs)


Each 1ml contains:-

Zuclopenthixol Acetate

…………200mg







case for further delibration on

the matter.Formulation is not

available in reference drug

agencies.*(both Deferred in 282nd

and 283rd Meeting)



Drotaverine HCI…40mg


M/s Saturn Pharmaceutical (Pvt) Ltd., Lahore.


Each ml contains:-

Cyanocobalamine

………..500mcg(Saturn Spec’s)



the matter.Formulation is not

approved in reference drug

agencies.Formulation is not

approved in reference drug

agencies*(all Deferred in 282nd in

283rd Meeting)



Lignocaine HCI …. 2% Adrenaline

…. 1:80,000(Saturn Specs)


Each 2ml contains:-

Pheniramine Maleate …. 25mg

M/s Macter International Limited, Karachi


Each 5ml contains:-



Ammonium Chloride …. 30mg

Menthol …. 0.98mg




the matter.Strength of ingredients

varies with the formulation approved

in reference agencies (Maalox Plus

Suspension MHRA) Composition is

not mentioned in the initial letter.

The same is written as provided by

the firm in Form-5BStrength of

ingredients varies with the

formulation approved in reference

agencies (Maalox Plus Suspension

MHRA) Composition is not

mentioned in the initial letter. The

same is written as provided by the

firm in Form-5BStrength of

ingredients varies with the

formulation approved in reference

agencies.Moreover the dosage form

is approved as chewable

tablet.Deferred for clarification

regarding manufacturing facility for

penicillin. *(003260, 003249,

013846, 73710, 073704 Deferred in



Each 5ml contains:-

Aluminum Hydroxide Gel … 215mg

Magnesium Hydroxide … 80mg



Each 5ml contains:-

Aluminum Hydroxide Gel…. 5.19mg

Magnesium Hydroxide …. 85mg



Bismuth sub-salicylate …. 265mg

28. 073710 Clatica 3.5gm

Injection


Ticarcillin as disodium …. 3gm

Clavulanic acid as Potassium Salt ….

200mg

M/s Danas Pharmaceuticals (Pvt) Ltd., Islamabad.


Each ml contains:- Registration Board deferred the


Pheniramine Maleate …. 22.7mg matter.*(Deferred in 282nd and 283rd

Meeting)

M/s Neutro Pharma (Pvt) Limited , Sheikhupura Road, Lahore

31. 074309 Nufos Dry Powder

Each 5ml contains:-

Fosfomycin(as Calcium)….250mg

(Neutro specs)

Deferred for the confirmation of

formulation from reference agencies.

M/s Sami Pharmaceuticals (Pvt) Ltd, Karachi

32. 075852 ITP 150mg Tablets

Each film coated tablets contains:-

Itopride HCl…150mg

(Manufacturer’s specification)



Kaizen Pharmaceuticals (Pvt) Ltd,Karachi

33. 073893 Proart Capsule


Dihydroartemisin.40mg

Piperaquine Phosphate …….…320mg

(Manufacturer ‘s specs)



M/s Opal Laboratories (Pvt) Limited, LC/41, LITE Landhi, Karachi

34. 075848 Watbal Orange Sachet

Each sachet contains:-

Sodium Chloride..2.6gm

Potassium Chloride ……….1.5gm

Trisodium Citrate Dihydrate…..2.9gm

Glucose…….13.5gm

(Manufacturer Specifications)

1. Deferred the case till the

rectification of following

shortcomings.Last inspection

report submitted by firm is

conducted by Provincial Inspector

of Drugs on 11.12.2017 and GMP

is rated as “GOOD”.Instead of

approval of the section firm has

submitted the approval of layout by

area FID.The firm informed that

they have not manufactured and

marketed product because of low

viability and applied for price

revision since 2013.Firm informed

that they will use BP specifications

35. 075849 Watbal Fruit Sachet


Sodium Chloride..2.6gm

Potassium Chloride……1.5gm

Trisodium Citrate Dihydrate…..2.9gm

Glucose…….13.5gm

(Manufacturer Specifications)

-do-

M/s Abbot Laboratories (Pakistan) Limited, Opp. Radio Pakistan Transmission Centre,

Hyderabad Road, Landhi Karachi.

36. 006708 Prothiaden 25mg Tablet



formulation from reference regulatory

Dosulepin HCI…. 25mg agencies.

37. 006709 Prothiaden Tablet 25mg


Dosulepin HCI…. 75mg



agencies.

38. 28429 Ganaton 50mg Tablet

Each tablet contain:Itopride HCI ….

50mg



agencies.

M/s Macquin’s International, F-2/H, P.T.C. Industrial Complex, S.I.T.E., Karachi.

39. 058114 Antimal Plus 20/120mg Tablet


Artemether…..20mg

Lumefantrine….120mg

(Manufacturer specifications)

Deferred the case for rectification of

following shortcomings;Evidence of

submission of last renewal.Details of

last production batch as only the date

of production is submitted.Product is

pharmacopeial.

40. 058115 Antimal Plus 40/240mg Tablet


Artemether…..20mg



-do-

41. 058115 Atodine 10mg/5ml Suspension

Each ml contains:-

Famotidine….10mg

(USP Specifications)




last production batch as only the date

of production is submitted.Product is

pharmacopeial.Clarification of

formulation being manufactured as

dry or liquid syrup.

42. 058117 M-Carry 50mg/5ml Syrup

Each 5ml contains:-

Iron III Hydroxide Polymaltose

complex eq. to Elemental Iron …..

50mg





last production batch not provided

only the date of production is

submitted.

43. 058118 Nifim DS 200mg/5ml Dry Suspension

Each 5ml contains:-

Cefixime as Trihydrate …. 200mg

USP Specification






submitted.

44. 058119 Azirom 250mg Tablet


Azithromycin as Dihydrate …. 250mg

USP Specification





only date of production is submitted.

45. 058120 Xamol DS 250mg/5ml Suspension

Each 5ml contains:-


BP Specification






submitted.

46. 058121 Xamol 500mg

Tab



BP Specification






submitted.

47. 058122 Aminocin 100mg

Injection

Each 2ml contains:-

Amikacin as Sulphate ….. 100mg

USP Specification

Evidence of submission of last

renewal.Details of last production

batch not provided only the date of

production is submitted.Clarification

whether the firm is manufacturing

vial/ ampoule as the dosage form is

not mentioned on registration

letter.Section approval letter.


Injection

Each 2ml contains:-


USP Specification






submitted.Clarification whether the

firm is manufacturing vial/ ampoule

as the dosage form is not mentioned

on registration letter.Section

approval letter.Formulation is

approved as 250mg/ml injection in

USFDA and 250mg/ml vial in

MHRA.


Injection

Each 2ml contains:-







submitted.Clarification whether the

firm is manufacturing vial/ ampoule

as the dosage form is not mentioned

on registration letter.Section

approval letter.

50. 058125 Ocotimol 0.5% Eye Drops

Each ml contains:-

Timolol as Maleate …. 0.5%USP

Specification






submitted.

51. 058126 Ocunaf Eye Drops

Each ml contains:-


USP Specification






submitted.

52. 058127 Ocusolone Eye Drops Deferred the case for rectification of

Each 5ml contains:-

Prednisolone Acetate …. 1%USP

Specification





submitted.

53. 058128 Ocuflox Eye Drops

Each 5ml contains:-

Ofloxacin as HCI …. 3mg

USP Specification






submitted.

54. 058129 Methox Comp Eye Drops

Each ml contains:-

Dexamethasone…. 0.1%

Chloramphenicol…0.5%Manufacturer

Specification






submitted.Evidence of availability of

formulation in reference agencies.

55. 058130 Ocutodex Eye Drops

Each ml contains:-

Tobramycin …. 3mg

Dexamethasone …. 1mg

USP Specification






submitted.

56. 058131 Omox Eye Drops

Each ml contains:-

Moxifloxacin as HCI ………….. ….

5mg

Manufacturer Specification






submitted.

57. 058363 Azirom 200mg/5ml Dry Suspension

Each 5ml contains:-

Azithromycin as Dihydrate …. 200mg







submitted.Clarification of

formulation being manufactured as

dry or liquid syrup.Section approval

letter.

58. 058364 Mac-Omez 40mg

Infusion


Omeprazole …. 40mg







submitted.Section approval letter.

59. 057777 Ucetam Injection

Each 5ml contains:-

Piractem …. 1gm







submitted.Section approval

letter.Evidence of availability of


60. 048507 Aqua Teas Eye Drops

Each ml contains:-

Destran …. 1mg

HPMC …. 3mg

Glycerin …. 2mg









61. 032049 Moxithro Tablets 150mg


Roxithromycin …. 150mg








62. 032050 Moxithro Tablets 300mg


Roxithromycin …. 300mg








63. 032051 Cutapam Tablets


Citalopram as HBr …. 20mg






64. 032052 Flubi Tab 100mg


Flurbiprofen …. 100mg






submitted.

65. 029475 Tissot Tablet








66. 029476 Euro Tablet 250mg


Ciprofloxacin …. 250mg






67. 029477 Euro Tablet 500mg








68. 029479 Meoceaf Capsules 250mg








69. 029480 Meoceaf Capsules 500mg








70. 029481 Mefaclor Capsules 250mg


Cefaclor …. 250mg






71. 029482 Mefaclor Capsules 500mg


Cefaclor …. 500mg






72. 029487 Meoceaf Vial 250mg








73. 029488 Meoceaf Vial 500mg








74. 029489 Macxone Vial 250mg


Ceftriaxone Sodium eq. to

Ceftriaxone … 250mg






75. 029490 Macxone Vial 500mg



Ceftriaxone … 500mg






submitted.

76. 029491 Macxone Vial 1gm



Ceftriaxone …. 1gm






77. 042129 Ucetam Syrup

Each 5ml contains:-

Piractem …. 1gm





only date of production is



M/s Pharmedic Laboratories Pvt Limited, 16-K.m Multan Road Lahore.

78. 047979 Cefipar Injection 500mg


Cefepime as HCI..500mg

Sterile Arginine…250mg


shortcoming;Latest inspection report

is required as submitted report is of

2012.

79. EX-001768 Blucin injection 15mg


Bleomycin Sulphate …. 15mg

-do-

80. 47980 Cefipar Injection 1000mg


Cefepime as HCI ………….1000mg

Sterile Arginine...500mg

-do-

M/s Noa Hemis Pharmaceuticals, Plot No. 154, Sector 23, Korangi Industrial Area, Karachi.

81. 048557 Tuf Tablet 1mcg


Alfacalcidol … 1mcg(Manufacturer’s

Specs)

1. Deferred the case for


shortcomings:Approval from

reference regulatory

agencies.Clarification regarding

storage condition of raw

material.

82. 048558 Tuf Tablet 0.5mcg


Alfacalcidol ….

0.5mcg(Manufacturer’s Specs)

2. Deferred the case for rectification

of following




storage condition of raw material.

83. 048559 Tuf 2mcg Drops

Each 2mcg drops contains:-

Alfacalcidol …. 2mcg(Manufacturer’s

Specs)

3. Deferred the case for





storage condition of raw

material.

M/s Abbot Laboratories (Pakistan) Ltd, Opp. Radio Pakistan Transmission Center, Hyderabad

Road, Landhi, Karachi.

84. 028432 Protium 20mg Tablet


Pantoprazole…..20mg

4. Deferred for following:Name of

manufacturer mentioned in the

Form-5B is different from

CoPP.Approval of change of

manufacturing site. Last invoice

attested by ADC.

85. 047598 Tarka 240/4mg Tablets


Verapamil HCI…. 240mg

Trandolapril…..4mg


manufacturer provided on the

letter varies from the name of

CoPP. Further address of

manufacturing site also requires

verification.AD attested invoice

for last imported batch.

86. 028433 Tarka Bilayer Film Coated Tablets


Verapamil HCI…. 180mg

Trandolapril…..2mg








87. 028427 Kaletra Oral Solution

Each ml contains:-

Lopinavir…….80mg

Ritonavir…..….20mg








M/s Medimarkers Laboratories (Pvt) Ltd., Hyderabad

88. 061002 Prizal 1mg Tablet


Alprazolam … 1mg

Registration Board deferred for

confirmation of DML status.

M/s Winilton Pharmaceuticals (Pvt) Limited Islamabad. 89. 041319 Sparsel Tablet 100mg

(Sparfloxacin)


case and decided to reconsider after

opinion of Legal Affair Division

for such cases.



No.


RRR-Section got no attention of the Board


Sr.

No.

Registration

No.


M/s Martin Dow Marker Limited (Formerly Merck Pvt Limited), 7-Jail Road, Quetta

1. 075906 Cosome DA Cough Syrup

Each 5ml contains:-

Acefylline piperazine…..45mg

Diphenhydramine

Hydrochloride……8mg

(Manufacturer specification)

Deferred for the approval status in

reference regulatory agencies

M/s Atco Laboratories Limited, B-18 S.I.T.E., Karachi

2. 000900-EX Zincviet Dry Suspension

Each 5ml contains:-

Elemental Zinc (as zinc sulphate

monohydrate USP)……….10mg


formulation by the firm.

M/s LINZ Pharmaceuticals (Pvt) Limited, Plot No. 31-G/H , Sector 15, Korangi Industrial Area,

Karachi

3. 053426 Osolinz Tablet


Alfacalcidol….0.5mcg(BP Specification)

Deferred for submission of

manufacturing process by firm.

M/s Uni-Tech Pharmaceuticals Pvt Limited Plot No. 4/ 116, Sector 21, Korangi Industrial Area

Karachi

4. 000961-Ex U-Viagra Tablet 100mg


Sildenafil as citrarte………100mg

Deferred for confirmation of

registration status by the

concerned section. Deferred for

confirmation of registration status

by the concerned section.

M/s. P.D.H. Pharmaceuticals (Pvt) Ltd., 19-K.m, Ferozepur Road, Lahore.

5. 029335 Myclar Suspension 125mg

Each 5ml contains:-

Clarithromycin..125mg

Deferred for clarification of pellets

source by the firm.

6. 029336 Myclar XL Tablet 500mg





M/s. Himont Pharmaceuticals (Pvt) Ltd., 17-K.m Ferozpur Road, Lahore.

7. 076884 Loxadril Drops


Cefadroxil (as Monohydrate)..100mg

(Himont’s Specs)

Deferred for approval status in

reference regulatory agencies.

8. 076888 Xesafin Drops


Cephalexin (as Monohydrate)…100mg

(Himont’s Specs)


reference regulatory agencies.

M/s. Paradise Pharma, 23-K.m Sheikhupura Road, Lahore.

9. 074319 Tincture Iodine External Preparation


Iodine … 2.5mg

Potassium Iodide ………..2.5mg

Deionised water..2.5mlEthanol 90%

QS … 100ml(Paradise’s Specs)


reference agencies.

10. 074321 Glycerol Suppositories

Each contains:-

Glycerin … 70% w/v(USP Specs)


reference agencies.

M/s. Benson Pharmaceuticals, Plot No. 119, Street No. 8, Sector, I-10/3, Industrial Area,

Islamabad.

11. 021569 Bepsin Tablet


Famotidine … 20mg

Deferred for status of DML from

Licensing Division

12. 021570 Bepsin Tablet


Famotidine … 40mg


Licensing Division

13. 021571 Bentoril-100 Tablet


Captopril … 25mg


Licensing Division

14. 021576 Keygesic Tablet


Diclofenac Potassium … 50mg


Licensing Division

15. 021577 Keygesic Tablet




Licensing Division

16. 021584 Unitrate-20 Tablet


Isosorbide mononitrate … 20mg


Licensing Division

17. 021587 Cardi 50 Tablet


Atenolol … 50mg


Licensing Division

18. 021591 Domotin Tablet


Domperidone … 10mg


Licensing Division

19. 030458 Benicef Capsule 250mg


Cephradine … 250mg


Licensing Division

20. 030459 Benicef Capsule 500mg




Licensing Division

21. 030460 Benicef Suspension 125mg

Each 5ml contains:-



Licensing Division

22. 030461 Benicef Suspension 250mg

Each 5ml contains:-



Licensing Division

23. 030462 Benifix Capsule


Cefixime … 400mg


Licensing Division

24. 030463 Benifix Suspension

Each 5ml contains:-

Cefixime … 100mg


Licensing Division

M/s. Nabiqasim Industries (Pvt) Ltd., 17/24, Korangi Industrial Area, Karachi

25. 000839-EX Rengat 125mg/5ml Suspension

Each 5ml reconstituted suspension

contains:-



source of granules by the firms.

M/s. Platinum Pharmaceuticals (Pvt) Ltd., A-20, North Western Industrial Zone, Bin Qasim,

Karachi.

26. 022052 Hi-Paradent ToothpasteContains:-

Permethol … 0.25% Deferred for approval status of


M/s Zantock Pharmaceutical Laboratories, F/5, S.I.T.E., Hyderabad.

27. 076484 Zancpal Extra Tablet


Paracetamol….500mg

Caffeine………..65mg

(Manufacturer Specification)


GMP status for QA&LT Division.

M/s Pharmatec Pakistan (Private) Limited, D-86/A, S.I.T.E., Karachi

28. 075815 Leflotec 500mg/ 100ml Infusion


Levofloxacin as hemihydrate…500mg



approval of manufacturing facility

from Licensing Division as firm

informed that manufacturing

facility is not available for the said

product.

M/s Sami Pharmaceuticals Pvt Limited, F-95, S.I.T.E., Karachi

29. 009743 Dicloran SR-100 Tablets

Each sustained release tablet contains:-

Diclofenac Sodium……100mg

a. Deferred for clarification of

following:Approval of change

of address from concerned

section.Submission of

differential fee for

regularization of renewal of

2014.Submission of renewal

application in 2018 instead in

2019.Approval of blister

packaging and BP specs from

concerned section.

30. 009744 Dicloran 50mg Tablets

Each enteric coated tablet contains:-


-do-

31. 009748 Dicloran 75mg

Injection

Each 3ml contains:-


a. Deferred for clarification of

following:Approval of change

of address from concerned

section.Submission of


regularization of renewal of

2014.Submission of renewal

application in 2018 instead of

2019.

32. 021386 Pulsate 50mg

Dispersible Pediatric Tablets


Roxithromycin Ph.Eur……50mg

Deferred for approval of

formulation in reference drug

agencies.

M/s Medisure Laboratories Pakistan (Pvt) Limited, A-115, S.I.T.E., Super Highway Karachi.

33. 047315 Xonboc Capsule


Sibutramine (as HCl)……10mg


Deferred for submission of

differential fee as application was

submitted after due date but within

sixty days and confirmation of

registration status from reference

regulatory agencies.

34. 047316 Xonboc Capsule


Sibutramine (as HCl)……15mg


-do-

35. 073517 Amesure Infusion


Ciprofloxacin as lactate……200mg


-do-

36. 073518 Evaxosure Infusion


Levofloxacin hemihydrate eq. to

Levofloxacin….500mg


-do-

37. 073519 Mezole Infusion

Each ml contains:-

Metronidazole ….5mg


-do-

38. 073520 Zoxam Infusion


Ofloxacin HCL eq. to

Ofloxacin….200mg


-do-

39. 073521 Biofloxacin Infusion


Moxifloxacin as HCl ……..400mg

(Manufacturer specs)

-do-

40. 073522 Fero-D Ampoule

Each ml ampoule contains:-

Cholecalciferol…5mg

-do-


M/s Martin Dow Marker Limited (Formerly Merck Pvt Limited), 7-Jail Road, Quetta

41. 010194 Concor Tablets 5 mg

Each film-coated tablet contains:-

-Bisoprolol Hemi fumarate … 5 mg

(USP Specification)

Deferred for further evaluation.

42. 026855 Lodopin Tablets 10 mg


-Amlodipine Besilate, equivalent to

Amlodipine.… 10 mg

(USP Specification)

-do-

43. 026853 Lodopin Tablets 2.5 mg



Amlodipine.…2.5 mg

(USP Specification)

-do-

44. 026854 Lodopin Tablets 5 mg



Amlodipine….… 5 mg

(USP Specification)

-do-

45. 027807 Lidocaine 1% Injection

Each ml contains:-

Lidocaine HCl, USP ……1%(As per

Innovator’s Specification)

-do-

46. 037634 Mercip Tablets 750 mg

Each Film coated Tablet contains:-

Ciprofloxacin Hydrochloride, USP

equivalent to Ciprofloxacin…750mg

(USP Specification)

-do-

47. 004158 Multibionta for Infusion

Each 10 ml contains:-

Vitamin A (Palmitate)...10,000 IU

Vitamin B1 (Thiamine Hydrochloride)..

50mg

Riboflavin 5’-Phosphate Sodium

............. 10mg

Vitamin B6 (Pyridoxine Hydrochloride)..

15 mg

Nicotinamide.. 100mg

Dexpanthenol..... 25mg

Vitamin C (Ascorbic Acid) ....... 500 mg

Vitamin E (dl-Alpha Tocopheryl

Acetate) ….... 5 mg

(As per Innovator’s Specification)

-do-

48. 020242 Multibionta M Syrup


Vitamin A (Palmitate)...3000 I.U.

Vitamin D (Cholecalciferol) ………..400

-do-

I.U.

Vitamin B1 (Thiamine

Hydrochloride).1.5 mg, Riboflavin 5’-

Phosphate Sodium, ….1.2 mg,

Vitamin B6 (Pyridoxine Hydrochloride)

...1mg,

Vitamin B12 (Cyanocobalmin),

……….3mcg,

Vitamin C (Ascorbic Acid)….50

mg,Nicotinamide…..10mg,Dexpanthenol

….5mg,Iron (as ferrous gluconate)

….3mg,Iodine (as potassium

Iodide)….75 mcg,Calcium (as Calcium

Lactate)…. 40 mg,Phosphorous (as

Hypophosphoric acid) ….43

mg,Manganese (as Manganese

gluconate) …. 0.5 mg,Magnesium (as

Magnesium gluconate) …. 3 mg,Zinc (as

Zinc Gluconate)…0.5mg,Choline (as

Choline Bitartrate)… 5 mg,Inositol

………. 5 mg


49. 027809 Merstatin Tablets 20mg

Each Tablet contains:-

Simvastatin.…20 mg

(USP Specification)

-do-

50. 010193 Neurofenac Capsules 50 mg


Diclofenac Sodium, USP…… 50 mg

(Source of pellets: Inventia Healthcare

Pvt. Ltd., Maharashtra state, India)(As

per Innovator’s Specification)

-do-

51. 018032 Optifam Tablets 20 mg

Each film- coated tablet contains:-

-Famotidine.… 20 mg

(USP Specification)

-do-

52. 018033 Optifam Tablets 40 mg

Each film- coated tablet contains:-

-Famotidine … 40 mg

(USP Specification)

-do-

53. 018718 Pcam Gel 0.5%Pcam gel contains:-

Piroxicam.... 0.5% w/w(BP

Specification)

-do-

54. 017582 Pcam Capsules 10 mg


Piroxicam ........ 10 mg

(BP Specification)

-do-

55. 018040 Pcam Capsules 20 mg


Piroxicam .........20 mg

-do-

(BP Specification)

56. 018048 Pcam Injection


Piroxicam ......20 mg


-do-

57. 000723 Polybion Forte Injection


Vitamin B1 (Thiamine Hydrochloride),

USP…..10 mg, Riboflavin 5’-Phosphate

Sodium, USP….4 mg,

Vitamin B6 (Pyridoxine Hydrochloride),

USP …… 4 mg,

Vitamin B12 (Cyanocobalmin),

USP…..8 mcg,Nicotinamide, USP …..40

mg,Dexpanthenol, USP….6 mg,(As per

Innovator’s Specification)

-do-

58. 025485 Ranulcid Tablets 300 mg


Ranitidine Hydrochloride equivalent

toRanitidine … 300 mg

(BP Specification)

-do-

59. 025486 Ranulcid Tablets 150mg


Ranitidine Hydrochloride equivalent

toRanitidine …. 150 mg

(BP Specification)

-do-

60. 014785 Refobacin Injection 10 mg


Gentamicin sulfate USP equivalent to

Gentamicin…….10 mg


-do-






-do-






-do-






-do-

64. 007434 Sangobion Syrup

Each 5ml contains:-

Ferrous Gluconate,USP....129.5 mg

Vitamin B1 (Thiamine Hydrochloride),

-do-

USP.... 1 mg

Vitamin B2 (Riboflavin), USP...............1

mg

Vitamin B6 (Pyridoxine Hydrochloride),

USP…..1.5 mg

Nicotinamide, USP............. 15 mg

Biotin, USP.......0.3 mg


65. 006475 Sistalgin Tablets


Pramiverine Hydrochloride.. 2 mg


-do-

66. 018039 Teril Tablets 200 mg


Carbamazepine USP ….. 200 mg


-do-

67. 044472 Vitabion Capsules

Each soft gelatin capsule contains:-

Vitamin A (Palmitate), USP.... 5000 I.U.

Vitamin B1 (Thiamine Mononitrate),

USP ......5 mg,

Vitamin B2 (Riboflavin), USP..........3

mg,

Vitamin B6 (Pyridoxine HCl), USP.... 5

mg,

Vitamin B12 (Cyanocobalamin),USP....3

mcg, Nicotinamide USP........... 25 mg,

Calcium D-Pantothenate , USP...... 10

mg

Biotin, USP ….50 mcg,Procaine HCL,

USP….. 55mg, Folic Acid USP…..

0.4mg,Inositol USP…. 30mg,Orotic

Acid Ext. Pharm …… 30 mg,

Vitamin C (Ascorbic Acid) USP.........60

mg,

Vitamin D (Cholecalciferol), USP .....

400 I.U.,

Vitamin E (dl-Alpha Tocopherol

Acetate), USP...10 mg,Ethyl Linolate,

USP … 28 mg, Lecithin from soya

beans, USP……60 mg,Choline

Hydrogen Tartrate, MDM..50mg, L-

Lysine Monochloride ……25 mg,

Hematoporphyrin ………..1 mg,

Adenosine…. 0.75 mg, Intrinsic factor

20U/g …..6.22 mg, Magnesium

glycerophosphate ……… 40 mg,

Dehydrated Calcium hydrogen

Phosphate… 35 mg, Potassium (as

Potassium sulfate), BP ….. 8

mg,Dehydrated Ferrous (II) sulfate… 10

-do-

mg, Dehydrated Cupric (II) sulfate…

0.5mg, Dehydrated Mangnous (II)

sulfate ….. 0.5mg, DehydratedCobaltous

(II) Sulfate ….. 0.1mg, Dehydrated

Sodium Molybdate…80 mcg,Zinc

Oxide…. 0.5 mg


68. 07483 Sangobion Fe Injection


-Iron Sucrose Complex Equivalent to

elemental Iron ………..… 100 mg

(USP Specification)

-do-

M/s Nawan Laboratories Pvt Limited, 136 Sector 15, KIA Karachi

69. 014103 Utavet Uterine Pessaries

Each pessary contains:-

Sulphathiazole.1750mg

Penicillin G ……100000IUStreptomycin

(as sulphate)…50mg

Ethinyloestradiol …..0.5mg


penicillin section from Licensing

Division.

70. 021302 Predivet Injection


Prednisolone acetate……2.5gm


steroidal section from Licensing

Division.

71. 021305 Amovet L.A. Injection


Amoxicillin trihydrate eq. to 15gm

Amoxicillin base



Division.

Amson Vaccines & Pharma (Pvt.) Ltd., Islamabad

72. 025848 Aceta INH TabletThiacetazone …50mg

INH…100 mg Deferred the case for the approval

status in Reference Regulatory

Agencies.

73. 038532 Aller-Eze Syrup

Each 5ml contains:-

Clemastine

Hydrogen Fumarate USP eq to

Clemastine USP….0.25mg

Deferred the case for the approval


Agencies.

74. 025581 Amchoram - 4 Tablet


Chlorpheniramine Maleate BP…. 4 mg



Agencies.

75. 024290 Amsoton Capsule


Mefenamic Acid BP…..250 mg


Reference Regulatory Agencies

76. 018089 Amspar Syrup

Each 5ml contains

Piperazine Citrate BP …. 937.5 mg

eq to

Piperazine Hydrate….. 500 mg



Agencies.

77. 018088 Amspar TabletPiperazine Citrate BP eq

to

Piperazine Hydrate ….100 mg



Agencies.

78. 040693 Calciglu Effervescent Tablets

Each Tablet Contains:-

Calcium

Lactate Pentahydrate BP eq. to Calcium

Lactate …..422mg

Calcium

D Gluconate Monohydrate BP eq. to

Calcium-D Gluconate....578mg

Calcium Carbonate

BP..........327mg

Vitamin C BP .........500mg



Agencies.

79. 017375 Coenza Capsules


Ubidecarenone…. 50 mg


Reference Regulatory Agencies

80. 025846 Ethrifid - P TabletRifampicin…120 mg

Ethambutol HCl…. 225 mg

INH….60 mg

Pyrazinamide…. 300 mg



Agencies.

81. 019650 Levam 40 mg Tablets


Levamisole USP (As HCl) ….40 mg



Agencies.

82. 018087 Pyraquin Syrup

Each 5ml contains

Chloroquine Phosphate…. 84 mg

eq. to Chloroquine….50 mg



Agencies.

83. 018086 Pyraquin Tablets

Each contains:-

(Film/Sugar) contains

Chloroquine Phosphate...242.5mg

eq. to Chloroquine ……..150 mg



Agencies.

84. 019669 Thiaben Tablet


Thiabendazole BP….. 500 mg



Agencies.

85. 025436 Vitam Tablet

Vitamin B1 B.P…………...15mg

Vitamin B2 B.P…………...10mg

Vitamin B6 B.P…………….5mg

Vitamin B12 B.P………….4mcg

Niacinamide B.P…………100mg

Calcium Pantothenate BP…20mg

Vitamin C B.P…………..500 mg



Agencies.

86. 019649 Worex Tablet


Mebendazole USP….. 500 mg



Agencies.

M/s. Trigon Pharmaceuticals (Pvt) Ltd., Lahore.

87. 047757 Pantagon Injection IM/IV

Each 1ml contains:-

Pentazocine (as Lactate) … 30mg


case for the confirmation of status

of License from Licensing

Division

88. 047758 Bubrifen Injection

Each ml contains:-

Buprenorphen (as HCl) … 0.3mg


case for the confirmation of status

of License from Licensing

Division



No.


Board deferred the agenda of RRR-Section



No.


M/s Leads Pharma Pvt Ltd, Plot No .81-A, Street No.6, I-10/3. Islamabad.

1. 035886 Leceph 500mg

Injection

Each ml contains:-

Cephradine…500mg

Deferred for evidence of approval of

applied formulation in reference

regulatory authorities/agencies

which were adopted by the

Registration Board in its 275th

meeting.

M/s Paramount Pharmaceuticals, 36-Industrial Triangle, Kahuta Road, Islamabad

2. 21859 Fertin Tablet

Each Tablet Contains:

Vitamin A…30,000IU

Vitamin E…70mg

Deferred for latest inspection report

declaring GMP compliant status,

since submitted report does not

conclude GMP compliant status.

3. 21860 Healet Tablet 200mg


Cimetidine…200mg





4. 21862 Healet Tablet 400mg


Cimetidine…400mg





5. 021862 Vitalet-M Tablet


Vitamin A…5500IU

Vitamin E…30IU

Vitamin D…400IU

Vitamin B1…3.0mg

Riboflavin…3.4mg

Pyrodoxine HCl…3.0mg

Cyanocobalamine …9.0mg

Nicotinamide…30mg

Pantothenic Acid …10mg

Ascorblic Acid…120mg

Folic Acid…0.4mg

Magnesium…100mg

Calcium…40mg

Zinc..15mg

Manganese...5mg

Iron...27mg

Copper...2mg

Chloride...7.5mg

Potassium...7.5mg

Iodine...150mcg

Molybdenum...15mcg

Biotin...15mcg

Chromium...15mcg





Selenium...10mcg

6. 021863 Vitalet-H Tablet


Vitamin A Acetate…8.333IU

Vitamin E…5.0IU

Vitamin D…133IU

Thiamine Monohydrate…3.3mg

Riboflavin…3.3mg

Cynocobalamine …50mcg


Calcium Pantothenate…11.7mg

Ascorbic Acid…100mg

Folic Acid…0.33mg

Magnesium…41.7mg

Iron…66.7mg

Copper…0.67mg





M/s. AGP Limited, B-23-C, S.I.T.E., Karachi.

7. 024881 Novafol 250mg

Capsules


Cephradine……250mg


the case for the opinion from legal

Affair Division and clarification

from the firm regarding the matter

related to dedicated section of

Cephalosporin under Schedule B

Section I (5.2).Dedicated Facilities

for Production of Drug Act 1976.

Whether firm is legally authorize to

hold the registration of such product

for which they do not have dedicated

section currently. According to the

firm, they have approved area for the

production of Cephalosporin at the

time of Registration later the firm

discontinued the production of

Cephalosporin and the firm do not

have approval of Cephalosporin

section vide letter no. F.2-3/92-Lic

(Vol-II) Dated 28th April, 2016 of

Licensing Division.

8. 024882 Novafol 500mg

Capsules



-do-

9. 024884 Novafol 250mg

Suspension

Each 5ml contains:-


-do-

10. 024878 Novafol 250mg

Injection (IM/IV)


-do-

Cephradine…..250mg

11. 024949 Tecadin Injection 250mg

IM/IV


Cefoperazone..250mg

-do-

12. 018070 Kefadim 1gm

Injection


Ceftazidime Sterile…..1.00gm


the case for the clarification of status

of Application of year 2011 for the

extension in contract manufacturing

from the concerned section. As the

firm submitted permission dated 15-

7-2008 of contract manufacturing

from M/s PharmEvo Pvt Limited

Karachi for three years. The firm

also informed that they had applied

for extension in 2011 from same

facility for five years but no evidence

of approval of extension is provided.

They further stated that product is

discontinued.

13. 018069 Kefadim 500mg

Injection


Ceftazidime Sterile…….500mg

-do-

14. 036178 Kefadim 250mg

Injection


Ceftazidime Pentahydrate eq. to

Ceftazidime…..250mg

. –do-

15. 021640 Phyllocontin 100mg Tablet


Aminophylline

Hydrate……100mg

As the product was initially

registered with the brand name

Phyllocontin Continus Tablet. The

transfer of registration also bears the

same name. However the transfer

letter dated 17-7-2008 bears only

“Phyllocontin” when the was

inquired about the evidence of

change of brand name, they informed

that:“The full brand name is

Phyllocontin Continus Tablet,

sometimes it is mentioned in short

form as Phyllocontin 100mg

Tablet”Registration Board decided

to defer the case for the

clarification from the firm

regarding the change of brand

name if any.

16. 016418 Nebcin Injection 80mg


Tobramycin Sulphate….. 80mg


the case for the clarification of

transfer of registration in the name of

M/s. AGP Limited, Karachi from the

concerned section.

17. 024951 Tecadin Injection 1gm

IM/IV


Cefoperazone…..1gm


the case for the opinion from legal

Affair Division and clarification

from the firm regarding the matter

related to dedicated section of

Cephalosporin under Schedule B

Section I (5.2).Dedicated Facilities

for Production of Drug Act 1976.

Whether firm is legally authorize to

hold the registration of such product

for which they do not have dedicated

section currently. According to the

firm, they have approved area for the

production of Cephalosporin at the

time of Registration later the firm

discontinued the production of

Cephalosporin and the firm do not

have approval of Cephalosporin

section vide letter no. F.2-3/92-Lic

(Vol-II) Dated 28th April, 2016 of

Licensing Division.

18. 024883 Novafol Suspension

Each 5ml Contains:-


-do-

19. 024880 Novafol Injection IM/IV


Cephradine…..1gm

-do-


IM/IV


Cefoperazone….500mg

-do-




-do-

22. 016908 Tojina 6.0mg Tablet


Bromazepam…..6mg

Defer for following:i. Opinion

from Legal Affair Division regarding

those firms where at the time of

registration there is no requirement

for approval of Psychotropic section

but later on it is mandatory to do so,

in the light of decision of Central

Licensing Board in its 233rd meeting

i.e. as follows:After thorough

deliberations and keeping in view the

directions of Policy Board,

recommendations of DRAP

Authority, recommendations of

Committee for Allocation of

Controlled Substances / Drugs (Inter-

Ministerial Committee), views of

honorable members, previous

decisions of Central Licensing Board

on the said issue, and ensuring

adequate availability of narcotic

drugs and psychotropic substances

for medical and scientific purposes

as highlighted by INCB, the Central

Licensing Board decided: - To

continue the previous policy /


of segregated facility for

manufacturing of Psychotropic /

Narcotic Drugs. To process all

pending layout plans / applications

accordingly in the light of above

decision. To carryout fresh panel

inspections of sections / areas of

Psychotropic / Narcotic Drugs

considered and deferred in 227th

meeting of CLB. ii. Clarification

from the firm regarding transfer of

registration in name of M/s AGP Pvt

Limited from the firm.



Bromazepam…..3mg

-do-

M/s Amson Vaccines & Pharma, 154, Industrial Triangle, Kahuta Road, Islamabad

24. 029052 Cepham 125mg

Suspension

Each 5ml Contains:-

Cephalexin Monohydrate eq. to

Cephalexin…125mg


the case for clairfaction regarding the

approval of manufacturing facility

from licensing division.

25. 029053 Cepham 250mg

Suspension

Each 5ml Contains:-


Cephalexin…250mg

-do-

26. 029054 Cepham 250mg

Capsule



Cephalexin…250mg

-do-

27. 029055 Cepham 500mg

Capsule


-do-


Cephalexin…500mg

28. 029056 Curoxime 250mg

Injection

Each Vial Contains:-

Cefuroxime Sodium eq. to

Cefuroxime…250mg

-do-

29. 029057 Curoxime 750mg

Injection



Cefuroxime…750mg

-do-

30. 029058 Curoxime 1.5g Injection



Cefuroxime…1.5g

-do-

31. 052403 Cesod 2gm

IV Injection


Ceftriaxone (as Sodium)…2gm

-do-

32. 052404 Cesod 2gm

IM Injection


Ceftriaxone (as Sodium)…2gm

-do-

M/s. Bio Fine Pharmaceuticals, 74-Industrial Estate, Multan-Pakistan

33. 30411 Tricaine Suspension

Each 5ml contains:

Dried Aluminum Hydroxide

Gel..291mg

Magnesium Hydroxide

…..…98mg

Oxethazine…10mg

Defer for the issuance of final

reminder for rectifcation of

shortcomings communicated vide

letter No. 1-65/2018 dated 15-1-

2019.

34. 30412 S-Pram Tablet


Citalopram Hydrobromide eq. to

Citalopram…20mg

-do-

M/s Ferroza International Pharmaceuticals, 33-Km, Ferozpur Road, Lahore.

35. 049826 Welfam Tablet 40mg


Famotidine…40mg

Defer of the status of GMP from

QA&LT Divison.

36. 049830 Montefer 5mg Tablet

Each Film Coated Tablet

Contains:-

Montelukast (as Sodium)…5mg

-do-

37. 049831 Montefer 10mg Tablet


Contains:-

-do-


38. 049832 Cipromax 250mg Tablet


Ciprofloxacin HCl ….…250mg

-do-

39. 049833 Cipromax 500mg Tablet


Ciprofloxacin HCl ….…500mg

-do-

40. 049834 Sparmax 100mg Tablet


Contains:-

Sparfloxacin…100mg

-do-

41. 049835 Sparmax 200mg Tablet


Contains:-


-do-

42. 049836 Maxzole 20mg

Capsule


Esomeprazole as Enteric Coated

Pellets…20mg

-do-

43. 049837 Ferolax Tablet 10mg


Escitalopram…10mg

-do-

44. 049839 D-K Tablet 75mg


Diclofenac Potassium…75mg

-do-

M/s. Delux Chemical Industries, LT, 26 A-1, Landhi Industrial Area, Karachi

45. 030342 Lactolac Syrup

Each 100ml Contains:

Lactulose…67gm

Source:M/s Biofac Denmark

Deferred for following:i. GMP and

status of renewal of Licence from

QA&LT and Licensing Division

respecetively.ii. Submission of

10000/- differential fee by the firm.

46. 030343 Rosaced Tablet

Each tablet contains:

Metronidazole Benzoate

321.6mg

eq. to Metronidazole …200mg

Deferred for GMP and status of

renewal of Licence from QA&LT

and Licensing Division

respecetively.

47. 030344 Rosaced Suspension

Each 5ml contains:


321.6mg


-do-

48. 030345 Rosaced-Forte Suspension

Each 5ml contains:


321.6mg


Di-Iodohydroquinolone

……200mg

-do-

49. 030995 Deemac Forte Tablet -do-



50. 030996 Deenopan Tablet


Hyoscine N-

Butylbromide…10mg

-do-

51. 030997 Deloquin Syrup

Each 5ml contains:

Chloroquine Phosphate 81mg

eq. to Chloroquine Base …50mg

-do-

M/s Hassan Pharmaceuticals, 99-A, Industrial Estate Hayatabad, Peshawar

52. 030606 Betacef Dry Suspension

Each 5ml Contains:-

Cefixime…100mg


the last renewal as there is no

statistical endorsement and R&I

receiving on evidence of renewal of

2013 provided by the firm.

53. 030607 Betacef Capsule 400mg


Cefixime…400mg

-do-

54. 030608 Hifenac Capsule 50mg


Diclofenac Sodium…50mg

Deferred for following:i.

Deferred for clarification

regarding the last renewal as there is

no statistical endorsement and R&I

receiving on evidence of renewal of

2013 provided by the firm.ii.

Source of pellets is not

provided by the firm

M/s IPP Pharma Products Manufacturer,

55. 021388 Coral-T Tablet


Nifedipine…30mg

Deferred for issuance of final

reminder for rectification of


letter No. No. 1-65/2018 dated 31-1-

2019.

M/s. Leads Pharma, Plot # 81-A, Street # 6, I-10/3, Islamabad

56. 035884 Leceph 125mg

Suspension

Each 5ml contains:-

Cephradine…125mg

Deferred for clarification from the

firm as the Formulation is not

approved by RRA

57. 036303 Temerol 20mg

Capsule


Omeprazole…20mg

Deferred for confirmation of source

of pellets and in case of imported

pellets the requisite fee thereof.

M/s Metro Pharmaceutical, Plot 14, Street No. SS-2, National Industrial Zone, RCCI, Rawat,

Islamabad

58. 075247 Wencin-250 Capsule

Each capsule contains:

Ciprofloxacin as Hcl … 250mg



approved in reference agencies

59. 75248 Wencin-500 Capsule






60. 075249 Myso-20 Capsule


Isotretinoin …. 20mg




61. 75263 Melcin-125 Dry Suspension

Each 5ml Contains:

Levofloxacin as

Hemihydrate…125mg




62. 75264 Melcin-250 Dry Suspension

Each 5ml Contains:

Levofloxacin as

Hemihydrate…250mg




63. 75265 Wencin-125 Dry Suspension

Each 5ml Contains:





64. 75266 Wencin-250 Dry Suspension

Each 5ml Contains:





65. 75274 Mepzol 20mg

Sachet

Each sachet contains:

Omeprazole…20mg




M/s Nawabsons Laboratories, Jia Bagga Off Raiwind Road, Lahore

66. 030320 Hemasol Syrup

Each 5ml Contains:-

Ferrous Sulphate…100mg

Ascorbic Acid…5mg


following:i. Reference

formulation of BPC is provided

which is 30g/1000ml i.e.

150mg/5ml.ii. Section approval

letter.

M/s Nexus Pharma Pvt Limited, Plot No. 4/19 Sector 21, Korangi Industrial Area Karachi

67. 039557 Nettle Capsules 250mg


Cefaclor…..250mg


following from concerned

section:The product was initially

registered in name of M/s Pride

Pharmaceuticals Plot No. 4/19 Sector

21, Korangi Industrial Area Karachi.

The title/ name of the firm was

changed from aforesaid name to M/s

Nexus Pharma Pvt Limited, Plot No.

4/19 Sector 21, Korangi Industrial

Area Karachi vide approval dated

22-10-2008 by Licensing Division.

However the product was not

transferred on the new title. It further

to mention that Brand Name of this

product was changed from Noor

Capsule 250mg

to Nettle Capsules 250mg

vide approval dated 8-11-2008 by

Registration Division in name of M/s

Nexus Pvt Limited.

68. 039558 Nettle capsules 500mg


Cefaclor……500mg



section:The product initially














Capsule 500mg

to Nettle Capsules 500mg



Nexus Pvt Limited.

69. 039561 Nitaxim 250mg

Injection


Cefotaxime (as

Sodium)….250mg
















product was changed from Noortax

Injection to Nitaxim Injection vide

approval dated 8-11-2008 by


Nexus Pvt Limited.

70. 039529 Flur Tablet 100mg


Flurbiprofen …..100mg
















product was changed from Purnoor

Tablets to Flur Tablet vide approval

dated 8-11-2008 by Registration

Division in name of M/s Nexus Pvt

Limited.

71. 039555 Nettle Suspension 125mg/5ml

Each 5ml contains:-

Cefaclor…….125mg

















Suspension 500mg

to Nettle Suspension 500mg



Nexus Pvt Limited.

72. 075973 Skelebenz 30mg

Capsules

Each extended release capsules

contains:-

Cyclobenzaprine HCl as

extended release pellets

equivalent to Cyclobenzaprine

HCl….30mg

(Manufacturer’s

Specification)Source:M/s RA

Chem Pharma Limited, Plot No.

A-19/C Road No. 18 , IDA ,

Nacharam Hyderabad-500 076.

A.P. Hyderabad.


reminder for submission of

differential fee

73. 075975 Rapitus Syrup

Each ml contains:-

Levodropropizine..6mg

(Manufacturer’s Specification)

Deferred for submission of approval

of formulation in reference drug

agencies.

74. 075974 Skelebenz 15mg Deferred for issuance of final

Capsule

Each extended release capsules

contains:-

Cyclobenzaprine HCl as

extended release pellets

equivalent to Cyclobenzaprine

HCl….30mg

(Manufacturer’s

Specification)Source:M/s RA

Chem Pharma Limited, Plot No.

A-19/C Road No. 18 , IDA ,

Nacharam Hyderabad-500 076.

A.P. Hyderabad.


differential fee

75. 039563 Nitaxim Injection 1gm

Each powder vial contains:-

Cefotaxime (as Sodium)….1gm


following:The product initially

















Nexus Pvt Limited.

76. 039562 Nitaxim Injection 500mg


Cefotaxime (as

Sodium)……500mg




















Nexus Pvt Limited.

77. 039633 Coozip Capsules 20mg


Omeprazole…..20mg
















product was changed from Shah-OM

Capsules to Coozip Capsules vide



Nexus Pvt Limited.Submission of

differential fee and source of pellets

M/s Noa Hemis Pharmaceuticals, Plot No. 154 Sector 23 Korangi Industrial Area Karachi

78. 050479 Isogyl Capsule

Each Capsule Contains:

Isotretinoin…20mg

Deferred for clarification from firm

as the Formulation is not approved in

reference agencies

79. 050492 Klarida 125mg

Suspension

Each 5ml Contains:

Clarithromycin…125mg


of granules from the firm.

M/s. Panacea Pharmaceuticals, Plot # 4, Street # S-6, National Industrial Zone, Rawat,

Islamabad.

80. 050163 Tasium 50mg

Capsule


Diclofenac Potassium (as Enteric

Coated Pellets)…50mg

Deferred for the issuance of reminder

for rectification of shortcomings by

the firm communicated vide letter

No. 1-65/2018 (RRR) dated 15-1-

2019

81. 050162 Fenum 50mg

Capsule


Diclofenac Sodium (as Enteric

Coated Pellets)…50mg

-do-

M/s Paradise Pharma, 23-KM Sheikhupura Road, Lahore

82. 076913 Pytacon Oral Suspension

Each 5ml Contains:

Vitamin B12

(Cyanocobalamin)…35mcg

Deferred for the GMP status from

QA&LT Division.

83. 076914 Parasolve Oral Suspension


-do-

Sodium Chloride…1.3gm

Trisodium Citrate

Dihydrate…1.45gm

Potassium Chloride…0.75gm

Glucose Anhydrous…6.75gm

84. 076912 Parasmith Oral Suspension

Each 5ml Contains:

Simethicone…25mg

Aluminum Hydroxide…215mg

Magnesium Hydroxide…80mg

-do-

M/s P.D.H. Laboratories (Pvt) Ltd. 9.5-Km, Sheikhupura Road, (Khaki) Lahore

85. 030609 Lignocaine 1%

InjectionContains:-

Lignocaine HCl…1%


Ampoule section from the firm.

M/s. Qintar Pharmaceuticals, 14-A P.S.I.E, Lahore Road, Sargodha.

86. 049232 B-Fit Tablet


Fluoxetine as HCl…20mg

Deferred for GMP and status of

Licence renewal from QA&LT and

Licensing Division respectively.

87. 049231 Kepinol Forte Tablet


Sulphamethoxazole

………800mg

Trimethoprim…160mg

-do-

M/s. Synchro Pharmaceuticals, 77-Industrial Estate, Kot Lakhpat, Lahore

88. 076945 Solanz Capsule 30mg


Lansoprazole…30mg

Deferred for approval of source of

pellets as the firm has submitted a

copy of request for change of their

approved i.e. M/s Spansule India to

new source i.e. M/s Vision

Pharmaceuticals Islamabad.

89. 076946 Proset Capsule 0.4mg


Tamsulosin HCl…0.4mg

Deferred for approval of source of

pellets as the firm has submitted a

copy of request for change of their

approved i.e. M/s Spansule India to

new source i.e. M/s Vision

Pharmaceuticals Islamabad.

M/s Searle, F-319, S.I.T.E. Karachi.

90. 004071 Tranxene 5mg

CapsuleContains:-

Dipotassium Clorazepate…5mg

Deferred for the issuance of final


shortcomings by the firm.

91. 004072 Tranxene 10mg

CapsuleContains:-

Dipotassium Clorazepate…10mg

-do-

M/s Spencer & Company (Pvt) Ltd. D-105, S.I.T.E., Karachi.

92. 004184 Minolad Syrup

Each 4ml Contains:-

Vitamin A…2800IU

Vitamin D2…400IUL-Lysine

Monohydrochloride ……….25mg

Iron Choline Citrate …40mg

Deferred for the issuance of final


shortcomings by the firm.

Calcium Glycerophosphate

….…20mg

Sodium Glycerophosphate…4mg

Manganese Sulphate…0.2mg

Copper Sulphate…0.2mg

Choline Chloride…1mg

Methionine…4mg

M/s Standpharm Pakistan, 20-Km, Ferozepur Road, Lahore

93. 049939 Deact Injection 1gm


Cefoperazone as

Sodium…500mg

Sulbactum as Sodium…500mg

Deferred for confirmation of section

from licensing division

94. 049940 Deact Injection 2gm


Cefoperazone as Sodium…1gm

Sulbactum as Sodium …1gm

-do-

95. 049941 Buten Tablet 200mg

Each sugar coated tablet

contains:-

Sulbutiamine…200mg



approved by RRA

96. 049957 Cefidox Tablet 100mg

Each film coated tablet contains:-

Cefpodoxime as

Proxetil…100mg



97. 049959 Tromit Injection 10mg/ml


Ketorolac Tromethamine…10mg



approved by RRA

98. 049960 Cefidox Dry Powder Suspension

Each 5ml contains:-

Cefpodoxime as Proxetil…40mg



99. 050266 Spical Sugar Free Sachet


Calcium Lactate

Gluconate…1000mg

Vitamin C…500mg

Calcium Carbonate…327mg



M/s. Wise Pharmaceuticals, Plot No. 3-A, Street No. S-1, RCCI Industrial Estate, Rawat,

Rawalpindi

100. 075448 Sita-Wis 50/500mg Tablet

Each film coated tablet contains:

Sitagliptin (as

Phosphate)…50mg

Metformin HCl …500mg

Defer for the GMP and status of

License renewal from QALT &

Licensing Division.

101. 075449 Sita-Wis 50/1000mg Tablet


Sitagliptin (as

Phosphate)…50mg

Metformin HCl …1000mg

-do-

M/s Xenon Pharmaceuticals, 9.5-Km, Sheikhupura Road, Lahore.

102. 022358 Steron Syrup

Each 5ml Contains:-

Prednisolone…15mg

Defer for clarification from

concerned section:Product was

initially registered in name of Dawn

Laboratories Lahore and Firm didn’t

provide the evidence of transfer in

name of Xenon Pharmaceuticals

Lahore

103. 014727 Zemvit Tablet


Vitamin-A…4,000IUVitamin-

D…400IUVitamin-

E…30IUVitamin-C…100mg

Folic Acid…0.8mg

Vitamin B-1…1.5mg

Vitamin B-2…1.6mg

Vitamin B-6…2.5mg

Vitamin B-

12…4.0mcgNiacinom…18.0mg

Calcium Carbonate…600.0mg

Ferrous Fumerate…60.0mg

Zink Sulphate …25.0mg

Defer for clarification from

concerned section:Product was

initially registered in name of Dawn

Laboratories Lahore, Firm didn’t

provide the evidence of transfer in

name of Xenon Pharmaceuticals

Lahore

M/s Global Pharmaceuticals, Rawat Islamabad

104. 049233 Toxirid 500mg

Injection IV


Cefoperazone as

Sodium…250mg

Sulbactam as Sodium…250mg

Defer for clalrifcation regarding

approval of formulation in reference

agencies.

M/s Sanofi-Aventis Pakistan, Plot No. 22, Korangi Industrial Area, Karachi.

105. 050372 Amaryl M SR 1mg Tablet

Each Bi-Layered Tablet

Contains:-

Glimepiride…1mg

Metformin (as HCl)…500mg

Defer for the status of show cause

issued by concerned section.

106. 050373 Amaryl M SR 2mg Tablet

Each Bi-Layered Tablet

Contains:-

Glimepiride…2mg


Deferred for the status of show cause


M/s. Welwrd Pharmaceuticals, Plot No. 3, Block A, Phase I-II, Industrial Estate Hattar-Pakistan

107. 049099 Welcetain Injection

Each 2ml Ampoule Contains:-

Paracetamol…300mg

Lidocaine. HCl…20mg


the approval of formulation in

reference agencies.

M/s Unexolabs, .5-Km, Sheikhupura Road, Lahore.

108. 022035 Dipotil Tablet


Diphenoxylate HCl…2.5mg

Atropine Sulphate…0.025mg

Deferred for GMP status from

QA&LT Division as the submitted

GMP report is of 2016.

109. 014271 Methacid Capsule 25mg


Indomethacin…25mg

-do-

110. 009910 Semidine 400mg Tablet


Cimetidine…400mg

-do-

111. 009911 Empicil Capsule 250mg


Ampicillin as

Trihydrate…250mg

-do-

M/s. Medipharm (Pvt) Ltd., 108 Kot Lakhpat Industrial Estate, Lahore

112. 009866 Ultravist-300

Solution for Injection or Infusion

or Solution for Oral Use 623.4mg

Iopromide (corresponding to

300mg

bound iodine) per 1ml solution

Deferred for submission of following

clarifications/ documents :i. The

address of manufacturer as per copy

of CoPP dated 27-12-2017 provided

by the firm varies from the address as

per registration letter, details are as

under:Bulk Manufacturer

Packaging & Final Release:M/s

Bayer AG Mullerstrasse 178, 13353

Berlin Germanyii. Original

legalized CoPP is required as firm

has submitted copy.(Bulk import

local repackaging)

113. 009865 Solution for Injection or Infusion

or Solution for Oral Use 768.86

mg

Iopromide (corresponding to 370

mg

bound iodine) per 1ml solution

-do-

M/s A. Feroz & Co., Medicine Street 1, Marriot Road, Karachi.

114. 014013 Ethyl Chloride (Anesthetic)

Liquid Spray

Each Tin of Aerosol Contains:-

Ethyl Chloride…100ml

Defer for issuance of final reminder

for rectification of shortcomings

communicated vide letter No. 1-

65/2018 dated 8-1-2019

M/s Martin Dow Pharmaceuticals, Plot No. 37, Sector 19, Korangi Industrial Area, Karachi.

115. 021126 Bonalfa Ointment

Each gm contains:-

Tacalcital…2mcg

Defer for clarification of following

by the firm:The manufacturing site

mentioned in CoPP is M/s Teijin

Pharma Limited, Iwakuni

Pharmaceutical Factory 2-1,

Kasumigaseki 3-chome, Chiyoda-ku,

Tokyo, which is different from the

site mentioned on the letter. The firm

is importing the drug from the

aforesaid new site which also evident

from the invoice submitted by the

firm.

M/s Allied Distributors, 1st Floor 103-K Block-2, P.E.C.H.S. Shahra-e-Qauideen, Karachi.

116. 021190 Broadsaf 250mg Deferred for issuance of final

IM/IV Injection



Ceftriaxone Sodium Base

….…250mg


shortcomings coomunicated vide

letter No. 1-65/2018 (RRR) dated 1-

1-2019.

117. 021191 Broadsaf 500mg

IM/IV Injection



Ceftriaxone Sodium Base

….…500mg

-do-

118. 021192 Broadsaf 1g IM/IV Injection



Ceftriaxone Sodium Base…1g

-do-

M/s. A.J. Mirza Pharma, 1st Floor, Shafi Court, Merewether Road, Civil Lines, Karachi

119. 047678 Oxaliplatin for Injection 50mg


Oxaliplatin Ph. Eur…..50mg




letter No. 1-65/2018 (RRR) dt: 11-1-

2019.

120. 047680 Oncobine 10mg/ml Injection

Each ml contains:-

Vinorelbine Tartrate USP

equivalent to Vinorelbine..10mg

-do-

121. 052260 Decarb-200 Injection


Dacarbazine USP….200mg

-do-

122. 047679 Oxaliplatin for Injection 100mg


Oxaliplatin Ph. Eur.100mg

-do-

123. 047681 Oncobine 50mg/5ml Injection

Each ml contains:-

Vinorelbine Tartrate USP

equivalent to Vinorelbine..10mg

-do-

M/s Ghani Brothers, 2nd floor Karimje Building, Opp. Habib Bank Ltd. North Napier Road,

Karachi

124. 072577 Dreico 4mg

Injection


Zoledronic Acid…4mg

Defer for issuance of final reminder

for rectification of shortcomings

communicated vide letter No. 1-

65/2018 (RRR) dated 11-1-2019.

125. 072578 Solvent for Dreico 4mg

Injection

-do-

126. 072570 Epirrubicina Dosa 10 Injection


(Lyophilized):

Epirubicin HCl…10mg

-do-

127. 072571 Epirrubicina Dosa 50 Injection


(Lyophilized):

-do-

Epirubicin HCl…50mg

128. 072572 Carboplatino Dosa 150 Injection

Each Vial Contains:

Carboplatin…150mg

-do-

129. 072573 Nagun 10 Injection

Each 5ml Vial contains:

Doxorubicin HCl…10mg

-do-

130. 072574 Nagun 50 Injection

Each 25ml Vial Contains:

Doxorubicin HCl…50mg

-do-

131. 072575 Water for Injection for

Epirrubicina 10 Dosa 5ml

-do-

132. 072576 Water for Injection for

Epirrubicina 50 Dosa 25ml

-do-

M/s Global Pharmaceuticals, Plot No. 204-205, Industrial Triangle, Kahuta Road, Islamabad

133. 047665 Refron 3MIU Injection


Recombinant Human Interferon

Alpha 2b…3MIU

Referred to Biological Evaluation &

Research division for processing at

their end

M/s Elko Organization, Plot No. 27 & 28, Sector 12/B, North Karachi, Industrial Area, Karachi.

134. 028600 LEOX Bolus

Each Bolus Contains:-

Levamisole HCl…1.125gm

Oxyclozanide…2.250gm

Deferred for submission of evidence

of renewal of 2013 by the firm.

M/s. Attabak Pharmaceutical Industries, 5-C I-10/3, Industrial Area, Islamabad

135. 075682 Oxyno Plus Water Soluble

Powder

Each 1000g Contains:

Oxytetracycline HCl…200g

Neomycin Sulphate…200g

Colistin Sulphate…240MIU

Deferred for status of decision of

Appellate Board.

136. 075683 E.N.C Man Water Soluble

Powder

Each 100gm contains:

Enrofloxacin HCl…10g

Colistin Sulphate…3.5g

Amantadine HCl…4g


Appellate Board and status of show

cause from concerned section for

Amantadine containing formulations.

137. 075684 Enromin Oral Liquid


Enrofloxacin…10gm

Colistin Sulphate…3.5g

Amantadine HCl…4g





138. 075685 Respi Bro Oral Liquid

Each ml contains:


Tylosin Tartrate…100mg

Colistin Sulphate…500,000IU

Bromhexine HCl…5mg


Appellate Board.

139. 705686 Coflox Oral Liquid



Appellate Board.

Enrofloxacin…10gm


140. 075687 CRD Kill Injection

Each ml contains:


Colistin Sulphate…10mg

Dihydrostreptomycin..100mg


Appellate Board.

141. 075688 Sulpha Super Injection

Each ml contains:

Sulfadimidine Sodium…33.30%


Appellate Board.

142. 075689 E-Cam Water Soluble Powder


:


Colistin Sulphate…4g

Amantadine HCl…4.5g





143. 075690 Pulmotin Water Soluble Powder


Doxycycline HCl…200g

Tylosin Tartrate…100g


Bromhexine HCl…5g


Appellate Board and Brand name

change approval by the firm

144. 075691 Col-En 70 Liquid





Appellate Board.

145. 075692 Dialysis Water Soluble Powder


Furosemide…20g

Calcium Carbonate…40g

Sodium Chloride…35g

Magnesium Sulphate…35g


Appellate Board.

146. 075693 Coli Liquid


Enrofloxacin…10gm

Colistin Sulphate…3g

Amantadine HCl…4g





147. 075694 Neomycin 70% Powder




Appellate Board.

148. 075695 Streptobak Water Soluble

Powder




Dihydrostreptomycin…20g

Bromhexine HCl…5g


Appellate Board and Brand name

change approval by the firm

149. 075696 Mandox-T Powder







Amantadine HCl…35g


150. 075697 Amantabak 10% Powder




Appellate Board.

151. 075698 Tylobrom-S Powder




Dihydrostreptomycin…40g

Bromhexine HCl…5g


Appellate Board.

152. 075699 Genta-5 Super Injection


Gentamycin Sulphate…5g


Appellate Board.

153. 075700 Genta-10 Super Injection


Gentamycin Sulphate…10g


Appellate Board.

154. 075701 Lincopect Injection

Each ml contains:

Lincomycin as HCl…50mg

Spectinomycin…100mg


Appellate Board.

155. 075702 Cloricox Water Soluble Powder

Each gm contains:

Sulphachlorpyridazine …33.33%

Vitamin K3…3mg


Appellate Board.

156. 075703 Linco Premix 1100 Powder

Each 100gm

Powder Contains:

Lincomycin HCI …. 1100mg


Appellate Board.

157. 075704 Tyco-G Oral Liquid




Guaifenesin…20g

Aminophylline…8g


Appellate Board.

158. 075705 Brom-Mat Oral Liquid

Each ml contains:

Bromhexine HCl…50mg


Appellate Board.

159. 075706 Tilmicobak Oral Liquid


Tilmicosin Phosphate…25g


Appellate Board.

160. 075707 Florfenicol Oral Liquid

Each ml contains:

Florefenicol…250mg


Appellate Board.

161. 075708 Enromat Oral Liquid


Enrofloxacin…10g


Appellate Board.

162. 075709 Gentymat Liquid Injection

Each ml contains:



Appellate Board.

Gentamicin Sulphate…50mg

163. 075710 Meloxi DS Injection

Each ml contains:

Meloxicam…20mg


Appellate Board.

164. 075711 Lincomat Injection

Each ml contains:

Lincomycin as HCl…50mg



Appellate Board.

165. 075712 Neo-Mix Powder


Oxytetracycline HCl…200gm


Erythromycin

Thiocyanate…100g


Appellate Board.

166. 075713 ESP-BAK Powder

Each gm contains:

Sulphachlorpyridazine…33.33%


Appellate Board.

167. 075714 Clozine-60 Water Soluble

Powder

Each gm contains:

Sulphaclozine Sodium…60%


Appellate Board.

168. 075715 Tylobid Powder




Bromhexine HCl…10g


Appellate Board.

169. 075716 Eryhtro-25 Powder



Erythromycin

Thiocyanate…150gm


Appellate Board.

170. 075717 Oxcinobak Powder





Appellate Board.

171. 075718 TB-Dox Powder




Bromhexine HCl…10g


Appellate Board.

172. 075719 Diaprim Powder


:

Sulfadiazine Sodium…40g

Trimethoprim…8g


Appellate Board.

173. 075720 Neostrep Powder

Each gm contains:

Neomycin Sulphate…60mg

Oxytetracycline HCl…200g

Streptomycin Sulphate…20mg


Appellate Board.

174. 075721 Frusa Min Water Soluble Powder


Furosemide…20g



Manganese Sulphate…1g



Appellate Board.

175. 075722 Uritox Powder


:

Methenamine…85g

Vitamin B1…700mg

Vitamin C…100mg

Sorbitol…5g


Appellate Board.

176. 075723 Broncoman Powder









177. 075724 Bella Flush Water Soluble

Powder


:

Furosemide…2g

Belladona Extract…0.2g


Appellate Board.

178. 075725 Hexamine Water Soluble Powder


:

Methenamine…85mg

Vitamin B1…800mg

Vitamin…B2…920mg

Vitamin…K3…200mg


Appellate Board.

179. 075726 Frusa Super Water Soluble

Powder


Furosemide…25g



Manganese Sulphate…1g

Potassium Chloride…4g



Appellate Board.

180. 075727 Flush-C Powder


Furosemide…20g


Potassium Chloride…4g


Vitamin C…5g


Appellate Board.

181. 075728 Levanol Oral Liquid

Each Liter Contains:


Appellate Board.

Bithionol Sulfoxide…100gm

Levamisole HCl…15gm

182. 075729 Samcoc Oral Liquid


Sulfaquinoxaline…20gm

Amprolium…30gm


Appellate Board.

183. 048214 Norak-20 Liquid


Norfloxacin HCl…..20gm





M/s. Delux Chemical Industries, LT, 26 A-1, Landhi Industrial Area, Karachi

184. 029671 Flum equel 20 Oral Liquid


Flemequine…20gm

Deferred for status of renewal of

License and GMP from Licensing &

QALT Division.

185. 029672 Reomicinia Compound Oral

Powder


Tylosin…25gm

Colistin…300MIU

Furaltadone…75gm

-do-

186. 075611 Mantobrom Oral Liquid


Bromhexine HCl…2% W/V

Menthol…4%

-do-

M/s. Martin Dow Marker Ltd., 7, Jail Road, Quetta ,Pakistan

187. 075906 Cosome DA Cough Syrup

Each 5ml contains:-

Acefylline Piperazine….45mg

Diphenhydramine

Hydrochloride….8mg


transfer of product from M/s. Merck

Pvt. Ltd to M/s Martin Dow Marker

Pvt Limited Quetta *(Deferred in

286th meeting)

188. 026369 Omelcid Capsule


Omeprazole.… 20mg

Deferred for the following:i.

clarification regarding transfer of

product from M/s. Merck Pvt. Ltd to

M/s Martin Dow Marker Pvt Limited

Quettaii. Source fixation approval le

189. 010193 Neurofenac Capsules 50mg


Diclofenac Sodium USP …

50mg

Source of pellets:M/s Inventia

Healthcare Pvt Limited,

Maharashtra State, India.

Deferred for submission of renewal

fee. *(Deferred in 286th Meeting)

190. 007567 Refobacin Eye Drops

Each ml contains:-

Gentamicin sulfate….5 mg

Deferred for the following:i.

Clarification from the Firm

regarding the facility for

manufacturing of eye drops. ii.

Clarification regarding transfer of

product from M/s. Merck Pvt. Ltd to

M/s Martin Dow Marker Pvt Limited

Quetta.iii. Clarification regarding the

production of batch in 2017

191. 001492 Polybion Forte C Tablets


contains:-


Mononitrate) …..15 mg

Vitamin B2 (Riboflavin)….15

mg

Nicotinamide …. 50 mg,

Vitamin B6 (Pyridoxine

Hydrochloride)… 10 mg

Calcium D-

Pantothenate………25 mg

Vitamin B12

(Cyanocobalamin)..10 mcg

Vitamin C (Ascorbic Acid) …….

300 mg

Clarification from the firm regarding

the difference in composition of

product in Form 5B and registration

letter.

192. 027952 Mercepam Tablets 1.5 mg


Bromazepam ……1.5 mg

Deferred for clarification from

Licensing Division.

193. 000719 Polybion Strong Tablets

Each Film coated Tablet

contains:-


Hydrochloride)…..15 mg,

Vitamin B2 (Riboflavin)….4 mg

Vitamin B6 (Pyridoxine

Hydrochloride)…… 10 mg

Vitamin B12

(Cyanocobalamin)…10

mcgNicotinamide…..50

mg,Calcium D-

Pentothenate….6mg


firm regarding the difference in

composition of product in Form 5B

and registration letter.

194. 033794 Osteocur-C-Effervescent

Granules

Each sachet of Effervescent

Granules contains:-

Calcium Lactate

Gluconate…….1000 mg,Calcium

Carbonate..327mg

Ascorbic Acid....... 500 mg

Deferred for the clarification from

the firm regarding the facility for

manufacturing of sachets.

195. 006474 Sistalgin Injection


Pramiverine Hydrochloride…..

2.25 mg


firm regarding the approval of


196. 032063 Ibusoft Capsules 200mg

Each soft gelatin capsule

contains:-

Ibuprofen Micronized

Powder…….200 mg

Deferred for the clarification

regarding the manufacturing

facility of soft gelatin capsule from

the firm.Product was initially on toll

manufacturing by M/s Catts Karachi,

after transfer of registration in 2008

the separate permission for extension

in toll is not provided.From the latest

batch manufacturing details dated 3-

10-2017 provided by the firm

indicates that firm is manufacturing

the product at its own

premises.However the Soft Gelatin

Capsule manufacturing facility is not

approved by Licensing Division and

the product is also not transferred in

name of M/s Martin Dow Marker

Limited Quetta.

197. 021394 Livicod Capsules

Each Soft Gelatin capsules

contains:-

Vitamin Rich Cod Oil…275 mg

Vitamin A………60,000 I.U.

Vitamin D……….6000 I.U.

Vitamin E……….3.0mg




the firm.Soft Gelatin Capsule

manufacturing facility is not


the product is not transferred in


Limited Quetta.



Diclofenac Sodium ….25 mg

Defer for the clarification regarding

justification of using Thiamine,

Pyridoxine and Cyanocobalamin in

formulation as mentioned in Batch

Manufacturing Record.

199. 032064 Ibusoft Capsules 400mg

Each soft gelatin capsule

contains:-

Ibuprofen... 400 mg

Defer for the clarification



the firm.Product was initially on toll

manufacturing by M/s Catts Karachi,

after transfer of registration in 2008

the separate permission for extension

in toll is not provided.From the latest

batch manufacturing details dated 3-

10-2017 provided by the firm

indicates that firm is manufacturing

the product at its own

premises.However the Soft Gelatin

Capsule manufacturing facility is not


the product is also not transferred in


Limited Quetta.



Diclofenac Sodium.100 mg


regarding source of pellets from the

firm.

201. 016100 Laxoberon Tablet



regarding transfer of registration in

Sodium Picosulfate … 5mg the name of M/s Martin Dow Marker

Pvt Limited Quetta from M/s. Merck

Pvt. Ltd.from the firm.

202. 019799 Laxoberon LiquidSodium

Picosulfate … 5mg


regarding transfer of registration in

the name of M/s Martin Dow Marker

Pvt Limited Quetta from M/s. Merck

Pvt. Ltd. From the firm.

203. 024605 Klaribact Dry Suspension

Each 5ml Contains:-

Clarithromycin…..125mg

Defer for the clarification from the

firm regarding Source of granules.

204. 017577 Azolam Tablet 0.5mg


Alprazolam … 0.5mg

Deferred for following:i.

Opinion from Legal Affair

Division regarding those firms where

at the time of registration there is no

requirement for approval of

Psychotropic section but later on it is

mandatory to do so, in the light of

decision of Central Licensing Board

in its 233rd meeting i.e. as

follows:After thorough deliberations

and keeping in view the directions of

Policy Board, recommendations of

DRAP Authority, recommendations

of Committee for Allocation of

Controlled Substances / Drugs

(Inter-Ministerial Committee), views

of honorable members, previous


on the said issue, and ensuring

adequate availability of narcotic

drugs and psychotropic substances

for medical and scientific purposes

as highlighted by INCB, the Central

Licensing Board decided: - To

continue the previous policy /


of segregated facility for

manufacturing of Psychotropic /

Narcotic Drugs. To process all

pending layout plans / applications

accordingly in the light of above

decision. To carryout fresh panel

inspections of sections / areas of

Psychotropic / Narcotic Drugs

considered and deferred in 227th

meeting of CLB. ii. Clarification

from the firm regarding transfer of

registration in name of M/s AGP Pvt

Limited from the firm.

205. 017576 Azolam Tablet 0.25 mg


Alprazolam … 0.25mg

-do-

206. 017578 Azolam Tablet 1mg


Alprazolam … 1mg

-do-

M/s Marvi Pharmaceuticals Pvt Limited Karachi

207. 012777 Pain Gay Ointment

Each gm contains:-

Methyl salicylate ……150mg

Menthol….100

Registration Board deferred the case

for the submission of copy of FIR

related to documents

stolen/misplaced/lost for onward

consideration of case.

M/s Stanely Pharmaceuticals (Pvt) Ltd.,84-B Industrial Estate,Hyatabad ,Peshawar

208. 029780 Senam Dry Suspension

Each 5ml contains:-

:Cefixime…….100mg


from Licensing Division.

209. 029781 Senam DS Dry Suspension

Each 5ml contains:-

:Cefixime …….200mg



M/s. Sanofi Aventis, Karachi.

210. 019564 Tritace 2.5mg Tablets


Ramipril…..2.5mg


above for clarification regarding the

status of bulk import from the firm.

211. 019565 Tritace 5mg Tablets


Ramipril…..5mg

-do-

212. 045390 Tritace 10 mg Tablets


Ramipril…..10mg

-do-

213. 019567 Amaryl 1 mg Tablets

Each tablets contains:-

Glimepride…..1mg

-do-



Glimepride…..2mg

-do-



Glimepride…..3mg

-do-



Glimepride…..4mg

-do-



No.


M/s. Radiant Pharma (Pvt) Ltd., 43-E Sundar Industrial Estate, Sundar Raiwind Road, Lahore

1. 076954 Radimether Tablets


Artemether….40mg,


Deferred for clarification as firm

responded that they are

manufacturing film coated tablets;

however the reference formulation is

uncoated.

M/s. Cirin Pharmaceuticals (Pvt) Ltd, 32/2A, Phase III, Industrial Estate, Hattar

2. 30784 Clavorin Injection

Each Vial Contains:

Clarithromycin (as

Lactobionate)…500mg


manufacturing facility by the firm.

M/s. Sami Pharmaceuticals (Pvt) Ltd., Plant F-95, Off. Hub River Road, S.I.T.E., Karachi

3. 9922 Pencit 500mg

inj

Each vial contains:

Sterile Ampicillin Sodium BP

equivalent to Anhydrous Ampicillin

250mg

Sterile Cloxacillin Sodium BP

equivalent to Anhydrous Cloxacillin

250mg


manufacturing facility by the firm

M/s. Universal Pharmaceuticals (Pvt) Ltd., 131-A, Industrial Estate, Hayatabad, Peshawar

4. 51005 U-Xib 200mg

Capsule


Celecoxib…200mg

Deferred for submission of renewal

fee as renewal application of 2013

was submitted after due date.

M/s. Usawa Pharmaceuticals, 146-Special Zone, (Export Processing Zone) Risalpur

5. 50826 Quinspar Tablet



Deferred for evidence of approval of

formulation in RRA by the firm.

M/s Standpharm Pakistan (Pvt) Ltd, 20-Km, Ferozepur Road, Lahore

6. 014292 Neuxam 1mg Tablet


Alprazolam…1mg


form Licensing Division.

M/s. Zafa Pharmaceutical Laboratories (Pvt) Ltd, L-4/1, A&B, Block-21, Federal “B” Industrial Area,

Karachi

7. 014459 Zampra Capsule


Omeprazole…20mg


of pellets from firm.

M/s Medera Pharmaceuticals (Pvt) Ltd, 249/A, Industrial Triangle, Kahuta Road, Islamabad

8. 024750 Amazole Capsule 20mg


Omeprazole Pellets 235mg

eq. to Omeprazole…20mg


of pellets

M/s. Univet Pharmaceuticals, 14-Km Adyala Road, Post Office Dahgal, Rawalpindi

9. 021423 Enflox Powder Deferred for status of License for

Each gm Contains:

Enrofloxacin…250mg

Licensing Division.

M/s. Pharmevo (Pvt) Ltd., A-29, North Western Industrial Zone, Port Qasim, Karachi

10. 047651 ONCOTAXEL 30 MG

INJECTIONS.

Each Vial Contains:

PACLITAXEL ….. 30MG. (ANTI-

CANCER).

Deferred for evaluation as per Import

Policy for Finished Drugs

11. 047652 OXALITIN 50 MG

INJECTIONS.

Each Vial Contains:

OXALIPLATIN … 50MG. (ANTI-

CANCER).



12. 047653 OXALITIN 100MG

INJECTION.

Each Vial Contains:

OXALIPLATIN …100MG. (ANTI-

CANCER).



M/s. Biocare Pharmaceutica, 807 Shadman-1, Lahore

13. 028469 Sulzone 2.0Gm

Injection.

Each Vial Contains:

Cefoperazone as sodium salt 1.0gm.

Sulbactam as sodium salt 1.0gm

Deferred for following:1. Deferred for

evaluation as per Import Policy for

Finished Drugs.2. Address of DSL

varies from address on registration

letter.3. Clarification required because

the clearance of the consignments was

obtained from DRAP Karachi on the

address M/s Biocare Pharmaceutica

705, Progressive Square , Block 6-

PECHS Karachi whereas the

registration holder is M/s. Biocare

Pharmaceutica, 807 Shadman-1,

Lahore4. Legalized FSC submitted by

the firm was expired on 30-3-2019,

however valid at time of submission.

14. 028468 Sulzone 1.0Gm

Injection

Each Vial Contains:

Cefoperazone as sodium salt 500mg.

Sulbactam as sodium salt 500mg

Deferred for following:1. Deferred for

evaluation as per Import Policy for

Finished Drugs.2. Address of DSL

varies from address on registration

letter.3. Clarification required because

the clearance of the consignments was

obtained from DRAP Karachi on the

address M/s Biocare Pharmaceutica

705, Progressive Square , Block 6-

PECHS Karachi whereas the

registration holder is M/s. Biocare

Pharmaceutica, 807 Shadman-1,

Lahore4. Legalized FSC submitted by

the firm was expired on 30-3-2019,

however valid at time of submission.

M/s. Getz Pharma (Pvt) Ltd, 29-30/27, Korangi Industrial Area, Karachi

15. 072591 Bekson Forte HFA Inhaler 250mcg

Each Metered Dose Contains:

Beclomethasone

Dipropionate…250mcg



16. 072590 Bekson HFA Inhaler 50mcg


Beclomethasone




17. 72592 Xaltide HFA Inhaler 100mcg/50mcg


Salbutamol (as Sulphate)…100mcg

Beclomethasone




M/s. Tagma Pharma (Pvt) Ltd, 12.5 Km Raiwind Road, Lahore

18. 049964 Reetag Tablet


Desloratadine…5mg

Registration deferred the above cases

for rectification of shortcomings as

mentioned against

Each and advised to issue a final

reminder.

19. 049965 Shic-5 Tablet

Each Film Coated Tablet Contains:

Levocetirizine…5mg

-do-

20. 049966 Safotil 250mg Tablet


Cefuroxime (Axetil)…250mg

-do-

21. 049967 Co-Losartin Tablet


Losartan Potassium…50mg

Hydrochlorothiazide…12.5mg

-do-

22. 049968 Lexicap Dry Suspension

Each 5ml Contains:

Cephalexin…125mg

-do-

23. 049969 Tagalox Dry Suspension

Each 5ml Contains:


-do-

24. 050934 T-Xium Capsule


Esomeprazole as Magnesium Enteric

Coated Pellets…40mg

Source: M/s Lee Pharma (P)

Limited, Flat No. 401-A, Saidatta

Apartments Srinivasa Nagar Colony

East Hyderabad India.

-do-

25. 051163 Tagalox Tablet



-do-

26.

022102

Tagasone Tablet


Dexamethasone…0.5mg

-do-

M/s. Farm Aid Group Pakistan, Plot 3/2, Phase 1/2, Industrial Estate, Hattar

27. 051034 Aidocin Tablets 200mg.

Each Tablet contains:

Ofloxacin……………………200mg.



mentioned against


reminder.

28. 051035 Aidocin Tablets 400mg.


Ofloxacin……………………400mg.

-do-

29. 051036 Zirow Tablets 250mg.


Azithromycin………….250mg.

-do-

30. 051038 Calfa Tablets 250mg.


Clarithromycin………..250mg.

-do-

31. 051039 Calfa Tablets 500mg.


Clarithromycin ………..500mg.

(USP Specs)

-do-

32. 051040 Esofarm 20mg Tablet


Esomeprazole (as magnesium

trihydrate) ….. 20mg

-do-

33. 051041 Esofarm 40mg Tablet


Esomeprazole (as magnesium

trihydrate) …… 40mg

-do-

34. 051042 Arlum Tablets.


Artemether…………….….20mg

Lumefantrine………………120mg.

-do-

35. 051043 Piproxcin Tablets 250mg.


Ciprofloxacin as HCl………250mg.

(B.P Specs)

-do-

36. 051044 Piproxcin Tablets 500mg.


Ciprofloxacin as

HCl…………500mg. (B.P Specs)

-do-

37. 29668 Emericid Powder


Diaveridin…50gm

Sulphaquinoxaline…200gm

Vitamin A…2.5MIU

Vitamin K3…5.0gm

Vitamin E…1.0gm

Sodium Citrate…50gm

-do-

Sodium Carbonate…250gm

38. 29669 Neomycin-72 Water Soluble Powder

Each Kg Contains:


-do-

39. 29670 Albenda Plus Suspension

Contains:

Albendazole…2.5%w/v

Cobalt Chloride…0.075%w/v

Sodium Selenite…0.035%w/v

-do-

40. 31434 Tylo-Cycline 450 Powder

Each gm Contains:



-do-

41. 31435 Farbendol 2.5 Suspension


Albendazole…2.5gm

Closantel…0.5gm

-do-

M/s. Pakistan Pharmaceutical Products (Pvt) Ltd, D-122, S.I.T.E., Karachi

42. 014278 Cepadin Injection 250mg

Each Vial Contains:

Cephradine Sterile…250mg



mentioned against


reminder.

43. 014279 Cepadin Injection 500mg

Each Vial Contains:

Cephradine Sterile…500mg

-do-

44. 014280 Cepadin Injection 1gm

Each Vial Contains:

Cephradine Sterile…1gm

-do-

45. 014281 Ulcedine Injection 200mg

Each 2ml Contains:

Cimetidine….200mg

-do-

46. 073667 Pemose 20mg

Capsule

-do-

47. 073668 Pemose 40mg

Capsule

-do-

48. 006792 Savimycin 100mg

Capsule

-do-

M/s. Ferroza International Pharmaceuticals (Pvt) Ltd, 33-Km Ferozepur Road, Lahore

49. 030260 Dosium Capsules 50mg


Diclofenac Potassium ..50mg



mentioned against


reminder.

50. 030258 Dross Capsule


Doxycycline (s Hyclate)..100mg

-do-

51. 030259 Riboprofen Tablets 100mg


-do-

Flurbiprofen …….100mg

52. 051199 Cefimax Dry Suspension

Each 5ml contains:

Cefixime…………….100mg

(USP Specs)

-do-

53. 051200 Azimax-250 Tablets


Azithromycin………….250mg

-do-

54. 49820 Maxvit Tablet 0.5mcg


Alfacalcidol…0.5mcg

-do-

55. 49821 Mecbin Tablet 500mcg


Mecobalamin…500mcg

-do-

56. 49822 Iromax Tablet


Iron Polymaltose Complex…100mg

Folic Acid…0.35mg

-do-

57. 49825 Glucolox Tablet


Glucosamine Sulfate…500mg

Chondroitin Sulfate

Sodium…400mg

-do-

58. 49827 Citofer 10mg Tablet


Citalopram…10mg

-do-

59. 49828 Citofer 20mg Tablet


Citalopram…20mg

-do-

60. 49838 O-Max Tablet 200mg


Ofloxacin…200mg

-do-

61. 49840 Gabocap 100mg

Capsule


Gabapentin…100mg

-do-

62. 49841 Gabocap 300mg

Capsule


Gabapentin…300mg

-do-

63. 49842 Gabocap 400mg

Capsule


Gabapentin…400mg

-do-

64. 49843 Malan Capsule 120/20mg


Artemether…20mg

Lumefantrine…120mg

-do-

65. 49844 Mecap Capsule 500mcg -do-



66. 49918 Cefimax Dry Suspension 200mg

Each 5ml Contains:

Cefixime…200mg

-do-

67. 49919 Cefimax 400mg

Capsule


Cefixime…400mg

-do-

68. 49823 Diclomax Tablet 75mg

Each Enteric Coated Tablet

Contains:


-do-

69. 49824 Ferother Tablet 120/20mg


Artemether…20mg


-do-

70. 30254 Melow 7.5mg Tablets


Meloxicam …… 7.5mg

-do-

71. 30255 Melow 15mg Tablets


Meloxicam …… 15mg

-do-

72. 30256 Lexical Capsules


Lansoprazole ……..30mg

-do-

M/s. Pharmedic Laboratories (Pvt) Ltd, 16-Km Multan Road, Lahore

73. 028663 Virazide-400 Tablet


Ribavirin…400mg



mentioned against


reminder.

74. 014294 Zynol-300 Tablet


Allopurinol…300mg

-do-

75. 50090 Malasunate Tablets (combo Pack)

100mg.

Each combo Pack:

1st Tablet contains:-

Artesunate…………………..100mg

& 2nd Tablet contains:-

Pyrimethamine……………25mg.

Sulfadoxine…………………500mg

-do-

M/s. MBL Pharma, Plot No. B-77/A, Hub Industrial Trading Estate, Baluchistan

76. 050384 MB Stine Tablet 10mg


Ebastine…10mg



mentioned against


reminder.

77. 050385 MB Cobal Tablet 500mcg -do-



78. 050386 MB Cobal Injection 500mcg

Each 1ml Contains:


-do-

79. 050387 Anbox Capsule 10mg


Piroxicam…10mg

-do-



Piroxicam…20mg

-do-

81. 050389 Anbox 0.5% Gel

Each gm Contains:

Piroxicam…5mg

-do-

82. 050390 Xaser Tablet 10mg


Cetirizine Dihydrochloride…10mg

-do-

83. 050391 Xaser 1mg/ml Syrup

Each ml Contains:


-do-

M/s. Alson Pharmaceutical, Plot No. 169, Road No. 7-B, Industrial Estate Hayatabad, Peshawar

84. 050830 Nefcol Tablet 200mg


Ofloxacin…200mg



mentioned against


reminder.

85. 050831 Salmonil Tablet 500mg


Levofloxacin…500mg

-do-

86. 050832 Salmonil Tablet 250mg



-do-

87. 050833 Neget Tablet 500mg


Ciprofloxacin as HCl…500mg

-do-

88. 050834 Neget Tablet 250mg



-do-

89. 050835 Dolaf Tablet



-do-

90. 050836 Ansol Tablet


Escitalopram as Oxalate…10mg

-do-

M/s Batala Pharmaceuticals, 23/B, Small Industrial Estate No. 2, Near Wapda Town, Khiali Bye-Pass,

Gujranwala.

91.

031128 Beflam Tablets 75mg


Diclofenac Potassium ….75mg



mentioned against


reminder.

M/s Synchro Pharmaceuticals, 77-Industrial Estate, KotLakhpat, Lahore

92. 050842 Trucef Injection 1500mg.

Each Vial Contains:

Cefuroxime…1500mg



mentioned against


reminder.

93. 050843 Ceftisyn Injection.

Each Vial Contains:

Ceftizoxime…500mg

-do-

94. 050844 Synolin Injection 250mg.

Each Vial Contains:

Cefazoline…250mg

-do-


Each Vial Contains:

Cefazoline…500mg

-do-


Each Vial Contains:

Cefazoline…1000mg

-do-

97. 050847 Taxocyn Injection 2000mg.

Each Vial Contains:

Ceftriaxone……………..2000mg.

(USP Specs)

-do-

98. 050848 Oxicef Capsules.


Cefadroxil as Monohydrate

USP……….....….500mg

(USP)

-do-

M/s. Wilson’s Pharmaceuticals, 387-388, I-9, Industrial Area, Islamabad

99. 030922 Herr-C 1000 Tablet (Effervescent)


Calcium Carbonate.........550mg

Calcium Lactate Gluconate..250mg

Vitamin C.................500mg

Folic Acid..................1mg

Vitamin B12..............250mcg



mentioned against


reminder.

100. 030923 Strength Sachets


Calcium

Glycerophosphate…...400mg

Vitamin C...............150mg

Thiamine..............5mg

Pyridoxine.........5mg

Riboflavin………...5mg

Nicotinamide.............15mg

-do-

101. 014237 Epirate Tablet


Sodium Valporate…200mg

-do-

102. 014240 Normacid Suspension -do-

Each 5ml Contains:

Cimetidine…100mg

103. 014239 Normacid Tablet


Cimetidine…400mg

-do-

104. 014241 Scabiderm Cream

Contains:

Permethrin…5%w/w

-do-

105. 031083 Gem-SR Tablet


Pantoprazole (as Sodium

Sesquihydrate)……40mg

-do-

106. 031082 Reset-SR Tablet


Lansoprazole…….30mg

-do-

107. 010011 Duodopa Forte Tablet


CARBIDOPA 25MG

LEVODOPA 250MG

-do-

108. 010021 CALCEE-500 SACHETS


CALCIUM LACTATE

GLUCONATE 1000MG

(CALCIUM GLUCONATE 578MG,

CALCIUM LACTATE 422MG)

VITAMIN C 500MG

CALCIUM CARBONATE 327MG

-do-

109. 010029 Slepam Capsule 15mg


EnalaprilTenazepam.....15mg

-do-

110. 022555 A2A Tablet 25mg



-do-

111. 022556 A2A Tablet 50mg



-do-

112. 022593 Promethazine Syrup

Each 5ml Contains:

Promethazine HCl…25mg

-do-

113. 022590 Talergin-F Capsule

Each Capsule contains:

Fexofenadine as Hcl.60mg

-do-

114. 054800 Season Sachet 4mg


Montelukast Sodium equivalent to

Montelukast…….……4mg

-do-

115. 053799 Teli-H Tablets


Telmisartan……………..80mg

Hydrochlorothiazide……25mg

-do-

M/s Pfizer Pakistan Ltd, B-2, S.I.T.E., Karachi

116. 075986 Antmal Suspension

Each 5ml contains:

Artemether……15mg

Lumefantrine…90 mg



mentioned against


reminder.

117. 075971 Celebrex 100mg

Capsule


Celecoxib…100mg

-do-

118. 075972 Celebrex 200mg

Capsule


Celecoxib…200mg

-do-

M/s Tabros Pharma (Pvt) Ltd, L-20/B, Sector-22, F.B. Industrial Area, Karachi

119. 014343 Hemsamic Capsule 250mg


Tranexamic Acid…250mg



mentioned against


reminder.




-do-

121. 014345 Hemsamic Injection 250mg/5ml

Each 5ml Contains:


-do-

M/s. Safe Pharmaceuticals (Pvt) Ltd, Plot No. C-I-20, Sector 6-B, North Karachi Industrial Area,

Karachi

122. 048847 Planex-DS 200mg/5ml Dry

Suspension

Each 5ml Contains:

Cefixime…200mg



mentioned against


reminder.

123. 048848 Sluber 100mg Tablet


Flurbiprofen…100mg

-do-

124. 048849 Ocebid 400mg Tablet


Ofloxacin…400mg

-do-

125. 048850 Ocebid 200mg/100ml Infusion


Ofloxacin…200mg

-do-

126. 048851 Saferozil 125mg/5ml Suspension

Each 5ml Suspension Contains:

Cefprozil…125mg

-do-

127. 048852 Saferozil 250mg/5ml Suspension


Cefprozil…250mg

-do-

128. 048853 Safedinir 50mg/5ml Suspension


Cefdinir…50mg

-do-

129. 048854 Safedinir 100mg

Capsule


Cefdinir…100mg

-do-

130. 048855 Safedroxil 500mg

Capsule


Cefadroxil (as

Monohydrate)…500mg

-do-

131. 048856 Safedroxil 1gm

Capsule


Cefadroxil (as Monohydrate)…1gm

-do-

132. 048857 Voltec 75mg Tablet



-do-

133. 048858 Voltec SR 100mg Tablet

Each Sustained Release Tablet

Contains:


-do-

134. 048859 Safelexin 125mg/5ml Suspension

Each 5ml Contains:

Cephalexin…125mg

-do-

135. 048860 Safelexin 250mg/5ml Suspension

Each 5ml Contains:

Cephalexin…250mg

-do-

136. 048861 Safelexin 250mg

Capsule


Cephalexin…250mg

-do-

137. 048862 Safelexin 500mg

Capsule


Cephalexin…500mg

-do-

138. 048863 Orpic 250mg Tablet


:

Ciprofloxacin (as HCl)…250mg

-do-

139. 048864 Orpic 500mg Tablet


:


-do-

140. 048865 Orpic 750mg Tablet -do-


:


141. 048866 Orpic 200mg/100ml Infusion



-do-

142. 048867 Safeclor 125mg/5ml Suspension


Cefaclor (as Monohydrate)…125mg

-do-

143. 048868 Safeclor 250mg/5ml Suspension



-do-

144. 048869 Safeclor 250mg

Capsule



-do-

145. 048870 Safeclor 500mg

Capsule



-do-

146. 048871 Saferoxime 125mg/5ml Suspension

Each 5ml Contains:

Cefuroxime (as Axetil)…125mg

-do-

147. 048872 Saferoxime 250mg

Injection

Each Vial Contains:

Cefuroxime (as Sodium)…250mg

-do-

148. 048873 Saferoxime 750mg

Injection

Each Vial Contains:

Cefuroxime (as Sodium)…750mg

-do-

149. 048874 Saferoxime 1.5g Infusion

Each Vial Contains:

Cefuroxime (as Sodium)…1.5gm

-do-

150. 048875 Safepime 500mg

Infusion

Each Vial Contains:

Cefepime (as HCl)…500mg

-do-

151. 048876 Safepime 1g Infusion

Each Vial Contains:

Cefepime (as HCl)…1gm

-do-

M/s. Spectrum Laboratories (Pvt) Ltd, 8 Km Raiwind Road, Lahore

152. 008399 Wormonil Syrup

Each 5ml Contains:

Piperazine (as Piperazine

Hydrate)…750mg



mentioned against


reminder.

153. 008400 Amenol Cough Syrup

Each 5ml Contains:

Ammonium Chloride…100mg

-do-

Sodium Citrate…60mg

Ephedrine HCl…7mg

Chlorpheniramine………2mg

Maleate Menthol…..1mg

154. 008243 Tincture Iodine Methyl USP

Contains:

Iodine…2%

Sodium Iodine…2.5%

Methylated Spirit…50%

Aqua…100%

-do-

155. 008245 Tincture Benzoin Co USP

Contains:

Rosin…8%

Benzoin…10%

Aloes…2%

Balsum Tolu…4%

Methylated Spirit…100%

-do-

156. 009495 Phenrol Tablet


Chlorpheniramine Maleate…4mg

-do-

157. 009494 Sodalk Syrup

Each 5ml Contains:

Sodium Acid Citrate…1.25g

-do-

158. 008244 Ichthammol Glycerin BPC

Contains:

Ichthammol…10%

Glycerin…100%

-do-

159. 008808 Sodamint

Tablet


Sodium Bicarbonate…300mg

-do-

160. 008401 Poultis

Contains:

Kaoline Heavy…52.7g

Boric Acid…4.5g

Methyl Salicylate…0.2ml

Peppermint Oil…0.05ml

Thymol…0.05ml

Glycerin…42.50g

-do-

161. 009502 Nilacid Mixture

Contains:

Sodium Bicarbonate…5%

Spirit Ammonia Aromatic…6.5%

Tincture Zinger Fort…0.4%

Tincture Card Co…6.5%

Spirit Chloroform…4%

Aqua Mentha Pip. Conc…4.8%

-do-

162. 009501 Aspodil Tablet


Aspirin…300mg

-do-

163. 009713 Hydrogen Peroxide 20 Vol.

-do-

164. 008398 Bevit Syrup

Each 15ml Contains:

Thiamine HCl…3.0mg

Riboflavine…3.0mg

Pyridoxine HCl…2.0mg

-do-

165. 008397 Caltol Syrup

Each 5ml Contains:

Paracetamol…120mg

-do-

166. 014714 Amenol-D Cough Syrup

Each 5ml Contains:

Dextromethorphan Hbr…10mg

Ephedrine HCl…7mg


-do-

M/s. ATCO Laboratories Ltd., B-18, S.I.T.E., Karachi

167. 50519 Trimalor Adult Tablet

Each co-blister contains:

Each six small tablets contains:-

Artesunate………..100mg

Each three large tablets contains:-

Sulfadoxine………500mg

Pyrimethamine……25mg



mentioned against


reminder.

M/s. Raazee Therapeutics (Pvt) Ltd, 48 Km, Lahore-Kasur Road, Kasur.

168. 21843 Cestonil Plus Syrup

Each 5ml Contains:

Pizotifen as Hydrogen

Malate…0.250mg

Thiamine HCl…0.875mg

Riboflavin Phosphate…1.310mg

Pyridoxine HCl…0.770mg




mentioned against


reminder.

169. 21844 Texcol Allergy Tablet 10mg


Loratadin…10mg

-do-

170. 30888 Tocor Forte Tablet


Codeine Phosphate…15mg

Paracetamol…500mg

-do-

171. 30889 Acabose Tablet 50mg


Acarbose…50mg

-do-

172. 30890 Acabose Tablet 100mg


Acarbose…100mg

-do-

173. 30891 Gewan Tablet 30mg


Gliquidone…30mg

-do-

174. 30892 Ferogad Drops 50mg -do-

Each ml Contains:


Complex eq. to Elemental

Iron…50mg

175. 30894 Reduse 10mg Tablet


Atorvastatin (as Calcium

Salt)…10mg

-do-




Salt)…20mg

-do-

177. 30896 Texcol Bronco Syrup

Each 5ml Contains:

Acefylline Piperazine…125mg

-do-

178. 30897 Texcol EX Syrup

Each 5ml Contains:

Acefylline Piperazine…45mg

Diphenhydramine HCl…8mg

-do-

179. 30898 Virol Tablet 600mg


Ribavirin…600mg

-do-




Salt)…40mg

-do-

181. 30900 Mipine 30mg Tablet


Mirtazapine…30mg

-do-

182. 30902 Calgesic SR 750mg Tablet


Naproxen (as Sodium)…750mg

-do-

183. 31963 Tributine 100mg Tablet


Trimebutine Maleate…100mg

-do-

184. 31964 Tributine Suspension

Each- 100ml Contains:

Trimebutine Maleate…0.48gm

-do-

185. 31965 Droverine 40mg Tablet


Drotacerine HCl…40mg

-do-

186. 31966 Nysol Oral Solution



Trisodium Citrate

Dihydrate…1.45gm


Glucose Anhydrous…10.0gm

-do-

187. 31967 Pethil Tablet 800mg


-do-

Piracetam…800mg

188. 53697 Xomal Plus DS Tablet


Artemether…40mg


-do-

189. 53698 Lamx 500mcg Tablet

Each Chewable Tablet Contains:


-do-

190. 53699 Melox 7.5mg Tablet


Meloxicam…7.5mg

-do-

191. 53700 Melox 15mg Tablet


Meloxicam…15mg

-do-

192. 53703 Ezevas 10/10mg Tablet


Ezetimibe…10mg

Simvastatin…10mg

-do-

193. 53704 Ezevas 10/20mg Tablet


Ezetimibe…10mg

Simvastatin…20mg

-do-

194. 53705 Gluchon Tablet


Glucosamine Sulphate…500mg

Chondroitin Sulphate…400mg

-do-

M/s. Shaigan Pharmaceuticals (Pvt) Ltd, 14 Km Adyala Road, Post Office Dahgal, Rawalpindi

195. 051100 Pegalin-75 Capsule


Pregabalin…75mg



mentioned against


reminder.



Pregabalin…150mg

-do-



Pregabalin…300mg

-do-

M/s. Medisure Laboratories Pakistan (Pvt) Ltd, A-115, S.I.T.E. II, Super Highway, Karachi

198. 050355 Quopine Tablet


Quetiapine (as Fumarate)…...300mg



mentioned against


reminder.

199. 4184-EX Rumapril Tablet 5mg


Lisinopril Dihydrate eq. to

Anhydrous Lisinopril…5mg

-do-

200. 4185-EX Rumapril Tablet 10mg


-do-

Lisinopril Dihydrate eq. to

Anhydrous Lisinopril…10mg

201. 4186-EX Gemxit Tablet 320mg


Gemifloxacin as

Mesylate…….320mg.

-do-

202. 4187-EX Rumagrel Tablet 75mg


Clopidogrel…75mg

-do-

203. 4188-EX Rumaflam Tablet 50mg



-do-

204. 4189-EX Rumaflam Tablet 100mg



-do-

205. 4190-EX Rumapine Tablet 10mg


Amlodipine…10mg

-do-

M/s. Jawa Pharmaceuticals (Pvt) Ltd, 112/10 Quaid-e-Azam Industrial Area, Kot Lakhpat, Lahore

206. 050299 Ulcicare 20mg

Capsule



Pellets eq. to…20mg

M/s Smilex Laboratories Ltd., Plot

No. 44 CIE Gandhi Nagar Balanagar,

Hyderabad India



mentioned against


reminder.

207. ` 050300 Ulcicare 40mg

Capsule



Pellets eq. to…40mg

M/s Smilex Laboratories Ltd., Plot

No. 44 CIE Gandhi Nagar Balanagar,

Hyderabad India

-do-

208. 050801 Lecetzi 5mg Tablet


Levocetirizine 2HCl…5mg

-do-

209. 050802 Amacure 5mg Tablet


Montelukast Sodium…5mg

-do-

210. 050803 Amacure 10mg Tablet



-do-

211. 050804 Joxicam 7.5mg Tablet


Meloxicam…7.5mg

-do-

212. 050805 Joxicam 15mg Tablet


Meloxicam…15mg

-do-

M/s. Neutro Pharma (Pvt) Ltd, 9.5 Km, Sheikhupura Road, Lahore

213. 049427 Claromy Tablet 250mg





mentioned against


reminder.

214. 049428 Azineu Tablet 250mg


Azithromycin…250mg

-do-

215. 049429 Pefalo Tablet


Pefloxacin…400mg

-do-

216. 049430 Neumox Tablet 400mg


Moxifloxacin…400mg

-do-

217. 049431 Lomef Tablet 200mg


Lomefloxacin…200mg

-do-

218. 049432 Affif Tablet 250mg



-do-

219. 049433 Affif Tablet 500mg



-do-

220. 049434 Bacrid Tablet 200mg


Ofloxacin…200mg

-do-

221. 049435 Lefoxin Tablet 250mg



-do-

222. 049436 Sparf Tablet 100mg



-do-

223. 049437 Numecomin Tablet


Methylcobalamin…500mcg

-do-

224. 049438 Indrop Alpha Tablet



-do-

225. 049439 Muvon Tablet


Piroxicam as Beta-

Cyclodextrin…20mg

-do-

226. 049440 Octina Tablet


Ranitidine as HCl…150mg

-do-

227. 049441 Levopri Tablet


Levosulpride…25mg

-do-

228. 049442 Otengel Tablet -do-


Naproxen Sodium…550mg

229. 049443 Inovel Tablet


Artemether…20mg


-do-

230. 049444 Nuwel Tablet 5mg


Levocetirizine 2HCl…5mg

-do-

231. 049445 Neutrin Suspension

Each 5ml Contains:

Cefatrizine…250mg

-do-

232. 049446 Neudoxine Suspension

Each 5ml Contains:


-do-

233. 049447 Actacef Capsule 250mg


Cefadroxil…250mg

-do-

234. 049448 Actacef Capsule 500mg


Cefadroxil as Monohydrate…500mg

-do-

235. 049449 Tefra Capsule 250mg


Cefradine…250mg

-do-

236. 049450 Neulexin Capsule


Cephalexin as

Monohydrate…250mg

-do-

237. 049451 Serve Capsule 400mg


Cefixime…400mg

-do-

238. 049452 Neutrocolor Capsule 250mg


Cefaclor…250mg

-do-

239. 049453 Neuprozil Capsule


Cefprozil…250mg

-do-

240. 049454 Neutrocolor Capsule 500mg


Cefaclor…500mg

-do-

241. 049455 Neudoxine Capsule



-do-

242. 049456 Otim Capsule


Cefuroxime as Axetil…250mg

-do-

243. 049457 Tefra Capsule 500mg


Cefradine as Monohydrate…500mg

-do-

244. 049458 Tefra Dry Suspension -do-

Each 5ml Contains:

Cefradine as Monohydrate

...........125mg

245. 049459 Otim Dry Suspension

Each 5ml Contains:


-do-

246. 049460 Neulexin Dry Suspension

Each 5ml Contains:

Cefalexin as Monohydrate…125mg

-do-

247. 049461 Serve Dry Suspension 100mg

Each 5ml Contains:

Cefixime as Trihydrate…100mg

-do-

248. 049462 Serve Dry Suspension 200mg

Each 5ml Contains:

Cefixime as Trihydrate…200mg

-do-

249. 049463 Neuprozil Dry Suspension

Each 5ml Contains:

Cefprozil as Monohydrate…125mg

-do-

250. 049464 Neutroclor Dry Suspension

Each 5ml Contains:

Cefaclor as Monohydrate…125mg

-do-

251. 049465 Actacef Dry Suspension 125mg

Each 5ml Contains:


-do-

M/s. Spencer & Company (Pvt) Ltd, D-105, S.I.T.E., Karachi

252. 030856 Diflubid Tablets 500mg


Diflunisal……..500mg



mentioned against


reminder.

253. 014283 Polygard Tablet 250mg


Ciprofloxacin HCl Monohydrate

250mg

eq. to Ciprofloxacin 250mg

Base

-do-

M/s. Paramount Pharmaceuticals, 36-Industrial Triangle, Kahuta Road, Islamabad

254. 050285 Respimet Syrup.

Each 1ml contains:

Ketotifen as Fumarate………0.2mg.



mentioned against


reminder.

255. 050286 Silicur Tablets.


Silymarin………………….200mg

-do-

256. 050287 Sycon Tablet 3mg.

Each film coated Tablet contains:

Risperidone……………3mg.

-do-

257. 050288 Sycon Tablets 4mg.


-do-

Risperidone…………4mg

258. 050986 Polymat Syrup

Each 15ml contains:

Iron Protein

Succinylate……...800mg

(eq to 40mg

elemental iron)

-do-

M/s. Drug’s Inn, 1-I, Parkview Plaza, Markaz F-10, Islamabad

259. 028464 Brunac Eye Drops


N-Acetylcysteine…5gm



mentioned against


reminder.

M/s. WellbornePharmachem&Biologicals, Plot 51/1, 52/2 Phase I&II Industrial Estate, Hattar

260. 77412 Mycophenol 500 mg Tablets


Mycophenolate Mofetil…...500 mg



mentioned against


reminder.

261. 77411 D-Well Injection

Each 1 ml contains:

Cholecalciferol…5 mg

(200,000.I.U.)

-do-

M/s. Sharex Laboratories Ltd., K.L.P. Road, Sharex Colony Sadiqabad, Distt. Rahim Yar Khan.

262. 14209 Anaren Tablet





mentioned against


reminder.

263. 14210 Anaren Injection

Each 3ml Contains:


-do-

264. 22259 Bibcol Drops

Each ml Contains:

Activated Dimethicone…10mg

Xanthun Gum…2.5mg

-do-

M/s. Trigon Pharmaceuticals (Pvt) Ltd., 8-Km Thokar Raiwind Road, Lahore

265. 049991 Aquanone Cream

Contains:

Hydroquinone…4%w/w



mentioned against


reminder.

266. 49992 Cefegon Dry Powder Injection 1gm

Each Vial Contains:

Cefepime as HCl…1gm

-do-

267. 49993 Cefegon Dry Powder Injection

500mg

Each Vial Contains:

Cefepime as HCl…500mg

-do-

268. 49994 Bugnil Infusion


Ofloxacin as HCl…200mg

-do-

269. 49995 Trirome Dry Powder Injection

Each Vial Contains:

Cefpirome as Sulphate…500mg

-do-

270. 49997 Moxilox Tablet 400mg



-do-

271. 49998 Trikiln Vaginal Cream

Each Tube Contains:

Clindamycin as Phosphate…2%

-do-

272. 49999 Dorcip Tablet 500mg



-do-

273. 50000 Dorcip Tablet 250mg



-do-

M/s. Murfy Pharmaceuticals (Pvt) Ltd., 8-Km Raiwind Road, Lahore.

274. 49910 Flamo-Nil Cream


Silver Sulphadiazine…1gm



mentioned against


reminder.

275. 49911 Gentadin Cream

Each gm Contains:

Gentamycin as Sulphate…0.1%w/w

-do-

276. 49912 Polyrex Ointment

Each gm Contains:

Polymyxin B Sulphate…10,000IU

Bacitracin Zinc…500IU

-do-

277. 49913 Clotrexem Cream


Clotrimazole…1gm

-do-

278. 49914 Ibufil Cream


Ibuprofen…10gm

-do-

279. 49915 Vaporex Balm


Methyl Salicylate…12.17gm

-do-

280. 49916 Somex Gel

Each gm Contains:

Lignocaine Base…0.6%w/w

-do-

281. 49917 Diclofil Gel


Diclofenac Diethyl ammonium Salt

eq. to Diclofenac Sodium…2gm

-do-

282. 52977 Lincomin DS Capsule 500mg


Lincomycin HCl eq. to

-do-

Lincomycin…500mg

283. 52978 Lopramex Capsule 2mg


Loperamide HCl…2mg

-do-

284. 52979 Piroxil Capsule 20mg


Piroxicam…20mg

-do-

285. 52982 Diclofil Capsule 50mg


Diclofenac Sodium Enteric Coated

Pellets of eq. to Diclofenac

Sodium…500mg

-do-

286. 52983 Diclofil SR Capsule 100mg


Diclofenac Sodium Sustained

Released Pellets eq. to Diclofenac

Sodium…100mg

-do-

287. 52984 Omeprin Capsule 20mg


Omeprazole Enteric Coated Pellets


-do-

288. 52985 Omeprin Capsule 40mg




-do-

289. 52986 Esomeprin Capsule 20mg


Esomeprazole Enteric Coated Pellets

Magnesium Trihydrate eq. to

Esomeprazole…20mg

-do-

290. 52987 Esomeprin Capsule 40mg



Magnesium Trihydrate eq. to

Esomeprazole…40mg

-do-

M/s. Oval Pharmaceuticals, 112/11, Industrial Estate, Township, Lahore

291. 49923 Reofen Suspension

Each 5ml Contains:

Ibuprofen…100mg



mentioned against


reminder.

292. 49924 Silvone Cream 50gm

Each Tube Contains:

Silver Sulphadiazine…1%w/w

-do-

293. 49928 Monocaine Gel 15gm

Each gm Contains:

Lidocaine HCl…2%w/w

-do-

294. 49929 Xettol Antiseptic Solution

Contains:

Chloroxylenol Solution…50%v/v

-do-

295. 49930 Iodine CMS Ointment 15gm

Each Tube Contains:

Polymyxin Iodine…4%w/w

Methyl Salicylate…5%w/w

-do-

296. 49931 Polymalt-III Syrup

Each 5ml Contains:

Iron (as Hydroxide

Polymaltose)…50mg

-do-

297. 49925 Septodine Antiseptic Solution


Povidone Iodine…10gm

-do-

M/s. Friends Pharma (Pvt) Ltd., 31-Km, Ferozepur Road, Lahore

298. 050136 Intelect Tablet


Citalopram as HBr…20mg



mentioned against


reminder.

299. 50137 Regainol Tablet


Tizanidine as HCl…2mg

-do-

300. 50139 Rounder Capsule


Cefdinir…100mg

-do-

301. 50140 Rounder Suspension

Each 5ml Contains:

Cefdinir…50mg

-do-

302. 50141 Bactirol Tablet


Moxifloxacin HCl…400mg

-do-

303. 50142 Trendone Tablet 1mg


Risperidone…1mg

-do-

304. 50143 Trendone Tablet 2mg


Risperidone…2mg

-do-

305. 50144 Brainagol Tablet


Olanzapine…5mg

-do-

306. 50145 Loctal Capsule


Gabapentin…300mg

-do-

307. 50146 Fledonil Capsule



-do-

308. 50147 Ritopar Tablet


Ritodrine HCl…10mg

-do-

309. 50148 Loctal Capsule


Gabapentin…100mg

-do-

310. 50149 Peprozol Tablet


Pantoprazole as Sodium

Sesquihydrate…40mg

-do-

M/s. Siza International (Pvt) Ltd., 18-Km Lahore Kasur Road, Dist. Kasur

311. 9888 Propranolol HCl 40mg

Tab


Propranolol HCl 40mg



mentioned against


reminder.

312. 10014 Dextrose 25% W/V Inj

Each 1000ml Infusion Contains:

Dextrose Anhydrous 250gms

-do-

313. 14214 Carsine 10mg Tablet


Tamoxifen…10mg

-do-

314. 30883 Prava Tablets


Pravastatin Sodium…..20mg

-do-

315. 30884 Convul SR Tablets 400mg


Carbamazepine BP……400mg

-do-

316. 30885 Numbaix Injection 25mg

Each 2.5ml contains:

Atracurium Besylate ….25mg

-do-

317. 30886 Dupophen 25mg

Injection

Each 1ml ampoule contains:

FluphenazineDecanoate….25mg

-do-

318. 30887 Ahyal 10mg

Injection

Each ml contains:

Sodium Hyaluronate …10mg

-do-

319. 31959 Dibent Capsule 250mg


Cefatrizine (as Cefatrizine Propylene

Glycol)……..250mg

-do-

320. 31960 Dibent Capsule 500mg




-do-

321. 31961 Dibent Suspension 250mg

Each 5ml contains:



-do-

322. 31962 Sopra 30mg

Capsules


Lansoprazole ……30mg

-do-

323. 50868 Supren 250mg -do-

Suspension.

Each 5ml Contains:

Cefaclor as Monohydrate

…….250mg

(USP Specs)

324. 50869 Supren 125mg

Suspension.

Each 5ml Contains:

Cefaclor as Monohydrate ….125mg

(USP Specs)

-do-

325. 50870 Ecanx 7.5mg Tablets.


Meloxicam…………………7.5mg.

(BP Specs)

-do-

326. 50871 Ecanx 15mg Tablets.


Meloxicam…………………15mg.

(BP Specs)

-do-

327. 50872 Lukrx 5mg Tablets.


Montelukast as

Sodium…………5mg

-do-

328. 50873 Lukrx 10mg Tablets.


Montelukast as

Sodium…………10mg.

-do-

329. 50874 Deslorat 5mg Tablets.


Desloratadine………………5mg.

-do-

330. 50875 Xyfex 120mg Tablets.


Fexofenadine HCl………120mg.

-do-

331. 50876 Siflogem 320mg Tablets.


Gemifloxacin as

Mesylate…….320mg.

-do-

332. 51052 Ezumac Capsules 20mg.


Esomeprazole as Magnesium

trihydrate…20mg.

-do-

333. 51053 Ezumac Capsules 40mg.



trihydrate…40mg.

-do-

334. 51108 Glosiflox 400mg

Infusion.


Moxifloxacin as HCl……400mg.

-do-

335. 51109 Glosiflox Tablets 400mg. -do-


Moxifloxacin as

HCl…………400mg

336. 52491 Lukrx Chewable 4mg Tablets.


Montelukast as

Sodium……...……4mg

-do-

337. 53681 Oredx 40mg

Suspension

Each 5ml contains:

Cefpodoxime Proxetil eq. to

Cefpodoxime ..... 40mg

-do-

338. 53682 Xurox125mg

Suspension

Each 5ml contains:

Cefuroxime Axetil eq. to Cefuroxime

..... 125mg

-do-

339. 53683 Kalsartan 50mg Tablet


Losartan Potassium ..... 50mg

-do-

340. 53684 Kalsartan-H Tablet


Losartan Potassium ..... 50mg,

Hydrochlorothiazide..... 12.5mg

-do-

341. 53685 Mecoza 500mcg Tablet


Mecobalamin (Vitamin B12) .....

500mcg

-do-

342. 53686 Mecoza 500mcg Injection

Each ml contains:

Mecobalamin (Vitamin B12) .....

500mcg

-do-

343. 53687 Zacol 0.5mcg Tablet


Alfacalcidol (Vitamin D) ..... 0.5mcg

-do-

344. 53688 Ferrux 100mg Tablet


Iron Hydroxide Polymaltose

Complex ..... 100mg

-do-

345. 53689 Ferrux-F 100mg Tablet


Iron Polymaltose Complex eq. to

Elemental Iron ..... 100mg, Folic

Acid..... 0.35mg

-do-

346. 53690 Iroxin 20mg

Injection

Each ml contains:

Iron Sucrose Complex eq. to

-do-

Elemental Iron ..... 20mg

347. 53691 Gliza 1mg Tablet


Glimepiride ..... 1mg

-do-




-do-




-do-

350. 53694 Atroclor 10mg Tablet


Atorvastatin Calcium eq. to

Atorvastatin ..... 10mg

-do-





-do-





-do-

M/s. Focus &Rulz Pharmaceuticals (Pvt) Ltd, 44-Industrial Triangle, Kahuta Road, Islamabad

353. 49294 Lakas 10mg Tablet


Montelukast as Sodium…10mg



mentioned against


reminder.

354. 49327 Cephcef Dry Suspension 250mg

Each 5ml Contains:

Cephradine…250mg

-do-

355. 49326 Cephcef Dry Suspension 125mg

Each 5ml Contains:

Cephradine…125mg

-do-

356. 49329 Exodril Dry Suspension 125mg

Each 5ml Contains:

Cefadroxil…125mg

-do-

357. 49318 Exodril Capsule 500mg


Cefadroxil…500mg

-do-

358. 49328 Exodril Dry Suspension 250mg

Each 5ml Contains:

Cefadroxil…250mg

-do-

359. 49288 Esro 40mg

Capsule



Trihydrate Enteric Coated

Pellets…40mg

-do-

360. 49287 Esro 20mg -do-

Capsule



Trihydrate Enteric Coated

Pellets…20mg

361. 49289 Omper 20mg

Capsule


Omeprazole as Enteric Coated

Pellets…20mg

-do-

M/s. Caraway Pharmaceuticals, Plot No. 12, Street No. N-3, National Industrial Zone (RCCI) Rawat

362. 50023 Isobact Cream

Each gm Contains:

Isoconazole Nitrate…10mg



mentioned against


reminder.

363. 50024 Fusiway-B Cream

Each gm Contains:

Fusidic Acid…20mg

Betamethasone as Valerate…1mg

-do-

364. 50025 Fusiway-H Cream

Each gm Contains:

Fusidic Acid…20mg

Hydrocortisone as Acetate…10mg

-do-

365. 50026 Myface Cream

Each gm Contains:

Tretinoin…0.5mg

-do-

366. 50027 Cef-Na 1gm

Injection

Each Vial Contains:

Cefoperazone as Sodium…500mg

Salbactum as Sodium…500mg

-do-

367. 50028 Cef-Na 2gm

Injection

Each Vial Contains:

Cefoperazone as Sodium…1gm

Salbactum as Sodium…1gm

-do-

368. 50029 Biamad Injection 250mg

Each Vial Contains:

Ceftazidime…250mg

-do-

369. 50030 Biamad Injection 1gm

Each Vial Contains:

Ceftazidime…1gm

-do-

370. 50031 Cef Moon Injection IM 250mg

Each Vial Contains:

Ceftriaxone as Sodium…250mg

-do-

371. 50032 Cef Moon Injection IM 500mg

Each Vial Contains:


-do-

372. 50033 Cef Moon Injection IM 1gm -do-

Each Vial Contains:

Ceftriaxone as Sodium…1gm

373. 50034 Carapime Injection 1gm

Each Vial Contains:

Cefepime…1gm

-do-

374. 50035 Carapime Injection 500gm

Each Vial Contains:

Cefepime…500mg

-do-

375. 50036 Hylaform Injection 250mg

Each Vial Contains:

Cefotaxime as Sodium…250mg

-do-

376. 50037 Hylaform Injection 1gm

Each Vial Contains:

Cefotaxime as Sodium…1gm

-do-

377. 50038 Amifate Injection 100mg

Each 2ml Contains:

Amikacin as Sulphate…100mg

-do-


Each 2ml Contains:


-do-


Each 2ml Contains:


-do-

380. 50041 Mecorise Injection 500mcg

Each ml Contains:


-do-

381. 50042 Citograin Injection

Each 2ml Contains:

Citicoline as Sodium…250mg

-do-

382. 50043 Surmount Infusion


Levofloxacin as

Hemihydrate…250mg

-do-

383. 50044 Caralox Infusion


Ciprofloxacin as Lactate…200mg

-do-

384. 50045 Topcal Tablet 50mg


Topiramate…50mg

-do-

385. 50046 Topcal Tablet 100mg


Topiramate…100mg

-do-

386. 50047 Topmate Tablet 400mg


Pefloxacin…400mg

-do-

387. 50048 Caramount Tablet 5mg


Mountelukast…5mg

-do-

388. 50049 Caramount Tablet 10mg


-do-

Mountelukast…10mg

389. 50050 Ranisifar Tablet


Ranitidine as HCl…150mg

-do-

390. 50051 Resigrin Tablet 1mg


Resperidone…1mg

-do-



Resperidone…2mg

-do-



Resperidone…3mg

-do-

393. 50054 Metadox Tablet 500mg


Metformin HCl…500mg

-do-




-do-




-do-

396. 50057 Esitaraway Tablet 10mg



-do-

397. 50058 Olimag Tablet 5mg


Olanzapine…5mg

-do-

398. 50059 Olimag Tablet 10mg


Olanzapine…10mg

-do-

399. 50060 Modivid Tablet


Piroxicam as Beta-

Cyclodextrin…20mg

-do-

400. 50061 Oridox Tablet


Cefpodoxime as Paroxetil…100mg

-do-

401. 50062 Lefluno Tablet 10mg


Leflunomide…10mg

-do-

402. 50063 Lefluno Tablet 20mg


Leflunomide…20mg

-do-

403. 50064 IHP Tablet


Iron as eq. to Elemental Iron

Polymaltose Complex…100mg

-do-

404. 50065 IHP-F Tablet


-do-

Iron as eq. to Elemental Iron

Polymaltas…100mg

Folic Acid…0.35mg

405. 50066 Metorate Lotion 20ml

Each Bottle Contains:

MometasoneFurate…1mg

-do-

406. 50067 Cefeye Suspension

Each 5ml Contains:

Cefdinir…50mg

-do-

407. 50068 Cinotec Suspension

Each 5ml Contains:

Cefpodoxime…40mg

-do-

408. 50069 Caradin Suspension

Each 5ml Contains:

Cephradine…125mg

-do-

409. 50070 Caradin DS Suspension

Each 5ml Contains:

Cephradine…250mg

-do-

410. 50071 Azitrix Suspension

Each 5ml Contains:


-do-

411. 50072 Claromin Suspension

Each 5ml Contains:


-do-

412. 50073 Regab Capsule 50mg


Pregablin…50mg

-do-



Pregablin…100mg

-do-



Pregablin…75mg

-do-



Pregablin…150mg

-do-

416. 50078 Caradine Injection 1gm

Each Vial Contains:

Cephradine…1gm

-do-

417. 50079 Caradine Injection 500mg

Each Vial Contains:

Cephradine…500mg

-do-

418. 50080 Lictyn Injection 250mg

Each Vial Contains:


-do-

419. 50081 Lictyn Injection 750mg

Each Vial Contains:


-do-

420. 50082 Caradine Injection 250mg

Each Vial Contains:

-do-

Cephradine…250mg

421. 50083 Caramether Injection

Each Vial Contains:

Artemether…80mg

-do-

422. 50084 Triway Injection

Each 1ml Ampoule Contains:

Triamcinolone Acetonide…40mg

-do-

423. 50085 Carawat Injection

Contains:

Water for Injection

-do-

424. 50086 Calyperol Injection

Each Vial Contains:

Ketamine HCl…50mg

-do-

425. 50087 Metrodex Infusion 500mg

Each Vial Contains:

Metronidazole…500mg/100ml

-do-

426. 50088 Surmont Infusion 500mg

Each Vial Contains:

Levofloxacin as

Hemihydrate…500mg

-do-

427. 50089 Topestin Infusion

Each Vial Contains:

Pefloxacin…400mg

-do-

428. 50807 Azitrix Capsules 20mg.


Omeprazole as enteric coated

pellets……20mg. (USP Specs)

-do-

429. 50808 Caralans Capsules 15mg.


Lansoprazole as enteric coated

Pellets……15mg. (USP Specs)

-do-

430. 50809 Caralans Capsules 30mg.



Pellets……30mg. (USP Specs)

-do-

431. 50810 Vogue Capsules 20mg.


Esomeprazole as magnesium

trihydrate enteric coated

Pellets.…………..20mg.

-do-

432. 50811 Vogue DS Capsules 40mg.


Esomeprazole as magnesium

trihydrate enteric coated

Pellets…………..40mg.

-do-

433. 50001 Fludecate 20 Capsules.


Fluoxetine as HCl …20mg. (USP

Specs)

-do-

434. 50002 Azitrix 250mg -do-

Capsules.


Azithromycin as

dehydrate……250mg. (USP Specs)

435. 50003 Cefaben Capsules.


Cefixime………200mg.

-do-

436. 50004 Cefaben DS Capsules.


Cefixime ………400mg.

-do-

437. 50005 Cefaben Suspension.

Each 5ml Contains:

Cefexime …….100mg.

-do-

438. 50006 Cefaben DS Suspension.

Each 5ml Contains:

Cefexime …….200mg.

-do-

439. 50007 Surmount Tablets 250mg.


Levofloxacin as

Hemihydrate…..250mg

-do-

440. 50008 Surmount Tablets 500mg.


Levofloxacin as

Hemihydrate…..500mg

-do-

441. 50009 Lomerol Tablets 400mg.


Lomefloxacin as HCl.......400mg.

-do-

442. 50010 Claromin Tablets 250mg.


Clarithromycin ….250mg. (USP

Specs)

-do-

443. 50011 Claromin Tablets 500mg.


Clarithromycin ..500mg. (USP

Specs)

-do-

444. 50012 Caralox Tablets 250mg.


Ciprofloxacin as HCl …….250mg.

(USP Specs)

-do-

445. 50013 Caralox Tablets 500mg.


Ciprofloxacin as HCl …….500mg.

(USP Specs)

-do-

446. 50014 Caramither Plus Tablets.


:

Artemether…….20mg.

Lumefantrine….120mg.

-do-

447. 50015 Mecorize Tablets 500mcg.


Mecobalamin…..500mcg

-do-

448. 50016 Licide Tablets


Levocetrizine 2HCl..5mg.

-do-

449. 50017 Feldax Tablets.


Flurbiprofen ………100mg. (BP

Specs)

-do-

450. 50018 Carafenac-P Tablets 50mg.


Diclofenac Potassium

…………..50mg. (USP Specs)

-do-

451. 50019 Carafenac-P Tablets 75mg.


Diclofenac Potassium …..75mg.

(USP Specs)

-do-

452. 50020 Myxole Cream.

Each Gram Contains:

Ketoconazole …..20mg.

-do-

453. 50021 Fusiway Cream.

Each Gram Contains:

Fusidic Acid …….20mg. (BP Specs)

-do-

454. 50022 Caracort Cream.

Each Gram Contains:

Miconazole Nitrate………20mg.

Hydrocortisone as acetate…..10mg.

(BP Specs)

-do-

M/s. Curatech Pharma (Pvt) Ltd., 35-Km Multan Road, Lahore

455. 049467 Melather DS tablets


Artemether 40mg

Lumefantrine 240mg



mentioned against


reminder.

456. 049466 Zanitech tablet 2mg


Tizanidine as HCL 2mg

-do-

457. 049470 Sudoproxim Tablet


Ibuprofen 200mg

Pseudoephedrine HCL 30mg

-do-

458. 049471 Sudoproxim Tablet


Ibuprofen 400mg

Pseudoephedrine HCL 60mg

-do-

M/s. Medipak Ltd., 132 Industrial Estate, Kot Lakhpat Lahore

459. 010005 Medigyl injection 0.5%

Each 100ml contains:

Metroidazole 500mg



mentioned against

sodium chloride 740mg Each and advised to issue a final

reminder.

460. 014260 Aqura Sterile Injection

Water for Injection

-do-

M/s. Wahabson Pharma (Pvt) Ltd., 4-Km Buner Road, Barikot, Swat

461. 052710 Kymol Suspension

Each 5ml Contains:

Paracetamol…120mg



mentioned against


reminder.

462. 052711 Kymol Forte Suspension

Each 5ml Contains:

Paracetamol…250mg

-do-

463. 052712 Wydryllin DM Syrup

Each 5ml Contains:

Diphenhydramine…5mg

Dextromethorphan..6.25mg

-do-

464. 052713 Wormnor Suspension

Each 5ml Contains:

Albendazole…100mg

-do-

465. 052714 Walidix Suspension

Each 5ml Contains:

Nalidixic Acid…250mg

-do-

M/s. Shaheen Pharmaceuticals, 3-Km Murghzar Road, Saidu Sharif, Sawat

466. 49330 Lanosh Capsules.

Each Enteric Coated Capsule

Contains:

Lansoprazole Pellets eq. to

Lansoprazole ....................30mg.

(USP Specs)



mentioned against


reminder.

467. 49331 Zoger Capsules.

Each enteric coated capsule contains

Omeprazole Pellets eq. to

Omeprazole……20mg. (USP Specs)

-do-

468. 49367 Dequit 25mg Tablets.


Quetiapine Fumarate eq. to

Quetiapine……..25mg.

-do-




Quetiapine……..200mg.

-do-

470. 49332 Pepnor 20mg Tablets.


Contains:


Trihydrate ……….20mg.

-do-

471. 49333 Pepnor 40mg Tablets.


-do-

Contains:


Trihydrate……….40mg.

472. 49334 Shalox Tablets.


Moxifloxacin HCl………..400mg.

-do-

473. 49335 Rager Tablets.

Each Enteric Coated tablet Contains:

Rabeprazole

Sodium…………..20mg.

-do-

474. 49336 Alenat Tablets.


Alendronate as Sodium ......70mg

(USP Specs)

-do-

475. 49337 Cyclodor Tablets.


Piroxicam B-Cyclodextrine eq. to

Piroxicam…20mg. (B.P Specs)

-do-

476. 49338 Ocedep 50mg Tablets.


Fluvoxamine Maleate BP……50mg.

(B.P Specs)

-do-

477. 49339 Ocedep 100mg Tablets.


Fluvoxamine Maleate ……100mg.

(B.P Specs)

-do-

478. 49340 Preston 250mg Tablets.


Mefenamic Acid ..250mg. (B.P

Specs)

-do-

479. 49341 Preston Forte 500mg Tablets.


Mefenamic Acid ..500mg. (B.P

Specs)

-do-

480. 49342 Butral 10mg Tablets.


Bambuterol ……10mg. (B.P Specs)

-do-

481. 49343 Butral 20mg Tablets.


Bambuterol ……20mg. (B.P Specs)

-do-

482. 49344 Normidol Tablets.


Paracetamol ….500mg. (B.P Specs)

-do-

483. 49345 Curedol Extra Tablets.


Paracetamol …500mg. Caffeine

…….65mg. (B.P Specs)

-do-




-do-

Quetiapine………..100mg.

M/s. Nawabsons Laboratories (Pvt) Ltd., Jia Bagga, Off Raiwind Road, Lahore

485. 49932 Hemogrel tablets 75mg


Clopidogrel Bisulphate 75mg



mentioned against


reminder.

486. 49933 Roastatin tablet 20mg


Atorvastatin as calcium 20mg

-do-

487. 49935 Roastatin tablet 10mg


Atorvastatin as calcium 10mg

-do-

488. 49937 S/S Cream

:

-do-

489. 49938 Methyl Salicylate Liniment

:

-do-

M/s. Swat Pharmaceuticals, Saidu Sharif, Swat, 19130 KPK

490. 77415 Zeromel DS Tablet


Artemether…40mg




mentioned against


reminder.

491. 77416 Zeromel Tablet


Artemether…20mg


-do-

492. 21627 Allorin Tablet



-do-

M/s. Zinta Pharmaceutical Industry, 168-Industrial Estate, Hayatabad, Peshawar

493. 051067 Cyprectin Syrup

Each 5ml Contains:

Cyproheptadine HCl…2mg



mentioned against


reminder.

M/s. Venus Pharma, 23-Km Multan Road, Lahore

494. 013993 Xylex 2% Injection with Adrenaline

Contains:

Lignocaine HCl…2%w/v

Adrenaline…0.001%w/v



mentioned against


reminder.

M/s. Lawrence Pharma (Pvt) Ltd., 10.5-Km Sheikhupura Road, Lahore

495. 014720 Lawrplex Forte Injection


Thiamine HCl…100mg

Pyridoxine HCl…100mg

Cyanocobalamin..1000mcg



mentioned against


reminder.

496. 050203 Sarbomol Injection.

Each 1ml ampoule contains:

-do-

Salbutamol as Sulphate………0.5mg

(BP Specs)

497. 050204 Lawrmazin Injection.

Each 1ml contains:

Promethazine as HCl…….25mg.

(BP Specs)

-do-

498. 050205 Xathonium Injection.

Each ml Ampoule contains:

Suxamethonium

Chloride……..50mg. (BP Specs)

-do-

499. 050206 Lamikacin Injection 250mg.

Each 2ml vial contains:

Amikacin as

Sulphate………..250mg. (BP Specs)

-do-



Amikacin as Sulphate.....100mg. (BP

Specs)

-do-

501. 050208 Lawrkomycin Injection 500mg.


Kanamycin as Sulphate……..500mg.

(BP Specs)

-do-

502. 050209 Lawrkomycin Injection 1gm.


Kanamycin as Sulphate……..1gm.

(BP Specs)

-do-

503. 050210 Lawrcimid Injection.

Each 2ml Ampoule contains:

Cimetidine………200mg. (BP

Specs)

-do-

504. 050211 Lawrgmycin Injection.


Gentamycin as

Sulphate………40mg. (USP Specs)

-do-

505. 050212 LeskopanInjeciton.

Each 1ml contains:

Hyoscine-N-Butyl

bromide……20mg. (BP Specs)

-do-

506. 050213 Lawrbocin Injection 80mg.


Tobramycin as

Sulphate……….80mg. (BP Specs)

-do-

507. 050214 Lawrbocin Injection 20mg.

Each ml vial contains:

Tobramycin as

Sulphate………20mg. (BP Specs)

-do-



Amikacin as Sulphate………500mg.

(BP Specs)

-do-

M/s. A. Z. Pharmaceutical Co. Ltd., 4-Km Manga Road, Raiwind, District Lahore.

509.

014233 Immunasol 5% IV Infusion


Dextrose Anhydrous…50gm



mentioned against


reminder.

510.

014234

Immunasol 10% IV Infusion



-do-

511.

014235

Immunasol NS IV Infusion



-do-

512.

014236

Immunasol DN IV Infusion




-do-

M/s. English Pharmaceutical Industries, Link Kattar Bund Road, Thokar NiazBaig, Multan Road,

Lahore

513. 014206 Uricol Syrup

Each 5ml Contains:

Sodium Acid Citrate…1.25g



mentioned against


reminder.

514. 014207 Cobact Suspension

Each 5ml Contains:

Trimethoprim…40mg

Sulphamethoxazole ................200mg

-do-

515. 037238 Fiterna Tablet


Vit A . . . . . . .6000iuVit D . . . . . . .

.500iuVit E . . . . . . .. 15mg

B1 . . . . . . . 1.6mg

B2 . .. . . . . . 1.8mg

B6 . . . . . . . . . 2.6mg

B12 . . . . . . . .. . . .

4mcgNicotonamide . . . . 19mg

Calcium pantothenate . . 10mg

Biotin . . . . . 0.2mg

Folic Acid . . . . . 0.8mg

Calcium elemental . . . 125mgVit C .

.. 100mg

Iron elemental . . . . 60mg

Phosphorus. . . . . 125mg

Manganese elemental . 1mg

Magnesium elemental ......100mg

Copper elemental. . . 1mg

Zinc elemental. . . . 7.5mg

-do-

516. 037239 Englopt Tablets


Vitamin A . . . . . 5000iu

-do-

Vitamin B1 . . . . . 5mg

Vitamin B2 . . . 3mg

Vitamin B6. . . . . 5mg

Vitamin B12. . . 3mcg

Nicotinamide . 25mg

DPanthenol . 10mg

Biotin. . .. . . 50mcg Procaine Hcl .

. 55mg

Folic Acid . . . . 0.4mg

Inositol . . . . . 30mg

Orotic Acid .. . . 30mg

Vitamin C . . . . 60mg

Vitamin D . . . . . 400iu

Vitamin E . . . . . 10mg

Rutin . . . . . . . 20mg

Ethyl Linolate . . 28mg

Lecithin . . . . . 60mg

Choline hydrogen tartrate . .50mg

LLysine monohydrochloride . . 25mg

Hematoporphyrin . 1mg

Adenosine. . 75mg

Intrinsic Factor... 6.25mg

Magnesium Glycerophospha . .

40mg

Dehydrated Calc . . 35mg

Potassium Sulphate...8mg

Dehydrated Ferous (ll) Sulphe . .

10mg

Dehydrated Cupric (ll) Sulph . .

0.5mg

Dehydrated Man . .0.5mg

Dehydrated cobaltous (ll) St . . .

0.1mg

Dehydrated Sodium Molybdc . .

80mcgZinc Oxide . . . . . 0.5mg

517. 037240 Iron (PS) Syrup


:

Iron Protein Succinylate . . . 800mg

(eq to iron 40mg)

-do-

518. 037229 Zecol + Tablet


Vitamin A...4000IU,

Vitamin B1…2mg,

Vitamin B2…2mg,

Vitamin B6…1mg,

Vitamin B12…1mcg, Ginseng

Extract…40mg, Dimethyle

aminoethanol Bitaratrate…26mg,

Vitamin C…60mg, Zinc…1mg,

Nicotinamide…15mg, Calcium

-do-

Pantothenate…10mg,

Rutine…20mg, Iron…10mg,

Calcium…90.3mg,

Phosphorus...70mg,

Fluorine...0.2mg, Copper...1mg,

Potassium...8mg, Manganese...1mg,

Magnesium...10mg, Lecithin...66mg

519. 037230 Evival Tablet


Vitamin A…700IU,

Vitamin D…5mcg,

Vitamin E…30mg,

Vitamin C…120mg,

Vitamin B1…15mg,

Vitamin B2…5mg, Niacin…45mg,

Vitamin B6…25mg,

Vitamin B12…9mcg, Folic

Acid…500mcg, Biotin…200mcg,

Pantothenic Acid…10mg,

Iron…8mg, Magnesium…100mg,

Zinc…15mg, Manganese…12mg,

Selenium...100mcg,

Chromium...200mcg,

Iodine...100mcg

-do-

520. 037231 Vitaferol Injection

Each Injection Contains:

Cholecalciferol…200,000IU

-do-

521. 037232 Kedvet Syrup

Each 80ml Contains:

Magnesium Glutamate

Hydroboromide…2gm

Gama-Amino-Butyric Acid…2gm

Gama-Amino-Beta-Hydroxy-Butyric

Acid…1gm

Vitamin B6…1gm

-do-

522. 037246 Englobi Tablet


Ginseng Radix…100mg,

Lecithin…9.5mg

(P….0.29mg),

Vitamin A Oil…2400IU, Thiamine

HCl…2.5mg, Vit. B2…2.5mg,

Vit.B6…1mg, Vit.B12…4.9mcg,

Vit.C…40mg, Vit.D2…240 IU,

Vit.E…2mg, Nicotinamide…20mg,

Calcium Pantothenate….10mg,

Anhydrous Dibasic Calcium

Phosphate...100mg, (Ca...29.5mg

P...22.8mg), Magnesium

Oxide...100mg

-do-

(Mg...6mg), Cupric Oxide...1mg

(Cu...0.8mg), Manganese

Sulfate...2mg

(Mn...0.47), Zinc Oxide...5mg

(Zn...4mg), Dried Ferrous

Sulfate...33mg

(Fe...10mg)

523. 049472 Engbone Injection 1mcg.

Each 0.5 ml contains:

Alfacalcidol……….1mcg

-do-

524. 049473 Engbone Tablets 0.5mcg.


Alfacalcidol….0.5mcg.

-do-

525. 049474 Pantakure Tablets 40mg.

Each enteric coated Tablet contains:

Lansoprazole as Sodium

Sesquihydrate…40mg.

-do-

526. 049475 Mewin Tablets 500mcg.


Mecobalamin…500mcg.

-do-

527. 049476 Celsef Capsule 500mg.


Cefadroxil…500mg. (USP)

-do-

528. 49477 Celsef Dry Suspension 125mg.

Each 5ml contains:

Cefadroxil…..125mg. (USP Specs)

-do-

529. 049478 Celsef Dry Suspension 250mg.

Each 5ml contains:

Cefadroxil…..250mg. (USP Specs)

-do-

530. 049479 Zapris Capsule.


Ziprasidone as HCl

monohydrate……40mg.

-do-

531. 049480 Klavor 250mg Tablets.



(USP Specs)

-do-

532. 049481 Klavor 500mg Tablets.


Clarithromycin..500mg. (USP Specs)

-do-

533. 049482 Engoxin Tablets.


Roxithromycin……….150mg.

-do-

534. 049483 Enzoxen Capsules 250mg.


Azithromycin…250mg. (USP Specs)

-do-

535. 049484 Zopiramate Tablets 25mg.


Topiramate……………25mg.

-do-

536. 049485 Zopiramate Tablets 50mg. -do-


Topiramate……50mg

M/s. Wise Pharmaceuticals, Plot No. 3-A, Street No. S-1, RCCI Industrial Estate, Rawat, Rawalpindi

537. 001016-EX Levise Tablet


Levocetirizine 2HCl ...5mg



mentioned against


reminder.

538. 001017-EX Rumak Tablet



-do-

539. \ 001018-EX Lovin Tablet 250mg


Levofloxacin as

Hemihydrate…250mg

-do-

540. 1019-EX Lovin Tablet 500mg


Levofloxacin as

Hemihydrate…500mg

-do-

541. 1021-EX Ciprise 250mg Tablet



-do-

542. 1022-EX Ciprise 500mg Tablet



-do-

543. 1023-EX Wisest 20mg

Capsule



eq. to Esomeprazole…20mg

-do-


Capsule




-do-

545. 1026-EX Wizol 20mg

Capsule




-do-

546. 1027-EX Hexim 400mg

Capsule


Cefixime as (Trihydrate)…400mg

-do-

547. 1028-EX Hexime Dry Suspension 100mg/5ml

Each 5ml Contains:


-do-

548. 1029-EX Hexime Dry Suspension 200mg/5ml

Each 5ml Contains:

-do-


549. 1030-EX Sofenac Capsule 500mg


Cephradine as

Monohydrate…500mg

-do-

550. 1031-EX Sofenac Capsule 250mg


Cephradine as

Monohydrate…250mg

-do-

551. 1032-EX Sofenac Dry Suspension 125mg/5ml

Each 5ml Contains:

Cephradine as

Monohydrate…125mg

-do-

552. 1033-EX Sofenac Dry Suspension 250mg/5ml

Each 5ml Contains:

Cephradine as

Monohydrate…250mg

-do-

553. 1034-EX Tarson Injection 250mg

Each vial contains:


-do-

554. 1035-EX Tarson Injection 1gm

Each vial contains:

Ceftriaxone as Sodium…1gm

-do-

555. 1036-EX Sefox Injection 1gm

Each vial contains:

Cefotaxime as Sodium…1gm

-do-

556. 1037-EX Sefox Injection 250mg

Each vial contains:

Cefotaxime as Sodium…250mg

-do-

M/s. Zumars Pharma FTY (Pvt) Ltd., 2-Malir Industrial Area, Malir, Karachi

557.

48639

Colstral 10mg Tablets


Simvastatin……10mg(USP

Specification)



mentioned against


reminder.

558.

48638

Zumazar 10mg Tablets



Salt)….10mg

)

-do-

559.

49556

NEOCEF WATER SOLUBLE

POWDER.


CHLORTETRACYCLINE

HYDROCHLORIDE 40GM.

NEOMYCIN (AS SULPHATE)….

12GM. FURALTADONE …30GM.

-do-

560.

48641

Zurafenac 50mg Tablets

EACH ENTERIC COATED

TABLET CONTAINS:

-do-

Diclofenac Sodium…..50mg(BP

Specification)

561.

48640

Zumaflam-P 50mg Tablets

Each sugar coated tablet contains:

Diclofenac Potassium…..50mg(BP

Specification)

562.

48642

Umaroxin 250mg Tablets


Ciprofloxacin (as

HCl)…..250mg(USP Specification)

-do-

563.

48643

Umaroxin 500mg Tablets


Ciprofloxacin (as HCl)…..500mg

(USP Specification)

-do-

M/s. Lisko Pakistan (Pvt) Ltd., L-10/D, Block-21, Federal-B Area, Karachi

564. 009292 Sefalex Syrup

Each 5ml Contains:


Cephalexin…125mg



mentioned against


reminder.

M/s. Crown Pharmaceuticals Islamabad, Plot No. 286, Industrial Triangle Kahuta Road, Islamabad

565.

050284

Ciprown 500mg Tablets.


Ciprofloxacin as HCl ….….500mg.

(USP Specs)



mentioned against


reminder.

566.

050278

Topiraid 50mg Tablets.


Topiramate…………….50mg.

-do-

567.

050283

Ciprown 250mg Tablets.


Ciprofloxacin as HCl ...…….250mg.

(USP Specs)

-do-

568.

050280

Levorown 500mg Tablets.


Levofloxacin as

Hemihydrate…500mg

(USP Specs)

-do-

569.

050282

Esorown 40mg Tablets.


Esomeprazole…….40mg.

-do-

570.

050272

Piroxirown Tablets.


Piroxicam ……...20mg

-do-

571.

050279

Levorown 250mg Tablets.


Levofloxacin as

Hemihydrate....250mg

(USP Specs)

-do-

572.

050269

Alfarown Tablets.


Alfacalcidol……..0.5mcg

-do-

573.

050276

Rabirown 20mg Tablets.


Rabeprazole………20mg.

-do-

574.

050281

Esorown 20mg Tablets.


Esomeprazole...........20mg.

-do-

575.

050274

Tizanic Tablets.


Tizanidine HCl…..2mg. (USP

Specs)

-do-

576.

050270

Paraxtil Tablets.


Paroxetine……..20mg. (B.P Specs)

-do-

577.

050268

Estarown Tablets.


Escitalopram as Oxalate……10mg

-do-

M/s. Pharmacare Laboratories (Pvt) Ltd., 129/1, Industrial Estate, Kot Lakhpat, Lahore

578. 030289 Protofix Tablets


Pantoprazole Sodium Sesquihydrate

eq. to Pantoprazole…..40mg



mentioned against


reminder.

579. 030340 Exmic-500 Tablets


Levofloxacin Hemihydrate eq. to

Levofloxacin…..500mg

-do-

580. 030290 Cetahist Tablets


Cetirizine 2HCl…..10mg

-do-

581. 030339 Exmic-250 Tablets




-do-

582. 030341 Citarid Tablets


Citalopram HBr…..20mg

-do-

M/s. Lahore Pharma, 9-Km Sheikhupura Road, Lahore

583. 021657 Lpzine Cream

Contains:

Silver Sulphadiazine…1gm

w/w



mentioned against


reminder.

M/s. Festel Laboratories, Jinnah Industrial Estate, Link Kattarband Road, ThokarNiazBaig, Multan

Road, Lahore.

584. 50216 Kartilin Plus Tablet




Glucosamine…500mg

Chondroitin Sulphate…400

mentioned against


reminder.

585. 50217 Kartilin Tablet


Glucosamine…500mg

-do-

586. 50218 Frisil Tablet


Magnesium Trisilicate…500mg

Aluminium Hydroxide Gel…250mg

-do-

587. 50219 Chlorpheniramine Tablet



-do-

588. 50220 Fersate Tablet

Each Sugar Coated Tablet Contains:


-do-

589. 50221 Folistel Tablet


Folic Acid…5mg

-do-

590. 50222 Festobal Tablet

Each Sugar Coated Tablet Contains:


-do-

591. 50223 Festahist Tablet


Loratidine…10mg

-do-

592. 50224 Festozin Tablet


Levocetirizine 2HCl …5mg

-do-

593. 74331 Sulpril 50mg Tablet


Levosulpride….50mg

-do-

M/s. Legacy Pharmaceuticals (Pvt) Limited, 111-A Industrial Estate Hayatabad, Peshawar

594. 50092 Lesozol 20mg

Capsule



Trihydrate…20mg



mentioned against


reminder.

595. 50093 Lesozol 40mg

Capsule



Trihydrate…40mg

-do-

596. 50094 Ompecid Capsule 20mg


Omeprazole Pellets…20mg

-do-




-do-

598. 50096 Lanso Capsule


-do-

Lansoprazole…30mg

599. 50097 Legofen Capsule


Diclofenac Sodium Pellets…50mg

-do-

600. 49854 Urinac Tablet


Norfloxacin…400mg

-do-

601. 49855 Legamox 400mg Tablet



-do-

602. 49856 Lepracit 10mg Tablet



-do-

603. 49857 Ribena-F Tablet




Iron…100mg

Folic Acid…0.35mg

-do-

604. 49858 Ciprate 20mg Tablet


Citalopram as HBr…20mg

-do-

605. 49859 Emitilium 10mg Tablet


Domperidone…10mg

-do-

606. 49860 Napxen 250mg Tablet


Naproxen…250mg

-do-



Naproxen…500mg

-do-

608. 49862 Acetamol 500mg Tablet


Paracetamol…500mg

-do-

609. 49863 Acetamol Extra Tablet


Paracetamol…500mg

Caffeine…65mg


-do-

610. 49864 Levobac 250mg Tablet


Levofloxacin as

Hemihydrate…250mg

-do-

611. 49865 Levobac 500mg Tablet


Levofloxacin as

Hemidydrate…500mg

-do-

612. 49866 Olax 200mg Tablet


Ofloxacin…200mg

-do-

613. 49867 Olax 400mg Tablet


Ofloxacin…400mg

-do-

614. 49868 Leganil 500mg Tablet



-do-

615. 49869 Leganil 1000mg Tablet



-do-

616. 49870 Legocip 250mg Tablet



-do-

617. 49871 Legocip 500mg Tablet



-do-

618. 49872 Lexime 400mg

Capsule


Cefixime…400mg

-do-

619. 49873 Roxif 500mg

Capsule



-do-

620. 49874 Fluzox 150mg

Capsule


Fluconazole…150mg

-do-

621. 49875 Depox 20mg

Capsule


Fluoxetine as HCl…20mg

-do-

622. 49876 Legicam 20mg

Capsule


Piroxicam…20mg

-do-

623. 49877 Legaceph 250mg

Capsule


Cephradine…250mg

-do-


Capsule


Cephradine…500mg

-do-

625. 49879 Efaclor 250mg

Capsule


Cefaclor…250mg

-do-

626. 49880 Efaclor 500mg

Capsule


-do-

Cefaclor…500mg

627. 49881 Lexina 250mg

Capsule


Cephalexin as

Monohydrate…250mg

-do-

628. 49882 Lexina 500mg

Capsule


Cephalexin as

Monohydrate…500mg

-do-

629. 49883 Fusidax Cream

Each gm Contains:

Fusidic Acid…20mg

-do-

630. 49884 Fusidax-H Cream

Each gm Contains:

Fusidic Acid…20mg

Hydrocortisone Acetate…10mg

-do-

631. 49885 Polybac Skin Ointment

Each gm Contains:

Polymyxin B Sulphate…10,000Units

Bacitracin Zinc…500Units

-do-

632. 49886 Clozam Cream

Each gm Contains:

Clotrimazol…10%

-do-

633. 49887 Legicam Cream

Each gm Contains:

Piroxicam…0.5%

-do-

634. 49888 Hydrol ORS Sachet

Each Sachet Contains:


Trisodium Citrate Dihydrate…2.9gm


Dextrose Anhydrous…13.05gm

-do-

635. 49889 Airin Syrup

Each 5ml Contains:

Salbutamol as Sulphate…2mg

-do-

636. 49890 Doxip Dry Suspension

Each 5ml Contains:


-do-

637. 49891 Leganil Suspension

Each 5ml Contains:


-do-

638. 49892 Leriton Syrup

Each 5ml Contains:


-do-

639. 49893 Acetamol Suspension

Each 5ml Contains:

Paracetamol…120mg

-do-

640. 49894 Metrol Suspension -do-

Each 5ml Contains:

Metronidazole as Benzoate…200mg

641. 49895 Lexime Dry Suspension

Each 5ml Contains:

Cefixime…100mg

-do-

642. 49896 Emitilium Suspension

Each ml Contains:

Domperidone…1mg

-do-

643. 49897 Roxif 125mg

Dry Suspension

Each 5ml Contains:


-do-

644. 49898 Roxif 250mg

Dry Suspension

Each 5ml Contains:


-do-


Dry Suspension

Each 5ml Contains:

Cephradine…125mg

-do-


Dry Suspension

Each 5ml Contains:

Cephradine…250mg

-do-

647. 49901 Laxina 125mg

Dry Suspension

Each 5ml Contains:

Cephalexin as

Monohydrate…125mg

-do-

648. 49902 Laxina 250mg

Dry Suspension

Each 5ml Contains:

Cephalexin as

Monohydrate…250mg

-do-

649. 49903 Efaclor 125 Dry Suspension

Each 5ml Contains:

Cefaclor…125mg

-do-

650. 49904 Efaclor 250 Dry Suspension

Each 5ml Contains:

Cefaclor…250mg

-do-

651. 49905 Cofnol-E Syrup

Each 5ml Contains:

Aminophylline…32mg



Menthol…0.98mg

-do-

652. 49906 Montekast Sachet


Montelukast as Sodium…4.0mg

-do-

653. 49907 Noscab Cream

Contains:

Lindane…1%

-do-

654. 49908 Skinazin Cream

Contains:

Silver Sulphadiazine ..1%

-do-

655. 49909 Remistate Cream

Contains:

Miconazole Nitrate…2%

-do-

656. 50098 Legofen-P Capsule


Diclofenac Potassium Pellets…50mg

-do-

657. 52832 Hireez 10mg Tablet


Cetirizine 2HCl…10mg

-do-

658. 52833 Legofen Gel


Diclofenac as Diethyl Ammonium

Salt…1gm

-do-

659. 52834 Hireez Syrup

Each ml Contains:

Cetirizine 2HCl…1mg

-do-

660. 52835 Ribena-F Syrup

Each 5ml Contains:

Iron-III Hydroxide Polymaltose


Iron…50mg

Folic Acid…0.35mg

-do-

661. 52836 Lebon Sachet


Calcium Lactate Gluconate…3.24g

Calcium Carbonate…0.30g

-do-

662. 52837 Ener-Cee Sachet


Calcium Lactate

Gluconate…1000mg

Vitamin C…500mg


-do-

663. 52838 Remistate-HC Cream

Each Tube Contains:

Miconazole Nitrate…2%

Hydrocortisone…1%

-do-

664. 53622 Spasmorin Tablet


Mebeverine as HCl…135mg

-do-

665. 53623 Ascorbic-500 Sachet


Vitamin C…500mg

-do-

M/s. Hansel Pharmaceuticals (Pvt) Ltd., Plot No. 2, Pharma City, 30-Km Multan Road, Lahore

666. 50132 Antimal Tablet Registration deferred the above cases

Each Large Tablet Contains:

Sulfadoxine…500mg

Pyriemthamine…25mg

Each Small Tablet Contains:

Artesunate…50mg


mentioned against


reminder.

667. 50133 Mebandasel Tablet


Mebendazole…100mg

-do-

668. 50134 Antimal-Forte Tablet

Each Large Tablet Contains:

Sulfadoxine…500mg

Pyriemthamine…25mg

Each Small Tablet Contains:

Artesunate…100mg

-do-

669. 50135 Artimet Tablet


Artemether…20mg


-do-

M/s. Vega Pharmaceuticals (Pvt) Ltd., 30-Km Multan Road, Lahore

670. 43446 Difsom Gel

Each gm Contains:

Diclofenac Diethylammonium eq. to


Letter of shortcomings was issued to

the firm vide letter No. F.1-65/ 2018

(RRR) dated 10-04-2019 which has

not yet been responded by the firm.

M/s. Otsuka Pakistan Ltd., F/4-9, Hub Industrial Trading Estate, Distt. Lasbella, Balochistan

671. 22318 Pan-Amin SG Injection


D-Sorbitol…5gm

L-Arginine HCl…0.8gm

L-Histidine HCl…0.4gm

L-Isoleucine…0.55gm

L-Leucine…1.23gm

L-Lysine HCl…1.86gm

L-Methionine…0.71gm

L-Phenylalanine…0.87gm

L-Threonine…0.54gm

L-Tryptophan…0.18gm

L-Valine…0.61gm

Glycine (Amino Acetic Acid)…1gm

Water for Injection qs



mentioned against


reminder.

672. 31125 Neodexsal Injection


Dextrose Monohydrate…100gm


Water for Injection qs to make 1000ml

-do-

673. 31126 Plabolyte-40 Injection


Dextrose Monohydrate…50gm

Potassium Chloride…3gm

Water for Injection qs to make 1000ml

-do-

M/s. Akhai Pharmaceuticals (Pvt) Ltd., A-248, A-256 to A-259, H.I.T.E., Lasbela, Baluchistan

674. 75995 Sulpy 100mg Tablet


Levosulpiride…100mg



mentioned against


reminder.

675. 75996 Togal 200mg Tablet


Quetiapine as Fumarate…200mg

-do-

M/s. Saffron Pharmaceuticals (Pvt) Ltd., 19-Km Sheikhupura Road, Faisalabad

676. 52953 Locus 500mg/100ml Infusion


Levofloxacin (as

Hemihydrate)…500mg



mentioned against


reminder.

677. 52954 Doplet-3 5mg/ml Injection

Each ml Contains:


-do-

678. 52955 Cetrix 5mg/5ml Syrup

Each 5ml Contains:


-do-

679. 52958 Terbisil 250mg Tablet


Terbinafine (as HCl)…250mg

-do-

680. 52959 Provate 0.05% w/w Cream

Each gm Contains:

Betamethasone Dipropionate 0.64mg

eq. to Betamethasone…0.50mg

-do-

681. 52961 Provate 0.05% w/w Ointment

Each gm Contains:



-do-

682. 52962 Cosmin 0.05% w/w Gel

Each gm Contains:

Isotretinoin…0.50mg

-do-

683. 52963 Provate-G Cream

Each gm Contains:



Gentamycin Sulphate…1.00mg

-do-

684. 52964 Provate-S Ointment

Each gm Contains:

Betamethasone (as

Dipropionate)…0.50mg

Salicylic Acid…30mg

-do-

685. 52965 Provate Lotion

Each ml Contains:



-do-

686. 52966 Provate-G Ointment -do-

Each gm Contains:



Gentamycin Sulphate…1.00mg

687. 52968 Water for Injection 5ml Ampoule

Each Injection Contains:

Water for Injection…5ml

-do-

688. 52969 Noctis 20mg

Capsule


Omeprazole (Omeprazole

Pellets)…20mg

-do-

689. 52988 Gatron Injection

Each ml Contains:

Granisetron (as HCl)…1.0mg

-do-

690. 52990 Amorob 500mg/100ml Injection


Metronidazole…500mg

-do-

691. 77026 Noctis 40mg

Capsule


Omeprazole (Pellets)…40mg

-do-

M/s. Regent Laboratories, C-20 S.I.T.E., Super Highway, Karachi

692. 4252 VITAMIN B COMPLEX TAB

EACH TABLET CONTAINS:

THIAMINE HCL 1MG,

RIBOFLAVIN 1MG,

NICOTINAMIDE 15MG,



mentioned against


reminder.

693. 4253 SULPHADIMIDINE TAB


SULPHADIMIDINE 500MG,

-do-

694. 4254 MULTIVITAMIN SYP

Contains:

VITAMIN A 14000 1UVITAMIN D

400 1UTHIAMINE HCL 2.8MG,

RIBOFLAVINE 3.4MG,

NICTINAMODE 28.4MG,

ASCORBIC ACID 85.2MG,

-do-

695. 4255 BISACODYL TAB


BISACODYL 5MG,

-do-

696. 4256 PARACETAMOL COMPOUND TAB


PARACETAMOL 200MG, ASPIRIN

300MG,

-do-

M/s. Ahsons Drug Company, T/1, S.I.T.E., Tando Adam, Sindh

697. 3865 Multivitamin Syrup

Each 5ml Contains:

Nicotinamide…5mg,

Vitamin A…2465Units, Thiamine



mentioned against


HCl…0.493mg,

Vitamin D…246, Riboflavin 5 Phos.

Sod. …0.600mg, Ascorbic

Acid…15mg

reminder.

698. 3864 ACRIFLAVIN NEUTRAL

OINTMENT

Each gm Contains:

ACRIFLAVIN NEUTRAL 0.1%,

-do-

699. 3866 METHYL SALICYLATE COMP.

BALM

Each gm Contains:

METHYLSALICYLATE 12.17%,

MENTHOL 2.6%, THYMOL 0.11%,

OIL EUCALYPTUS 9.11%,

-do-

700. 3867 PARACETAMOL ELIXIR

Contains:

PARACETAMOL 120MG,

-do-

701. 3868 VITAMIN B COMPOUND SYP

Each 5ml Contains:

Nicotinamide…7.66mg, Thiamine

HCl…1mg, Riboflavin 5Phos. Sod.

…1mg, Pyridoxine HCl…0.666mg

-do-

702. 30937 Cal-VC 1000 Tablet


Calcium Lactate Gluconate…1000mg



-do-

M/s. Swiss Pharmaceuticals (Pvt) Ltd, A/159, S.I.T.E., Super Highway, Karachi

75994 Sanamidol 40mg

Capsule


Omeprazole Enteric Coated Pellets eq.

to Omeprazole…40mg



mentioned against


reminder.

703. 76071 Glumet 1gm Tablet



-do-

704. 76070 Glumet 850mg Tablet



-do-

705. 76067 Mecomide 5mg/5ml Syrup

Each 5ml Contains:

Metoclopramide HCl…5mg

-do-

706. 76068 Mecomide 10mg Tablet


Metoclopramide HCl…10mg

-do-

707. 76069 Glumet 250mg Tablet



-do-

708. 18258 Lincomycin Capsule


-do-

Lincomycin HCl eq. to

Lincomycin…500mg

M/s. Novartis Pharma (Pakistan) Ltd, 15 West Wharf, Dockyard Road, Karachi

709. 22200 Azomax 250mg

Capsule





mentioned against


reminder.

710. 22201 Azomax 200mg

Oral Suspension

Each 5ml Contains:


-do-

711. 47670 Tamoxifen-Sandoz 10mg Tablet


Tamoxifen…10mg

-do-

712. 47671 Tamoxifen-Sandoz 20mg Tablet


Tamoxifen…20mg

-do-

713. 52235 Lozal 40mg

Powder for Infusion

Each Vial of Powder for Solution for

Infusion Contains:

Omeprazole Sodium eq. to 40mg

Omeprazole

-do-

714. 48831 Risperidone-Sandoz 1mg Tablet


Risperidone……….1mg

-do-




-do-




-do-




-do-

M/s. Pearl Pharmaceuticals, Plot No. 204, Street No. 1, I-10/3 Industrial Area, Islamabad.

718. 051121 Claribest Tablets 250mg


Clarithromycin…….250mg

(USP Specs)



mentioned against


reminder.

719. 051122 Claribest Tablets 500mg.


Clarithromycin….500mg

(USP Specs)

-do-

M/s. Epla Laboratories (Pvt) Ltd., D-12, Estate Avenue, S.I.T.E., Karachi

720. 050359 Esgerd 40mg

Capsule

Each capsules contains:



mentioned against

Esomeprazole enteric coated pellets

(as Magnesium Trihydrate)…40mg

Source: M/s Inventia Healthcare Pvt

Limited, F1-F1/1, additional

Ambernath M.I.D.C Ambernath (East)

421 506, Distt Thane Maharashtra

State India.


reminder.

721. 050358 Esgerd 20mg

Capsule



(as Magnesium Trihydrate)….20mg

Source: M/s Inventia Healthcare Pvt

Limited, F1-F1/1, additional

Ambernath M.I.D.C Ambernath (East)

421 506, Distt Thane Maharashtra

State India.

-do-

M/s. Frontier Dextrose Ltd., Plot No. 18/3, Phase-I, Hattar Industrial Estate, Haripur

722. 049285 Sterifluid-DS 1/2 Infusion


Dextrose Monohydrate eq. to

Anhydrous Dextrose…5gm




mentioned against


reminder.

723. 049286 Sterifluid-Pead's Infusion



Anhydrous Dextrose…4.3gm


-do-

724. 049818 Sterifluid-5 Infusion



Anhydrous Dextrose …..……5gm.

(B.P Specs)

-do-

725. 049819 Sterifluid-10 Infusion



Anhydrous Dextrose

…..………….……10gm.(B.P Specs)

-do-

M/s. Cherwel Pharmaceuticals (Pvt) Ltd., Plot No. 20, Phase 4, Hattar Industrial Estate, Hattar

726. 49490 Cherofex Tablets 60mg


Fexofenadine

USP………………60mg.



mentioned against


reminder.

727. 49489 Cipwel Tablet 250mg


Ciprofloxacin as HCl USP……250mg.

(USP Specs)

-do-

728. 49487 Execc Tablets 10mg


-do-

Escitalopram as Oxalate………10mg.

729. 051068 Chergab Capsules 300mg


Gabapentin……..300mg.

-do-

730. 049491 Myzan 2mg Tablet


Tizanidine USP……….2mg. (USP

Specs)

-do-

731. 050806 Ferwel Tablets


Iron III Hydroxypolymaltose complex

eq. to elemental Iron …….….100mg.

Folic Acid …………0.35mg.

-do-

732. 049488 Kerwel Tablets


Diclofenac Potassium USP……50mg.

(USP Specs)

-do-

M/s. Novins International (Pvt) Ltd., E-37-38, Port Bin Qasim Authority, Karachi

733. 48837 PGMin Tablet


Pioglitazone (as HCl)…15mg




mentioned against


reminder.

734. 48838 NoviCip 250mg Tablet



-do-

735. 48839 NoviCip 500mg Tablet



-do-

736. 48840 Loxiwell 250mg Tablet


Levofloxacin (as


-do-

737. 48841 Loxiwell 500mg Tablet


Levofloxacin (as

Hemidydrate)…500mg

-do-

M/s. Maple Pharmaceutical (Pvt) Ltd., Plot#147, Sector 23, Korangi Industrial Area, Karachi.

738. 48788 Adgab 100mg

Capsule


Gabapentin…100mg



mentioned against


reminder.

739. 48789 Acelo 100mg Tablet


Aceclofenaac…100mg

-do-

740. 48790 Olisa 5mg Tablet


Olanzapine…5mg

-do-

741. 48791 Olisa 10mg Tablet -do-


Olanzapine…10mg

742. 48792 Gemap 320mg Tablet


Gemifloxacin (as Mesylate)…320mg

-do-

743. 48793 Glibetic Tablet


Pioglitazone…15mg

Glimepiride…2mg

-do-

744. 48794 Levolife 250mg Tablet


Levofloxacin (as


-do-



Levofloxacin (as


-do-



Levofloxacin (as


-do-

747. 48797 Megab 75mg

Capsule


Pregabalin…75mg

-do-

748. 48798 Megab 150mg

Capsule


Pregabalin…150mg

-do-

749. 48799 Megab 300mg

Capsule


Pregabalin…300mg

-do-

M/s. Elko Organisation (Pvt) Ltd., 27&28, Sector 12/B, North Karachi Industrial Area, Karachi

750.

6065

LINCOMYCIN 600MG

INJ

Contains:

LINCOMYCIN HCL 600MG,



mentioned against


reminder.

751.

14274

Elkogent Injection

Each 2ml Contains:

Gentamicin Sulphate eq. to 80mg

Gentamicin Base -do-

M/s. Bio-labs (Pvt) Ltd, Plot No. 145 Kahuta Triangle Industrial Estate, Islamabad.

752.

52570

Leptic tablets 200mg


Carbamazepine ..…200mg

(USP Specs)



mentioned against


reminder.

753. 52571 Glicala Tablets 80mg -do-


Gliclazide….…80mg

(B.P Specs)

754.

52572

Bidop Tablets


Carbidopa as

monohydrates……….25mg

Levodopa …………250mg

(USP Specs)

-do-

755.

29673

Kerry Quine 20 Liquid

Each ml Contains:

Flumequine…200mg

-do-

756.

29674

Kerry Flush Water Soluble Powder


Methenamine…90gm

Vitamin B1…700mg

Vitamin C…100mg

Sorbitol…5000mg

-do-

757.

29675

Kerry ADEK Water Soluble Powder

Each kg Contains:

Vitamin A…20MIU

Vitamin D3…2MIU

Vitamin E…6000mg

Vitamin K3…5000mg

-do-

M/s. GlaxoSmithKline Pakistan Limited, Plot No. 5, Sector 21, Korangi Industrial Area, Karachi

758. 21770 Calpol Plus Tablet


Paracetamol…500mg

Caffeine…65mg



mentioned against


reminder.

759. 012427 Calpol 6 Plus Suspension

Each 5ml Contains:

Paracetamol…250mg

-do-

760. 000354 Calpol Suspension

Each 5ml Contains:

Paracetamol…120mg

-do-

761. 001612 Calpol Tablet


Paracetamol…500mg

-do-

762. 003375 Ceporex Capsule 250mg


Cephalexin Anhydrous (as

Cephalexin)…250mg

-do-




Cephalexin)…500mg

-do-

764. 010806 CeporexPaediatric Drops

Each 1.25ml Contains:

-do-

Cephalexin…125mg

765. 003374 Ceporex Syrup 125mg/5ml

Each 5ml Contains:


Cephalexin)…125mg

-do-


Each 5ml Contains:


Cephalexin)…250mg

-do-

767. 000060 Furacin Cream

Contains:

Nitrofurazone in Water-Soluble

Base…0.2%w/w

-do-

768. 000068 Furadantin Tablet


Nitrofurantoin…100mg

-do-

769. 001608 Lanoxin Injection

Each 2ml Ampoul Contains:

Digoxin…0.5mg

-do-

770. 000365 Lidosporin Ear Drops

Each ml Contains:


Lignocaine HCl…50mg

Propylene Glycol…0.92ml

-do-

771. 000370 Otosporin Ear Drops

Each ml Contains:


Neomycin Sulphate…3,400Units


-do-

772. 003100 Dermovate Cream

Contains:

Clobetasol Propionate…0.05%w/w

-do-

773. 006230 Dermovate NN Ointment

Contains:


Neomycin Sulphate…0.5%w/w

Nystatin.100,000 Units per gm

-do-

774. 003139 Dermovate Ointment

Contains:


-do-

775. 008382 Marzine Syrup

Each 5ml Contains:

Cyclizine HCl…12.5mg

-do-

776. 000179 Maxolon Syrup

Each 5ml Contains:

Metoclopramide HCl eq. to Anhydrous

Sustance…5mg

-do-

777. 089275 Maxolon Injection

Each 2ml Contains:

Metoclopramide…10mg

-do-

778. 000219 Orbanin Syrup

Each 5ml Contains:

Cloxacillin as Cloxacillin

Sodium…125mg

-do-

779. 000401 FefolSpansule Capsule

Each Spansule Capsule Contains:

Exsiccated Ferrous Sulphate…150mg

Folic Acid…0.5mg

-do-

780. 000402 Feospen Z Spansule Capsule


Exsiccated Ferrous Sulphate…150mg

Zinc Sulphate Monohydrate…61.8mg

-do-

781. 20543 Fefol Z Spansule Pellets


Dried Ferrous Sulphate…150mg

Zinc Sulphate Monohydrate (eq. to

22.5mg

Elemental Zinc)…61.8mg

Folic Acid…0.5mg

-do-

782. 013321 Nemazole Suspension

Each 5ml Contains:

Mebendazole…100mg

-do-

783. 013320 Nemazole Tablet


Mebendazole…100mg

-do-

784. 017306 Nemazole-500 Chewable Tablet


Mebendazole…500mg

-do-

785. 000355 Cicatrin Powder

Each gm Contains:

Neomycin Sulphate…3300 Units

Bacitracin Zinc…250 Units

-do-

786. 000357 Cortisporin Eye Ointment

Each gm Contains:

Polymyxin B Sulphate…5000 Units



Hydrocortisone…10mg

-do-

787. 000301 Cytacon Liquid

Each 5ml Contains:

Cynocobalamin…25mcg

-do-

788. 015819 Fortum Injection 250mg

Each Vial Contains:

Ceftazidime as Ceftazidime

Pentahydrate…250mg

-do-

789. 010078 Fortum Injection 500mg

Each Vial Contains:


Pentahydrate…500mg

-do-

790. 010077 Fortum Injection 1gm -do-

Each Vial Contains:


Pentahydrate…1gm

M/s. Karachi Pharmaceutical Laboratories, S/54, Hawkes Bay Road, S.I.T.E., Karachi

791. 50681 Acepril Tablet


Captopril..……………...50mg

Hydrochlorothiazide...…25mg



mentioned against


reminder.

792. 50680 Pyrocam 20mg

Capsule


Piroxicam….... .20mg

-do-

793. 9930 Ministal Tablet 250mg


MEFENAMIC ACID 250MG

-do-

M/s. MeDLey Pharmaceuticals, 41-A, P.S.I.E. JhangBahtar Road, WahCantt. Rawalpindi

794. 075453 Le-Ride 100mg

Capsule


Levosulpiride….100mg



mentioned against


reminder.

795. 075454 Arte-M Capsule 20/120


Artemether…20mg


-do-

796. 075455 Arte-M Capsule 40/240


Artemether…40mg


-do-

797. 075456 Z-Cin 250mg

Capsule


Azithromycin Dihydrate…250mg

-do-

798. 075457 Mexo120mg

Capsule


Fexofenadine…120mg

-do-

799. 075458 MecoCap 500mcg Capsule



-do-

800. 075459 Meroxi 20mg

Capsule


Piroxicam as Beta-

Cyclodextrin…20mg

-do-

801. 075460 Medifos 500mg

Capsule


Fosfomycin Calcium eq. to

-do-

Fosfomycin…500mg

802. 075461 Maltoley Syrup

Each ml Contains:


Complex..100mg

Folic Acid…0.35mg

Sugar Free Syrup

-do-

803. 075462 Letose Syrup

Each 5ml Contains:


Complex…50mg

-do-

804. 075463 Medfir 10mg Tablet


Adefovir Dipivoxil…10mg

-do-

805. 075464 Medcavir 0.5mg Tablet


Entecavir as Monohydrate…0.5mg

-do-

806. 075465 T-Poxi 20mg Tablet


Paroxitine (as HCl)…20mg

-do-

807. 075466 Ice 30 Capsule


Lansoprazole (Pellets)…30mg

Source : M/s Vision Pharmaceuticals

Islamabad.

-do-

808. 075467 Olx 20mg

Capsule




Islamabad.

-do-

809. 075468 D-Lox 40mg

Capsule


Duloxetine as HCl (Pellets)…40mg


Islamabad.

-do-

810. 075469 Kanamed 1gm

Injection


Kanamycin Sulphate eq. to Kanamycin

Base…1000mg

-do-

811. 075472 Medka 100mg

Injection

Each Vial Contains:

Amikacin (as Sulphate)…100mg

-do-

812. 075473 Medka 250mg

Injection

Each Vial Contains:


-do-

813. 075474 Medka 500mg

Injection

Each Vial Contains:


-do-

M/s. Attabak Pharmaceuticals, Plot No. 5C, Industrial Area I-10/3, Islamabad

814. 48159 Levofas Gold Oral Suspension


Levamisole HCl…3gm

Oxyclozanide…6gm

Cobalt Chloride…0.764gm

Sodium Selenite…0.076



mentioned against


reminder.

815. 48160 Respitil Aqueous Concentrate

Each ml Contains:

Tilmicosin (as Phosphate)…250mg

816. 48161 Levacid Oral Solution



817. 48162 Pulmorol-T Aqueous Solution

Each ml Contains:



Bromohexine HCl…10mg

818. 48163 Meloxibak Injection

Each ml Contains:

Meloxicam…7.5mg

819. 48164 Albak Granules

Each kg Contains:

Albendazole…200gm

820. 48165 AXY-Vit Powder

Each 450g Powder Contains:

oxytetracycline HCl…50g


Vitamin D3…360,000IU

Vitamin E…800mg

Vitamin K…720mg

Vitamin B2…300mg

Vitamin B12…200mcg

Niacinamide…12000mg

Calcium-D-Pentothenate…4600mg

821. 48166 Fosfabak Injection

Each ml Contains:

Toldimfos Sodium…100mg

(Source of Phosphours in Medicine)

822. 48167 Gentabak-Plus Injection

Each ml Contains:

Gentamycin (as Sulphate)…30mg

Trimethoprim…25mg

Sulphadimidine…125mg

823. 48168 Toltrabak Oral Solution

Each ml Contains:

Toltrazuril…25mg

824. 48169 Gentylobak Injection

Each ml Contains:

Gentamycin (as Sulphate)…50mg

Tylosin (as Tartrate)…100mg

825. 48170 Tiamubak 45% Oral Powder


Tiamulin Hydrogen Fumarate eq. to

Tiamulin Base…45gm

826. 48173 Levofas Oral Suspension



Oxyclozanide…3gm

Cobalt Chloride…0.382gm

827. 48174 Asper-Cool Water Soluble Powder


Acetylsalicyclic Acid…67gm

Vitamin C…200gm


Sodium Citrate…7gm

828. 48171 Colibak Injection



829. 48176 Tylometrol Injection

Each ml Contains:



Dimetridazole…100mg

830. 48177 EC-Cool Plus Oral Suspension


Ascorbic Acid…200gm



Sodium Citrate…7.8gm

831. 48178 Oxfenda Gold Oral Suspension

Each ml Contains:

Oxfendazole…22.65mg

Cobalt Chloride…3.82mg

Sodium Selenite…0.35mg

M/s. SB Pharma, Plot No. 5-F, Industrial Triangle, Kahuta Road, Islamabad

832. 48219 SB Tiamulin Oral Powder



Tiamulin Base…12.5gm



mentioned against


reminder. 833. 48221 SB Tiamulin 45% Oral Powder




834. 48222 SB Protectine Oral Powder


Tylosine Tartrate eq. to Tylosine

Base…100gm

Doxycycline HCl eq. to Doxycycline

Base…200gm

Colistine Sulphate eq. to Colistine

Base…500MIU

Phenylbutazone…12gm

Bromohexine…5gm

835. 48223 SB Tiaclor Oral Powder




Chlortetracycline HCl eq. to

Chlortetracycline Base…300gm

836. 48224 SB Exitil Oral Suspension


Albendazole…12.5%

M/s. Star Laboratories (Pvt) Ltd., 23-Km Multan Road (Chung), Lahore

837. 49550 Alvenax-150 bolus

Each bolus contains:

Albendazole 150mg



mentioned against


reminder. 838. 49551 Alvenax-300 bolus


Albendazole 300mg

839. 49552 Alvenax-360 bolus


Albendazole 360mg

840. 49554 Tetraclozan Sheep 900 bolus


Tetramisole HCL 450mg

Oxyclozanide 450mg

841. 49553 Nizam Bolus


Levamisole 1000mg

Oxyclozanide 1400mg

842. 30808 Glucoride-1 Tablets


Glimepride…….1mg

843. 30809 Glucoride -2 Tablets



844. 30810 Tyzitec Syrup

Each 5ml contains:

Cetirizine Dihydrochloride…..5mg

845. 4347 Water for injection

846. 30802 Stardone Tablets


Domperidone 10mg

847. 30803 Stardone Suspension

Each 1ml contains:

Domperidone 1mg

848. 30804 Stargesic tablet


Orphenadrine Citrate 35mg

Paracetamol 450mg

849. 14141 PENICILLIN-40 INJECTION

Each Vial Contains:

BENZYL PENICILLIN 1000000

I.U.

PROCAINE PENICILLIN 3000000

I.U.

850. 14142 OXAZOL DRENCH

Each ml contains:

OXFANDAZOLE 2.265%

851. 14143 OXYCORT SPRAY

Each 300ML contains:

OXYTETRACYCLINE HCL

1500MG


M/s. Symans Pharmaceuticals (Pvt) Ltd., 10-Km Sheikhupura Road, Lahore

852. 14133 Symostress Water Soluble and Feed

Additive Powder

EACH KG CONTAINS:


Vitamin D3…3,000,000IU

Vitamin E…6000mg

Vitamin K3…4000mg

Vitamin B1…5000mg

Vitamin B2…6000mg

Vitamin B6…4000mg

Vitamin B12…9000mcg

Vitamin C…15000mg

Folic Acid…750mg

Nicotinic Acid…25000mg

Calcium Pantothenate…10,000mg



mentioned against


reminder.

M/s. Breeze Pharma (Pvt) Ltd., (125-126-127) A, Industrial Triangle, Kahuta Road, Islamabad

853. 75666 ALBA 10 SUSPENSION

Each 100 ml contains:

ALBENDAZOLE ……10% W/V

SODIUM SELENITE……...0.035%

W/V

COBALT CHLORIDE……..0.075%

W/V



mentioned against


reminder.

854. 75662 ALMOXIN-C WATER SOLUBLE

POWDER

Each gm Contains:

AMOXYCILLIN TRIHYDRATE

………..200MG

COLISTIN SULPHATE....

60,00,000 IU

855. 75677 AVICOX WATER SOLUBLE

POWDER

EACH KG CONTAINS:

SULPHAQUINOXALINE

(SODIUM)…….200,000 MG,

SULPHADIMIDINE

(SODIUM)……....82,500MG,

DIAVERIDINE…...40, 000MG,

Vitamin A….28, 00,000IU,

Vitamin K3……...2000MG

856. 75668 COXIKIL WATER SOLUBLE

POWDER


2,4-DIAMINO-5

(VERATRYPYRIMIDINE)..25GM

SULPHABENZYLPYRAZINE……

……………100GM

VIT-A……….12,50,000 IU VIT-

K3…………..2.5GM

857. 75654 DIMOX INJECTION

Each ml contains:

SULPHADIMIDINE (AS

SODIUM)…………33% W/V

858. 75663 ENROCAM LIQUID


ENROFLOXACIN……….10GM

COLISTIN SULPHATE….... 3GM

AMANTADINE…….... 4GM

859. 75673 Rodox Water Soluble Powder


TYLOSIN TARTRATE……10GM

DOXYCYCLINE HCI…..20GM

860. 75652 MELONAC PLUS INJECTION

Each ml contains:

MELOXICAM…… ...10MG

861. 75671 MOTIL LIQUID

Each ml contains:

TILMICOSIN

PHOSPHATE………250MG

862. 75659 NCO-60 WATER SOLUBLE

POWDER

Each gm Contains:

OXYTETRACYCLINE

HCI……………...20% W/V

COLISTIN SULPHATE…….20%

W/V

NEOMYCIN…..20% W/V

863. 75661 OXYTRON 100 INJECTIONS

Each ml contains:

OXYTERTRACYCLNE...100MG

864. 75653 OXYTRON LA INJECTION

Each ml contains:

OXYTERTRACYCLINE ….200MG

865. 75676 PYRAMINOL INJECTION

Each ml contains:

DIMINAZINE

ACETURATE….…105MG

ANTIPYRINE……...131MG

866. 75660 RAPID-TD WATER SOLUBLE

POWDER

EACH 100 GM CONTAINS:

TYLOSIN TARTARATE ….20

GMDOXYCYCLINE HYCLATE

………....25 GM

867. 75656 RESPORAL LIQUID

Each ml contains:

TYLOSIN TARTRATE…...100MG

DOXYCYCLINE HCI ...200MG

COLISTIN

SULPHATE……….500000 IU

BROMHEXINE HCL …....2MG

868. 75674 SOLODEX INJECTION.

Each ml contains:

PREDNISOLONE (AS

ACETATE)………7.5MG

DEXMETHASONE (AS SODIUM

PHOSPHATE)…........2.5MG

869. 75667 SOLVITA-S SOLUTION


VITAMIN E…...5.00GM

SODIUM SELENITE ...15.00MG

870. 75672 SUPER FLUSH WATER

SOLUBLE POWDER

EACH KG CONTAINS:

FUROSEMIDE………...20GM,

POTASSIUM CHLORIDE….4GM,

CALCIUM CARBONATE...45GM,

MANGANESE SULPHATE...1GM

871. 75658 SUPER LEVA WATER SOLUBLE

POWDER


LEVAMISOLE HCL …….15%

872. 75669 TOLZUR PLUS LIQUID


TOLTRAZURIL……2.5GM

VIT-K3……………..0.2GM

873. 75657 TRICLOFON POWDER

Each gm Contains:

TRICHLORFON…. 985MG

874. 75670 TY-DOX PLUS LIQUID

EACH 1000ML CONTAINS:

TYLOSINTARTRATE…...100GM,

DOXYCYCLINE HCI…200GM,

COLISTIN SULPHATE.500 MIU,

BROMHEXINE…...12GM

875. 75655 TYLOX-20 INJECTION

Each ml contains:

TYLOSIN (AS

TARTARATE)……..200MG

876. 75664 Y-Gent 5% Injection

Each ml contains:

GENTAMYCIN SULPHATE

EQUAL TO 50MG

GENTAMYCIN BASE

M/s. Mallard Pharmaceuticals (Pvt) Ltd., 23-Km Lahore Road, Multan.

877. 049561 Target 10 Liquid

Each ml Contains:

Fenbendazole…10mg



mentioned against


reminder. 878. 049562 Wealdox Powder

Each kg Contains:

Doxycycline HCl…200gm

879. 049563 Wealcol Powder


Colistin Sulphate…500,000.000IU

880. 049564 Wealcoc Powder

Each kg Contains:

Amprolium…200gm

Furaltadone…200gm

Vitamin K3…5gm

881. 049565 Neoct-C Powder

Each kg Contains:

Colistin Sulphate…8gm

Neomycin…140gm

Chlortetracycline…160gm

882. 049566 Liso 10 Powder

Each gm Contains:

Lysozyme…22%

Vitamin E 50 SD…0.5%

883. 049567 Daro Mall Powder



Streptomycin Sulphate…400mg

Suphaguanidine…4gm

Kaolin…4gm

Pectin…400mg

Bismuth Subnitrate…2gm

Vitamin A…8000IU

884. 049568 Enromall 20 Liquid

Each ml Contains:

Enrofloxacin…200mg

885. 049569 Saprox Liquid

Each ml Contains:

Sulphadiazine…35.500mg

Sulphadimidine…28.400mg

Neomycin Sulphate…1.800gm

Hyoscine Methyl bromide…0.040mg

Pectin…7.100gm

Kaolin…103.3mg

Vitamin B1…0.150mg

Vitamin B2…0.220mg

M/s. Efroze Chemical Industries (Pvt) Ltd., 146/23, Korangi Industrial Area, Karachi

886. 048811 Declot Tablet

Each tablet contains::

Clopidogrel (as

Bisulphate)….75mg(USP

Specification)



mentioned against


reminder.

887. 048815 Efome Capsule

Each Capsule Contains::

Omeprazole enteric coated pellets eq.

to Omeprazole……40mg

888. 048816 Efrozole 20mg

Capsule



(as Magnesium Trihydrate) …20mg

889. 048817 Efrozole 40mg

Capsule



(as Magnesium Trihydrate).…40mg

890. 048812 Montef 4mg

Chewable Tablet

Each chewable tablet contains:

Montelukast (as Sodium) …….4mg

891. 048813 Montef 5mg

Chewable Tablet


Montelukast (as Sodium)…….5mg

892. 048814 Montef 10mg Tablet

Each film coated tablet contains::


M/s. Alina Combine Pharmaceuticals (Pvt) Ltd, A-127, S.I.T.E., Super Highway, Karachi

893. 48183 Oxytetracycline 10% Injectable

Solution

Each ml Contains:



mentioned against

Oxytetracycline HCl…100mg Each and advised to issue a final

reminder. 894. 48184 Tylosin 20% Injectable Solution

Each ml Contains:

Tylosine (as Tartrate)…200mg

895. 49536 Alfamycine 10% Injectable Solution

Each ml Contains:

Gentamicin (as Sulphate)…100mg

896. 48180 Alfamec 1% Injectable Solution

Each ml Contains:

Ivermectin…10mg

897. 48181 Xylazine 2% Injectable Solution

Each ml Contains:

Xylazine (as HCl)…20mg

898. 48182 Lincomycine-Spectinomycin 5/10

Injectable Solution

Each ml Contains:

Lincomycin (as HCl)…50mg

Spectinomycin (as HCl)…100mg

899. 48185 Multivitamin Injectable Solution

Each ml Contains:

Vitamin A (as Synthetic Concentrate

Oily Form)…15,000IU

Cholecalciferol (as Concentrate Oily

Form)…1000IU

Alpha tocopheryl Acetate…20mg

Thiamine HCl…10mg

Riboflavine Sodium

Phosphate…6.85mg

Pyridoxin HCl…3mg

Cyanocobalamin…50mcg

Nicotinamide…35mg

Dexpanthenol...25mg

900. 48269 Altrim Injectable solution

Each ml contains:

Sulphadiazine Sodium 200mg

Trimethoprin 40mg

901. 48270 Oxyla 10% Injectable

Contains:

Oxytetracycline HCL 100mg

902. 48271 Colistin S Injectable solution

Each ml contains:

Colistin Sulphate 200000IU

903. 48272 Almec 1% Injectable solution

Each ml contains:

Ivermection 10mg

904. 48273 Oxyta Injectable solution

Each ml contains:

oxytetracycline 200mg

905. 48282 Altrim pus Injectable solution

Each ml contains:

Sulphadiazine Sodium 400mg

Trimethoprin 80mg

906. 48283 Alfacin 5% Injectable solution

Each ml contains:

Gentamicin 50mg

907. 48284 Alfacin 10% injectable solution

Each ml contains:

Gentamicin 100mg

908. 48285 Floxin 10% injectable solution

Each ml contains:

Norfloxacin 100mg

909. 48290 Genta-AC Injection

Each ml Contains:

Gentamycin…25mg

Amoxicillin…50mg

910. 48291 Colitylo DM Injection

Each ml Contains:



Dimetridazole…100mg

911. 48292 Spec-Lin Injection

Each ml Contains:

Lincomycin…50mg


912. 48278 Alfacin 15% Injectable Solution

Each ml Contains:

Gentamycin…150mg

913. 48279 C-Phenicol Injectable Solution

Each ml Contains:

Chloramphemicol…200mg

914. 48280 Vutazon SS Injectable Solution

Each ml Contains:

Phenylbutazone…200mg

915. 48281 Tylosin 20% Injectable Solution

Each ml Contains:

Tylosin…200mg

916. 48266 Ciprolina 20% Solution


Ciprofloxacin…20gm

917. 48267 Flumicon-50 Powder

Each kg Contains:

Flumequine…500gm

918. 48268 T-Mycin Oral Solution

Each ml Contains:

Tilmicosin…250mg

919. 48286 Dinsolone Injection

Each ml Contains:

Prednisolone…25mg

920. 48287 Enflox 5% Injectable Solution

Each ml Contains:

Enrofloxcacin…50mg

921. 48288 Foxylina Injection

Each ml Contains:

Oxytetracycline…300mg

(as eq. to Oxytetracycline Dihydrate)

Flunixin Meglumine…20mg

922. 48289 Methasolone Injection

Each ml Contains:

Prednisolone…7.5mg

Dexamethasone…2.5mg

923. 48293 Doctyl Plus E/S Powder


Tylosin Tartrate…20gm


924. 48294 Tycoli Powder


Tylosin Tartrate (Vet)…10gm

Doxycycline HCl (Vet)…20gm

Colistin Sulphate (Vet)…500MIU

Bromohexine (Vet)…5gm

Phenyl Butazone (Vet)…12gm

M/s. Novartis Pharma (Pakistan) Ltd, 15 West Wharf, Dockyard Road, Karachi

925. 021129 Femara 2.5mg Tablet


Letrozole…2.5mg



mentioned against


reminder.

M/s. Atco Pharma International (Pvt) Ltd., B-18, S.I.T.E., Karachi

926. 047676 FEMIZET TABLETS 1MG

Each FILM COATED TABLETS

contains:

ANASTROZOLE IH*…1MG

(In House)



mentioned against


reminder.

M/s. Medi Mark Pharmaceuticals, 588-B/1, LiaquatChowk, Sahiwal

927. 21920 Traxef 250mg

IV Injection

Each Vial Contains:


Ceftriaxone Sodium Base…250mg



mentioned against


reminder.

928. 21919 Traxef 500mg

IV Injection

Each Vial Contains:



929. 21921 Traxef 1gm

IM Injection

Each Vial Contains:


Ceftriaxone Sodium Base…1gm

930. 21200 Traxef 1gm

IV Injection

Each Vial Contains:


Ceftriaxone Sodium Base…1gm

931. 21923 Traxef 250mg

IM Injection

Each Vial Contains:



932. 21922 Traxef 500mg

IM Injection

Each Vial Contains:



M/s. Better Traders International, 23-Z, Saifullah Shaheed Road, Madina Town, Faisalabad

933. 049560 Kepromec Oral

Each ml Contains:

Ivermectin…10mg



mentioned against


reminder.

M/s. Vet Line International, Flat No. 55/5, First Floor, Shadman Market, Lahore

934. 049749 Tylo-Suscit Powder

Each gm Contains:




mentioned against


reminder. 935. 049750 Sulfaclozin Na 60% Powder

Each gm Contains:

Sulfaclozin Sodium…600mg

M/s. ICI Pakistan Ltd., 5-West Wharf, Karachi

936. 003023 Nilzan Bolus

Each Bolus Contains:

Tetramisole HCl B.Vet.C…2gm

Oxyclozanide BP Vet…1.4gm



mentioned against


reminder. 937. 003021 Nilverm Bolus

Each Bolus Contains:

Tetramisole HCl B.Vet.C…2gm

M/s Marvi Pharmaceuticals Pvt Limited Karachi

938. 012777 Pain Gay Ointment

Each gm contains:-

Methyl salicylate ……150mg

Menthol….100

Registration Board deferred the above

case for opinion of Legal Affairs

Division. *(Deferred in 288th Meeting)

M/s ICI Pakistan Limited Karachi.

939. 001318 Ketress tablet 40mg


Levamisole HCL BP 47.2mg

Eq. to 40mg

as Levamisole


case for opinion of Legal Affairs

Division.

940. 001317 Ketress Syrup

Each 5ml contains:-

Levamisole 40mg( as HCl 47.2mg)

a) M/s. Atco Laboratories Limited, Karachi

941. 044868 Fytosid 100mg

Injection

Each ml contains:-

Etoposide USP…20mg

Manufactured by M/s Dabur

Pharma Ltd,India


cases for evaluation under Import

Policy for Finished Drugs, however

the renewal status shall be

communicated to the concerned

section for processing of post

registration variation at their end. 942. 044869 Adrim 50mg

injection


Doxorubicin HCl…..50mg

943. 044870 Adrim 10mg

injection

Each 5ml contains:-

Doxorubicin HCl…..10mg

944. 044881 Intaxel 30mg

Injection

Each ml contains:-

Paclitaxel USP…..6mg


Pharma Ltd,India

945. 044882 Intaxel 100mg

Injection

Each ml contains:-

Paclitaxel USP…..6mg


Pharma Ltd,India

946. 044872 Cytarine 500mg

Injection

Each ml contains:-

Cytarabine B.P….500mg


Pharma Ltd,India

947. 044871 Cytarine 100mg

Injection

Each ml contains:-

Cytarabine B.P….100mg


Pharma Ltd,India



No.


M/s. Eros Pharmaceuticals (Pvt) Ltd, 94-95/23 Korangi Industrial Area, Karachi

1. 004498 COFSED SYPAmmonium Chloride Deferred

M/s. Benson Pharmaceuticals, Plot No. 119, Street No. 08, Sector I-10/4, Industrial Area, Islamabad

2. 022541 Lovin Tablets


Clomiphene Citrate…50mg

Deferred for the clarification of

address from the licensing division.

M/s. Elko Organization (Pvt) Ltd, Plot No. 27 & 28, Sector 12-B, North Karachi, Industrial Area,

Karachi.

3. 076092 El-Clari 250mg Tablet


Clarithromycin ……..250 mg


products for rectification of

shortcomings as mentioned in the last

column.

4. 076093 El-Clari 500mg Tablet


Clarithromycin ............500 mg

-do-

5. 014412 Vibsan Capsule100mg


Doxycycline Hyclate…100mg

-do-

6. 001017 GENTAMYCIN -EYE/EAR

DROPSEach ml contains:-

Gentamycin…3mg

-do-

M/s. Cirin Pharmaceuticals (Pvt) Ltd, 32/2-A, Phase III, Industrial Estate, Hattar.

7. 052664 Advoxil Tablets 10mg.


Adefovir Dipivoxil…..10mg.




column.

8. 052665 Virnil Tablets 100mg.


Lamivudine…….100mg

-do-

9. 052666 Tazopip Injection.


Piperacilline as Na …………2gm.

Tazobactum as

Na……………..0.250gm.

-do-

10. 022531 Febridol Tablet 500mg


Paracetamol………500mg

-do-

11. 022532 Arthodol Tablet 50mg



-do-

12. 022533 Protopin Capsule 30mg

Each Film Coated Tablet Contains:-

Lansoprazole…30mg

-do-

13. 022534 Protopin HA Capsule 15mg


Lansoprazole…15mg

-do-

14. 004311-EX Moral Tablets



Misoprostol…200mcg"

-do-

15. 004312-EX Moral Tablet



Misoprostol…200mcg"

-do-

16. 052668 Capvir Tablets 400mg.


Ribavirin ……….400mg.

-do-

17. 052669 Capvir Tablets 200mg.


Ribavirin ……….200mg.

-do-

M/s. IPP Islamabad, 34-Industrial Triangle, Kahuta Road, Islamabad.

18. 031242 Rebugen Tablets


Ibuprofen……….600mg




column.

19. 031243 Nallergy Tablet



-do-

20. 031244 Histeese Tablets


Loratadine……….10mg

-do-

21. 031245 Diflofen-K Tablets Each tablet

contains:-

Diclofenac Potassium….50mg

-do-

22. 031246 Lotemp Tablets


Paracetamol…….500mg

-do-

M/s. Novae Pharmaceuticals, Plot No. 123, Phase V, Industrial Estate, Hattar.

23. 077471 Xibocel 200 mg

Capsule


Celecoxib………200 mg




column.

24. 077472 Navozith 250 mg

Capsule


Azithromycin dihydrate ≡

Azithromycin …250 mg

-do-

25. 077473 Novaedaxin 250 mg

Dry Powder Suspension

Each 5ml contains:-

Ciprofloxacin Hydrochloride ≡

Ciprofloxacin …..250 mg

-do-

26. 077474 Arthefant Dry Powder Suspension

Each 5ml contains:-

Artemether………..15 mg

Lumefantrine……...90 mg

-do-

27. 077475 Novaeflox 125 mg


Each 5ml contains:-

Levofloxacin hemihydrates ≡

Levofloxacin ….125 mg

-do-

28. 077476 Zason 10 mg


-do-

Each 5ml contains: Zinc

Sulphate monohydrate ≡ Zinc

(element)……10 mg

29. 077477 Bevexin 20 mg Tablets


Piroxicam β-Cyclodextrin. ≡

Piroxicam…..….20 mg

-do-

30. 077478 Novaeflox Tablets 250 mg


Levofloxacin Hemihydrate ≡

Levofloxacin ………..250 mg

-do-

31. 077479 Novaeflox Tablets 500 mg


Levofloxacin Hemihydrate ≡

Levofloxacin……500 mg

-do-

32. 077480 Novaedaxin 250 mg Tablets


Ciprofloxacin Hydrochloride

≡ Ciprofloxacin ….250 mg

-do-

33. 077481 Novaedaxin 500 mg Tablets



≡ Ciprofloxacin… .500 mg

-do-

34. 077482 Montigrat Tablets 10 mg


Montelukast Sodium

≡Montelukast …………….….10 mg

(Leukotriene Receptor Antagonist)

-do-

35. 077483 Novacid 100 mg Tablets


Flurbiprofen..........100 mg

-do-

M/s. Jaens Pharmaceutical Industries (Pvt) Ltd.

36. 052918 Dicip I/V Infusion

Each 100ml Contains:-

Ciprofloxacin as Lactate …. 200mg




column.

37. 052919 Hi Tears Eye Drops

Each ml contains:-

Hypromellose (HPMC) …. 0.3%

Dextran …. 0.1%

-do-

M/s. Caraway Pharmaceuticals, National Industrial Zone, (RCCI) Rawat, Islamabad.

38. 052608 Ranisifar Injection

Each ampoule 2ml contains:-

Ranitidine (as HCl)……………..50

mg




column.

39. 052731 Cara-IN-D Each ampoule

contains:-

Vit. D-3(Cholecalciferol)…5mg

-do-

M/s. Helicon Pharmaceutek Pakistan (Pvt) Ltd, Model Town Road, Faisalabad.

40. 005308 Entevigor Tablet


Domperidone…10mg




column.

41. 005107 Coughsodex Cough Syru



Terpin Hydrate…200mg

Pot-Bicarbontae…2mg


Tr. Senega…1mlMenthol…20mg

Ephedrine HCl…100mg

Pot. Guaiacol Sulphate…100mg

Pot-Citras…2mg

Tr. Ipecac…0.5mlExt Glycyrrhiza

Liq…2mlSyrup Simplex & Honey

QS to...100ml"

-do-

42. 004745 Cafeprin Tablets



-do-

43. 013423 Neo Triad Tablets


Flurbiprofen…100mg

-do-

44. 007618 Triad Plus Cough Syrup

Each 5ml Contains:-

Aminophylline…32mg



Menthol…0.98mg

-do-

45. 002779 Paragin Tablets



-do-

M/s. Inshal Pharmaceutical Industries, Plot No. 2, Street SS 2 National Industrial Zone, Rawat,

Islamabad.

46. 075754 Nilzacon Super Suspension


Oxyclozanide……..3.0%

Levamisole Hcl………1.5% Cobalt

Chloride (6H20).0.075% Sodium

Selenite ……...0.035%




column.

47. 075755 Clobenda Shell Suspension`

Each ml of

suspensionAlbendazole………..2.5%

Closantel…………...0.5%

-do-

48. 075756 Oxfacon Suspension


Oxfendazole……2.265%

-do-

49. 075757 levami 1.5% suspension


Levamisole HCI……….…1.5%

-do-

50. 075758 Tol shell Liquid \

Each ml contains:-

Doxycycline HCl…..…..200mg

Tylosin tartrate….100mg

Colistin sulphate…...450000 IU

Bromhexine HCI……….…4mg

-do-

51. 075759 Mentho Flush Oral Liquid -do-


Sorbitol……...….140mg

1,2propane diol……60mg

Magnesium Sulphate

(6H20)……………40mg

Potassium Chloride……..…20g

Sodium Propionate……3g

52. 075760 Enco Tin Liquid


Enrofloxacin……....10g Colistin

Sulphate….50MIU

-do-

53. 075761 Respidine liquid


Enrofloxacin……...10g Colistin

sulphate…….3.5g Amantadine

HCl……………….4.0g

-do-

54. 075762 Bromo Shell Liquid


Bromhexine HCI…….05g

-do-

55. 075763 Amento Water Soluble Powder

Each 100g powder contains

Enrofloxacin

HCl…....10%Amantadine

HCl……...…4%Colistin

Sulphate……3%

-do-

56. 075764 Shelldox Water Soluble Powder


Doxycycline HCl……………400g

Tylosin Tartrate……200g

-do-

57. 075765 Oxy Neo 10/10 water soluble powder

Each 100g contains:-

Neomycin

sulphate………..10gOxytetracycline

HCl…...….10g

-do-

58. 075766 Levashell 15 Powder


Levamisole HCl……….….15%

-do-

59. 075767 Tifo Shell Powder


Trichlorfon…………98%

-do-

60. 075768 P.C Water Soluble Powder


Enrofloxacin…….100Amantadine

HCl……….…40gColistin

Sulphate……35g

-do-

61. 075769 E.C.A Water soluble powder


Enrofloxacin…...100gAmantadine

HCl………..…40gColistin

Sulphate……35g

-do-

62. 075770 Enta Col Water Soluble Powder

Each 100gm

powder contains:-

-do-

Enrofloxacin…………..….10%Ama

ntadine HCl………...…4%Colistin

Sulphate……4%

63. 075771 Amino Flush Water Soluble Powder


Ammonium

Chloride……...45gSodium

Sulphate……..25gm

Magnesium Sulphate

7H2O……………...25g

-do-

64. 075772 Vita Shell Water Soluble Powder

Each 1000gm

powder contains

Vitamin

c………….…200gacetylecylicic

acid…….….67gPotassium

Chloride……....3gSodium

citrate…….….7g

-do-

65. 075773 Tyloxin Water Soluble Powder

Each 1000g powder contains

Doxycycline

HCl….…..200gTylosin

Tartrate……….100gBromhexine…

………5g

-do-

66. 075774 Amproshell 60% Water Soluble

Powder

Each 100gm

powder contains Amprolium

HCl……….…60gm

-do-

67. 075775 Tetra Shell 20 Water Soluble Powder


Chlortetracycline

HCl…….….200gm

-do-

M/s. Akson Pharmaceuticals (Pvt) Limited, Plot No. 9-B/1 & 2, Sector D-1, Old Industrial Estate,

Mirpur, Azad Kashmir.

68. 031670 Aksolox 100ml Infusion

Each ml Contains:-

Levofloxacin…5mg




column.

69. 031671 Cithrox 100ml Infusion

Each ml Contains:-

Ciprofloxacin…2mg

-do-

M/s. Epoch Pharmaceuticals, Plot No. 83-85, Sector 15, Korangi Industrial Area, Karachi.

70. 053186 Epovel Infusion

Each ml contains:Levofloxacin (as

Hemihydrate)… 5mg




column.

71. 031737 Epozoline Injection 250mg


Cefazoline Sodium eq. toCefazoline

base …..250mg

-do-

72. 053187 Epozol 500 mg

Infusion

Each ml contains:-

Metronidazole… 5mg

-do-

73. 078201 ESCOUR ORAL SUSPENSION

Each ml

contains:SULPHADIAZINE

BP…….35.50MG

SULPHADIMIDINE

BP..…28.40MG

NEOMYCIN SULPHATE

BP..1.80MG

HYSOINE

METHYLBROMIDE……….0.040

MG

PECTIN USP…………...…7.1MG

KAOLIN BP………….…103.3MG

VITAMIN B1 BP….……0.150MG

VITAMIN B2 BP….……0.220MG

-do-

74. 053185 Epoflox 200 Infusion

Each ml contains:-

Ofloxacin …..….2mg

-do-

75. 033984 Q-Flur Tab


Flurbiprofen ……….100mg

-do-

76. 078202 EPOTIZER INJECTION

Each 3ml Contains:THIAMINE HCI

(VITAMIN

B1)……………………...100MGPY

RIDOXINE HYDROCHLORIDE

(VITAMIN

B6)…………...100MGCYANOCOB

ALAMIN (VITAMIN

B12)………………...…500MCG

-do-

77. 031744 Epocef Injection 500mg Each vial

contains:-

Ceftazidime (as Ceftazidime

Pentahydrate)………500mg

-do-

78. 031743 Epocef Injection 250mg Each vial

contains:-


Pentahydrate)………250mg

-do-

79. 031742 Sodocef Injection 1Gm



Ceftriaxone base ..1gm

-do-

80. 031741 Sodocef Injection 500mg



Ceftriaxone base ..500mg

-do-

81. 031728 Redyclor Dry Syrup 250mg

Each 5ml contains:-

-do-

Cefaclor Monohydrate 275.32mg

eq. to Cefaclor………250mg

82. 031739 Epozoline Injection 1Gm


Cefazoline Sodium eq. to Cefazoline

base …..1gm

-do-

83. 031738 Epozoline Injection 500mg


Cefazoline Sodium eq. to Cefazoline

base…..500mg

-do-

84. 031729 Redyclor Caps 250mg


Cefaclor Monohydrate ..262.24mg

eq. to Cefaclor……....250mg

-do-

85. 031740 Sodocef Injection 250mg



Ceftriaxone base ..250mg

-do-

86. 031727 Redyclor Dry Syrup 125mg

Each 5ml contains:-

Cefaclor Monohydrate .137.66mg

eq. to Cefaclor……..125mg

-do-

87. 045343 Redyclor 50mg

Drops

Each ml contains:-

Cefaclor…………...50mg

(USP Specification)

-do-

88. 031722 Cepaxin Capsules 500mg


Cephalexin ……….500mg

-do-

89. 031721 Cepaxin Capsules 250mg


Cephalexin ….…….250mg

-do-

90. 031720 Cepaxin Dry Syrup 250mg

Each 5ml contains:-

Cephalexin (as anhydrous) ..250mg

-do-

91. 031719 Cepaxin Dry Syrup 125mg

Each 5ml contains:-

Cephalexin ( as anhydrous) 125mg

-do-

92. 031745 Epocef Injection 1GmEach vial

contains:-


Pentahydrate)…… …1gm

-do-

93. 031733 Rouscef Injection 1Gm


Cephradine sterile ….1gm

-do-

94. 031732 Rouscef Injection 500mg


Cephradine sterile ….500mg

-do-

95. 031731 Rouscef Injection 250mg


Cephradine sterile ….250mg

-do-

96. 031724 Rouscef Dry Syrup 250mg

Each 5ml contains:-

-do-

Cephradine ……..250mg

97. 031723 Rouscef Dry Syrup 125mg

Each 5ml contains:-


-do-

98. 031730 Epoclor Capsules 500mg


Cefaclor Monohydrate

..524.48mgeq. to

Cefaclor………500mg

-do-

99. 031725 Rouscef Capsules 250mg



-do-

100. 031726 Rouscef Capsules 500mg



-do-

M/s. Brookes Pharma Private Limited, Plot No. 58-59, Sector 15, Korangi Industrial Area, Karachi

101. 055002 Nezocin Infusion


Linezolid……………..…..200mg




column.

102. 055003 Nezocin Suspension

Each 5ml contains:-

Linezolid…..100mg

-do-

103. 055004 Nezocin Tablets 400mg

Each film coated contains:-

Linezolid…..400mg

-do-

104. 055005 Nezocin Tablets 600mg

Each film coated contains:-

Linezolid…..600mg

-do-

105. 055006 Fluticort Cream

Each gram contains:-

FluticasonePropionate…0.05%w/w

-do-

106. 055007 Gen-Cipro I.V Infusion

Each 100 ml

contains:Ciprofloxacin(asHCl)….20

0mg

-do-

M/s. Efroze Chemical Industries,146/23 Industrial Area, Karachi

107. 053111 Arbitel 20mg Tablet


Telmisartan………..20mg(Anti-

hypertensive)




column.



Telmisartan………40mg

(Anti-hypertensive)

-do-



Telmisartan………80mg

(Anti-hypertensive)

-do-

110. 053103 Savuros 5 mg Tablets


Rosuvastatin (as calcium)….5 mg

-do-

(Hypolipidemic agent)



Rosuvastatin (as calcium)….10 mg


-do-


Each tablet contains:Rosuvastatin (as

calcium)….20 mg


-do-

113. 053108 Valcard 5/80mg Tablet


Amlodipine (as Besylate)….5mg

Valsartan…………80mg

(Anti-hypertensive)

-do-

114. 053109 Valcard 5/160mg Tablet Each tablet

contains:-

Amlodipine (as Besylate)….5mg

Valsartan…………160mg(Anti-

hypertensive)

-do-

115. 053110 Valcard 10/160mg Tablet

Each tablet contains:Amlodipine (as

Besylate)….10mg

Valsartan…………160mg

(Anti-hypertensive)

-do-

M/s. Hi-Tech Pharma, I-C Shadman Chowk, Jail Road Lahore

116. 004555 Vit. Electrolytes Powder

Contains:-

Citric Acid Sodium Bicarbonate Vit.

A Supplement, D-activated

Animal Sterol (Source of Vit. D3)

Vit. E Supplement, Vit. B12

Supplement, Riboflavin

Supplement, Niacin Supplement,

Calcium Pantothenate, Folic

Acid d-biotin ascorbic acid,

Potassium Chloride




column.

117. 026423 Dicural Oral SolutionEach ml

contains:-

Difloxacin ….. 100mg

-do-

M/s. Unimark Pharmaceuticals (Pvt) Ltd, Plot No. 7-A, St No. S-7, National Industrial Zone, Islamabad

118. 052736 Petro-20



Sesquihydrate ..... 20mg




column.

119. 052831 Rits 20 Tablet


Piroxicam B-cyclodextrin 191.2mg

eq. to Piroxicam ………….. 20mg

(UniMark’s Specs)

-do-

120. 053502 Esaal


Escitalopram (as Oxalate) ..... 10mg

-do-

M/s. Mediways International, 16Km Multan Road, Lahore

121. 051136 Energor Syp Registration Board deferred the above


Pizotifen as Hydrogen Malate (B.P

Specs) ….. 0.5mg



column.

M/s. Spencer & Company, D-105, S.I.T.E Karachi

122. 053037 Andin Tablets


Loratadine……….10mg(USP

Specification)




column.

123. 053030 IRI Syrup

Each 5ML CONTAINS:-

Lactulose …...3.35gm

-do-

124. 053031 Nalcam 7.5mg Tablets


Meloxicam ……7.5mg

-do-

125. 053038 Andin Syp

Each 5ml contains:-

Loratadine……….5mg

-do-

126. 053032 Nalcam 15 mg Tablets


Meloxicam ……15mg

-do-

127. 053034 Nortic Tablets


Norfloxacin………400mg

-do-

M/s. Attabak Pharmaceuticals, Plot No. 5C, I-10/3, Industrial Area, Islamabad

128. 049693 SULPHAGOLD INJECTION.

Each ml contains:

SULPHADIMIDINE SODIUM

(B.P. VET) 333.33MG.




column.

129. 049694 TYLOBAK 20 INJECTION.

Each ml contains: TYLOSIN

TARTRATE (B.P. VET) 200MG.

-do-

130. 049695 ANZOLE GOLD SUSPENSION.


ALBENDAZOLE (USP) 2.5GM.

COBALT CHLORIDE (BP)

0.075GM. SELENIUM SELENITE

(BP) 0.035GM.

-do-

131. 049696 TRICLOBAK SUSPENSION.


TRICLABENDAZOLE…….

5.0GM. LEVAMISOLE HCL (BP)

3.75GM.

-do-

132. 049697 NORSULTRIM AQUOUS

SOLUTION.


NORFLOXACIN HCL……. 5GM.

SULPHAMETHOXYPYRIDAZINE

(B.P) 7.5GM. TRIMETHOPRIM

(B.P) 1.5GM.

-do-

133. 049699 CIPROPLUS AQUEOUS

SOLUTION.

Each ml contains:-

CIPROFLOXACIN (B.P) 200MG.

-do-

BROMOHEXINE HCL (B.P) 5MG.

134. 049700 TRIGOLD WATER SOLUBLE

POWDER.


TRICHLOROPHON (USP/PB)

980GM.

-do-

135. 049701 NEOBAK-72 WATER SOLUBLE

POWDER.

Each 1000GM CONTAINS:

NEOMYCIN (AS SULPHATE) B.P.

720GM.

-do-

136. 049702 AMCODINE WATER SOLUBLE

POWDER.

Each KG CONTAINS:-

-SULPHADIMIDINE SODIUM

83GM.DIAVERIDINE…………..

40GM.AMPROLIUM HCL ……..

200GM.

-do-

137. 049703 TOXIBAK WATER SOLUBLE

POWDER.


METHENAMINE (B.P) 95GM.

RIBOFLAVIN (USP) 1GM.

CALCIUM PANTOTHENATE

0.5GM. NICOTINAMIDE (BP)

2GM.

-do-

138. 049705 TYLOBAK WATER SOLUBLE

POWDER. Each 1000gm

contains: TYLOSIN

TARTRATE (B.P) 400GM.

-do-

139. 049706 ALBAK 400 GRANULES.

Each KG CONTAINS:-

-ALBENDAZOLE (B.P) 400GM.

-do-

140. 049707 COLIBAK WATER SOLUBLE

POWDER.

Each 100gm contains: COLISTIN

SULPHATE (B.P) 48000,000 IU.

-do-

141. 049710 NEOTIN.C WATER SOLUBLE

POWDER.


NEOMYCIN AS SULPHATE (BP)

70GM. CHLORTETRACYCLINE

HCL (BP) 80GM. COLISTIN AS

SULPHATE 4GM.

-do-

142. 049711 BRONCOLINE PLUS WATER

SOLUBLE POWDER.

Each 100gm contains: COLISTIN

SULPHATE 50,000,000 I.U.

BROMOHEXINE HCL ….. 500MG.

-do-

143. 049712 CRD-RAZE WATER SOLUBLE

POWDER.

Each 1000gm contains: TYLOSINE

TARTRATE (BP) 100GM.

DOXYCYCLINE

-do-

HYDROCHLORIDE (BP) 200GM.

COLISTIN SULPHATE (BP) 500

MIU. BROMOHEXINE HCL (BP)

5GM.

144. 049713 POLYQUEEN GOLD WATER

SOLUBLE POWDER.

Each KG CONTAINS:-

-OXYTETRACYCLINE HCL (BP

VET) 100GM.

-do-

145. 049714 MEBENDAGOLD SUSPENSION.

Each ml contains:

MEBENDAZOLE (BP) 70.0MG.

SODIUM SELENITE (BP) 0.35MG.

COBALT SULPHATE 2.05MG.

-do-

M/s. Danas Pharmaceuticals, 312 Industrial Triangle Kahuta Road Islamabad

146. 052675 Saveril Tablets 100mg.


Clozapine

……………………..100mg. (USP

Specs)




column.

147. 052676 Saveril Tablets 25mg.Each Tablet

contains:-

Clozapine …………………..25mg.

(USP Specs)

-do-

148. 052677 Danrexin Tablets 20mg.


Piroxicam as Beta

cyclodextrin……20mg.

-do-

149. 052678 Esolong Tablets 20mg.



Trihydrate…………………………

……20mg.

-do-

150. 052679 Esolong Tablets 40mg.

Each Tablet contains;-Esomeprazole

as Magnesium

Trihydrate…………………………

…….40mg.

-do-

151. 052680 Lanzodan Tablets 30mg.


Lansoprazole………………………

…30mg. (USP Specs)

-do-

152. 052681 Pepdan Tablets 10mg.


Rabeprazole

Na………………………10mg.

-do-

153. 052682 Pepdan Tablets 20mg.


Rabeprazole as

Na……………………..20mg.

-do-

154. 052683 Sulpeol Tablets 100mg.


Levosulpiride………………..100mg

.

-do-

155. 052684 Monkast Tablets 4mg.

Each chewable Tablet contains:-

Montelukast…………………………

…4mg.

-do-

156. 052685 Vendep Tablets 50mg.


Venlafaxine as

HCl………………..50mg. (BP

Specs)

-do-

157. 052686 Rabedan Capsules 20mg.

Each Capsule contains:-

Rabeprazole Na

Pellets………………..20mg.

-do-

158. 052687 Danflu Capsule 150mg.


Fluconazole………………………..1

50mg. (USP Specs)

-do-

159. 052688 Ribadan Capsules 400mg.


Ribavirin……………………………

……400mg. (BP Specs)

-do-

160. 052689 Xepex Capsules 20mg.


Ziprasidone as

HCl…………………..20mg.

-do-



Ziprasidone as

HCl………………………40mg.

-do-



Ziprasidone as

HCl………………..60mg.

-do-



Ziprasidone as HCl………..80mg.

-do-

164. 052693 Isonas Capsule 10mg.


Isotretinoin ….10mg.

-do-

165. 052694 Isonas Capsule 20mg.


Isotretinoin…20mg.

-do-

166. 052695 Neurodan Capsule 300mg.


Gabapentin….300mg.

-do-

167. 052696 Neurodan Capsules 100mg.


Gabapentin.100mg.

-do-

168. 052697 Neurodan Capsules 400mg.


Gabapentin..400mg.

-do-

169. 052698 Orlidan Capsules 120mg.


Orlistat…120mg.

-do-

170. 052699 Mometaderm Cream.Each Tube

contains:-

Mometasone Furoate….0.1%. (USP

Specs)

-do-

171. 052700 Mometaderm Ointment.

Each Tube contains:-

Mometasone Furoate……0.1%.

(USP Specs)

-do-

172. 052701 Medan Cream.


Permethrin……..5%

-do-

M/s. Sapient Pharma, Lahore

173. 006938 IODINE ONTContains:-

IODINE 50gm, Archis Oil 100gm,

Yellow Soft Paraffin…150mg,

Methyl Salicylate…50ml




column.

174. 006937 BENZYL BENZOATE 25%

LOTIONContains:-

BENZYL BENZOATE 25%,

-do-

M/s. Ethical Laboratories, 14-km Thokar Niaz Baig, Multan Road, Lahore

175. 004434 Phenobarbitone Tablet 30mg Registration Board deferred the above



column.

176. 004435 VITAMINOL SYPEach 28.4ml

contains:-

VITAMIN A 14000U

Vitamin D2 1400U THIAMINE

HCL 2.8MG, RIBOFLAVIN

3.4MG, NICOTINAMIDE 28.4MG,

Vitamin C 85.2MG,

-do-

M/s. Highnoon Laboratories, Ltd 17.5 Km Multan Road, Lahore

177. 010010 HI-ASPIRIN (SOLUBLE) TAB


ASPIRIN 300MG




column.

178. 022070 Daycare Caps Each capsule

Contains Paracetamol ….

500mg

Phenylpropanolamine HCI ….

12.5mg

Dextromethorphan Hbr …. 7.5mg

-do-

179. 022521 Daycare Syp Contains

Paracetamol …. 5%

Phenylpropanolamine HCI ….

0.125% Dextromethorphan Hbr

…. 0.075%

-do-

180. 022068 Nightcare Cap Contains


Promethazine HCI …. 12.5mg

Dextromethorphan Hbr …. 7.5mg

-do-

181. 022069 Nightcare Syp

Each 5ml Contains Paracetamol

…. 250mg

-do-

Promethazine HCI …. 5mg

Dextromethorphan Hbr ….

3.75mg

182. 013127 Loprin 150mg

Tab

Each Enteric coated tablet contains:-

Aspirin …. 150mg

-do-

183. 013128 Loprin 300mg

Tab

Each Enteric ccoated tablet

contains:-

Aspirin …. 300mg

-do-

184. 052940 Cidine Tablets.

Each tablet Contains:-

Cinitapride as acid

tartrate……...1mg.

-do-

185. 077032 Xormet XR 1000mg Tablet

Each extended release tablet

contains:-

Metformin HCl…..1000mg

-do-

M/s. Welwrd Pharmaceuticals, Plot No. 3, Block No. A, Phase I-II, Industrial Estate, Hattar

186. 076810 Safbal 500mcg Tab


Mecobalamin………500ug




column.

M/s. Saydon Pharmaceutical Industries (Pvt) Ltd, 77-A, hayatabad Industrial Estate, Peshawar

187. 022381 Baby-S Sachet

Each Sachet Contains:-

Sodium chloride …. 3.5 gm

Sodium Citrate …… 2.9gm

Potassium Chloride …. 1.5gm

Destrose Anhydrous …... 20gm




column.

188. 022380 ORA-C Sachet


Calcium Lactate Gluconate ….

1000mg

Calcium Carbonate …. 0.327mg


-do-

189. 022484 Ostefen 50mg Tablets


Diclofenac Potassium …. 50mg

-do-

190. 022485 Ostefen 75mg Tablets



-do-

191. 022486 Arcam 20mg

Talets


Piroxicam …. 20mg

-do-

Ghani Brothers 2nd Floor, Karimje Building, North Napier Road, Karachi Pakistan

192. 072597 Carboplatino Dosa 600 injection.

Each vial conatins:-

Carboplatin…….600mg




column.

193. 072598 Detavi 50mg

injection.

Each vial conatins:-

Decitabine…………50mg

-do-

M/s Kaizen Pharmaceuticals (Pvt) Limited, Plot No. E-127, E-128 & E-129 North Western Zone Port

Qasim Authority Karachi.

194. 076095 Cipotent 125mg

Dry Suspension

Each 5ml contains:-

Ciprofloxacin HCl eq. to

Ciprofloxacin….125mg

Deferred for clarification of source of

granules and diluent.

195. 076095 Cipotent 250mg

Dry Suspension

Each 5ml contains:-




granules and diluent.

M/s. Trison Research Laboratories (Pvt) Limited, 27-A Punjab Small Industrial Estate Sargodha

196. 075480 Astrid –OD SR 150mg Tablets


Itopride HCL……150mg

Deferred for approval of formulation

in RRA.

M/s Atco Laboratories Limited, B-18 SITE Karachi

197. 022323 Heal Skin Ointment


Bacitracin

B.P……..500unitPolymyxin B

Sulphate

BP……..5000UnitsNeomycin base

(Neomycin Sulphate) B.P…..3.5mg

Lidocaine…….40mg


in RRA.

198. 022347 Betaderm NM Cream


Miconazole Nitrate

USP……2%Neomycin Sulphate

BP….0.5%Betamethasone as 17-

Valerate BP…..0.1%


in RRA.

M/s. AGP (Pvt) Ltd., B-23, Sindh Industrial Trading Estate, Karachi

199. 015675 Norquin Tablet


Norfloxacin…400mg

Deferred for further evaluation

200. 015676 Oslin Syrup

Each 5ml Contains:

Lincomycin HCl eq. to 250mg

Lincomycin Base

Deferred for further evaluation

201. 031053 Osnate Ce Tablets


:

Calcium Lactate

Gluconate…..1gmVitamin C

(Ascorbic Acid)….500mgCalcium

Carbonate…..0.327mg


in RRA.

202. 022309 Cap-Itra Capsule


Itraconazole (as Microspheres)

100mg

Deferred for source of pellets.

M/s. Lowitt Pharma, Pvt Limited, Plot No 24 Industrial Estate Hayatabad Peshawar

203. 052796 Napzol Capsule 20mg.Each capsule

contains:-


Trihydrate enteric coated

pellets……………….20mg

Deferred for submission of differential

feeas source of pellets is imported.

204. 052797 Nurzol Capsules 20mg.Each Capsule

contains:-

Omeprazole as enteric coated

pellets……………………..20mg



205. 052798 Letzol Capsule 30mg.



Pellets………………………..30mg

M/s Smilex Laboratories Hyderabad

India



M/s. Eros Pharmaceuticals (Pvt) Ltd., 94-95/23 Korangi Industrial Area, Karachi

206. 004295 Spasmospan Tablet


Paracetamol…500mg

Hyoscine-N Butyl Bromide…10mg

Deferred for approval of RRA.

M/s. NabiQasim Industries Pvt Limited,17/24 Korangi Industrial Area Karachi

207. 076132 Tecmiso 100mcg tablet


Misoprostol……………100mcg

Deferred for further evaluation of

active ingredient.

M/s. Pharmevo (Pvt) Ltd., A-29, North Western Industrial Zone Port Qasim, Karachi

208. 050620 Evopride Plus Tablet



Metformin…..500mg

Deferred for status of showcoause


M/s. Remington Pharmaceutical Industries (Pvt) Ltd., 18-Km Multan Road Lahore

209. 051021 Myodip 5/10mg Tablets


Amlodipine besylate equivalent to

amlodipine…………….5mg

Atorvastatin calcium equivalent to

Atorvastin……………..10mg

Deferred for submission of approval of

transfer of product from M/s

Remington Pharmaceuticals Industries

(Pvt) Limited Allama Iqbal Town

Lahore to 18-Km Multan Road Lahore

210. 051022 Myodip 5/20 Tablets



amlodipine……………….5mg


Atorvastatin……………..20mg

-do-

211. 051023 Myodip10/10 Tablet



amlodipine……………..10mg


Atorvastatin ……………10mg

-do-

212. 051030 Rapril 5mg Tablets -do-


Ramipril…….5mg

213. 051031 Rheumid 10mg Tablets


Leflunomide…10mg

-do-

214. 051032 Rheumid 20mg Tablets


Leflunomide…20mg

-do-

215. 051015 Diarid 3mg Tablet


Glimepiride ….3mg

-do-

216. 051016 Diarid 4mg Tablets

Each tablets contains:

Glimepiride…….4mg

-do-

217. 051017 Diarid-M 2mg Tablet


Glimepiride….2mg

(USP Specs)

-do-

218. 051011 Cegrel –A 75/75 Tablets


Clopidogrel Hydrogen sulfate

equivalent to clopidogrel…….75mg

Aspirin……….75mg

-do-

219. 051012 Cegrel-A 75/150 Tablets


Clopidogrel Hydrogen sulfate

equivalent to clopidogrel ….75mg

Aspirin………150mg

-do-

220. 051027 Rapril 1.25mg Tablets.

Each table Contains:

Ramipril……1.25mg. (B.P Specs)

-do-

221. 051029 Rapril 2.5mg Tablets.

Each Table Contains:

Ramipril…….2.5mg. (B.P Specs)

-do-

222. 051028 Rapril 10mg Tablets


Ramipril……10mg

(BP Specs)

-do-

223. 051024 Neurogab 200mg Tablets


Gabapentin….200mg

-do-

224. 051025 Neurogab 400mg Tablets.

Each film Coated tablet Contains:

Gabapentin…..400mg.

-do-

225. 051026 Neurogab 600mg Tablets.


-do-

Gabapentin…..600mg.

226. 051018 Dolbon 0.25mcg Tablets.

Each tablet Contains:

Alfacalcidol…0.25mcg.

-do-

227. 051019 Dolbon 0.5mcg Tablets.


Alfacalcidol……………….0.5mcg.

-do-

228. 051020 Dolbon 1mcg Tablets.


Alfacalcidol……………….1mcg.

-do-

229. 050900 Valzar Plus 160/25


Valsartan……………..160mg

Hydrochlorothiazide……25mg

(USP Specs)

-do-

230. 050901 Valzar Plus 80/12.5 Tablets


Valsartan…………..80mg

Hydrochlorothiazide….12.5mg

(USP Specs)

-do-

231. 050910 Q-Lox 100mg Tablets


Sparfloxacin………….100mg

-do-

232. 050911 Q-Lox 200mg


Sparfloxacin……….200mg

-do-

233. 050878 Flutex Nasal Spray

Each ml contains:

Fluticasone propionate …..0.50mg

Each actuation delivers 50mcg of

fluticasone propionate from the nasal

actuator. (BP Specs)

-do-

234. 050877 Dozypress –T Eye Drops

Each ml contains:

Dorzolamide HCl eq.to

Dorzolamide……….…. 20mg

Timolol maleate equivalent to

timolol………………..5.00mg

-do-

235. 052653 Esler 20mg

Capsules.


Esomeprazole as Mgnesium

Trihydrate….20mg.

-do-

236. 52654 Esler 40mg

Capsules.




-do-

237. 051033 Zoride Tablet 50mg


Itopride HCl……………….50mg.

-do-

238. 076962 Remisole Neo Syrup

Each 5ml contains:

Chlorpheniramine maleate…2.5mg,

Ammonium chloride…..125mg,

Sodium citrate…..55mg,

Glycerine…….150mg

-do-

239. 076963 Eyclear Eye Drops

Each ml contains:

Naphazoline HCl…..0.25mg

-do-

240. 050892 Rosulip 10mg Tablets


Rosuvastatin calcium equivalent to

rosuvastatin ………………10mg

-do-

241. 050884 Loxiget Eye drops

Each ml contains:

Gatifloxacin…………3.0mg

-do-

242. 050886 Prostilet-T Eye Drops

Each ml contains:

Latanoprost…………….50mcg

Timolol maleate equivalent to

timolol…………….…..5.00mg

-do-

243. 050890 Remikair 5mg Tablets


Montelukast sodium eq. to

montelukast acid …………..5.0mg

-do-

244. 500905 Xoglit-M 15/500 Tablets.


Pioglitazone Hydrochloride

quivalent to piogltazone………15mg

Metformin HCl………….500mg.

-do-

245. 050906 Xoglit-M 15/850 Tablets.



quivalent to piogltazone………15mg

Metformin HCl…………850mg.

-do-

246. 050891 Remilak Eye drops

Each ml contains:

Ketorolac tromethamine……5mg

-do-

247. 050879 Kanpress 16mg Tablets


Candesartan cilexetil……….16mg

-do-

248. 050880 Kanpress 8mg Tablets


Candesartan cilexetil………8mg

-do-

249. 050881 Kanpress Plus Tablets


Candesartan cilexetil……16mg

-do-

Hydrochlorothiazide……12.5mg




montelukast acid …………10mg

-do-

251. 050888 Remikair 4mg

Sachet



montelukast…………….4mg

-do-




montelukast acid………..4mg

-do-

253. 050895 Timvast plus 20/10 Tablets


Simvastatin…………20mg

Ezetimibe…………..10mg

-do-

254. 050896 Timvast Plus 40/10 Tablets

Each film coated tablets contains:

Simvastatin………………40mg

Ezetimibe………………..10mg

-do-

255. 050897 Timvast Plus Tablets 10/10


Simvastatin……………..10mg.

Ezetimibe……………….10mg.

-do-

256. 050898 Valzar 160mg Tablets


Valsartan …………….160mg

-do-

257. 050899 Valzar 80mg Tablets


Valsartan ……………….80mg

-do-

258. 050907 Zidopril Tablets


Lisinopril As dihydrate……..20mg

Hydrochlorothiazide….12.5mg

-do-

259. 050908 Dexcip Ear Suspension

Each ml contains:


equivalent to ciprofloxacin

base……………..3.0mg

Dexamethasone……..1.0mg

-do-

260. 050909 Ocumox Tablets

Each film coated tablets contains:

-do-

Moxifloxacin HCl quivalent to

Moxifloxacin …………400mg

261. 050893 Rosulip 20mg Tablets.


Rosuvastatin Calcium equivalent to

rosuvastatin ……...20mg

-do-

262. 050902 Xoglit 15mg Tablets



equivalent to pioglitazone…….15mg

-do-

263. 050903 Xoglit 30mg Tablets



equivalent to pioglitazone…….30mg

-do-

264. 050904 Xoglit 45mg Tablet



equivalent to

pioglitazone……..45mg

-do-

265. 050894 Rosulip 5mg Tablets


Rosuvastatin calcium equivalent to

rosuvastatin……………..5mg

-do-

266. 051013 Diarid 1/500 Tablets.


Glimepiride……………1 mg.

Metformin HCl………..500 mg.

-do-

267. 051014 Diarid 1mg Tablets


Glimepiride……………..1mg

-do-

M/s. Lisko l-10 Block 21 Shaheed Rashid Minhas Road F.B Industrial Area Karachi

268. 50428 Liskoxime 400mg

Capsule


Cefixime (as Trihydrate)…400mg



269. 022277 Tuberin Tablet


Ethambutol HCl…300mg

Rifampicin…150mg

Isoniazid…75mg

Deferred for evalution as per WHO

recommended formulation

270. 022278 Tuberin-P Tablet


Ethambutol HCl…225mg

Rifampicin…120mg

Isoniazid…60mg

Pyrazinamide…300mg

Deferred for evalution as per WHO

recommended formulation

271. 050427 Liskoxime Dry Suspension Deferred for confirmation of section

Each 5ml contains:-

Cefixime (as Trihydrate)…100mg


272. 022276 Liskomycitin Suspension

Each 5ml Contains:-

Chloramphenicol Palmitate eq. to

Chloramphenicol Base…125mg


in RRA.

273. 050429 Karsaz 125mg

Dry Suspension

Each 5ml contains:-

Cephradine……………125mg



274. 050430 Karsaz 250mg

Dry Suspension

Each 5ml contains:-

Cephradine…………250mg



275. 050431 Amoxipen Forte Syrup

Each 5ml contains:-

Amoxicillin (as Trihydrate)..250mg



M/s. GSK Pakistan Limited, 35- Dockyard Road Karachi.

276. 004512 Amoxil Vial 500mg


Amoxicillin sodium eq. to

Amoxicillin……500mg

Manufacturer: M/s. Smithkline

Beecham Limited, Clarendon Road,

Worthing West Sussex BN148QH

United Kingdom

Deferred for evaluation as per

submitted CoPP.

M/s. Neutro Pharma (Pvt) Limited, 9.5 Km Sheikhupura Road Lahore.

277. 050912 Omeneu Tablet 20mg


Omeprazole …..20mg




column.

M/s. Qintar Pharmaceuticals 14-Ab PSIE Lahore Road, Sargodha

278. 075475 Xepra 20mg Tablet


RabeprazoleS Sodium….20mg




column.

279. 075476 Teslo 50mg Tablets



-do-

280. 075477 Depfit 37.5mg Tablet


Venlafaxine HCl eq. to

Venlafaxine….37.5mg

-do-

M/s Alina Combine Pharmaceuticals Pvt Limited, Plot No. A-127 SITE North Karachi

281. 076034 Hibet Forte Tablets


Betahistine

Dihydrochloride……16mg




column.

282. 076035 Tdol-P Tablets


Tramadol HCl…..37.5mg

Paracetamol……325mg

-do-

M/s Pharmedic Pvt Limited, 16 KM Multan Road Lahore

283. 030366 Malasan Injection

Each ml contains:-

Artemether…….80mg




column.

M/s Dyson Research Laboratories Pvt Limited, 28Km, Ferozpur Road Lahore.

284. 051161 Danke Plus Tablets


Artemether…..20mg





column.

285. 051162 Dyte Capsules


Orlistat…….120mg

-do-

M/s. Helicon Pharmaceutick Pakistan (Pvt) Ltd., Model Town Road, Faisalabad

286. 030273 Cantil Suspension

Each 5ml contains:

Famotidine……10mg




column.

287. 030274 Cantil Tablets


Famotidine……20mg

-do-

288. 030275 Senidon Tablets


Secnidazole…….1000mg

-do-

289. 030276 Mexicobal Tablets


Mecobalamine……..500mcg

-do-

290. 030277 Megasef Tablets


Cephradine………250mg

-do-

291. 030278 Heligesic Tablets


Orphenadrine Citrate….35mg

-do-

M/s. Global Pharmaceuticals (Pvt) Ltd., Plot No. 204-205, Industrial Triangle Kahota Road, Islamabad

292. 051006 Nimoconil Dry Suspension.

Each 5ml contains:-

Azithromycin as Dihydrate

…….200mg




column.

293. 051007 Nimoconil Capsules 250mg.


Azithromycin as Dihydrate

…….250mg

-do-

294. 051008 Orthomin Plus Tablets.


Glucosamine

Sulphate……….500mg. Chondroitin

Sulphate……..…400mg.

-do-

295. 051010 Profol Injection IM/IV.

Each ml Contains:-

Propofol.........................10mg

-do-

M/s. Medisure Laboratories Pakistan (Pvt) Ltd., A-115, S.I.T.E., Super Highway, Karachi

296. 031149 Clarocin Tablets 500mg




Clarithromycin ….500mg shortcomings as mentioned in the last

column.

297. 004222-EX Rumatidine Tablet 300mg

Contains:

Ranitidine HCl eq. to

Ranitidine…300mg

-do-

M/s. Venus Pharma, 23-KM Multan Road, Lahore

298. 030814 Vio-Dine Plus Tablets


Loratadine…………..5mg

Pseudoephedrine…..120mg




column.

M/s. Z-JANS Pharmaceutical (Pvt) Ltd., 148-A Industrial Area Hayatabad, Peshawar

299. 051078 Migxa D/S

Each 5ml contains::

Cefpodoxime as

Proxetil……….40mg

(USP Specs)




column.

300. 051079 Anoxonil Tablets.


Escitalopram………….10mg.

-do-

301. 051080 Zemont Tablets.


Montelukast as

Sodium………...5mg.

-do-

302. 051081 Zemont Tablets.


Montelukast as Sodium……...10mg.

-do-

303. 030593 Infarel 20mg

Capsule


Piroxicam Beta Cyclodextrin

191.2mg

eq. to Piroxicam…20mg

-do-

M/s. High-Q Pharmaceuticals, Plot No. 244, Sector No. 23, Korangi Industrial Area, Karachi

304. 076105 Pytex 20mg Tablet


Piroxicam Betacyclodextrin eq. to

Piroxicam………20 mg




column.

M/s. Zam Zam Corporation, Ground Floor, Beaumont Plaza 6-CL-10 Beaumont Road Lahore

305. 047526 Liposic Eye Gel

Each gm contains:-

Carbomers 2.00mg

Manufacturer: M/a Baush & Lomb

USA C/O Dr Gerard Mann Chem

Pharm Fabrik GmbH Germany.




column.

M/s. Mehran International, 498-C, Feroz Shah Mehta Road, Karachi

306. 047696 DIMENHYDRINATE INJECTION

50MG/1ML.

Each ml contains:

DIMENHYDRINATE 50MG.

(ANTICEMETIC &

ANTINAUSEANTS).




column.

307. 047697 Omiperazole Injection 40mg

Each vial contains:

-do-

Omeprazole Sodium eq. to 40mg

Omeprazole

308. 047688 EPIRUBICIN HYDROCHLORIDE

FOR INJECTION 10MG.

Each Vial Conatins:

EPIRUBICIN HYDROCHLORIDE

10MG.

-do-

309. 047689 EPIRUBICIN HYDROCHLORIDE

FOR INJECTION 50MG.

Each Vial Conatins:

EPIRUBICIN HYDROCHLORIDE

50MG.

-do-

310. 047690 DOXORUBICIN

HYDROCHLORIDE FOR

INJECTION.

Each Vial Conatins:

DOXORUBICIN

HYDROCHLORIDE 50MG.

(ANTHRACYCLINE

ANTINEOPLASTIC

ANTIBIOTIC).

-do-

311. 047691 DOXORUBICIN

HYDROCHLORIDE FOR

INJECTION.

Each Vial Conatins:

DOXORUBICIN

HYDROCHLORIDE 10MG.

(ANTHRACYCLINE

ANTINEOPLASTIC

ANTIBIOTIC).

-do-

312. 047692 VINCRISTINE SULFATE FOR

INJECTION.

Each Vial Conatins:

VINCRISTINE SULFATE 1MG.

(ANTINEOPLASTIC AGENTS).

-do-

313. 47693 IDARUBICIN HYDROCHLORIDE

FOR INJECTION.

Each Vial Conatins:

IDARUBICIN HCL ….. 10MG.

(ANTINEOPLASTIC

ANTHRACYCLINE).

-do-

314. 047694 PACLITAXEL INJECTION.

Each 5ML VIAL contains:

PACLITAXEL ………

30MG.(ANTITUMOR).

-do-

M/s. Highnoon Laboratories Ltd., 17.5 Km Multan Road, Lahore

315. 072583 ASTHAVENT HFA INHALER.

Each ACTUATION contains:-

SALBUTAMOL SULPHATE

EQUIVALENT TO

SALBUTAMOL 100MCG.




column.

316. 072584 AEROCORT HFA INHALER.

Each ACTUATION contains:

BECLOMETHASONE

-do-

DIPROPIONATE (ANHYDROUS)

……50MCG.SALBUTAMOL

SULPHATE EQUIVALENT TO

SALBUTAMOL ……..100MCG

317. 072588 BUDEFORM 100 HFA INHALER


BUDESONIDE ……..100MCG

-do-

318. 072589 BUDEFORM 200 HFA INHALER


BUDESONIDE ………200MCG

-do-

319. 072586 FORACORT 100 HFA INHALER.


FORMOTEROL FUMARATE

DIHYDRATE

6MCG.BUDESONIDE

………100MCG

-do-

320. 072587 FORACORT 200 HFA INHALER.


FORMOTEROL FUMARATE

DIHY0DRATE

6MCG.BUDESONIDE

………...200MCG.

-do-

321. 072585 SPRAHALER 20 HFA INHALER


IPRATROPIUM BROMIDE

…20MCG

-do-

M/s. Mehran International 498-C Feroz Shah Mehta Road Karachi

322. 049570 Colistin Sulphate Injection


Colistin -60,000,000IUManufacturer:

M/s Jiangxi Jinkonka Biochemical

Pharmaceutical Co. Ltd.,

ChinaExported by: Sinochem

Ningbo Limited Ningbo China




column.

323. 049571 Colistin Sulphate Injection


Colistin -30,000,000IUManufacturer:





-do-

324. 049573 Ceftiofur Sodium for Injection


Ceftiofur……1gm

(As Ceftiofur sodium)Manufacturer:





-do-

325. 049574 Florfenicol Injection 200mg/ml


Florfenicol……20gm

Manufacturer: M/s Jiangxi Jinkonka

Biochemical Pharmaceutical Co.

-do-

Ltd., ChinaExported by: Sinochem


326. 049576 Vitamin AD3 Injection

Each ml contains:-

Vitamin A 80000IU

Vitamin D3 40000IU

Vitamin E 20mg





-do-

327. 049577 Sodium Selenite &

Vitamin E Injection

Each ml contains:-

Sodium selenite…0.5mg

Vitamin E….50mg





-do-

M/s. Global Veterinary & Technical Services (Pvt) Limited, House No. 2507/ 25A-10J New Abdali

Colony Multan

328. 021437 Entropil Solution

Each litre contains:-


Manufacturer: M/s Eagle Vet. Tech

Co., Ltd, 235-34 Chusa-RO Shinam

Myun Tesan –Kun Chungchongnam-

Do Korea.




column.

329. 021438 Entropil 50- Injection

Each ml contains:-





Do Korea.

-do-

330. 021440 Collie SP PowderManufacturer: M/s

Eagle Vet. Tech Co., Ltd, 235-34

Chusa-RO Shinam Myun Tesan –

Kun Chungchongnam-Do Korea.

-do-

331. 021441 Cocci-AF Powder

Each kg contains:-

Amprolium…..200gm

Furaltadone HCL……200gm




Do Korea.

-do-

332. 049602 Cefazol Injection


Cepazolin sodium…..2500mg


Co., Ltd, Korea.

-do-

333. 049603 Gentamicin 10% Injection -do-

Each ml contains:-

Gentamicin sulphate eq. to 100mg

Gentamicin baseManufacturer: M/s

Eagle Vet. Tech Co., Ltd, Korea

334. 049604 Pacprim Injection

Each ml contains:-

Trimethoprim 40mg

Sulfamethoxazole….200mg


Co., Ltd, Korea

-do-

M/s Pantex Pharmaceutica 26 Abbot Road Lahore

335. 049736 Doxycyclin 500 Water Solube

Powder

Each gm contains:-

Doxycycline Hyclate….500mg

Manufacturer: M/s Pantex Holland

B.V., Holland




column.

336. 049735 Amoxy C Water Soluble Powder

Each gm contains:-

Colistin as base (as sulphate)…50mg

Amoxicillin base as

trihydrate….200mg

Manufacturer: M/s Pantex Holland

B.V., Holland

-do-

M/s Prix Pharmaceutica 26 Abbot Road Lahore

337. 049578 Oxtra Effervescent Tablets


Oxytetracycline hydrochloride eq. to

Oxytetracycline …..1gm

Manufacturer: M/s Fatro S.p.A Italy.




column.

338. 021492 Aminolife Poultry W/S

PowderManufacturer: M/s Fatro

S.p.A Italy.

-do-

339. 049579 Micospectone

Each ml contains:-

Lincomycin 50mg

as Lincomycin HCL 56070mg

Spectinomycin 100mg

as Spectinimycin HCl 150mg

Manufacturer: M/s Fatro S.p.A Italy.

-do-

M/s. Sanna Laboratories, 1019-B, PSIF, Sargodha Road, Faisalabad

340. 022121 SANBIOTIC LIQUID

EACH 1000ML CONTAINS::

ENROFLOXACIN…300GM




column.

341. 021496 PENSTEP-50 POWDER

Each KG POWDER contains:

PENICILLIN V POTASSIUM

15GM, STREPTOMYCINE…50GM

-do-

342. 021497 RESPINIL -50 WATER SOLUBLE

POWDER

Each KG POWDER contains:

TYLOSIN TARTRATE….50GM,

ERYTHROMYCIN

-do-

THIOCYANATE…60GM,

RURALTADONE HCL…140GM

M/s. Medi-Excel Pharmaceuticals, Plot No. 282 Industrial Triangle, Kahuta Road, Islamabad

343. 031401 Specnolin Powder

Each 100gm contains::

LINCOMYCIN 3.33GM.

SPECTINOMYCIN 6.67GM.

(ANTIBIOTIC).




column.

344. 031402 Asciticid Powder


FRUSEMIDE 2000MG. EXTRACT

BELLADONNA 200MG.

(DIURETIC/FLUSHER.

-do-

345. 031403 Lincofeed Oral Powder


LINCOMYCIN HCL

MONOHYDRATE 1.1GM.

(ANTIBIOTIC).

-do-

346. 031404 Vermexcel Plus Powder

Each 100 ml contains::

LEVAMISOLE

HYDROCHLORIDE 1.50GM.

OXYCLOZANIDE 3.00GM.

COBALT 0.380GM. SELENIUM

0.035GM.

(ANTHALMENTIC)(DEWORMER

).

-do-

347. 031405 Enroexcel 20 Oral Solution


ENROFLOXACIN 20.00GM.

(ANTIBACTERIAL).

-do-

348. 031406 Vermexcel Liquid


LEVAMISOLE HCL 1.50GM.

OXYCLOZANIDE 3.00GM.

(ANTHALMENTIC).

-do-

349. 031407 Zanifax Liquid


OXFENDAZOLE 2.265GM.

(ANTHALMENTIC).

-do-

350. 031408 Darviexcel Oral Solution


SULPHAQUINOXALINE 2.56GM.

DIAVERDINE 0.64GM.

(ANTICOCCIDIAL)(ANTIPROTO

ZONAL).

-do-

351. 031409 Methipol Powder


CHOLINE CHLORIDE 45GM. DL-

METHIONINE 4GM. L-LYSIN

MONOHYDRATE 4GM.

MANAGNESE SULPHATE 9GM.

ZINC SULPHATE 2.2GM.

Vitamin B2-80 0.3GM.

-do-

Vitamin D3 0.5GM. (AMINO

ACIDS, MINERALS &

VITAMINS).

352. 031410 Vermout 1.5% Liquid


LEVAMISOLE HCL 1.50GM.

COBALT CHLORIDE 0.382GM.


).

-do-

353. 031411 Trissen Oral Suspension


SULPHADIAZINE 40.00GM.

TRIMETHOPRIM 8.00GM.

(ANTIBACERIAL).

-do-

354. 031412 Albexcel Suspension


ALBENDAZOLE 2.50GM.

COBALT CHLORIDE 0.075GM.

SODIUM SELENITE 0.035GM.


).

-do-

355. 031413 Saracin Solution


SARAFLOXACINE 10GM.

(ANTIBACTERIAL).

-do-

356. 031414 Zanifax Plus Liquid

Contains:

OXFENDAZOLE 2.265GM.

COBALT 0.20GM.

SELENIUM 0.05GM.

(ANTHALMENTIC).

-do-

357. 031415 Coximicin Oral Powder


SULPHAQUINOXALINE NA

16.00GM. DIAVERDINE 4.00GM.

Vitamin A 0.40MIU.

Vitamin K3 1.00GM.

(ANTIBIOTIC).

-do-

358. 031416 Albexcel 10% Oral Powder


ALBENDAZOLE 10GM.

(ANTHALMENTIC).

-do-

359. 031417 Tylox 30% Oral Powder


TYLOSIN TARTRATE (AS BASE)

10.00GM. DOXYCYCLINE HCL

(AS BASE) 20.00GM.

(ANTIBACTERIAL).

-do-

360. 031418 Vermout 15% Oral Powder


LEVAMISOLE 15GM.

(ANTHALMENTIC).

-do-

361. 031419 Coxiend Oral Powder


-do-

SULPHAQUINOXALINE (EQUAL

TO BASE) 20.00GM.

AMPROLIUM HCL (EQUAL TO

BASE) 30.00GM.

Vitamin K3 600.00MG.

(ANTICOCCIDIAL)(ANTIPROTO

ZONAL).

362. 031420 Coliexcd-D Oral Powder


COLISTINE SULPHATE

20,000,000IU. DOXYCYCLINE

HCL 10.00GM. (ANTIBIOTIC).

-do-

363. 031421 Oracin 50 Powder


AMOXYCILLIN AS

TRIHYDRATE 50GM.

(ANTIBIOTIC).

-do-

364. 031422 Spirachlor Oral Powder


SPIRAMYCIN ADIPATE 5.00GM.

CHLORTETRACYCLINE HCL

15.00GM. (ANTIBIOTIC).

-do-

365. 031423 Toxidot Oral Powder


METHENAMINE 95.00GM.

Vitamin B1 800.00MG.

Vitamin B2 920.00MG.

Vitamin K3 200.00MG.

(ANTITOXIC).

-do-

366. 031424 Medak Oral Powder


Vitamin A 4GM.

Vitamin D3 0.4GM.

Vitamin E 600MG.

Vitamin K3 500MG. (VITAMINS).

-do-

367. 031425 Mediquin-50 Oral Powder


FLUMEQUINE 50GM.

(ANTIBACTERIAL).

-do-

368. 031426 Imagicin Oral Powder


TYLOSIN TARTRATE 5GM.

ERYTHROMYCIN

THIOCYANATE 6GM.

FURALTADONE HCL 15GM.

(ANTIBACTERIAL).

-do-

M/s. Helix Pharma (Pvt.) Ltd., A/56,S.I.T.E., Karachi

369. 031232 Peprid Suspension

Each 5ml contains:-

Famotidine….10mg

Deferred for approval status in RRA.

M/s. CCL Pharmaceuticals (Pvt.) Ltd. 62-Industrial Estate Kot Lakhpat,Lahore

370. 052703 Cef-OD Tablet 200mg


Cefixime as Trihydrate….200mg


Cephalosporin by the firm.

371. 052704 Cef-OD DS Suspension

Each 5ml contains:-

Cefixime as Trihydrate….200mg

-do-

372. 052705 Kefrox 500mg Tablet


Cefuroxime as Cefuroxime

Axetil…500mg

-do-

373. 052706 Sterile Solvent with Lidocaine HCl

1% IM

Each 4ml Ampoule Contains:-

Lidocaine HCl…40mg

Sterile water for injection…4ml

-do-

M/s. Himont Pharmaceuticals (Pvt.) Ltd. 17 Km Ferozepur Road, Lahore

374. 031032 Wangkolin 500mg

Injection


Vancomycin HCl eq. to Vancomycin

base…500mg


formulation.

375. 031033 Wangkolin 1gm

Injection


Vancomycin HCl eq. to Vancomycin

base…1gm

-do-

M/s. Crystolite Pharmaceuticals, Plot No. 1 & 2 Road S-2, RCCI Industrial Estate, Rawat

376. 077616 Oratane 10mg

Capsule


Isotretinoin…10mg


formulation.

377. 077617 Oratane 20mg

Capsule


Isotretinoin…20mg


formulation.

M/s. Hansel Pharmaceuticals Pvt. Ltd. Plot No. 2, Pharma City,30 Km, Multan Road, Lahore

378. 076964 Vitadol-d Injection






column.

379. 076965 D-Prostol-F Tablet



Misoprostol…200mcg

-do-

M/s. GlaxoSmithKline Pakistan Limited, 35-Dockyard Road, West Wharf, Karachi

380. 000372 POLYFAX (FOR EYE) ONT

Each gm Contains:

POLYMYXIN B SULPHATE

10000 UBACITRACIN ZINC 500 U




column.

381. 000371 POLYFAX (FOR SKIN) ONT

Each gm Contains:

POLYMYXIN B SULPHATE

10000 IUBACITRACIN ZINC 500

IU

-do-

382. 000299 Piriton Expectorant Linctus

Each 5ml Contains:

AMMONIUM CHLORIDE 125MG,

-do-

SODIUM CITRATE 55MG,

CHLORPHENIRAMINE

MALEATE 2.5MG, Glycerin 150mg

383. 010890 Z-SPAN SPANULE CAPSULE


ZINC SULPHATE

MONOHYDRATE 61.8MG

-do-

M/s. GlaxoSmithKline Pakistan Limited, F-268 S.I.T.E., Karachi

384. 000188 Penbritin 250mg

Capsule

EACH CAPSULE CONTAINS:

Ampicillin as Ampicillin

Trihydrate…250mg




column.

385. 006364 TAGAMET 400Mg Tablet

EACH TABLET CONTAINS:-

CIMETIDINE…. 400MG

-do-

386. 004509 ZYLORIC 300Mg Tablet

EACH TABLET CONTAINS:-

ALLOPURINOL 300MG,

-do-

387. 000293 PIRITON TABLET



-do-

388. 000189 Penbritin 500mg

Capsule

EACH CAPSULE CONTAINS:

AMPICILLIN 500MG,

-do-

389. 000217 Penbritin Drops


AMPICILLIN TRIHYDRATE

125MG,

-do-

390. 000216 Penbritin Syrup

Each 5ml Contains:

AMPICILLIN TRIHYDRATE

125MG,

-do-

391. 006729 ZENTEL TAB


ALBENDAZOLE 200MG,

-do-

392. 006730 ZENTEL Suspension

Each 5ml Contains:

ALBENDAZOLE 100MG,

-do-

393. 006226 Ventolin Expectorant

Each 5ml Contains:

SALBUTAMOL 1MG,

GUAIPHENESIN 50MG,

-do-

394. 005904 Ventolin Injection

Each ml Contains:

Salbutamol (as Sulphate)…0.5mg

-do-

395. 0013350 Ventolin Respirator Solution

Contains:

Salbutamol as sulphate… 0.5 % w/v

-do-

396. 00287 Ventolin Syrup -do-

Each 5ml Contains:

Salbutamol (as Sulphate)…2mg

397. 000286 Ventolin Tablet 2mg


SALBUTAMOL (AS

SULPHATE)... 2MG,

-do-

398. 017692 Ventolin SR Tablet 4mg


Salbutamol (as Salbutamol

Sulphate)…4mg

-do-

399. 010807 Ventolin SR Tablet 8mg


SALBUTAMOL...8MG

-do-

400. 000395 STELABID TAB


ISOSORBIDE IODINE 5MG,

TRIFLUOPERAZINE HCL 1MG,

-do-

401. 000063 STELAZINE 1MG

TAB


TRIFLUOPERAZINE 1MG,

-do-

402. 008752 SEPTRAN DS Suspension

Each 5ml Contains:

TRIMETHOPRIM 80MG,

SULPHAMETHOXAZOLE

400MG,

-do-

403. 000384 SEPTRAN Suspension

Each 5ml Contains:

SULPHAMETHOXAZOLE

200MG, TRIMETHOPRIM 40MG,

-do-

404. 000388 SEPTRAN TAB


TRIMETHOPRIM 80MG,

SULPHAMETHOXAZOLE

400MG,

-do-

405. 008626 Zantac Injection

Each 2ml Contains:

Ranitidine (as HCl)…50mg

-do-

406. 022034 Zantac Tablet 300mg


Ranitidine (as HCl)…300mg

-do-

M/s. GlaxoSmithKline Pakistan Limited, Plot No.5,Sector 21,Korangi Industrial Area, Karachi

407. 019882 Starvits Tablet


Vitamin A…400mcg

Vitamin D…5mcg

Vitamin C…30mg

Thiamin (Vitamin B1)…7mg

Riboflavin (Vitamin B2)…8mg

Pyridoxine (Vitamin B6)…1mg

Folacin (Folic Acid)…100mcg

Vitamin B12…1mcg

Iron…7mg




column.

408. 019883 Revital-B Tablet


Thiamin (Vitamin B1)…2.8mg

Riboflavin (Vitamin B2)…3.2mg

Niacin…36mg

Vitamin B6…4mg

Folacin (Folic Acid)…400mcg

Vitamin B12…2mcg

Biotin…0.15mg

Pantothenic Acid…12mg

Choline…10mg

Inosital…10mg

-do-

409. 019884 Revitale Multi Tablets


Vitamin A…800mcg

Vitamin D…5mcg

Vitamin E…10mg

Vitamin C…60mg

Thiamin (Vitamin B1)…1.4mg

Riboflavin (Vitamin B2)…1.6mg

Niacin…18mg

Vitamin B6…2mg

Folacin (Folic Acid…200mcg

Vitamin B12…1mcg

Biotin…0.15mg

Pantothenic Acid…6mg

Calcium…80mg

Iron…14mg

Magnesium...50mg

Zinc...7.5mg

Iodine...150mcg

Chromium...25mcg

Selenium...25mcg

-do-

410. 014484 Ceporex Injection 500mg

IV


Cephalexin (as sodium

Cephalexin)…500mg

-do-

411. 014485 Ceporex Injection 500mg

IM


Cephalexin (as sodium

Cephalexin)…500mg

+



-do-

M/s. Jaens Pharmaceuticals Industries ( Pvt.) Ltd. 28-Km,Lahore Sheikhupura Road, Sheikhupura

412. 051186 Pinadex Ear Drops

Each ml contains:-


Ciprofloxacin…..3mg

Dexamethasone….1mg




column.

413. 051187 Ligcy Ear Drops -do-

Each ml contains:-


Ciprofloxacin…3mg

Lignocaine….50mg

M/s. Candid Pharmaceuticals Opp. Pasrur Sugar Mills Sialkot Road, Pasrur

414. 030825 Relent Tablet


Loratadine…10mg




column.

415. 051002 Viva-F Capsules



Folic Acid….0.5mg

-do-

M/s. Le Mendoza Pharmaceuticals (Pvt.) Ltd. Plot No. 7, Sector 23, Korangi Industrial Area Road,

Karachi

416. 050470 Kilcam 500mg Tablet






column.

417. 050468 Robaxicam 20mg Tablet


Rabeprazole (as Sodium)…20mg

-do-

418. 050469 Kilcam 250mg Tablet



-do-

M/s. Reliance Pharma, Plot No. 8, Street No. S-8 , RCCI Industrial Estate, Rawat.

419. 072164 Genbet Cream 30gm contains:-

Betamethasone as DP 0.05%

Gentamycin as Sulphate




column.

420. 075076 Religent-B Ointment

Each gm contains:-

Gentamycin (as sulphate)…0.1%,

Betamethasone (as dipropionate) …

0.05%

-do-

421. 075077 Religent-SB Ointment

Each gm contains:-

Betamethasone (as

dipropionate)…0.5 mg, Salicylic

acid … 30 mg

-do-

422. 072951 Relaxipain 20mg

Capsule


Piroxicam…20mg

-do-

M/s. Bio-Labs Pvt. Ltd., Plot No. 145, Industrial Triangle, Kahuta Road, Islamabad.

423. 052732 Bio-Prox Tablets 500mg


Naproxen….500mg




column.

424. 052733 Bio-Prox Tablets 250mg


Naproxen….250mg

-do-

M/s. Wise Pharmaceuticals, Plot No. 3-A,s-1,RCCI Industrial Estate, Rawat ,Rawalpindi

425. Ex-003066 Piroxi 20mg Tablet Registration Board deferred the above


Piroxicam as Beta

Cyclodextrin….20mg



column.

426. Ex-003067 Dothine 25mg Tablet


Dothiepin (as HCl)….25mg

-do-

427. Ex-003068 Cepzon 2gm

Injection

Each vial Contains:-

Sterile Cefoperazone(as sodium +

Sulbactum (as sodium) (1:1)…2gm

-do-

428. Ex-003069 Cepzon 1gm

Injection

Each vial Contains:-

Sterile Cefoperazone(as sodium +

Sulbactum (as sodium) (1:1)…1gm

-do-

429. Ex-003070 Lpride 50mg Tablet



-do-

430. Ex-003071 Lpride 25mg Tablet



-do-

431. Ex-003072 Cirta 50mg


Sertraline (as HCl)…50mg

-do-

432. Ex-003073 Cirta 25mg


Sertraline (as HCl)…25mg

-do-

433. Ex-003074 Nepro 550mg Tablet


Naproxen Sodium…550mg

-do-

434. Ex-003075 Lozapin 10mg Tablet


Olanzapine as (citrate)….10mg

-do-

435. Ex-003076 Resp 1mg Tablet


Risperidone…1mg

-do-

436. Ex-003077 Vepim 1gm

Injection


Cefepime as HCl with L-Arginine

….1gm

-do-

437. Ex-003078 Vepim 500mg

Injection


Cefepime as HCl with L-Arginine

….500mg

-do-

438. Ex-003079 Esta 10mg Tablet


Escitalopram (as oxalate)…..10mg

-do-

M/s. Farm Aid Group Pakistan, Plot 3/2 Phase ½ Industrial Estate, Hattar

439. 051045 Piroxifarm 20mg Tablet


Piroxicam-beta-cyclodextrin




….20mg

column.

440. 051046 Rabefarm 10mg Tablet


Rabeprazole Sodium …….… 10mg

-do-

441. 051047 Rabefarm Tablet


Rabeprazole Sodium …….… 20mg

-do-

442. 051048 Fa-Cin Tablets 250mg.



-do-

443. 051049 Fa-Cin Tablets 500mg.



-do-

444. 051050 Xoitro Tablets 150mg.


Roxithromycin…..150mg

-do-

445. 051051 Xoitro Tablets 300mg.


Roxithromycin…..150mg

-do-

M/s. Onyx Pharmaceuticals 30-A Small Industrial Estate Manshera

446. 077418 Alfanyx-D Tablet


Alfacalcidol….0.5mcg (20

I.U.)Calcium Carbonate equivalent

to calcium (element)…400mg




column.

M/s. Fedro Pharma,149 Indus Estate,Jamrud Road, Peshawar

447. 051147 Leefed 500mg Tablet


Levofloxacin as

Hemihydrate….500mg




column.

M/s. Caraway Pharmaceuticals, National Industrial Zone RCCI Rawat ,Islamabad

448. 050983 Ofraway Tablets 200mg


Ofloxacin….200mg




column.

449. 050984 Fexicame Capsule 60mg


Fexofenadine as HCl….60mg

-do-

450. 050985 Ofraway Infusion

Each 100ml vial contain:Ofloxacin

as HCl…200mg

-do-

M/s. Adamjee Pharmaceuticals (Pvt.) Ltd. Plot-39,Sector-15 Korangi Industrial Area, Karachi

451. 001060 Enzar Tablet


(Amylase Protease)

Each eq. to 389mg

Lipase of Pancreatin USNF Malt

Diastase…65mg

Sodium Tauroglycocholate…65mg




column.

Dioctyl Sodium

Sulphosucinate…11mg

M/s. Oval Pharmaceuticals, 112/11, Industrial Estate,Township,Lahore

452. 009884 Gentian Violet LotionContains:-

Gentian Violet BPC 0.5% w/v




column.

453. 00972 Acriflavine Lotion B.P.C 0.1% -do-

M/s. Lahore Chemical Works,(Pvt.) Ltd.9km Sheikhupura Road, LAHORE

454. 031037 Histafex 120 tablet


Fexofenadine HCl….120mg




column.

455. 031038 Histafex 180 tablet


Fexofenadine HCl….180mg

-do-

456. 031039 Supraclor Drops 50mg

Each ml contains:-

Cefaclor….50mg

-do-

457. 031040 Supraclor Suspension 125mg

Each5 ml contains:-

Cefaclor….125mg

-do-

458. 031041 Supraclor Suspension 250mg

Each5 ml contains:-

Cefaclor….250mg

-do-

M/s. Saibins Pharmaceuticals Plot No. 316,Industrial Triangle Kahuta Road,Islamabad

459. 077662 Excite CR 25mg Tablet

Each enteric coated controlled

release tablet contains:-

Paroxetine HCl eq. to

Paroxetine…..25mg




column.

460. 075471 Sairoxin 20mg Tablet


Piroxicam Beta Cyclodextrin

191.2mg

(eq. to Piroxicam….20mg

-do-

461. 077661 Saiflow 0.4mg

Capsules


Tamsulosin HCl (as extended release

Pellets)…..0.4mg

Source Of Pellets:M/s. Vision

Pharmaceuticals

-do-

M/s. Brookes Pharma Private Limited,58-59 Sector 15,Korangi Industrial Area, Karachi

462. 009128 Phlogin-50 Capsules

Each capsules contains:-





column.

463. 009129 Phlogin-SR-100 Capsule


Diclofenac Sodium….100mg

-do-

464. 009529 Pyodine Gargle & Mouth Wash -do-


Polyvinylpyrolidine I odine

465. 009528 Pyodine Solution


Polyvinylpyrrolidine Iodine

-do-

466. 009031 Hepa-Merz Syrup

Each ml contains:-

Ornithine Asparate….60mg

Nicotinamide….4.8mg

Riboflavin-5-Phosphate

Sodium….0.153mg

Sodium Benzoate…1.2mg

Potassium Sorbate…1.2mg

Citric Acid…6.0mg

-do-

467. 009939 Sterile Water for InjectionContains:-


-do-

468. 022304 Ponsac Tablets


Mefenamic Acid….250mg

-do-

M/s. Alfalah Pharma (Pvt.) Ltd. 12 Km,Sheikhupura Road,Lahore

469. 051110 Limperide Tablet 1mg


Glimepiride….1mg




column.



Glimepiride….2mg

-do-

471. 051112 Methoxine Tablet


Sulfadoxine….500mg

Pyrimethamine…25mg

-do-

472. 051113 Benbit Tablet 5mg


Glibenclamide….5mg

-do-

473. 051114 Pyomic Tablet 25mg



-do-

474. 051115 Alfakalium Tablet 50mg



-do-

475. 051116 Mczole Tablets 400mg


Metronidazole….400mg

-do-

476. 051117 Vasit Tablet 20mg


Atorvastatin….20mg

-do-




-do-

478. 051119 Zolo Tablets



Sesquihydrate)….40mg

-do-

M/s. Orta Laboratories (Pvt.) Limited,24Km,Multan Road,Off Defence Road,mohlanwal,Lahore

479. 050980 Orteso Capsule 40mg


Esomeprazole Magnesium

Trihydrate Pellets eq. to

Esomeprazole….40mg

Source of pellets M/s. Glenmark

Pharma Ltd,Gide Estate

Ankeshwar Gujrat India




column.

480. 050982 Provitine Capsule 20mg


Fluoxetine…20mg

-do-

481. 050981 Ortalanz Capsule 30mg


Lansoprazole (Pellets)….30mg

-do-

M/s. Macter International Limited,F-216,S.I.T.E.,Karachi

482. 050581 Kefanur Capsule


Cefdinir….300mg




column.

483. 050582 Kefanur 125mg

Suspension

Each 5ml contains:-

Cefdinir….125mg

-do-

484. 050583 Kefanur 250mg

Suspension

Each 5ml contains:-

Cefdinir….250mg

-do-

485. 050584 Invapime 500mg

Injection


Cefepime (as HCl)…500mg

Sterile Arginine….250mg

-do-

486. 050585 Invapime 1gm

Injection


Cefepime (as HCl)…1gm

Sterile Arginine….500mg

-do-

487. 012637 Vicks VaporubContains:-

Camphor….5.26%w/wMenthol….2.

82%w/wTurpentine…4.68%w/wOil

of Eucalyptus…1.33%w/w

-do-

488. 050686 Sante 40mg

Capsule


Enteric coated Pellets of

Omeprazole….40mg

Source of pellets:M/s. Spansules

Formulations.Plot No.163.

Subhash Nagar,IDA,

Jeedimetla,Hyderabad,Telangana

State, India

-do-

489. 050576 Esante 20mg

Capsule


-do-


(as Magnesium Trihydrtae)….20mg

Source of pellets:M/s. Spansules

Formulations.Plot No.163.

Subhash

490. 022355 Sante Capsules


Omeprazole…10mg

-do-

M/s. Himont Pharmaceuticals (Pvt.) Ltd. 17 Km Ferozepur Road, Lahore

491. 051148 Isocane Gel


Isotretinoin….0.05%w/w




column.

M/s. Nawabsons Laboratories (Pvt.) Ltd. Jia Bagga Off Raiwind Road, Lahore

492. 006891 Diazepam Tablet


Diazepam…5mg




column.

M/s. Pearl Pharmaceuticals Plot No. 204,Street No. 1,I-10/3 Industrial Area, Islamabad

493. 075494 Diflosone Forte Cream


Diflucortolone Valerate….0.3%




column.

494. 075495 Diflosone Forte Ointment


Diflucortolone Valerate….0.3%

-do-

M/s. Pharmix Laboratories (Pvt.) Ltd., 21-KM,Ferozpur Road, Lahore

495. Ex-001806 Kwatadin Tablet 10mg


Loratadine….10mg




column.

496. Ex-001805 Metfodi Tablet 300mg


Tenofovir Disoproxil Fumarate

300mg

equivalent to Tenofovir Disoproxil

-do-

497. Ex-001804 Zidetin Suspension 5mg

Each 5ml contains:-

Loratadine….5mg

-do-

M/s.Saydon Pharmaceuticals Industries (Pvt.) Ltd.,77/A-Hayatabad Industrial Estate, Peshawar

498. 001087-Ex Azores 500mg

Capsules






column.

499. 001088-Ex Riget Tablet 750mg


Ciprofloxacin HCl….750mg

-do-

M/s. Helix Pharma (Pvt.) Ltd., A/56,S.I.T.E., Karachi

500. 031232 Tobracin-D Eye Drops

Each ml contains:-

Tobramycin….3.0mg

Dexamethasone….1mg




column.

M/s. Epoch Pharmaceutical Plot No.85,Sector -15 Korangi, Karachi

501. 050474 Aktis Injection Registration Board deferred the above

Each ml contains:-

Cyanocobalamin….1000mcg



column.

502. 050472 Mynoside 20 Injection

Each ml contains:-

Tobramycin (as Sulphate)….10mg

-do-

503. 050471 Helga Injection

Each ml contains:-


-do-

504. 050473 Mynoside 80 Injection

Each ml contains:-

Tobramycin (as Sulphate)….40mg

-do-

505. 050475 Fenaclod Injection

Each ml contains:-


-do-

506. 050476 Phenerzine Injection

Each ml contains:-

Promethazine HCl….25mg

-do-

507. 050477 Fragran 250mg

Injection

Each 5ml contains:-


-do-

508. 050478 Fragran 500mg

Injection

Each 5ml contains:-


-do-

M/s. Medicraft Pharmaceuticals (Pvt.) Limited 126-B,Industrial Estate, Hayatabad, Peshawar

509. 051082 Aciphexa 10mg Tablets


Rabeprazole….10mg




column.

510. 051083 Astharid 10mg Tablet


Montelukast (as Sodium)….10mg

-do-

511. 051084 Astharid 5mg Tablet


Montelukast (as Sodium)….5mg

-do-

512. 051087 Prevexa 10mg Tablet

Each fim coated tablet contains:-

Escitalopram (as Oxalate)…10mg

-do-

513. 051088 Clafax Dry Suspension

Each 5ml contains:-


-do-

514. 051089 Deprid Tablet


Sertraline as HCl…100mg

-do-

515. 051090 Dicloking Injection

Each 1ml contains:-


-do-

516. 051092 Dyrid-P 500mg

Injection



-do-

517. 051094 Medikort Injection

Each 1ml contains:-

Triamcinolone Acetonide….40mg

-do-

518. 051095 Deprid Tablet


Sertraline as HCl…50mg

-do-

519. 051096 Gasrid Suspension

Each 5ml contains:-

Aluminium Hydroxide…215mg

Magnesium Hydroxide…80mg

Simethicone ….25mg

-do-

520. 052471 Som 40mg

Capsule



Trihydrate pellets eq. to

Esomeprazole…40mg

Source of Pellets:

M/e. Similax Laboratories

Ltd.,India

-do-

521. 052472 Malart Injection 80mg

Each ml contains:-

Artemether ….80mg

-do-

M/s. Medinet Pharmaceuticals Building No.601, Lane. No. 5, Main Peshawar Road, Rawalpindi

522. 028482 Hydra Capsule


Hydroxyurea….500mg

Imported from Dae Han New

Pharm. Co., Ltd.66- Jeyakgongdan

1-gil,Hyangnam-eup,Hwaseog-

si,Gyeonggi-do,Republic of Korea.




column.

523. 028482 DAC Injection

Each vial

contain:Dacarbazine….200mg

Imported from Dae Han New


1-gil,Hyangnam-eup,Hwaseog-

si,Gyeonggi-do,Republic of Korea.

-do-

524. 028491 Etoside Injection

Each ampoule contains:-

Etoposide….100mg

Manufactured by:M/s.

Laboratorio Varifarma S.A.

Argentina

-do-

525. 028489 Tamodex Tablets


Tamoxifen Citrate equivalent to

10mg

Tamoxifen baseManufactured

by:M/s. Laboratorio Varifarma

S.A. Argentina

-do-

526. 028493 Progace Tablet


Megestrol Acetate…160mg

-do-

Manufactured by:M/s.

Laboratorio Varifarma S.A.

Argentina

M/s. Alina Combine Pharmaceuticals (Pvt.) Ltd. A-127,S.I.T.E.,Super Highway,Karachi

527. 014083 Dermofix Cream 30gm


Sertaconazole Nitrate…2gm

Manufactured by Ferrer Pharma

International S.A.,Barcelona,Spain




column.

M/s. Gene Tech Laboratories 246/B-P.E.C.H.S. Block-6, Karachi

528. 047659 Methogen Injection

Each Injection contains:-

Methotrexate Freeze Dried

Lyophilized Powder for

Injection….50mg

Imported by M/s. Jiangsu Hengrui

Medicine Co. Ltd., Jiangsu, P.R.

China




column.

529. 047660 Methogen Injection

Each Injection contains:-

Methotrexate Freeze Dried

Lyophilized Powder for

Injection….500mg

Imported by M/s. Jiangsu Hengrui

Medicine Co. Ltd., Jiangsu, P.R.

China

-do-

M/s GlaxoSmithKline Pakistan Limited, 35-Dockyard Road, West Wharf, Karachi

530. 019501 SEROXAT TABLETS


PAROXETINE HCl…20MG

Product license holder / marketing

authorization holder:M/s. Smithkline

Beecham Limited, 980 Great West

Road, Brentford, Middlesex, TW8

9GS, United Kingdom.Manufacturer

/ Packagers:M/s. Glaxosmithkline

Pharmaceuticals S.A. Ulica

Grunwaldzka 189, Poznan, PL-60-

322, Poland




column.

531. 010058 IMURAN TABLETS


AZATHIOPRINE…50MG

Manufactured By:M/s. Wellcome

Foundation Ltd., London

-do-

532. 004512 AMOXIL INJECTION 500

Each VIAL

CONATINS:AMOXYCILLIN

500MG

-do-

533. 022660 Zeffix Tablets


Lamivudine…100mg

-do-

534. 020468 VALTREX TABLETS -do-


VALACICLOVIR HCL 500MG

535. 009570 TRACRIUM INJECTABLE 2.5ML

EACH 2.5ML CONTAINS:-

ACTRACURIUM BESYLATE

25MG, Manufactured By:UK

Wellcome(According to Registration

Letter)

-do-

536. 009571 TRACRIUM INJECTABLE 5ML

EACH 5ML CONTAINS:-

ACTRACURIUM BESYLATE

50MG,

-do-

537. 010333 ZOVIRAX CREAM

Cream Contains:-

ACYCLOVIR 5% W/WManufacture

By:M/s. Wellcome Foundation Ltd.,

London/U.K.(as per Registration

Letter)

-do-

538. 009975 Zovirax IV for Infusion

Each Vial contains:-

Acyclovir Sodium…250mg

Sterile, Freeze-dried acyclovir as the

Sodium SaltManufacture By:M/s.

Wellcome Foundation Ltd., 183-

Euston Road, London/U.K.(as per

Registration Letter)

-do-

539. 009974 Zovirax Tablet


Acyclovir…200mg

Manufacture By:M/s. Wellcome

Foundation Ltd., 183-Euston Road,

London/U.K.(as per Registration

Letter)

-do-

540. 027381 Seretide Evohaler 25/50mcg


SALMETEROL XINAFOATE

36.3MCG.FLUTICASONE

PROPIONATE

50.0MCGManufactured by:M/s.

Glaxo Wellcome Operations,

Greenford Middlesex, UK(as per


-do-


Each Actuation Contains:-


36.3MCGFLUTICASONE

PROPIONATE





-do-



-do-


36.3MCGFLUTICASONE

PROPIONATE





543. 019532 LAMICTAL TABLETS (

DISPERSIBLE / CHEWABLE

5MG)


LAMOTRIGINE 5MG

-do-

544. 014918 LAMICTAL TABLETS


LAMOTRIGINE 25MG

-do-



LAMOTRIGINE 50MG

-do-



LAMOTRIGINE 100MG

-do-

547. 010338 AUGMENTIN 600MG

Each Vial Conatins:

AMOXICYLLIN 500MG,

CLAVULANIC ACID 100MG

Manufacture by:M/s. Beecham

Research Laboratories, Singapore

-do-

548. 011523 AUGMENTIN INJECTION 1.2GM

EACH VIAL CONATINS:

AMOXICYLLIN 1G

CLAVULANIC ACID 200MG

Manufacture by:M/s. Beecham

Research Laboratories, Singapore

-do-

549. 052208 AUGMENTIN DROPS.

Each ml contains:-

AMOXICILLIN TRIHYDRATE

EQUIVALENT TO AMOXICILLIN

50MG

POTASSIUM CLAVULANATE

EQUIVALENT TO CLAVULANIC

ACID 13.125MG

Manufactured By:SmithKline

Beecham , Worthing, UK

-do-

M/s. Ghazi Brothers,Ghazi House D-35,K.D.A Scheme # 1,Miran Muhammad Shah Road, Karachi

550. 049607 Cocci-Guard Powder

Each dose of Cocci-Guard Contains:-

Steriodal Sapoginins

13600ppmManufactured by M/s.

Distributors Processing

Incorporated,USA




column.

551. 049606 Terramycin Soluble Powder with

Anti-germ 77


Terramycin(Oxytetracycline

Chlorhidrate) 5.6gm

Anti-germ 77 (benzetonium

chloride)5.5gm


Laboratories Pfizer Ltd.,Brazil

-do-


552. 031432 Boviton Plus Granules

Each Kg contains:-

Vitamin D ….1000,000,00 I.U.

Vitamin E…300 I.U.

Iron (ferrous sulphate) 1000mg

Cobalt (cobalt sulphate) 15mg.Iodine

(potassium iodide) 200mg.Copper

(copper sulphate) 600mg.Zinc (zinc

sulphate) 3,000.00mg.Manganese

(sulphate) 2,000.00mg.Selenium

(sodium selenite) 9mg.Sodium

(sodium chloride) 45gm.Magnesium

(sulphate) 55gm.Calcium (D.C.P)

195gm.Phosphorus (D.C.P) 153gm


formulation from the concerned

section.

553. 031480 Kerry Vit Amino Powder


Vitamin A…2,000,000 I.U.

Vitamin D3..400,000 I.U.

Vitamin E 160 I.U.

Vitamin K3 ….. 900mg.

Vitamin B1 ….. 125mg.

Vitamin B2 …..2,000mg.


Vitamin B12 3,000mcg.

Vitamin C…1,000mg. Folic acid

…200mg. Nicotinic acid 10,000mg.

Calcium Pantothenate 3,000mg. L-

lysine 50,000mg. Di-Methionine

30,000mg.



section.

M/s. Nawan Laboratories (Pvt.) Ltd.,136-138 Sector 15,Korangi Industrial Area,Karachi

554. 049605 Cefur-RTU Injection

Each ml contains:-

Ceftiofur (as Hydrochloride)….50mg


section from Licensing Division.


555. 026401 Bio-ALD A C.S. Oral Suspension


Albendazole…2.50gm

Cobalt Chloride….0.075gm

Sodium Selenite….0.035gm




column.

556. 026407 Coxout Oral Powder


Sulphaquinoxaline (equal to

base)…20gm

Amprolium HCl (equal to

-do-

base)…30gm

Vitamin K3….600mg

M/s. Cherished Pharmaceuticals (Pvt.) Ltd. 10th Km,Sunder Raiwind Road, Lahore

557. 049611 Zancox AK3 Water Soluble Powder


2,4-Diamino-

5(Vetatrylpyrimidine)25gm

Sulphabenzylpyrazine…100gm

Vitamin A….12,50,000 I.U.

Vitamin K3….2.5gm




column.

558. 049612 Fairy-5 Water Soluble Powder


Tylosin Tartrate….100gm

Doxycyclin HCl….100gm

Bromhexine HCl…5gm


-do-

M/s. International Pharma Lab’s,Raiwind Road, Bhohtain Chowk, Defense Road,1-Km Toward

Kahna,Lahore

559. 53982 ANTI-BECTER INJECTION

Each ml contains::

SULPHAMERAZINE…100MG

SULPHADIAZINE…60MG

SULPHATHIAZOLE….40MG

TRIMETHOPRIM….40MG




column.

560. 53980 DR-FLOX-10 INJECTION

Each ml contains::

ENROFLOXACIN…….10GM

-do-

561. 53983 ENROCK INJECTION

Each ml contains::

ENROFLOXACIN…..20GM

-do-

562. 53979 JEXINEL INJECTION

Each ml contains::

CEFTIOFUR HCL…..5GM

-do-

563. 53981 ITOSIN INJECTION

Each ml contains::

TYLOSIN TARTRATE…..200MG

-do-

564. 53984 I-VIT SUPER INJECTION

Each ml contains::

CALCIUM

GLUCONATE….20.83GM

MAGNESIUM

HYPOPHOSPHITE….5.33GM

MAGNESIUM CHLORIDE….2GM

CALCIUM D

SACCHARATE….1GM

BORIC ACID….4.33GM

DEXTROSE….20GM

VITAMIN B-1….10MG

VITAMIN B-6…70MG

-do-

VITAMIN B-12…..3MG

565. 53987 ITOFEN INJECTION

Each ml contains::

KETOPROFEN….10GM

-do-

566. 53986 DR-OXY-LA INJECTION

Each ml contains::

OXYTETRACYCLINE HCL

B.P…..21.60GM

-do-

567. 53985 I-FENAC INJECTION

Each ml contains::

MELOXICAM…..1GM

-do-




Steriodal Sapoginins

13600ppmManufactured by M/s.


Incorporated,USA




column.


Anti-germ 77


Terramycin(Oxytetracycline

Chlorhidrate) 5.6gm


chloride)5.5gm


Laboratories Pfizer Ltd.,Brazil

-do-


570. 031432 Boviton Plus Granules

Each Kg contains:-

Vitamin D ….1000,000,00 I.U.

Vitamin E…300 I.U.

Iron (ferrous sulphate) 1000mg

Cobalt (cobalt sulphate) 15mg.Iodine

(potassium iodide) 200mg.Copper

(copper sulphate) 600mg.Zinc (zinc

sulphate) 3,000.00mg.Manganese

(sulphate) 2,000.00mg.Selenium

(sodium selenite) 9mg.Sodium

(sodium chloride) 45gm.Magnesium

(sulphate) 55gm.Calcium (D.C.P)

195gm.Phosphorus (D.C.P) 153gm




column.

571. 031480 Kerry Vit Amino Powder


Vitamin A…2,000,000 I.U.

Vitamin D3..400,000 I.U.

Vitamin E 160 I.U.

Vitamin K3 ….. 900mg.


Vitamin B2 …..2,000mg.

-do-


Vitamin B12 3,000mcg.

Vitamin C…1,000mg. Folic acid

…200mg. Nicotinic acid 10,000mg.

Calcium Pantothenate 3,000mg. L-

lysine 50,000mg. Di-Methionine

30,000mg.

M/s. Nawan Laboratories (Pvt.) Ltd.,136-138 Sector 15,Korangi Industrial Area,Karachi

572. 049605 Cefur-RTU Injection

Each ml contains:-

Ceftiofur (as Hydrochloride)….50mg


section from Licensing Division.


573. 026401 Bio-ALD A C.S. Oral Suspension


Albendazole…2.50gm

Cobalt Chloride….0.075gm

Sodium Selenite….0.035gm




column.

574. 026407 Coxout Oral Powder


Sulphaquinoxaline (equal to

base)…20gm

Amprolium HCl (equal to

base)…30gm

Vitamin K3….600mg

-do-

M/s. Cherished Pharmaceuticals (Pvt.) Ltd. 10th Km,Sunder Raiwind Road, Lahore

575. 049611 Zancox AK3 Water Soluble Powder


2,4-Diamino-

5(Vetatrylpyrimidine)25gm

Sulphabenzylpyrazine…100gm

Vitamin A….12,50,000 I.U.

Vitamin K3….2.5gm




column.

576. 049612 Fairy-5 Water Soluble Powder


Tylosin Tartrate….100gm

Doxycyclin HCl….100gm

Bromhexine HCl…5gm


-do-

M/s. International Pharma Lab’s,Raiwind Road, Bhohtain Chowk, Defense Road,1-Km Toward

Kahna,Lahore

577. 53982 ANTI-BECTER INJECTION

Each ml contains::

SULPHAMERAZINE…100MG

SULPHADIAZINE…60MG

SULPHATHIAZOLE….40MG

TRIMETHOPRIM….40MG




column.

578. 53980 DR-FLOX-10 INJECTION

Each ml contains::

ENROFLOXACIN…….10GM

-do-

579. 53983 ENROCK INJECTION

Each ml contains::

ENROFLOXACIN…..20GM

-do-

580. 53979 JEXINEL INJECTION

Each ml contains::

CEFTIOFUR HCL…..5GM

-do-

581. 53981 ITOSIN INJECTION

Each ml contains::

TYLOSIN TARTRATE…..200MG

-do-

582. 53984 I-VIT SUPER INJECTION

Each ml contains::

CALCIUM

GLUCONATE….20.83GM

MAGNESIUM

HYPOPHOSPHITE….5.33GM

MAGNESIUM CHLORIDE….2GM

CALCIUM D

SACCHARATE….1GM

BORIC ACID….4.33GM

DEXTROSE….20GM

VITAMIN B-1….10MG

VITAMIN B-6…70MG

VITAMIN B-12…..3MG

-do-

583. 53987 ITOFEN INJECTION

Each ml contains::

KETOPROFEN….10GM

-do-

584. 53986 DR-OXY-LA INJECTION

Each ml contains::

OXYTETRACYCLINE HCL

B.P…..21.60GM

-do-

585. 53985 I-FENAC INJECTION

Each ml contains::

MELOXICAM…..1GM

-do-

M/s Neutro Pharmaceuticals Pvt. Limited,9.5 km, Sheikhupura Road, Lahore

586. 052804 Heumetic SR Tablets.


Diclofenac Sodium

………..….75mg.


formulation(enteric coating)

M/s Zafa Pharmaceutical Laboratories Pvt. Limited, l-4/1, A&B, Block-21, Federal B Industrial Area,

Karachi

587. 053335 Yes 2 Zinc Syrup

Each 5ml contains:-

Zinc Sulphate Monohydrate 56mg

Equivalent to Elemental Zinc20mg



section in comparision to Reg. no

053119 issued in favor of M/s Zafa

Pharmaceutical Laboratories Pvt.

Limited

M/s S.J&G Fazul Ellahie (Pvt) Ltd, E/46, S.I.T.E., Karachi.

588. 048532 Graber Capsule


Orlistat ……120mg


source of pellets.

M/s Sharex Laboratories, Pvt. Limited, K.L.P. Road, Sharex Colony Sadiqabad, Rahim Yar Khan.

589. 014713 Tracodil-DM Syrup

Each 5ml Contains:-

Dextromethorphan Hbr…10mg


Ephedrine Hcl…7mg

Deferred for clarification of brand

name from the concerned section.

M/s. NoaHemis Pharmaceuticals, Plot no. 154, Sector 23, Korangi Industrial Area, Karachi (Human)

590. 053469 Noazol Capsule

Each Capsule Contains: Omeprazole

enteric coated Pellets 20mg


pallets

591. 053470 Noazol-D Capsule

Each Capsule Contains: Omeprazole

enteric coated Pellets 40mg


pallets

M/s. Neomedix, Plot No. 05, N/5, National Industrial Zone, Islamabad

592. 052602 Neolorin Syrup 5mg

Each 5ml Contains:-

LoratidineHCl5mg

(USP Specs)




column.

M/s. Ideal Pharmaceutical Industries, 18-Km Ferozpur Road, Lahore

593. 004427 Aspirn Compound Tablet


-Aspirin 300mg, Paracetamol

200mg, Caffeine 30mg,




column.

594. 007602 Iodopyrin Tablet


-Aspirin 300mg, Paracetamol

75mg,Caffeine 10mg,

-do-

M/s Onyx Pharmaceuticals Pvt. Limited,30-A, Small Industrial Estate, Mansehra

595. 077470 LED-50 Tablet Registration Board deferred the above



column.

596. 077441 Famonyx Suspension -do-

597. 077442 Sate Suspension -do-

M/s Pakheim International, 19-Km, Ferozpur Road, Lahore.

598. 031123 Paraheim Tablets


Paracetamol 500mg




column.

599. 031124 Omeheim Tablet


Omeprazole 20 mg

-do-

M/s M/s Harrison Pharmaceuticals, 10-Km, Lahore Road, Sargodha.

600. 050102 Anagix DS Tablets 500mg.


Mefenamic Acid …………..500mg.

(B.P Specs)




column.

601. 050103 Anagix DS Tablets 250mg.


Mefenamic Acid …………..250mg.

(B.P Specs)

-do-

602. 050104 Harriprox 550mg Tablets.


-do-

Naproxen Sodium ……….550mg.

(B.P Specs)

603. 050107 Diclokam-K Tablets 75mg.


Diclofenac Potassium ….75mg.

(USP Specs)

-do-

604. 050108 T-Zine Tablets 10mg.


Cetirizine 2HCl ………….10mg.

-do-

M/s Neutro Pharmaceuticals Pvt. Limited,9.5 km, Sheikhupura Road, Lahore

605. 052600 B-Fusid Cream

Each gm Contains:-

Fusidic Acid…………….20mg

Betamethasone (as valarate).10mg




column.

606. 052601 Benate Cream

Each gm Contains:-

Betamethasone Dipropionate 0.05%

-do-

M/s Pulse Pharmaceuticals Pvt. Limited, MozayBadoke, Raiwind Road, (SuaAasil Rd), Lahore

607. 052525 Rovapulse Tablets 5mg.


Rosuvastatin….5mg.




column.

608. 052526 Rovapulse Tablets 10mg.


Rosuvastatin….10mg

-do-

609. 052527 Piozone Plus Tablets.


Metformin HCl 850mg. Pioglitazone

..15mg.

-do-

610. 052528 Piozone Plus 500/15 Tablets.


Metformin HCl …..500mg.

Pioglitazone…15mg

-do-

611. 052529 Gamiflet Tablets 320mg.


Gemifloxacin..320mg

-do-

612. 052530 Moxipulse Tablets 400mg.


Moxifloxacin.400mg.

-do-

M/s OBS Pakistan Pvt. Limited, C-14, Mangopir Road, S.I.T.E,Karachi

613. 076116 C-Yalta 20mg

Capsule


Duloxetine HCl enteric coated

pellets eq. to Duloxetine ..20 mg




column.

614. 076117 C-Yalta 60mg

Capsule



pellets eq. to Duloxetine ..60 mg

-do-

615. 076118 C-Yalta 30mg

Capsule


-do-


pellets eq. to Duloxetine ....30 mg

M/s Mass Pharmaceutical Pvt. Limited, 17- Km, Ferozpur Road, Lahore.

616. 030211 Bifomyk Cream 1%Contains:-

Bifonazole…1%w/w




column.

617. 030213 Triazolin Capsule 150mg


Fluconazole…150mg

-do-

618. 030214 Revaquin Cream 2%Contains:-

Hydroquinone… 2%w/w

-do-

619. 030215 Revaquin Cream 4%Contains:-

Hydroquinone…..2%w/w

-do-

M/s English Pharmaceuticals Industries,LinkKattar Bund Road, ThokarNiazBaig,Multan Road,

Lahore.

620. 052405 Valtan Tablets 80mg.


Valsartan…80mg. (USP Specs)




column.

621. 052406 Valtan Plus Tablets.


Valsartan….160mg.

Hydrochlorthiazide…..25mg. (USP

Specs)

-do-

622. 052407 Valtan Tablets 160mg.


Valsartan….160mg. (USP Specs)

-do-

623. 052408 Rival Capsule 100mg.


Celecoxib ….100mg.

-do-

624. 052409 Rival Capsules 200mg.


Celecoxib….200mg.

-do-

625. 052410 Fexokure Tablets 120mg.


Fexofenadine120mg.

-do-

626. 052411 Fexokure Tablets 180mg.


Fexofenadine180mg.

-do-

M/s Friends Pharma Pvt. Limited,31-Km, Ferozpur Road, Lahore.

627. 076960 Friendine Injection


Ranitidine (as HCl) ….. 25 mg

(B.P. Specs)




column.

M/s Goodman Laboratories Pvt. Limited, Plot No.5, Street No. S-5, National Industrial Zone, RCCI

Estate Rawat, Rawalpindi.

628. 052533 Loxigood 7.5mg Tablets


Meloxicam..7.5mg.




column.

629. 052541 Loxigood 15 mg Tablets.


Meloxicam .15mg.

-do-

630. 052542 Armer Tablets.


Artimether….20mg. Lumefantrine

120mg.

-do-

631. 052545 Alfagood Tablets.

Each Tablet Contains;-

Alfacalcidol.0.5mcg.

-do-

632. 052549 Luox Capsules.


Fluoxetine as HCl……..20mg.

-do-

633. 052550 Azigood 250 Capsules.


Azithromycin as dehydrate…250mg

-do-

M/s Amros Pharmaceuticals, A-96, S.I.T.E. North Karachi.

634. 031192 Amdik Tablets 50mg

Each tablet contains;-Diclofenac

Potassium…50mg




column.

635. 031193 Amrofec Tablet 50mg


Sodium….50mg

-do-

636. 022565 Amroton Syrup


Ferric Ammonium Citrate…900mg

Folic Acid…10mg

Vitamin B1…20mg

Vitamin B6…40mg

Nicotinamide…20mg

Vitamin B12..360mcgD-

Panthenol…33mg

-do-

M/s Caraway Pharmaceuticals, Plot No. 12, Street No. N-3, National Industrial Zone (RCCI), Rawat,

Islamabad.

637. EX-003080 Viro-Quit 300mg Tablet


TenofovirDisoproxil

Fumarate…300mg




column.

638. 052573 Caradin Capsules 250mg.


Cephradine….250mg

-do-

639. 052574 Caradin Capsules

500mg.Cephradine….500mg.

-do-

640. 052575 Cefeye Capsules 100mg.


Cefdinir……100mg.

-do-

641. 052576 Dicway-C Injection.

Each 2ml contains:-

Diclofenac Sodium………..75mg.

Lignocaine HCl20mg.

-do-

642. 052577 Benoder Cream. -do-

Each gm contains:-

Bifonazole……10mg.

643. 052578 Terb-C Cream.

Each gm contains:-

Terbinafine as HCl…………..10mg.

-do-

644. 052523 Iron Sucrose Injection.

Each 5ml contains:-

Iron Sucrose complex eq. to

Elemental iron .100mg.

-do-

M/s RekoPharmacal (Pvt) Ltd, 13 Km, Multan Road, Lahore

645. 022010 Clomocite Tablet






column.

M/s Medisure Laboratories Pakistan Pvt. Limited, A-115, S.I.T.E., Super Highway, Karachi.

646. 004214-EX Rumapine Tablet


Amlodipine Besilate eq. to

Amlodipine…5mg




column.

647. 004220-EX Rumatidine Tablet 150mg


Ranitidine HCl eq. to Ranitidine

150mg

-do-

648. 031269 Loxfen Tablets


Loxoprofen Sodium 68.1mg

eq. to Loxoprofen

(Anhydrous).60mg

-do-

M/s Harmann Pharmaceutical Laboratories Pvt. Limited, P.O Chung, 16 Km, Multan Road, Lahore.

649. 003612 Diazepam 2mg Tablet


Diazepam…2mg




column.

650. 003664 Diazepam 5mg

Tab


Diazepam 5mg,

-do-

651. 003665 Paracetamol 500mg

Tab


Paracetamol 500mg,

-do-


Elixer

Each 5ml Contains:-

Paracetamol 120mg,

-do-

653. 003932 Vitonol Syrup


Nicotinamide..23mg

Riboflavin…3mg

Thiamine Hcl 3mg

Pyridoxine Hcl 2mg

-do-

654. 004748 Ammo Plus Syrup

Each 5ml Contains:-

Ammonium Chloride 100mg,

-do-

Chlorpheniramine Maleate 2mg,

Ephedrine Hcl 7mg, Sodium Citrate

60mg, Menthol 1mg,

M/s. Maple Pharmaceuticals Pvt. Limited, Plot No. 147, Sector 23, Korangi Industrial Area, Karachi.

655. 076051 Calcivit Sachet


Calcium Citrate

Maleate…..2500 mg

Vitamin D ..400 IU




column.

M/s Pliva Pakistan Pvt. Limited, Plot No. B-77, Hub Industrial Trading Estate, Hub, Balochistan.

656. 076002 Plimether 20mg/120mg Tablet


Artemether …20mg

Lumefantrine .. 120mg




column.

657. 076003 Plivaquin 30mg/ml Injection

Each ml contains:-

Quinine Dihydrochloride …....300

mg

-do-

658. 076004 Brozicam 20mg/ml Injection

Each ml contains:-

Piroxicam…..20mg

-do-

M/s S.J&G Fazul Ellahie (Pvt) Ltd, E/46, S.I.T.E., Karachi.

659. 050637 Ferricure Capsule


Polysaccharide-Iron Complex eq. to

Elemental Iron…….150mg




column.

660. 076041 Cinoflox 400mg/100ml Infusion


Ciprofloxacin as

Lactate…....400 mg

-do-

661. 076042 Ufan-DS Dry Suspension

Each 5ml contains:-

Artemether 30 mg

Lumefantrine..80 mg

-do-

662. 050693 Contour 40mg

Injection

Each Vial Conatins:-Esomeprazole

(as Sodium)….40mg

-do-

663. 050694 Asist 400mg

Injection

Each Vial Conatins:-

Teicoplanin.400mg

-do-

664. 050695 Maparix 500mg

Injection

Each Vial Conatins:-Vancomycin

(as HCl).…..500mg

(USP Specification)

-do-

665. 050697 Ufan Tablet


Artemether… 20mg

Lumefantrine 120mg

-do-

666. 050698 Noll Plus 15mg/850mg Tablet -do-


Metformin HCl 850mg

Pioglitazone (as HCl)…….15mg

667. 050699 Eteva Tablet


Entecavir ..0.5mg

-do-

668. 050700 Vivacol Injection

Each 1.5 ml contains:-

Iron Sorbitol Citric Acid Complex

Eq. To Elemental Iron ….. 75mg

Folic Acid ...750mcg

Vitamin B12 ..75mcg

-do-

669. 050701 Bone-Lift 0.25mcg Tablet


Alfacalcidol0.25mcg

-do-

670. 050702 Bone-Lift 0.5mcg Tablet


Alfacalcidol 0.5mcg

-do-

671. 050703 Spify 250mg

Injection


Cefoperazone (as Sodium) …250mg

-do-

672. 050704 Spify 500mg

Injection


Cefoperazone (as Sodium)…500mg

-do-

673. 050705 Brilanta 250mg

Injection


Cefazolin (as Sodium) ……250mg

-do-

674. 050706 Grafro Injection


Ceftizoxime (as Sodium)…...1gm

-do-

675. 050707 Lute 1.5gm

Injection


Cefuroxime (as Sodium) …1.5gm

-do-

676. 050708 Magnett 100mg Tablet


Cefixime .100mg

-do-

677. 076088 Bionic 3mg/3ml Injection

Each 3ml contains:-

Ibandronate Sodium eq. to

Ibandronic Acid..……….3 mg

-do-

M/s Glaxosmithkline Pakistan Limited,F-268, S.I.T.E., Karachi.

678. 000364 Lanoxin Tab


Digoxin 0.25mg,




column.

679. 010516 Lotrix CreamContains:-

Permethrin 5%W/W

-do-

680. 000383 Migril Tab


Ergotamine Tartrate 2mg, Cylizine

-do-

Hcl 50mg, Caffeine Anhydrous

100mg,

681. 000813 Phillips Milk Of Magnesia

SuspensionContains:-

Megnesium Hydroxide Mixture

Magnesia 7.9%, W/V

-do-

682. 023511 Polyfax Plus Skin Ointment

Each gm Contains:-

Polymyxin B Sulphate 1000Units,

Bacitracin Zinc 500Units,

Lignocaine 40mg

-do-

683. 022433 Silvat CreamContains:-

Silver Sulphadiazine 1%W/W

-do-

M/s Glaxosmithkline Pakistan Limited,Plot No. 5, Sector 21, Korangi Industrial Area, Karachi.

684. 028094 Bactroban CreamContains:-

Mupirocin Calcium (Micronised) (as

Mupirocin free acid) 2% w/w




column.

685. 027811 Cutivate Cream 5gm contains:-

Fluticasone Propionate 0.05%w/w

-do-

686. 019881 Chewcal Tablet


Elemental Calcium 400mg,

Vitamin D 2.5mcg

-do-

687. 050687 CipVal 250mg Tablet


Ciprofloxacin (as HCl)….250mg

-do-

688. 050688 CipVal 500mg Tablet


Ciprofloxacin (as HCl)….500mg

-do-

M/s Fedro Pharmaceuticals Labs. Pvt. Limited, 149 Industrial Estate, Hayatabad, Peshawar.

689. 052473 Rofer Tablets


Iron as Hydroxide

Polymaltose...100mg




column.

M/s Kohinoor Industries, 159-160, Small Industrial Estate, Sahiwal.

690. 076947 Safenol Liquid Contains:-

Parachlorometaxylenol

…1.44%Terpineol…..1.8%




column.

M/s Shaigan Pharmaceuticals Pvt. Limited, 14 Km, Adyala Road, Post office Dahgai, Rawalpindi.

691. 053844 Iroton Chewable Tablet




Iron…100mg




column.

692. 030062 Paxil -20 Dispersible Tablets


Piroxicam…….20mg

-do-

693. 030063 NS- 250mg Tablets


Naproxen Sodium eq. to Naproxen

…….250mg

-do-

694. 030064 NS- 500mg Tablets


Naproxen Sodium eq. to Naproxen

…….500mg

-do-

695. 052790 Hibon 0.5 Capsule


Alfacalcidol..0.5mcg

-do-

696. 052792 Hibon 0.25 Capsule


Alfacalcidol 0.25mcg

-do-

697. 052791 Hibon Oral Drops

Each ml Contains:-

Alfacalcidol…2mcg

-do-

698. 052812 Deezon Plus 1gm

Injection


Cefoperazone 500mg,Sulbactam

500mg

-do-

M/s. AkhaiPharmaceuticals Pvt. Limited, Plot No. A-248 & A-256 to A-259, Hub Industrial Trading

Estate, Lasbela, Balochistan.

699. 050780 Zertigo 8mg Tablet


Betahistine (as 2HCl) …….8mg




column.

700. 050781 Zertigo 16mg Tablet

Each tablet contains:Betahistine (as

2HCl) …….16mg

-do-

701. 050782 Tanedor 5mg Tablet


Risedronate (as Sodium)….5mg

-do-

702. 050783 Tanedor 35mg Tablet


Risedronate (as Sodium)….35mg

-do-



Levosulpiride.25mg

-do-



Levosulpiride...50mg

-do-

705. 050786 Lefid 10mg Tablet


Leflunomide 10mg

-do-

706. 050787 Lefid 20mg Tablet


Leflunomide.20mg

-do-

707. 050788 Aclova 800mg Tablet


Acyclovir..800mg

-do-

708. 050789 Rnofer 20/120mg Tablet


-do-

Artemether.…..20mgLumefantrine.1

20mg

709. 050790 Rnofer 40/240mg Tablet


Artemether.....40mgLumefantrine

240mg

-do-



Quetiapine (as Fumarate)…25mg

-do-



Quetiapine (as Fumarate).100mg

-do-

712. 050793 Zonacin Capsule


Azithromycin 250mg

-do-

M/s. TAS Pharmaceutical Pvt. Limited, 209 Industrial Area, Kahuta Road, Islamabad.

713. 050114 Ciprotas Tablets 250mg


Ciprofloxacin (as HCl)……250mg




column.

714. 050115 Dipot Gel


Diclofenac diethylamine….2%.

-do-

715. 050118 Ciprotas Tablet 500mg


Ciprofloxacin.500mg

-do-

716. 050122 Kanatas-N cream


Neomycin Sulphate ……0.5%

Dexamethasone ………..0.1%

-do-

717. 016516 Tasofam 40mg Tablet


Famotidine…40mg

-do-

M/s. Munawar Pharma Pvt. Limited, 31 Km, Ferozpur Road, Lahore.

718. 076959 Periactin Tablets


Cyproheptadine HCl…..4mg




column.

M/s. Hamaz Pharmaceuticals Pvt. Limited, 13 Km, Bosan Road, Lutfabad, Multan

719. 052621 Erysin Suspension

Each 5ml contains:-

Erythromycin as Estolate..... 200mg




column.

720. 052622 Neophed-P Elixier

Each 5ml contains:-

Triprolidine .1.25mg

Pseudoephedrine 30mg, Paracetamol

...80mg

-do-

M/s. Hilton Pharma Pvt. Limited, 13-14, Sector-15, Korangi Industrial Area, Karachi.

721. 031436 Mycocid injection

Each ml contains:-

Tylosin (as tylosin tartrate) 200mg.




column.

722. 031437 Unigen injection

Each ml contains:-

Gentamicin sulphate equivalent to

100mg

gentamicin base.

-do-

723. 031440 Pronide plus suspension

Each ml contains:-

Oxfendazole 22.65mg. Oxyclozanide

62.5mg. Selenium (as sodium

selenate) 0.5mg. Cobalt (as cobalt

sulphate) 1.67mg.

-do-

M/s Sanna Laboratories, 1019-B, Punjab Small Industrial Estate, Sargodha Road, Faisalabad.

724. 031441 Senrox-10 Injection

Each ml contains:-

Enrofloxacin HCl …100mg

(as base).




column.

725. 031442 Scs-20 Injection

Each ml contains:-

Colistin sulphate 20 MIU.

-do-

726. 031443 Flumesan-50 Oral Solution.


Flumequine.. 50gm.

-do-

727. 031444 Gentamisan-50 Injection.

Each ml contains:-

Gentamycin sulphate equivalent to

50mg

gentamycin base.

-do-

728. 031445 Cpm-100 External Spray


Cypermethrin 10gm.

-do-

729. 031446 Coxicide W/S Powder


Sulphadimidine sodium 22.5gm.

Diaverdine HCl 2.65gm.

Vitamin k3 2.05mg.

-do-

730. 031447 Exact Injection

Each gm Contains:-

Ceftiofur Sodium 1000mg

-do-

731. 031486 Resbro-300 W/S Oral Powder.

Each gm Contains:-

Doxycycline HCl 200mg. Tylosine

tartrate 100mg. Bromhexine HCl

2.5mg.

-do-

732. 031487 Santrifon-100 W/S Powder.

Each gm Contains:-

Dimethylester of (2,2,2,-trichloro-1-

hydroxyethyl) phosphonic acid

-do-

(trichlorophon 980mg. Silicon

dioxide 20mg.

733. 031488 Sanamisol 30 Oral Solution.

Each ml contains:-

Levamisole HCl 30% W/V.

-do-

734. 031489 Slectromin Forte W/S Oral

Powder.


Vitamin A …2,025,000 IU.

Vitamin D3 …1,850,000 Iu.

Vitamin E ..5,500 Iu.

Vitamin K3 5,000mg.

Riboflavin1,110mg.Calcium-D-

Panthothenate ………10,200mg.

Folic Acid….850mg. Thiamine HCl

4,150mg. Potassium Chloride

4,000mg.

Vitamin B12 20mcg. Sodium

…1,000mg. Chloride… 2,000mg.

Biotin…… 100mg.

Vitamin C 1750mg.

-do-

M/s. Vetcon Pharmaceutical Pvt. Ltd, Plot No. 7-10 B, Industrial Estate, Bhimbar, AJK

735. 031499 Levacon-50 Liquid Solution.

Each ml contains:-

levamisole hydrochloride 500mg.




column.

736. 031500 Oxfendacon Liquid Suspension.

Each ml contains:-

Oxfendazole 22.65mg.

-do-

737. 031501 Clozacon Liquid Suspension.

Each ml contains:-

Oxyclozanide 34mg.

-do-

738. 031502 Ivercon-10 Injection

Each ml contains:-

Ivermectin 10mg.

-do-

739. 031503 Predcon-D Injection.

Each ml contains:-

Prednisolone acetate 7.5mg.

Dexamethasone sodium phosphate

2.5mg.

-do-

740. 031504 Gentacon-100 Injection.

Each ml contains:-

Gentamicin Sulphate (As Base)

100mg

-do-

741. 031505 Albacon-10% Liquid Suspension.

Each ml contains:-

Albendazole 100mg

-do-

M/s Venus Pharma, 23-km, Multan Road, Lahore

742. 031511 Dexamethasone 1mg/Ml Injection.

Each ml contains:-

Dexamethasone (as sodium

phosphate) …1mg.




column.

M/s Alina Combine Pharmaceuticals (Pvt) Ltd, A-127, S.I.T.E., Super Highway, Karachi.

743. 049691 Imunogin water soluble powder.

Each gm Contains:-

Ammonium chloride …650mg.

Methionine..100mg. Sorbitol………

50mg.

Vitamin A2500 I.U.

Vitamin C 100mg.




column.

744. 049692 Lysovit-C liquid.

Each Liter Contain:

Vitamin

C…50gm.Lysine……250gm.

-do-

745. 049674 Tilcolina Injection.

Each ml contains:-

Tilmicosin …300mg.

-do-

746. 049675 Colimox injection.

Each ml contains:-

Colistin sulfate …. 300,000 IU.

Amoxicillin …120mg. (equivalent to

amoxicillin trihydrate).

-do-

747. 049676 Ketolina injection.

Each ml contains:-

Ketoprofen… 100mg.

-do-

748. 049677 Atropin Injection.

Each ml contains:-

Atropine sulfate…. 1mg.

-do-

749. 049682 Mepylina Injection

Each ml contains:-

Mepyramine maleate …50mg.

-do-

750. 049683 Nitroxy injection.

Each ml contains:-

Nitroxynil …340mg.

-do-

751. 049684 Lactocin injection.

Each ml contains:-

Oxytocin …10 I.U.

-do-

752. 049685 Frusicon injection.

Each ml contains:-

Furosemide…50mg.

-do-

753. 049678 Almec plus injection.

Each ml contains:-

Ivermectin… 10mg.

Clorsulon…100mg.

-do-

754. 049679 Amoxinal LA 15% injection.

Each ml contains:-

Amoxicillin trihydrate …150mg.

-do-

755. 049680 Clomix injection.

Each ml contains:-

Cloxacillin … 50mg. (as cloxacillin

sodium).Amoxicillin.. 100mg. (as

amoxicillin trihydrate).

-do-

756. 049681 Coliflu injection.

Each ml contains:-

Flumequine. 150mg. Colistin sulfate

…1,000,000 I.U.

-do-

757. 049688 Tialin water soluble powder.

Each 100gm contains: Tiamulin

45gm.(As Tiamulin Hydrogen

Fumarate)

-do-

758. 049689 Cdc Plus Water Soluble Powder.

Each Kg Contains:-

"Tiamulin ..100gm.(As

Tiamulin Hydrogen

Fumarate)Chlortetracyclin .. 300gm

(As Chlortetracyclin Hcl)."

-do-

759. 049690 Amoxicol Water Soluble Powder.

Each Kg Contains:-

- Amoxicillin B.P. …..

150gm.(As Equivalent To

Amoxicillin Trihydrate)Colistin

Sulphate B.P. 250,000 I.U.

-do-

M/s Lisko Pakistan (Pvt) Ltd, L-10/D, Block-21, Federal B Area, Karachi

760. 014464 Dard Aram Tablet


Paracetamol…200mg

Aspirin…300mg


formulation in RRA

761. 014318 INH Tablet


Isoniazid…100mg


formulation in WHO.

M/s Standpharm Pakistan (Pvt) Ltd, 20-km, Ferozepur Road, Lahore

762. 022343 Rumaxin Injection 200mg


Premixed Indomethacin…200mg

Sodium with bufers and tonics



section and by the firm.

763. 049067 Anemix Drops.

Each ml contains:-

Iron(III) Hydroxide Polymaltose

Complex eq.to elemental to Iron

(III) …50mg


for the confirmation of renewal of

2013 and post registration variation in

between.

764. 049956 Ophen Tablets.


Aceclofenac…100mg.


for the confirmation of renewal of

2013 and post registration variation in

between.

M/s. Zafa Pharmaceutical Laboratories, L-1/B, Block 22, Federal B Industrial Area, Karachi

765. 053119 Yes 2 Zinc DS Dry Syrup

20mg/5ml

Each 5ml contains:-

Zinc Sulphate Monohydrate eq. to

Elemental Zinc..20mg



section in comparision to Reg. no

053335 issued in favor of M/s Zafa

Pharmaceutical Laboratories Pvt.

Limited

M/s. Glitz Pharma, Plot#265, Industrial Triangle, Kahuta Road, Islamabad

766. 051183 S-Per Tablet 100 mg


Sparfloxacin…………100 mg


formulation in RRA

767. 051184 Ginglitz Syrup

Each 5 ml Contains:-


formulation in RRA

Ginkgo biloba Extract … 120 mg

768. 051185 Ginglitz Capsule


Ginkgo biloba Extract… 120 mg


formulation in RRA

M/s. Unison Chemical Works, Post Office Araaian, 15km Raiwind Road, Lahore

769. 052707 Unifin Tablet 75mg


Diclofenac Potassium ..... 75mg


showcause notice issued by the

concerned section.

M/s. Noa Hemis Pharmaceuticals, Plot No. 154, Sector 23, Korangi Industrial AreaKarachi

770. 053172 Slimax Capsule


Orlistat ……120mg


source of pellets.

771. 053173 Fiibra Capsules


Fenofibrate……….200mg(Lipid

regulating agent)(BP Specifications)

Deferred for the confirmation of active

ingredients.

772. 003989-EX Doxin Capsule


Doxycycline…100mg

Renewal application was received after

expiry of registration (8 month

approx.) ,product registration status

needs further delibration by the Board

under Rule 27 (LR&A).

M/s Standpharm Pakistan(Pvt) Ltd, 20-kmFerozepur road, Lahore

773. 030829 Riomed Suspension 125mg

Each 5ml contains:-

Clarithromycin …..125mg


source of taste masked granules.

774. 030830 Riomed Drops 125mg

Each 5ml contains:-

Clarithromycin …..125mg


source of taste masked granules.

M/s Geofman Pharmaceuticals, Plot no. 20, Sector 23, Korangi Industrial Area, Karachi.

775. 030847 Lansocid Capsule 30mg


Lansoprazole Pellets …..30mg


source of pellets.

M/s Weather Folds Pharmaceuticals, Plot#69/2, Phase-II, Industrial Area, Hattar

776. 051196 Rahdin 500mg

Injection

Each injection contains:-

Cephradine with L-Arginine eq. to

Cephradine …500mg


formulation in RRA.

M/s. A&K Pharmaceuticals, 94-A, Small Industrial Estate, Sargodha Road, Faisalabad (Veterinary)

777. 049668 Colmox Powder.


Amoxicillin Trihydrate….15gm.

COLISTIN SULPHATE ..50 MIU.

Deffered for the confirmation of


Division.

M/s. English Pharmaceuticals Industries. Link Kattar Bund Road, Thokar Niaz Baig, Multan Road.

Lahore.

778. 001849-EX Nogensol 125mg/5ml Dry

Suspension

Each 5ml of Reconstituted

Suspension Contains:-

Cefaclor…125mg




column.

779. 001850-EX Nogensol 250mg/5ml Dry

Suspension

Each 5ml of Reconstituted

-do-

Suspension Contains:-

Cefaclor…125mg

780. 001851-EX E-SPA Tablet


Phloroglucinol Hydrate…80mg

Trimethylphloroglucinol…80mg

-do-

M/s Macter International (Pvt) Ltd, F-216, S.I.T.E., Karachi

781. 076122 Itoguard OD 150mg

Capsule


Itopride hydrochloride as sustained

release pellets...150mg

Pellet source:M/s Spansules

Formulations, Plot#154/A4, I.D.A

Bollaram, Medak Dist, Hyderabad,

India

Deferred. Differential fee for import of

pellets not submitted

M/s Macter International (Pvt) Ltd, F-216, S.I.T.E., Karachi

782. 028633 Septipan Capsule


Cefixime…400mg

Deferred. Fee not submitted. Applying

late

M/s. Alfalah Pharma (Pvt) Ltd. 12-KM SAheikhupura Road Lahore.

783. 052492 Nucol Tablets 0.5mcg.


Alfacalcidol …0.5mcg.




column.

784. 052493 Nucol Tablets 1mcg.


Alfacalcidol …1mcg.

-do-

785. 052494 Arlum 20/120 Tablets.


Artemether …20mg. Lumefantrine

…120mg

-do-

786. 052495 Arlum 40/240 Tablets.


Artemether …40mg. Lumefantrine

…240mg.

-do-

787. 052496 Digesso Tablets 20mg.


Esomeprazole …20mg.

-do-

788. 052497 Digesso Tablets 40mg.

Each enteric coated Tablet contains:-

Esomeprazole …40mg.

-do-

789. 052498 Wycin Tablets 250mg.


Clarithromycin ….

-do-

790. 052499 Nocox Tablets 15mg.


Meloxicam …15mg.

-do-

791. 052500 Nocox Tablets 7.5mg.


Meloxicam …7.5mg.

-do-

792. 052501 Inver Tablets 50mg.


Levosulpiride …50mg.

-do-

793. 052502 Ezichron Tablets 10mg.


Montelukast …10mg.

-do-

794. 052503 Ezichron Tablets 5mg.


Montelukast …5mg.

-do-

795. 052504 Cydex Tablets.


Piroxicam as Beta cyclodextrin

…20mg

-do-

796. 052505 Phobic Tablets 10mg.


Escitalopram …10mg.

-do-

797. 052506 Fungo Tablets 125mg.


Terbinafine …125mg.

-do-

M/s. Hassan Pharmaceuticals (Pvt) Ltd., 99-A Industrial Estate , Jamrud Road, Peshawar

798. 031248 Alumag Forte Suspension

Each 5ml contains:-

Magenesium Hydroxide …400mg

Aluminum Hydroxide Dried Gel

….400mg

Simethicone …30mg




column.

799. 031249 Broncosaf -P Syrup

Each 5ml contains:-

Ammonium Chloride....100mg

Diphenhydramine hydrochloride

…8mg

-do-

800. 031250 Broncoride-P Syrup

Each 5ml contains:-

Ammonium Chloride …100mg

Diphenhydramine Hydrochloride

…8mg

Chlorpheniramine maleate …2mg

-do-

801. 031251 Bronconol Cough Syrup


Chlorpheniramine maleate …100mg

Terpine hydrate …200mg

Potassium Bicarbonate …2mg

Ammonium Chloride …500mg

Tr. Senega …1ml Menthol …20mg

Ephedrine hydrochloride …100mg

Pot. Guaiacol sulphonate …100mg

Pot. Citras …2mg

Tr.Ipecac …0.5ml Ext. Glycyrrhiza

…2ml

-do-

M/s. The Searle Company Limited., Plot# F-319, Sindh Industrial Trading Estate, Karachi.

802. 076023 Tizax 2mg Tablet


izanidine …2mg




column.

803. 076022 Tizax 4mg Tablet


-do-

Tizanidine …4mg

804. 014479 Maxaquin 400mg Tablet

Each Tablet Contains

Lomefloxacin…400mg

-do-

M/s. Zafa Pharmaceutical Laboratories, L-1/B, Block 22, Federal B Industrial Area, Karachi

805. 022553 Zaftolin Inhaler

Each Dose Contains:-

Salbutamol…100mcg




column.

806. 022554 Beclo-Sal Inhaler

Each Dose Contains:-

Salbutamol…100mcg

Beclomethasone


-do-

M/s. Atlantic Pharmaceutical (Pvt) Ltd, 89-D, Industrial Estate, Jamrud Road, Peshawar.

807. 052475 Pexsol Infusion.


Pefloxacin Mesylate eq. to

Pefloxacin…………………400mg




column.

808. 052476 Transol-M. I.V Infusion.


Mannitol……………………87.5g

Sorbitol……………………12.5g

-do-

809. 052477 Aqualan Ampoule.

Each 5ml ampoule Contains:-

Sterile Water for Injection …….5ml

-do-

810. 052478 Transol Infusion.

Each 100ml Infusion Contains:-

Dextrose Anhydrous………..5gm.

Water for Injection……1000ml

-do-

811. 052479 Transol DS Infusion.

Each 100ml bag Contains:-

Sodium Chloride………….0.9gm

Dextrose Anhydrous………5gm.

Water for Injection……….1000ml

-do-

812. 052480 Transol NS Infusion.

Each 100ml bag Contains:-

Sodium

Chloride………………0.9gm

Water for

Injection…………..1000ml

-do-

M/s. Pulse Pharmaceuticals (Pvt) Ltd, Mozay Badoke, Raiwind Road, (Sua Asil Road) Lahore

813. 046718 Lisinolib 10mg Tablet


Lisinopril……………..10mg




column.

814. 057434 Low vase 20 Tablets


AmlodipineasBesylate……5mg

Atorvastatin as calcium

trihydrate…..20mg

-do-

815. 057433 Low vase 10 Tablets


AmlodipineasBesylate…..5mg

-do-

Atorvastatin as calcium

trihydrate….10mg

M/s. Hizat Pharmaceutical Industries (Pvt) Ltd, 170-Industrial Estate Jamrud Road, Peshawar

816. 031214 Pomex 100mg

Suspension

Each 5ml contains:-

Cefixime Trihydrate 111.90mg

eq. to Cefixime …100mg




column.

817. 031213 Zoroxin Tablets


Norfloxacin ……400mg

-do-

818. 031215 Silkocin 250mg Tablets


Clarithromycin ……250mg

-do-

819. 031216 Silkocin 500mg Tablets



-do-

820. 031217 Silkocin 125mg

Suspension

Each 5ml contains:-


-do-

821. 031218 Hizemox 250mg

Dry Suspension

Each 5ml contains:-

Amoxicillin Trihydrate 287mg

eq to Amoxicillin …………..250mg

-do-

822. 031219 Oflazat Tablets


Ofloxacin ………200mg

-do-

823. 031220 Ciprozat 250mg Tablets


Ciprofloxacin HCl 277.52mg

eq. to Ciprofloxacin….250mg

-do-

824. 031221 Ciprozat 500mg Tablets


Ciprofloxacin HCl 555mg

eq. to Ciprofloxacin……….500mg

-do-

825. 031222 Hizexin Tablet


Naproxen................500mg

-do-

M/s Z.Jans Pharmaceuticals, 148-A, Industrial Estate, Hayatabad Peshawar.

826. 052603 Cesef Capsules 400mg.

Each Capsule Contains: Cefixime

…400mg.




column.

827. 052605 Hudamec Tablets 500mcg.


Mecobalamine …500mcg.

-do-

828. 052606 Abidacam Tablets 15mg.

Each tablet contains: Meloxicam

…15mg.

-do-

829. 052607 Abidacam Tablets 7.5mg.

Each tablet contains: Meloxicam

…7.5mg.

-do-

830. 052470 Ul-Nil Suspension

Each 5ml contains: Sodium

Alginate…250mg

Cal Carbonate…80mg. Sodium

Bicarbonate…133.5mg

-do-

M/s Elko Organization (Pvt) Ltd, 27 & 28, Sector 12/B, North Karachi Industrial Area, Karachi

831. 009926 Metron Infusion


Metronidazole …500mg




column.

832. 021476 Elkomin Injection

Each ml contains:

Cyanocobalamin …250mcg

-do-

833. 021478 Elkavil Injection

Each ml contains: Pheniramine

maleate …25mg

-do-

834. 021479 Elkogent Injection

Each ml contains: Gentamycin

sulphate eq. to 200mg

Gentamycin base

-do-

835. 021480 Elkoneurin Injection

Each 3ml Contains: Thiamine

HCl (B1) …100mg, Pyridoxine HCl

(B6) …100mg, Cyanocobalamin

(B12) …500mcg

-do-

836. 021481 Elkocaine InjectionInjection

Contains:-

Lignocaine HCl…2%,

Sodium Chloride ... 0.60%, Methyl

Hydroxy Benzoate … 0.10%

-do-

837. 031475 Leox D.S. Suspension.

Each 100 ml contains: Levamisole

HCl …3gm. Oxyclozanide …6gm.

-do-

838. 031474 Levanil D.S. Solution

Each 100 ml contains: Levamisol

HCl … 3gm.

-do-

Karachi Chemical Industries (Pvt) Ltd, F/25, Estate Avenue, S.I.T.E, Karachi

839. 009710 Hydrogen Peroxide B.P 20

Vol.Contains Hydrogen Peroxide

(35%) 20%




column.

840. 003990 Kcinol Solution


-do-

Chloroxylenol …5gm

841. 014425 Klox Forte Syrup

Each 5ml Contains Amoxycillin

Trihydrate eq. to 250mg

Amoxycillin Base

-do-

M/s Pakistan Pharmaceutical Products (Pvt) Ltd, D-122, S.I.T.E, Karachi

842. 003490 Combidine Syrup

Each 5ml Contains

Pholcodein…10mg

Ephedrine HCl…5mg



Sucrose…3.33gm

Sodium Benzoate…10mg




column.

843. 076043 Amoxynate Dry Suspension

Each 5ml contains:-

Amoxicillin as

Trihydrate…125 mg

Clavulanic Acid as Potassium

…31.25 mg

-do-

844. 076044 Amoxynate Dry Suspension

Each 5ml contains:-

Amoxicillin as

Trihydrate…250 mg

Clavulanic Acid as Potassium …62.5

mg

-do-

845. 076045 Amoxynate 1gm Tablet


Amoxicillin as

Trihydrate…875mg

Clavulanic Acid as Potassium … 125

mg

-do-

846. 076046 Arcofix Suspension DS200mg/5ml

Each 5ml contains:-

Cefixime…200mg

-do-

847. 076047 Zentrix 250mg

Capsule



-do-

848. 076048 Zentrix 500mg

Capsule



-do-

849. 076049 Lumina 80mg/ml Injection


Artemether …80mg/ml

-do-

850. 076050 Candinil 150mg

Capsule


Fluconazole …150mg

-do-

M/s. Getz Pharma (Pvt) Ltd, 29-30, Sector 27, Korangi Industrial Area, Karachi

851. 050644 Calecta Syrup

Each 5ml contains:-



Calcium Glubionate…...1.4375g

Calcium Lactobionate.….0.295g


column.

852. 022522 Florex-D Suspension


Pseudoephedrine HCI…120mg

Loratadine…10mg

-do-

M/s. Karachi Chemical Industries (Pvt) Ltd, F/25, Estate Avenue, SITE, Karachi.

853. 014426 Klox Syrup

Each 5ml Contains:-

Amoxycillin Trihydrate eq. to 125mg

Amoxycillin Base




column.

854. 031058 Kaydrox 125mg

Oral Suspension

Each 5ml contains:-

Cefadroxil ………….125mg

-do-

855. 031059 Kaydrox 250mg

Oral Suspension

Each 5ml contains:-


-do-

856. 031060 Kaydrox 500mg

Capsules



-do-

857. 031061 Coxlan 7.5mg Tablets


Meloxicam ….7.5mg

-do-

858. 031201 Kaysef Suspension 125mg

Each 5ml contains:-

Cephradine………..125mg

-do-

859. 031202 Kaysef Suspension 250mg

Each 5ml contains:-

Cephradine………..250mg

-do-

M/s Bloom Pharmaceuticals (Pvt) Ltd, Plot #30, Phase I & II, Industrial Estate, Hattar

860. 025469 Kamcid Suspension

Each 5ml contains:-

Famotidine..........10mg




column.

861. 021702 Kanic Tablet 50mg



-do-

862. 021703 Myfer TabletContains:-

Ferrous Fumarate…200mg

Vitamin B1…25mg

Vitamin B2…2.5mg

Vitamin B6…25mg

Vitamin B12…25mcg

Nicotinamide…25mg

Folic Acid…1mg

Cal. Pantothenate…10mg

-do-

863. 021704 Myfer SyrupContains:-

Ferrous Gluconate…130mg

Vitamin B1…1.5mg

Vitamin B2…1mg

Vitamin B6…1.5mg

-do-

Nicotinamide…15mg

Cal. Pantothenate…1mg

L-Lysine Mono HCl…50mg

M/s Medicaids Pakistan Pvt. Ltd., Plot#10, Sector 27, Korangi Industrial Area, Karachi

864. 031006 Magix 7.5mg Tablet


Meloxicam…7.5mg




column.

865. 031007 Magix 15mg Tablet


Meloxicam…15mg

-do-

866. 031008 Zeboxil 125mg

Suspension

Each 5ml Contains:-

Cefadroxil Monohydrate eq. to

Cefadroxil…125mg

-do-

867. 031009 Zeboxil 250mg

Suspension

Each 5ml Contains:-


Cefadroxil…250mg

-do-

868. 031010 Zeboxil 500mg

Capsule

Each capsule Contains:-


Cefadroxil…500mg

-do-

869. 031011 Lithen CR Tablets


Lithium Carbonate BP…..400mg

-do-

870. 031012 Tefnel Tablet 250mg



Levofloxacin……..250mg

-do-

871. 031013 Tefnel Tablets 500mg



Levofloxacin……..500mg

-do-

M/s WnsFeild Pharmaceuticals, Plot#122, Block-A, Phase V, Indusrial Estate, Hattar

872. 052517 Esowin 40mg

Capsules.


Esomeprazole

Pellets………….40mg.Source of

pellets:Murli Krishna Pharma (Pvt)

Ltd, Shop#08, Pearl building, Powai

Vihar Complex, Powai, India




column.

873. 077437 Deslozam 5mg Tablet

Each dispersible tablet contains:-

Desloratadine …5 mg

-do-

874. 077438 Calciwns 1 mcg Injection

Each 1 ml ampoule contains:-

Calcitriol …1 mcg

-do-

M/s Bryon Pharmaceuticals Pvt Ltd. 48-Hayatabad Industrial Estate, Peshawar, K.P.K

875. 052562 Desolar Tablets. Registration Board deferred the above

Each film Tablet contains;-

Desloratadine…5mg.



column.

876. 052563 Fluxaquin Tablets.


Moxifloxacin as HCl…400mg.

-do-

877. 052566 Steady Tablets 4mg.


Glimepiride…4mg.

-do-



Glimepiride…3mg.

-do-



Glimepiride…2mg.

-do-



Glimepiride…1mg.

-do-

881. 052661 Sopral Plus 10mg Tablets.


Bisoprolol Fumarate..10mg

Hydrochlorothiazide…6.25mg

-do-

882. 052662 Esophag Capsules 20mg



Trihydate…20mg

Source of pellets:Smilax

Laboratories Ltd, Plot#44, CIE

Gandhi Nagar, Balanagar,

Hyderabad, India

-do-

883. 052663 Esophag Capsules 40mg



Trihydrate…40mg

Source of pellets:Smilax

Laboratories Ltd, Plot#44, CIE

Gandhi Nagar, Balanagar,

Hyderabad, India

-do-

M/s Lahore Chemical & Pharmaceutical Works, 137 Shahrah Maulana Jalal-ud-din Roomi, Lahore

884. 052465 Fleximox Eye Drops.

Each ml contains:-

Moxifloxacin….5mg.




column.

885. 052466 Trop Eye Drops

Each ml contains:-

Ciprofloxacin as HCl…0.3%.

-do-

886. 052467 Arnot Eye Drops.

Each ml contains:-

Tobramycin ...3mg.

-do-

887. 052468 Morfix Eye Drops.

Each ml contains:-

Ketotifen as Fumarate.....0.5mg.

-do-

888. 022216 Sazolene Injection 500mg -do-


Cefazolin (as Sodium) ……500mg

889. 022217 Setex Injection 250mg


Cefotaxime (as Sodium) …2500mg

-do-

890. 022218 Setex Injection 500mg



-do-

891. 022219 Setex Injection 1gm



-do-

M/s Regent Laboratories, C-20, S.I.T.E, Super Highway, Karachi.

892. 076099 Regdone SolutionContains:-

Povidone Iodine…10%




column.

893. 076100 Regdone Surgical ScrubContains:-

Povidone Iodine…10%

-do-

894. 076014 Alofenac 100mg Tablet


Aceclofenac 100 mg

-do-

M/s Lisko Pakistan (Pvt) Ltd, L-10/D, Block-21, Federal B Area, Karachi

895. 002769 Rediron Syrup

Each 5ml Contains:-

Ferrous gluconate …300mg

Deferred. Change of brand name on

10/02/2003Transfer of registration to

new address not

submittedShortcoming Letter issued on

18-06-2019 which has not yet been

responded by the firm.

M/s Shaheen Agency, P.No.GK-3/13, Adamji Dawood Road, Karachi. IMPORT HUMAN NON-

REFERENCE COUNTRIES)

896. 031312 Nitromint Retard Tablets 6.5mg


Nitroglycerin 6.5MG.Manufacturer:

M/s Egis Pharmaceuticals Ltd,

Hungary.




column.

M/s. Bio-care Pharmaceutica 807 Shadman-1, Lahore IMPORT HUMAN NON-REFERENCE

COUNTRIES)

897. 052215 Hisun (Vancomycin

hydrochloride) for Injection

(1000mg)


Vancomycin 1000MG.Manufacturer:

M/s Zhejiang Hisun Pharmaceutical

Co. Ltd, China




column.

898. 052214 Hisun (Vancomycin

hydrochloride) for Injection

(500mg)

Each Vial Conatins:-

VancomycinManufacturer: M/s

Zhejiang Hisun Pharmaceutical Co.

Ltd, China

-do-

M/s. Sanofi-Aventis Pakistan Limited, Plot#23, Sector 22, Korangi Industrial Area, Karachi (IMPORT

HUMAN REFERENCE COUNTRIES)

899. 075978 CoPlavix Tablets 75/75mg Registration Board deferred the above


Clopidogrel (as Hydrogen Sulphate)………..……75mg Acetylsalicylic Acid…..75mg Product License Holder: Sanofi Clir SNC, 54, rue La Boetie, F-75008 Paris, France. Manufacturer as per CoPP: Sanofi Winthrop Industrie, 1,

rue de la Vierge, Ambares &

Lagrave, F-33565 Carbon Blanc

cedex, France



column.

900. 075977 Plavix Tablets


Clopidogrel (as Hydrogen Sulphate) …………….300 mg Product License Holder: Sanofi Clir SNC, 54, rue La Boetie, F-75008 Paris, France. Manufacturer as per CoPP: Sanofi Winthrop Industrie, 1,

rue de la Vierge, Ambares &

Lagrave, F-33565 Carbon Blanc

cedex, France

-do-

M/s. Noa Hemis Pharmaceuticals, Plot no. 154, Sector 23, Korangi Industrial Area, Karachi

901. 006418 NUTRIMIX-L POWDER

Each Kg Contains:-

Vit.A 10 Miu,Vit D3 1.5miu,Vit K3

1gm,Vit B2 4gm,Vit E 2000 I.U,Cal

Pantothenate 5gm,Nicotinamid

15gm, Choline Choloride 200gm,

Methionine 25gm, Maganese 80gm, ,

Iron 20gm, Copper 6gm,Iodine 1gm,

Zinc 51gm, Bht 50gm




column.

902. 006420 Aquavit Powder

Each kg contains:-

-

Vitamin A 12 miu,

Vitamin D3 2miu,

Vitamin E 4000 i.u.,

Vitamin B2 3gm,

Vitamin K3 4gm, Calcium

Pantothenate 10gm, Folic acid

500mg,

Vitamin C 5gm, Biotin 10mg,

Potassium 4gm, Sodium 1gm,

Chlorine 2gm

-do-

903. 006843 Adevit Powder

Each Kg Contains:-

vitamin A 33 Miu,

Vitamin D3 3.3miu,

Vitamin E 250mg, ,

Vitamin K3 2000mg,

-do-

904. 006844 Olyvit A Liquid

Each gm Contains:-

Vitamin A 1,000iu,

-do-

Vitamin D3 100iu

905. 006302 C-Tetra-45 Powder

Each Kg Contains:-

Chlortetracycline 100gm,

-do-

906. 006305 Nitrosol Powder

Each Kg Contains:-

- Nitrofurazone 100gm, Furazolidone

14.50

-do-

907. 006307 Biovin-40 Powder

Each Kg Contains:-

Nitrovin 40gm

-do-

908. 006861 Levamax Liquid

Each Kg Contains:-

Levamisole Hcl (1.5% Levamisole

Hcl Solution) 15mg

-do-

909. 006862 Bacitrin 10% Powder

Each Kg Contains:-

Zinc Bacitrin 100gm

-do-

910. 008330 Coccinil Powder

Each Kg Contains:-

Sulphaquinoxaline 140gm,

Diaverdine 35gm,

Vitamin A 2miu,

Vitamin K3 4gm

-do-

911. 009594 Cnf-100 Powder

Each Kg Contains:-

Chlortetracycline Hcl

40gm,Neomycin Sulphate

12gm,Furaltadone 30gm,

-do-

912. 013249 Dewomix Powder 200mg

Each Kg Contains:-

Phenothiazine 145gm, Piperazine

Adipate 70gm, Dibutyltin Dilaurate

35gm

-do-

913. 013250 Vitamax Super Water Soluble

Powder

Each Kg Contains:-

vitamin A 15miu,

Vitamin D3 3miu,

Vitamin E 6,000iu,

Vitamin K3 4,000mg,

Vitamin B1 5,000mg,

Vitamin B2 6,000mg,

Vitamin B6 4,000mg,

Vitamin B12 9,000mcg,

Vitamin C 15gm, Nicotinic Acid

25gm, Calcium Pantothenate 10gm,

Folic Acid 750mg

-do-

914. 013251 Cotrizin Powder

Each Kg Contains:-

Trimethoprim 40mg

Sulphadiazine 200mg

-do-

915. 013252 Clopidol-25 Powder

Each Kg Contains:-

-do-

- Clopidol 250gm

916. 013668 Erysol FD Powder

Each Kg Contains:-

Erythromycin Thiocynate (Eq. Val

To 10.90gm

Of Erthromycin) 12gm, Furaltadone

Hcl 8gm

-do-

917. 013669 Avamix Plus Powder

Each 5kg Contains:-

vitamin A 15miu,

Vitamin E 30,000iu,

Vitamin B1 3,000mg, Nicotinic Acid

60,000mg, Calcium Pantothenate

12,000mg,

Vitamin B12 40mg, Biotin 50mg,

Di-Methionine 150,000mg, BHT

62,500mg, Zinc Sulphate

240,000mg, Copper Sulphate

30,000mg,

Vitamin D3 3miu,

Vitamin K3 3,000mg,

Vitamin B2 7,000mg,

Vitamin B6 4,000mg,Folic Acid

1,500mg, Choline Chloride 50%

800,000mg, L-Lysine 75,000mg,

Manganese Sulphate 258,000mg,

Ferrous Sulphate 200,000mg,

Potassium Iodide 2,000mg

-do-

918. 013670 Amproquin Powder

Each Kg Contains:-

-Sulphaquinoxaline 9.0%,

Amprolium Hcl 12.0%,

Vitamin A 5miu,

Vitamin K3 5gm

-do-

919. 013671 D.O.T Plus Powder

Each Kg Contains:-

-Dinitolamide 25%, (3-5 Dinitro-O-

Tolumide Ethopabate 1.6%

-do-

920. 013672 Coccidine Powder

Each Kg Contains:-

- Robenidine 6.6% (66 Gm)

-do-

921. 015433 Lychomin Powder

Each Kg Contains:-

- Di-Methionine 40%, L-

Lysine…30% Choline Chloride

50%...20%

-do-

922. 015434 Tylosin - 10 Powder

Each Kg Contains:-

- Tylosin 100gm

-do-

923. 015435 Nefron Supplement Powder

Each Kg Contains:-

- Furazolidone 240gms

-do-

924. 015436 Hymax Premix Powder

Each 2.5kg Contains:-

-do-

vitamin A 11miu,

Vitamin D3 2miu,

Vitamin E 6,000iu,

Vitamin K3 1,200mg,

Vitamin B1 1gm,

Vitamin B2 4gm,

Vitamin B6 1gm,

Vitamin B12 10,000mcg, Folic Acid

750mg, Calcium Pantothenate 6gm,

Biotin 10mg, Nicotinic Acid 20gm,

Lysine 30gm, Methionine 60gm,

Choline Chloride 50% 200gm,

Manganese 65gm, Iron 28gm, Zinc

42gm, Copper 2.5gm, Iodine 1gm,

BHT 31.25gm

925. 015437 Amino Plus VM W/S Powder

Each Kg Contains:-

-

Vitamin A 22miu,

Vitamin D3 3miu,

Vitamin E 8,000iu,

Vitamin K3 2gm,

Vitamin B1 2gm,

Vitamin B2 5gm,

Vitamin B6 2gm,

Vitamin B12 9,000mcg,

Vitamin C 20gm, Folic Acid 1gm,

Calcium Pantothenate 10gm,

Nicotinic Acid 25gm, Lysine 75gm,

Methionine 75gm, Threonine 9.5gm,

Tryptophan 2gm, Arginine 12gm,

Histidine 4200mg, Isoleucine 8gm,

Leucine 14gm, Phenylalmine 6gm,

Valine 12gm

-do-

926. 018850 Methesol Plus Powder

Each Kg Contains:-

- Methenamine 950gm,

Thiamine Hcl (Vit B1) 3gm,

Riboflavine (Vit B2) 4gm, D-

Calcium Pantothenate 4gm,

Pyridoxine Hcl (Vit B6) 3gm,

Nicotinamide 3gm

-do-

927. 019929 Adevit Plus Powder

Each Kg Contains:-

-

Vitamin -A10 Miu,

Vitamin -D.3 Miu,

Vitamin -E.5000 I.U.

Vitamin-K3.3000mg, Vitamin-

C.30,000mg

-do-

928. 021424 Enrolone-20 Oral Solution

Each 100 Ml Contains:

Enrofloxacin…20gm

-do-

929. 027443 Enrolone-10 Oral Solution -do-

Each 100 Ml Contains:

Enrofloxacin…10gm.

930. 028507 Pro Sb Powder

Each Kg Contains:-

-Procaine Penicillin B.P.

12.00gm.Streptomycin Sulphte

36.00gm.Zinc Bacitracin

52.00gm.(Antibacterial).

-do-

931. 028508 Pro Sb-Plus Powder

Each Kg Contains:-

-Procaine Penicillin B.P.

12.00gm.Streptomycin Sulphte

36.00gm.Zinc Bacitracin

52.00gm.Colistin Sulphate 60

Miu.(Antibacterial).

-do-

M/s. UM Enterprises, Plot#12, Sector No 5, Korangi Industrial Area, Karachi (VETERINARY)

IMPORT

932. 031513 Monensin 20% Powder

Each Kg Contains:-

Monensin…20%Manufacturer: M/s

Shandong Qilu King-Phar

Pharmaceutical Co. Ltd, No.21

Qinglong Road, Pingyin, Jinan,

Shandong, China




column.

933. 021447 Try-Ban Powder for Injection


Quinapyramine Sulphate…1.5gm

Quinapyramine Chloride…1.0gm

Manufacturer: M/s Arab Veterinary

Industrial Company (AVICO)

Amman, Jordan

-do-

M/s. Vigilant Veterinary Services, A-3, 24 Jail Road,Lahore (VETERINARY) IMPORT

934. 021471 Oxysol 25 Powder

Each gm Contains:-

Oxytetracycline HCl eq. to 250mg

Oxytetracycline BaseManufacturer:

M/s. Veterinary & Agricultural

Products Manufacturing Co. Ltd.

(VAPCO), Amman, Jordan




column.

935. 021473 Chlorosol 50 Powder

Each gm Contains:-

Chloramphenicol…500mg

Manufacturer: M/s. Veterinary &

Agricultural Products Manufacturing

Co. Ltd. (VAPCO), Amman, Jordan

-do-

936. 021474 Megavit-AM PowderManufacturer:




-do-

937. 021475 Megamin Powder

Each gm Contains:-

Magnesium Oxide…2%

Sodium Chloride…6%

Trace Elements…2%Manufacturer:

-do-




M/s. Mehran International, JM-498/D, Hume Road, Quaideen Colony, Opposite: World Map, Near 3star

hall, Karachi(VETERINARY) IMPORT

938. 049613 Amoxycillin LA Injection 15%


Amoxycillin Sodium eq. to

Amoxycillin Base…15mg


Biochemical Pharmaceutical Co. Ltd.

China.Exported byM/s Sinochem

Ningbo Limited, Ningbo, China.




column.

Deferred Cases of 291stMeeting of Registration Board (RRR-Section)


No.

Product Name DecisionRegistration Board deferred

for

M/s. Opal Laboratories (Pvt) Ltd., Lc-41, L.I.T.E. Landhi Karachi

1. 032020 Pendoona Suspension 10mg

Each 5ml contain:

Famotidine…..10mg

Clarification regarding formulation is

required from the firm.

M/s. Standpharm Pakistan (Pvt) Ltd., 20-Km, Ferozepur Road, Lahore

2. 053673 Thrombonil Plus 75mg Tablet

Each Tablet Contain:

Clopidogrel ….75mg

Aspirin…75mg

Clarification regarding formulation is

required from the firm.

M/s. Albro Pharmaceuticals (Pvt) Ltd., 340-S, Industrial Area, KotLakhpat, Lahore

3. 004422 Becopan Tablets

Each Tablet contain:

Nicotinamide BP-15mg, B1(BP)-

1mg, B2(BP)-1mg

Confirmation of post registration

variation if any.

M/s. Highnoon Laboratories Ltd., 17.5-Km Multan Road, Lahore

4. 032071 Hitrazole Tablet 100mg


Itraconazole….100mg

Confirmation of formulation in

Reference Regulatory Agencies is

required by the firm.

M/s. LiakatPharma, Plot No. 12, Sector-15 Korangi Industrial Area, Karachi

5. 031340 Hyalgan Pre-filled syringe

Each 2ml contains:

Hyaluronic Acid Sodium Salt 20mg

Manufactured by: M/s Fidia SPA

Italy

Deferred for the rectification of

following shortcoming : Drug Sale

License (DSL) as the submitted DSL is

of Matrix Pharma Pvt Limited Karachi.

Source of Hyaluronic Acid Sodium

Salt.Free sale status of product in

market.CoPP submitted is not as per

WHO Format moreover the GMP

status is also not mentioned in the

submitted CoPP.Original legalized

valid GMP certificate is required as

copy is submitted.

M/s. Hakimsons (Impex) (Pvt) Ltd., Hakimsons Building, 19 West Warf Road, Karachi

6. 078107 Xelocel-500

Each tablet contain:

Capecitabine….500mg

Manufactured by: M/s. Celon

Laboratories Limited,Plot No.

2,ALEAP Industrial

Estate,Gujlaramaram,Ranga Reddy

District,Andhra Pradesh,India

i) Deferred for the rectification of

following shortcoming :Valid

legalized CoPP/ FSC & GMP

issued by the Regulatory Authority

of country of origin.Inspection

report of manufacturer abroad at

the time of registration. Latest

DRAP attested import invoice.

M/s Medisure Laboratories Pakistan Pvt Limited Karachi

7. 028462 Hyal Prefilled Injection

Each ml contain:

Sodium hyaluronate…10mg

Manufactured by: M/s Shin Poong

Pharmaceuticals Co., Ltd Seoul

Korea.

i) Deferred for the rectification of

following shortcoming :Approval


agencies.Evidence of submission

of last renewal. Differential fee as

per SRO 1005 (I)/ 2017.Valid

legalized CoPP/ FSC and

GMPLast DRAP attested import

invoice.Valid Drug Sale License

8. 014004 Trizoline 400mg Tablet


Norfloxacin USP….400mg

Manufactured by: M/s Remedica

Ahmon Street Limassol Cyprus

i. Deferred for the rectification of

following shortcoming

:Approval of formulation in

reference drug

agencies.Evidence of submission

of last renewal. Differential fee

as per SRO 1005 (I)/ 2017.Valid

legalized CoPP/ FSC and


invoice.Valid Drug Sale License.

M/s. Zam Zam Corporation, Suite No. 205 & 206, Beaumont Plaza, 6-CL-10 Beaumont Road, Karachi

9. 005964 Fucidin Tablet

Contains:

Sodium Fusidate Ph.Eur…..250mg

Product License Holder:M/s Leo

Pharma A/S 55 Industriparken DK

2750 Ballerup

Denmark.Manufacturer:M/s

Laboratories LEO 39, Route De

Chartres 28500Vernouillet France

i. Deferred for rectication of

shortcomings commincated vide

letter dated 17-07-2019. Details

are as under: Valid Legalized

CoPP as the copy has been

submitted.Last DRAP attested

import invoice.Address of

importer mentioned on

registration letter varies from

address on the DSL & Form-5B.

Approval of change of name of

manufacturer as per your letter

dated 28-11-2014.

M/s. Ghazali Brothers, 19-SR-7 Campbel Street Azzainab Court Complex, Karachi

10. 010085 Dexamethasone Sodium phosphate

Injection 4mg

Each ml ampoule contain:

Dexamethasone sodium

phosphate……4mg

Manufactured by: M/s Shanghai

Pharmaceutical Industry Corporation

China

Deferred for rectication of

shortcomings commincated vide letter

dated 17-07-2019. Details are as under:

Valid legalized CoPP/ FSC and


invoice

M/s Vet Pharma Trading Company New Steel Market Near Reagent Cinema GT Road Gujranwala

11. 049741 Avante Injection

Each Vial contains:

Ceftiofur (as Ceftiofur

Sodium)…1000mg

Manufactured by: M/s KBNP Inc

Korea.



dated 11-07-2019, details are as under:

Valid legalized CoPP/ FSC & GMP

issued by the Regulatory Authority of

country of origin.Inspection report of

manufacturer abroad at the time of

registration.Differential fee is required

as renewal is submitted after due date

but within sixty days for product are

Sr. No 590.

12. 052301 Ampros Solution

Each Liter Contains:

Amprolium…96gm

Benzoic Acid…1gm


Korea.

-do-

13. 052302 Estrim-P Water Soluble Powder

EACH KG CONTAINS:-

-do-

Erythromycin Thiocyanate…90gm

(pot)

Sulfadiazine Sodium…75gm

Trimethoprim…15gm


Korea.

M/s. International Chempharma (Pakistan), 33-Anarkali, Lahore

14. 031514 Genta-TylosinInj

Each ml contain:

Tylosin (as tartrate) 100mg.

Gentamicin (as Sulphate) 50mg

Manufactured by: M/s Bio-

Pharmachemic Co., Ltd Vietnam.



dated 03-07-2019,details are as under:

Original valid legalized CoPP/ FSC

and GMP. Address of manufacturer

abroad in not mentioned on the copy of

registration letter submitted. Copy of

approval of import from M/s Franklin

Pharmaceuticals Ireland is required.

Copy of valid Drug Sale License

(DSL). DRAP attested latest import

invoice. Copy of inspection of

manufacturer abroad for the product at

Sr. No 2-4 before the grant of

registration. Address of DSL varies

from address on registration letter.

15. 031515 Bio-Tylo 200 Inj

Each ml contain:

Tylosin (as tartrate) 200mg

Manufactured by: M/s Bio-


-do-

16. 031516 Bio-Genta 10% Inj

Each ml contain:

Gentamicin (as

Sulphate)Manufactured by: M/s Bio-


-do-

17. 014529 Prednisolone 2.5% Inj

Each Ml contain:

Prednisolone acetate 25mg

Manufactured by: M/s Franklin

Pharmaceuticals Ireland.

-do-

M/s. SB Pharma, Plot No. 5-E, Industrial Triangle, Kahuta Road, Islamabad

18. 052381 SB Amoxytin oral powder

Each 100gm contain:

Amoxicillin Trihydrate eq to

e58amoxcillin Base 150g Colistin

Sulphate eq. to Colistin base

500MIU

Deferred for rectification of

shortcomings issued vide letter dated

03-07-2019,details are as under: Latest

cGMP Inspection Report.Undertakings

as mentioned in SOP of renewal

Section approval letter for Penicillin

issued by Licensing Division

M/s. Kailgon Agro Industries (Pvt) Ltd., 849, Pathra RCD Road, Hub Chowki, Balochistan

19. 004380-EX Trizokail 50 Oral Suspension

Each 100ml contain:

Triclabendazole..5gm

i. Deferred for rectification of

shortcomings issued vide letter

dated 30-07-2019,details are as

under: Valid DML. Section

approval letter issued by

Licensing Division.Latest cGMP

Inspection Report.An undertaking

that the applied products have

never been de-registered (on

Stamp Papar).An undertaking

that submitted documents are true

copy of the originals and that, if at

any stage any discrepancy /

misinformation is detected /

observed the firm/company will

be held responsible as per relevant

laws (on Stamp Papar).Brief

report of last batch

manufactured.Differential fee is

required as the renewal is

submitted after due date but

within sixty days.

M/s. Manhattan Pharma, 209/3-B, Sector-5, Korangi Industrial Area, Karachi

20. 052365 Trimoxin Injection

Each ml contain:

Amoxicillin (As Amoxicillin

Trihydrate)….150mg

Defferred for issuance of showcause

under and section 42 of Drug Act 1976

read with Schedule B-I (5.2) of Drug

(LRA) Rules 1976 to the firm


pencillins.

M/s. Mediceena Pharma (Pvt) Ltd., 27-Km Raiwind Road, Lahore

21. 051126 Medi-Enam Injection,

Each vial contains:

Imipenem (as

monohydrate)….250mg

Cilastatin (as

sodium)………...250mg

a) Deferred for rectification of

shortcomings issued vide letter

dated: 12-06-2019 which has not

been responded yet. Following are

details: Section approval letter

issued by Licensing

Division.Latest cGMP Inspection

Report.An undertaking that the

applied products have never been

de-registered (on Stamp

Papar).An undertaking that

submitted documents are true copy

of the originals and that, if at any

stage any discrepancy /


observed the firm/company will be

held responsible as per relevant



manufactured.Evidence of

submission of last

renewal.Description of all applied

tablet dosage forms.Source of

granules for Klaridox Suspension

(031168) and in case of imported

granules, the differential fee is

required.

22. 051127 Bioceena 1gm

Injection

-do-

Each vial contains:

Ampicillin (as

sodium)………..500mg

Cloxacillin (as

sodium)………..500mg

23. 051128 Bioceena Injection

Each Vial Contains:

Ampicillin (as sodium) …..125mg

Cloxacillin (as sodium) …..125mg

24. 051129 Medi-clox Injection

Each Vial Contains:


-do-


Each Vial Contains:


-do-


Each Vial Contains:

Cloxacillin (as sodium) …...1gm

-do-

27. 051132 Painrest – M Tablets


Diclofenac sodium ………..50mg

Misoprostol…..200mcg

-do-

28. 051133 Quinocil Tablets


Levofloxacin (as

hemihydrate)…750mg

-do-

29. 051134 Azimycin Tablets


Azithromycin (as

dihydrate)…..500mg

-do-

30. 051135 Lincoceena Suspension

Each 5ml contains:

Lincomycin (as HCl) ……...250mg

-do-

31. 031151 Xycam 10mg Tablets


Piroxicam ………10mg

-do-

32. 031152 Asmarax Tablets


KetotifenFumarate…..1mg

-do-

33. 031153 Asmarax Syrup

Each ml contains:

KetotifenFumarate…..0.2mg

-do-

34. 031154 Painrest Tablet 50mg



-do-

35. 031155 Painrest-SR Tablet 100mg



-do-

36. 031156 Zogyl 200mg Tablets


Metronidazole……….200mg

-do-

37. 031157 Zogyl 400mg Tablets



-do-

38. 031158 Zogyl Suspension 200mg

Each 5ml contains:

Metronidazole (as

Benzoate)…200mg

-do-

39. 031159 Medicoxib 100mg Tablets


Celecoxib……100mg

-do-

40. 031160 Erymox Tablets 250mg


Erythromycin Stearate eq. to

Erythromycin………250mg

-do-

41. 031161 Erymox Tablets 500mg


Erythromycin Stearate eq. to

Erythromycin………500mg

-do-

42. 031162 Erymox Suspension

Each 5ml contains:

Erythromycin Ethyl Succinate eq. to

Erythromycin…200mg

-do-

43. 031163 Diloxamet DS Tablets


DiloxanideFuroate……500mg

Metronidazole……….400mg

-do-

44. 031164 Diloxamet Suspension

Each 10ml contains:

DiloxanideFuroate……250mg

Metronidazole (as

Benzoate)...200mg

-do-

45. 031165 P-Floxin Tablets 400mg


Pefloxacin…..400mg

-do-

46. 031166 Klaridox Tablets 250mg


Clarithromycin………250mg

-do-

47. 031167 Klaridox Tablets 500mg



-do-

48. 031168 Klaridox Suspension

Each 5ml contains:


-do-

49. 031169 Ciprobact Tablet 250mg



-do-

50. 031170 Ciprobact Tablet 500mg



-do-

51. 031171 Wormdox Tablets


Mebendazole…100mg

-do-

52. 031172 Wormdox Suspension

Each 5ml contains:

Mebendazole…100mg

-do-

53. 031173 Medispan Tablets


-do-

Cefixime……..400mg

54. 031174 Medispan Suspension

Each 5ml contains:


-do-

55. 031175 Bestmox Tablets 10mg


Ebastine……..10mg

-do-

56. 031176 Mebcidina Suspension

Each 5ml contains:

Mebhydrolin (as

Napsylate)……….50mg

-do-

57. 031177 Methacil Tablets


Indomethacin……25mg

-do-

58. 031178 Mediflam SR 100mg Tablets


Diclofenac Potassium……100mg

-do-

59. 031179 Respilax Tablets 4mg


Salbutamol (as Sulphate).4mg

-do-

60. 031180 Oxymed Tablets 250mg


Oxytetyracycline (HCl)..250mg

-do-

61. 031181 Ofcil Tablets 200mg


Ofloxacin……….200mg

-do-

62. 031182 Clonil Vaginal Tablets 500mg


Clotrimazole…..500mg

-do-

63. 031183 Zandin Tablets 2mg


Tizanidine (as HCl)….2mg

-do-

64. 031184 Ulceroc Suspension

Each 5ml contains:

Cimetidine…….200mg

-do-

65. 031185 Baclorax Tablets 10mg


Baclofen……….10mg

-do-

66. 031186 Cofcina-D Syrup

Each 5ml contains:

Dextromethorphan HBr.10mg


Pseudoephedrine HCl…..5mg


-do-

67. 031187 Water for Injection

Each 5ml contains:

Water for injection……5ml

-do-

M/s. English Pharmaceuticals Industries Link Kattar Bund Road, Thokar Niaz Baig, Multan Road,

Lahore.

68. 014310 Engvit-L Syrup

Each 5ml contains:-

Vitamin B1 HCl….5mg

Vitamin B2….1.66mg

Vitamin B6 HCl….1mg

a. Deferred for rectification of

following shortcomings: Approval

status of product in Reference

Drug Agencies.Latest cGMP

Inspection Report.Brief report of

Vitamin B12….10mcg

Nicotinamide…20mg

Panthenol….2.5mg

Inositol….5mg

Lysine Mono HCl…35mg

last manufactured batch.Copy of

Monograph of BP for Diclofenac

Potassium Capsule.Differential fee

required for imported pellets for

the regularization of renewal of

year 2013 and 2018.Approval of

the section / manufacturing facility

(by Central Licensing Board).

69. 014311 Engpar Elixir

Each 5ml contains:-

Piprazine Citrate equivalent to

750mg

Piprazine Hydrate

-do-

70. 014312 Panam Syrup

Each 5ml contain:

Paracetamol…120mg

-do-

71. 051172 Engrol 75mg

Capsules



Bulk import of Pellets from M/s.

Amoli Organics (Pvt.) Ltd.,407

Dalamal House J.B. Road

Nariman Mumbai

-do-

72. 050150 E-Z Capsule 40mg



Trihydrate…40mg


Similax Laboratories Ltd. Plot

No.44,CIE Gandhi

Nagar,Balanagar,

Hyderabad,India

-do-

73. 050151 E-Z Capsule 20mg



Trihydrate…20mg


Similax Laboratories Ltd. Plot

No.44,CIE Gandhi

Nagar,Balanagar,

Hyderabad,India

-do-

M/s. Medicraft Pharmaceuticals (Pvt.) Limited 126-B,Industrial Estate, Hayatabad, Peshawar

74. 022209 Dyrid P Suspension Metronidazole

(As Benzoate)….200mg


following shortcomings: The firm

has to submit notarized copy of

initial registration letter and to

submit original letter through Firm

representative which may be

returned after verification of date

of registration. The firm has gain

submitted the same notarized copy

from the date of registration is not

clear. Change of brand name for

Clocit Tablet is not submitted.


renewal is not provided. Approval

letter of source of pellets for Omed

Capsules is not submitted.

75. 022210 Medgel Suspension

Each 5ml contains:-

Basic Aluminium Sucrose sulfate

(Sucralfate)….1gm

-do-

76. 022211 Medgel 1gm Tablet


Basic Aluminium Sucrose sulfate

(Sucralfate)….1gm

-do-

77. 022212 Clocit Tablets 50mg



-do-

78. 022213 Omed 20mg

Capsule


Omeprazole ….20mg

-do-

79. 022214 Motil Suspension

Each 5ml contains:-

Domperidone…5mg

-do-

80. 022215 Motil Tablet


Domperidone….10mg

-do-

M/s. Welmark Pharmaceuticals, Plot No. 122, Block-B,Phase-V, Industrial Estate ,Hatta

81. 050938 Lidcoron Injection

Each 2ml contains:-

Diclofenac Na….75mg

Lidocaine HCl….20mg


following shortcomings: Evidence

of approval of formulation

submitted is not traceable.

M/s. Vega Pharmaceuticals (Pvt) Ltd., 30-Km Multan Road, Lahore

82. 077007 V-Es 20 mg

Capsule

Each delayed release capsule

contains:

Esomeprazole magnesium Trihydrate

enteric coated Pellets 22.5%w/w ≡

Esomeprazole……20mg


following shortcomings:

Approval of source of pellets w.r.t

your letter dated 09-03-2015

regarding request of change of

source from M/s Spansules

Limited India to M/s Vision

Pharma.

83. 077008 V-Es 40 mg

Capsule


contains:

Esomeprazole magnesium

trihydrateeenteric coated Pellets

22.5%w/w ≡

Esomeprazole……40mg

-do-

M/s. Medicaids Pakistan (Pvt) Ltd., Plot No. 10, Sector 27, Korangi Industrial Area, Karachi

84. 006897 PETACIN TAB


a) Defferred for rectifcation of

following:Section approval letter

PENTAZOCINE HCL 25MG, issued by Licensing

Division.Latest cGMP Inspection














submission of last renewal.

85. 014220 Orphagesic-P Tablet


Paracetamol…450mg

Orphenadrine Citrate…35mg

-do-

M/s. Lowitt Pharma (Pvt.) Ltd. Plot No. 24,Industrial Estate, Hayatabad, Peshawar

86. 050989 Lowpime Injection 500mg

IV/IM.

Each vial contains:

Cefepime as HCl…………500mg

Defferred for rectifcation of

following:Confirmation of

Cephalosporin Injectable section by

the firm.

M/s. Abbott Laboratories (Pakistan) Ltd., Opp. Radio Pakistan Transmission Centre, Hyderabad Road,

Landhi, Karachi

87. 022352 Arinac Forte Tablet


Ibuprofen……..400mg

Pseudoephedrine HCl….60mg

Deferred for submission of renewal for

year 2013.

88. 022353 Arinac Suspension

Each 5ml Contains:-

Ibuprofen…….100mg

Pseudoephedrine HCl….15mg

-do-

89. 009876 Vidaylin-T Tablet


Vitamin A…………...2500IU

Vitamin D……..400IU

Vitamin E………...15IU

Vitamin B1…….1.05mg

Vitamin B2……1.2mg

Vitamin B12…..4.5mcg

Niacinamid…...13.5mg

Vitamin C…..60mg

Folic Acid……….0.3mg

Vitamin B6….…1.05mg

-do-

M/s. Cherwel Pharmaceuticals (Pvt) Ltd., Plot No. 20, Phase 4, Hattar Industrial Estate, Hattar

90. 52805 A-Gic Tablets 10mg


Ebastine…….10mg

i) Deferred for rectification of

following:Valid DML.Latest

GMP reportDescription of all

applied tablet dosage

forms.Evidence of approval of

formulation in reference

regulatory agencies for product at

Sr. No. 13, Initial registration

letter for product Azitab 250mg

Tablet and Myzan 4mg

TabletDifferential fee is not

submitted by the firm as

application was submitted after

due date but within sixty days.

91. 52806 Trizel Tablet 500mg


Clotrimazole……500mg

-do-

92. 52807 Moncher 5mg Tablet



-do-

93. 52808 Cherofex 120mg Tablet



-do-.

94. 52810 Bewel Tablet 20mg


Piroxicam as Beta

cyclodextrin….20mg

-do-

95. 54533 Cherdox 100mg

Capsule

Each capsule Contain:

Doxycycline as Hyclate....100mg

Deferred for rectification of following:

Valid DML.Latest GMP

reportDescription of all applied tablet

dosage forms.Evidence of approval of

formulation in reference regulatory

agencies for product at Sr. No. 13,

Initial registration letter for product

Azitab 250mg Tablet and Myzan 4mg

Tablet

96. 54534 Histawel 10mg Tablet


Loratadine……10mg

-do-

97. 54535 Maxolide 150mg Tablet


Roxithromycin…150mg

-do-

98. 54536 Azitab 250mg Tablet


Azithromycin Dihydrochloride eq.

To Azithromycin....250mg

-do-

99. 54537 Alena 10mg


Alendronate Sodium equivalent to

Alendronic Acid….10mg

-do-

100. 54538 Panther 40mg Tablet


Pantoprazole Sodium sesquihydrate

45.1mg

eq to Pantoprazole…40mg

-do-

101. 54539 Welcam 20mg Tablet


Piroxicam……20mg

-do-

102. 54540 Natwel 75mg Tablet



Deferred for rectification of following:

Evidence of approval of formulation is

not provided by the firm instead copy

of USP monograph of formulation is

submitted.

103. 54541 Twinks 20mg Tablet


Paroxetine…..20mg

-do-

104. 54542 Clopigen 75mg Tablet


Clopidogrel (as Bisulphate)….75mg

-do-

105. 54543 Nano-Bid 250mg Tablets



-do-

106. 54544 Famwel 40mg


Famotidine…..40mg

-do-

107. 54558 Myzan 4mg Tablet


Tizanidine 4mg/tab

-do-

108. 54844 C-Zine Tablet 10mg


Cetirizine Dihydrochloride….10mg

-do-

M/s Getz Pharma (Pvt) Ltd., 29-30, Sector-27, Korangi Industrial Area, Karachi

109. 047481 Telart Tablet 20mg


Telmisartan…20mg

Deferred for rectification/ clarification

of following: Firm was advised to

submit initial registration letter instead

the firm has again submitted the copy

of approval of change of brand name

for export purpose only dated 07-09-

2009 wherein the firm was allowed to

use name Telart for export purpose

only. The approved name as per said

letter is Tasmi for local marketing.



Telmisartan…40mg













Telmisartan…80mg











112. 19866 M-Low Tablet


Amlodipine….10mg


of following: Confirmation of brand

name is required.

M/s. Libra (Pvt) Ltd., 77, Peshawar Industrial Estate, Hayatabad

113. 022905 Clomipril 10mg


Clomipramine HCL..10mg


of following: Decision of 266th

Meeting of CLB Panel has been

constituted for inspection and

production will remain suspended till

recommendation of panel.

114. 022906 Clomipril 25mg


Clomipramine HCL..25mg

-do-

115. 022909 Domipar suspension

Each 5ml contain:

Domperidone…5mg

-do-

116. 022908 Domipar Tab


Domperidone…10mg

-do-

117. 022907 Hoff caps

Each Capsules contain:

Loperamide HCL…2mg

-do-

118. 022899 Swint 10mg

Tab


Amlodipine Besylate..10mg

-do-

119. 022898 Swint 5mg Tablet


Amlodipine Besylate..mg

-do-

120. 022913 Zag Syrup

Each 5ml contain:

Ketotifen …1mg

-do-

M/s. Healer Laboratories (Pvt) Ltd., 96/102C, S.I.T.E., Kohat Road, Peshawar

121. 053707 Oneedal Tablet



Caffeine…….65mg

Chlorpheniramine Maleate….2mg

i. Deferred for rectification/ clarification

of shortcomings communicated vide

letter dated 18-07-2019,details are as

under: i. Latest GMP report

(Inspection report dated 23-10-2018

and Show Cause Notice has been

issued) ii. Evidence of submission of

last renewal iii.Section approval letter


122. 053709 Ramit SR Tablet



-do-

123. 053708 Cum-D Tablet


Calcium (as carbonate)……125mg

Vitamin D…..500IU

-do-

M/s. Shrooq Pharmaceuticals (Pvt) Ltd., 21-km Ferozpur Road, Lahore

124. 77076 Dantron Syrup

Each 5ml contain:

Ondensteron as Hydrochloride..4mg

i) Deferred for rectification/

clarification of shortcomings

communicated vide letter dated 17-

07-2019,details are as under: Valid

DML.Approval of section

Undertakings as mentioned in for

renewal.

M/s. Amros Pharmaceuticals, A-96, S.I.T.E., North Karachi

125. 022186 Phenobarbitone Injection

Each ml contain:

Phenobarbitone sodium……200mg

i. Deferred for rectification/



07-2019,details are as under: Valid

DML. Section approval letter for

injectable dosage form issued by

Licensing DivisionSection

approval letter for psychotropic

injectabledosage form issued by

Licensing DivisionBrief reports of

last batch manufactured.Allocation

of last quota for Phenobarbitone by

Controlled Drug DivisionLatest

GMP Inspection reportEvidence of

approval of formulation in

reference agencies. Renewal

application has submitted late but

within 60 days prescribed fee

required.

126. 022187 Phenylbutazone Injection

Each 1ml contain:

Phenylbutazone….200mg

-do-


contains:

Lignocaine HCL…2% Sodium

Chloride…0.6% Methyl

hydroxybenzoate B.P 10%

-do-

M/s. Opal Laboratories (Pvt) Ltd., Lc-41, L.I.T.E. Landhi Karachi

128. 032021 Venrith Dry Suspension 125mg

Each 5ml Contain:


Deferred for confirmation source of

coated granules of Clarithromycin and

in case of imported source fee is

required.

M/s.Candid Pharmaceuticals, Opp. Pasrur Sugar Mills Sialkot Road, Pasrur

129. 022333 Pepdis Tablets


Famotidine USP…40mg

a. Deferred for rectification/



07-2019,details are as under:

Latest GMP inspection

report.Valid DML.

130. 022336 Napex Tablet


Naproxen Sodium..550mg

-do-

131. 022337 Flexar Tablets


Orphenadrine Citrate…35mg


-do-

M/s. MunawarPharma (Pvt) Ltd., 31-Km, Ferozepur Road, Lahore

132. 022934 Chloroquine Phosphate 150mg

Tablet




communicated vide letter dated

Chloroquine Base 150mg 22-07-2019,details are as under:

Latest cGMP Inspection

Report.Undertakings as

mentioned in SOP of renewal.

Last Renewal Valid

DML/evidence of renewal

application for renewal of

license submitted in DRAP

M/s. Pacific Pharmaceuticals Ltd., 30-Km, Multan Road, Lahore

133. 021649 Levopraid Tablet 25mg


L-Sulpiride… 25.0mg

Deferred for following: Differential fee

is not submitted by the firm as the

application is submitted after due date

but within sixty days.

134. 021650 Levopraid tablets 100mg

Each talet contain:

L-Sulpiride..…100mg





135. 001136-EX Flamotase Tablet


Trypsin…..1mg

Bromelain..…40mg




but within sixty days. The COA

submitted by the firm states the source

of API is pancreas. Therefore the

evaluation of drug substance with

respect to its manufacturing

requirements and quality control is

required.

M/s. Lahore Chemical& Pharmaceutical Works Pvt Limited, 137 Ferozpur Road Lahore.

136. 022888 Vefradin Capsules 250mg

Each capsule contain:

Cephradine B.P …. 250mg

Deferred for following: As per

inspection report dated 26-06-2018

w.r.t. decision of CLB in its 256th

meeting the panel has recommended

that the production will remain stop in

Cephalosporin Capsules and Dry

Powder Suspension till the

development of Self contained and

Segregated facilities.

M/s. Medicaids, Plot No. 10, Sector 27, Korangi Industrial Area, Karachi

137. 053454 Mediamin Injection

Each ml contain:

Mecobalamin ….500mcg

a) Deferred for rectification/




Section approval letter issued by

Licensing Division.Latest cGMP




Stamp Papar).An undertaking that








report of last batch manufactured.

138. 053455 Arteblax Injection

Each ml contain:

Artemether….80mg

-do-

139. 053456 Dart Injection

Each 2ml contain:

Ranitidine…..50mg

-do-

M/s. Aries Pharmaceuticals (Pvt) Ltd., 1-W, Industrial Estate, Hayatabad, Peshawar

140. 078437 Invocet 5mg Tablet

Each film coated tablet Contain:

Levocetirizine……5mg





Evidence of approval of


agencies for products having reg.

no.

078437,056124,054524,054525,05

4526. Approval of source of pellets

for product at sr.no.259-263


renewal for product having reg.no.

056124,054524,054525

141. 056124 Volfenac SR 100mg

Capsules

Each Capsules Contain:

Diclofenac Sodium……..100mg

Source: M/s Spansule formulations

India.

-do-

142. 054524 Volfenac 50mg

Capsules


Diclofenac sodium….50mg

Source: M/s Vision Pharma

Islamabad.

-do-

143. 054525 Volfenac 75mg

Capsules




India.

-do-

144. 054526 Ariflam 50mg

Capsules



Source: M/s Vision Pharma

Islamabad.

-do-

145. 054527 Ariflam 75mg

Capsules


-do-

Diclofenac Potassium…..75mg


India.

146. 054528 Esox 20mg

Capsules



-do-

147. 054529 Esox 40mg Tablet

Each capsules contain:


-do-

148. 054530 Omec 20mg

Capsules


Omeprazole Delayed Released

Enteric Coated Pellets eq. to

Omeprazole…20mg

-do-

149. 054531 Losin 30mg

Capsules


Lansoprazole ….30mg

-do-

150. 054532 Aptec 40mg

Capsules

Each Capsule contain:

Pantoprazole coated pellets

equivalent to Pantoprazole ….40mg

-do-

151. 054845 Flutix 20mg

Capsule

Each Capsule Contain:

Fluoxetine hydrochloride equivalent

to Fluoxetine…..20mg

-do-

152. 053795 Acifix 20mg Tablet

Each Enteric Coated Tablet contain:

Rabeprazole Sodium….20mg

-do-

153. 053796 Trican 150mg

Capsules


Fluconazole….150mg

-do-

M/s. English Pharmaceutical Industries, Link Kattar Bund Road, ThokarNiazBaig, Multan Road,

Lahore

154. 022926 Cartac 50mg Tablet


Atenolol ..50mg




07-2019,details are as under: Latest

GMP inspection reportAs per letter

dated 09-03-2015 regarding

renewal of DML, your Tablet

section (General) was not renewed,

therefore clarification in this

respect is needed Evidence of

approval of formulation on

reference drug agencies for

products at Sr. No. 269&270



Atenolol…...100mg

-do-

156. 022928 Ardi-75 Tablet


Diclofenac Sodium 75mg

-do-

157. 022929 Ornivit Syrup

Each 5ml contains:

L-Ornithine L-Aspartate 300mg

Nictinamide.24mg

Riboflavin-5 phosphate Sodium

0.76mg

-do-

158. 022930 Cezen Tablets


Cetrizine Dihydrochloride 10mg

-do-

159. 022931 F-100 Tablet


Flurbiprofen 100mg

-do-

M/s. Noa Hemis Pharmaceuticals, Plot No. 154, Sector-23, Korangi Industrial Area, Karachi

160. 032201 Fosoril Capsules


Fosfomycin (as calcium

salt….500mg)

Deferred for following: Evidence of

formulation provided is not traceable.

161. 032202 Fosoril suspension

Each 5ml contain:

Fosfomycin (as calcium

salt….250mg


formulation provided is not traceable.

162. 032205 Pericort Skin Ointment

Each gram contain:

Polymyxin B sulphate.8000I.U

Bacitracin Zinc…..500I.U Neomycin

(as neomycin sulphate)..3.0mg

Lidocaine (As lidocaine

HCL)….40mg


approved formulation in same strength

is required as the evidence submitted

does not indicate the same

163. 032210 Hyocort Cream

Each 100gm contain:

Hydrocortisone Acetate….1.0mg


approved formulation in same strength

is required as the evidence submitted

does not indicate the same

M/s. Festel Laboratories, Jinnah Industrial Estate, Link Kattarband Road, ThokarNiazBaig, Multan

Road, Lahore

164. 054564 Festpram 10mg Tablet


Escitalopram (as HBr)……10mg




22-07-2019,details are as

under: Latest GMP inspection

report

165. 054565 Moxifest 400mg Tablet


Moxifloxacin (as HCL)…..400mg

-do-

166. 054566 Asthlu 10mg Tablet



-do-

167. 054567 Feflam 50mg Tablet -do-



168. 054568 Sulpril 25mg Tablet


Levosulpride…25mg

-do-

M/s. Bio Fine Pharmaceuticals 74 Industrial Estate , Multan

169. 031952 Fruit Fawar Sachet

Each Sachet (5gm) contain:

Sod. Bicarbonate…2.8gm

Tartaric Acid…1.33gm

Citric Acid….0.82gm




under: Latest GMP inspection report.

Valid DML Section approval letter

issued by Licensing Division. Brief


Undertakings as required under SOP of

renewal of registration.

170. 031951 Povisol Vaginal Douches


Povidone Iodine (10%)..10gm

-do-

171. 031949 Povisol Solution

Each 100ml contain:

Povidone –Iodine (10%)…10gm

-do-

172. 031950 Povisol Surgical Scrub

Each 100ml contain:

Povidone-Iodine (7.5%)…7.5mg

-do-

M/s. Medisure Laboratories Pakistan (Pvt) Ltd., A-115, S.I.T.E, Super Highway, Karachi

173. 076193 Trankilium 250mg

Injection

Each 5ml contain:





under: Evidence of approval of



Injection

Each 5ml contain:







175. 076147 Suregine Oral Solution

Each ml contain:

Co-degrocrine mesylate……1mg






176. 032033 Clarocin Granules

Each 5ml contain:





under: Approval of source of granule

and in case of imported granules the

differential fee thereof.

177. 076160 Colistat Powder for injection

Each vial contain:

Colistimethate

sodium………1million I.U




under: Clarification of formulation as

the formulation approved in the

reference agencies is lyophilized

powder however the inspection report

doesn’t indicate the availability of

lyophilizer. Brief details of last batch

manufactured.

178. 031747 Sulvo Tablet 25mg






under: Differential fee required as

renewal application is submitted after

due date.Section approval letter issued

by Licensing Division.




-do-



Levosulpiride…..100mg

-do-

181. 031750 Faclo Tablet 135mg


Mebeverine HCL BP…..135mg

-do-

182. 022547 Nidol Granules 100mg

Sachet

Each 100mg

Sachet contain:

Nimesulide….100gm




under: Approval of formulation in

RRA. Differential fee Legible and

complete copy of registration letter

183. 022546 Nidol Tablet 0.100g


Nimesulide ….0.100gm




under: Approval of formulation in

RRA. Differential fee Legible and

complete copy of registration letter

M/s. Zephyr Pharmatec (Pvt) Ltd., A-39, S.I.T.E. II, Super Highway, Karachi

184. 055013 Nyloz 20mg

Capsule


Esomeprazole (as pellets)…20mg

M.s Meenaxy Pharma Pvt limited, 5

Phase TLE Balanagar Hyderabad.


submission of renewal fee of imported

pellets for year 2014.

185. 055014 Nyloz 40mg

Capsules


Esomeprazole (as pellets)…40mg

M.s Meenaxy Pharma Pvt limited, 5

Phase TLE Balanagar Hyderabad.


submission of renewal fee of imported

pellets for year 2014.

M/s. Neomedix, Plot No. 05, N/5, National Industrial Zone, Islamabad

186. 054629 E-Therol 200mg

Capsules


Alpha Tocopherol acetate (Vitamin

E)….200mg





formulation in reference drug agencies.

187. 054630 E-Therol 400mg

Capsules



E)….400mg






188. 054631 E-Therol 600mg

Capsules



E)….600mg





formulation in reference drug agencies. 189. 054632 Azifine 250mg

Capsules


Azithromycin (as

dehydrate)…250mg





formulation in reference drug agencies. 190. 054633 Transadix 250mg

Capsules


Tranexamic Acid….250mg






191. 054634 Transadix 500mg

Capsules


Tranexamic Acid….500mg






192. 054781 Neomep 20mg

Capsule


Omeprazole (Pellets)…..20mg




under: Approval of source of pellets

and in case of imported pellets

differential fee for the year 2014 and

2019.

193. 054782 Neomep 40mg

Capsule


Omeprazole (Pellets)..40mg

-do-

194. 054783 Esofix 20mg

Capsule



trihydrate (Pellets) equivalent to

Esomeprazole…20mg

-do-

195. 054784 Esofix 40mg

Capsule



trihydrate (Pellets) equivalent to

Esomeprazole…40mg

-do-

196. 054785 Neolans 30mg

Capsule



pellets equivalent to

Lansoprazole…30mg

-do-

M/s. Scotmann Pharmaceuticals, Plot No. 05-D, Sector I-10/3, Industrial Area, Islamabad

197. 054751 Dostax Capsules 30mg


Duloxetine (as HCL) Enteric Coated

Pellets…30mg




under: Differential fee is required for

M/s Mack & Co., GmbH

Bahnhofstrasse Rotenburg Germany

the year 2014 & 2019 as the product is

imported pellets.

198. 054752 Dostax Capsules 60mg


Duloxetine (as HCL) Enteric Coated

Pellets…60mg

M/s Mack & Co., GmbH

Bahnhofstrasse Rotenburg Germany

-do-

199. 054750 Dune Sachet 4mg


Montelukast as sodium…..4mg




under: Section approval letter issued


M/s. Micko Industrial Chemicals Co. (Pvt) Ltd., 28-Km Ferozepur Road, Lahore

200. 022935 Povidin Scrub


PovidoneLodine 7.5gm

eq 0.75%



communicated vide letter


under: Copy of registration

letter submitted does not bear

the date of issuance.Valid

DMLLatest GMP

reportSection approval letter

issued by Licensing

DivisionBrief details of last

batch manufacturedEvidence

of approval of formulation in

reference drug agencies.

201. 022936 Lactinex HC Lotion

Each HC Lotion:

Hydrocortisone…25gm

-do-

202. 022937 Veracort Cream

Contains:

Econazole nitrate…1%

-do-

203. 022938 FongifixSolutoin . Shampoo

Contains:

Tarextract in Archis oil. 1%w/w

Pyrithione Zinc…1%w/w Oleyl

alcohol…1%w/w

-do-

204. 022939 Oxytal Emollient

Contains:

Tarext in Archis oil..25% light liquid

Paraffin B.P.35%

-do-

205. 022940 Nixdermal Cram

Contains:

Permethrin…5%w/w

-do-

M/s. Mass Pharma (Pvt) Ltd., 17-Km, Ferozpur Road, Lahore

206. 022392 Maclexin Drops 125mg


Cephalexin Micronized

B.P…..125mg




24-07-2019,details are as under:

Latest GMP inspection

report.Section approval letter

issued by Licensing Division.

207. 022868 Clintol Tablet 10mg


Loratadine……10mg

-do-

208. 022869 Bioplus-C Tablet


Betacarotone….9mg

Vitamin E…..100mg

Vitamin C…500mg

Zinc…..10mg

Selenium…….0.02mg




dated 24-07-2019,details are

as under: Latest GMP

inspection report.Section


Licensing Division.Evidence



209. 022870 Flute Capsule 20mg


Fluoxetine HCL….20mg





report.Section approval letter issued by

Licensing Division.

210. 046362 Enclot Tablet 75mg


Clopidogrel (as hydrogen

sulphate)……75mg






Licensing Division.

211. 030869 Lotrigen Cream

Contain:

Clotrimazole……1%






Licensing Division.

212. 030867 Mecare-C Cream

Contain:

Isoconzaole Nitrate….1%








Licensing

Division.Differential fee

required under SRO 1005 (I)/

2017 as the application

received after 60 days.

213. 030868 MecarePessaries 300mg

Each Pessaries contains:

Isoconazole Nitrate…300mg








Licensing





214. 030874 Azelaxin Cream

Contain:

Azelaic Acid..20%








Licensing





215. 035720 Xamogine Tablet 50mg


Lamotrigine….50mg








Licensing



2017 OR evidence of

submission of renewal of 2014

in accordance with initial

registration date.

216. 035739 Xaslexx Tablet SR 75mg


Bupropion HCL…75mg






Licensing Division.Differential fee

required under SRO 1005 (I)/ 2017

OR evidence of submission of renewal

of 2014 in accordance with initial

registration date. 217. 035740 Xaslexx Tablet SR 150mg


Bupropion HCL…150mg










registration date. 218. 035741 XprodineInjeciton 10mg

Each 2ml ampoule contain.:

Procyclidine HCL…10mg










registration date. 219. 036190 Xaspine Tablet 100mg

Each film coated tablet contain:

Quetiapime (as Furnarate)…100mg










registration date. 220. 040700 Xantol Tablet 10mg


Memantine HCL…10mg








Licensing



2017 OR evidence of



registration date.

221. 041646 Xaspine Tablet 25mg


Quetiapine (as Fumarate)…..25mg








Licensing



2017 OR evidence of



registration date.

222. 041647 Xexor SR Tablet 75mg


Venlafaxine (as

Hydrochloride)…..75mg








Licensing



2017 OR evidence of



registration date.

223. 041648 Xastrin Tablet 100mg


Sertraline (as HCL)….100mg










registration date.

224. 051155 Letirizine Tablet 5mg


Levocetirizine

Dihydrochloride…5mg








Licensing





225. 051156 Xaspine Tablet 300mg


Quetiapine (as Fumarate)….300mg








Licensing





226. 051158 Zilify Tablet 10mg


Aripiprazole….10mg








Licensing





M/s. EPLA Laboratories (Pvt) Ltd., D-12, Estate Avenue, S.I.T.E., Karachi

227. 053408 Gliguard M1 Tablet


Metformin HCL…500mg

Glimepiride….1.0mg

Deferred for statsus of show cause

notice has been issued by the

concerned section regarding

cancellation of registration of said

formulation to M/s Sanofi Aventis

Karachi

228. 053409 Gliguard 3mg Tablet


Glimepiride…3mg






inspection report.

229. 053410 Gliguard 4mg Tablet


Glimepiride….4mg

-do-

230. 053411 Azocin 250mg

Capsules

Each Capsule contain:

Azithromycin (as Dihydrate)

-do-

231. 053412 Azocin 200mg/5ml Dry Suspension

Each 5ml contain:

Azithromycin (as

Dihydrate)…..200mg

-do-

M/s. Dyson Research Laboratories (Pvt) Ltd., 28-Km, Ferozepur Road, Lahore

232. 078837 Apollo Tablet 10mg


Rosuvastatin (as calcium)….10mg





Latest GMP inspection reportYou

are also advised produce Original

Registration Letter through your

authorized representative which

shall be returned after

verification.

233. 078840 Timzi Tablet 4mg


Tizanidine (as HCL)…..4mg

-do-

234. 078839 Gencox Tablet 60mg


Etoricoxib…..60mg

-do-

235. 078841 Limi Tablet 2/500mg


Glimepride…..2mg

Metformin Hydrochloride…500mg

-do-

236. 078843 Limi Tablet 1/500mg


Glimepride…..1mg

Metformin Hydrochloride…500mg

-do-



Rosuvastatin (as Calcium)..…20mg

-do-

238. 078848 Rabicol Tablet 20mg


Rabeprazole as sodium……20mg

-do-



Rosuvastatin (as Calcium)..…5mg

-do-

240. 078851 Duodil Tablet 20mg


Nicorandil…..20mg

-do-

241. 078849 Gluchk Tablet 850mg


Metformin HCL….850mg

-do-

242. 078844 Bacnor Tablet 400mg


Norfloxacin….400mg

-do-

243. 078838 Atorex-E Tablet


Atorvastatin (as calcium)…10mg

-do-

M/s. Hilton Pharma (Pvt) Ltd., Plot No. 13-14, Sector 15, Korangi Industrial Area, Karachi

244. 015103 Enterocin Dry suspension

Each gm contain:

ColistinSulphate….1 M.U





formulation of formulation in reference

drug agencies.

M/s. Karachi Pharmaceutical Laboratories, S-54 Maripur Road, S.I.T.E., Karachi

245. 007034 Chlorpheniramine Maleate Syrup

2mg/ 5ml





Valid DML. Evidence of



Licensing Division esp. for

product at Sr. No. 5 being

steroidal dosage form.Latest

cGMP Inspection Report.An

undertaking that the applied

products have never been de-

registered (on Stamp Papar).An

undertaking that submitted

documents are true copy of the

originals and that, if at any stage

any discrepancy / misinformation

is detected / observed the

firm/company will be held

responsible as per relevant laws

(on Stamp Papar).Brief report of

last batch manufactured.

Differential fee for the product at

Sr. No.480 due to imported source

of pellets. Evidence of approval of


246. 007035 Methagan Elixir

Promethazine Elixir 5mg/ 5ml

-do-

247. 007050 Pexocitral Syrup

Sodium Acid Citrate Syrup 1.25gm/

5ml

-do-

248. 007051 Sulphatran Tablet


Sulphamethoxazole….400mg

-do-

Trimethoprim…..80mg

249. 007091 Prednisolone Tablet 5mg

-do-

250. 007253 Hydrogen Peroxide Solution 6% w/v

-do-

251. 055016 Pastrazole Capsules


Lansoprazole (as Pellets) ….30mg

Source: M/s Titan Laboratories Pvt

Limited, Mumbai India

-do-

M/s. Shaheen Pharmaceuticals, 3-Km Murghzar Road, Saidu Sharif , Swat (KPK)

252. 054626 Shavozin 5mg Tablet


Levocetirizine

Dihydrochloride….5mg


for the year 2013 has not been

submitted as the renewal application of

year 2013 has been received but within

60 days.

253. 054617 Flucosh capsules


Fluconazole…150mg

-do-

254. 054618 Clarish 500mg Tablet



-do-

255. 054621 Olox Tablets


Ofloxacin….200mg

-do-

256. 054619 Batin 100mg Tablet


Gabapentin….100mg

-do-

257. 054620 Batin 300mg Tablet


Gabapentin….300mg

-do-

258. 054622 Alfadal Tablet


Alfacalcidol (Vitamin D

analogue)…0.5mcg

-do-

259. 054623 Tapzol Tablets


Pantoprazole sodium sesquihydrate

equivalent to Pantoprazole…40mg

-do-

260. 054624 Shoride 50mg Tablets


Itopride HCL eq. to Itopride…50mg

-do-

261. 054625 Lacenac 100mg Tablet


Aceclofenac….100mg

-do-

262. 054627 Depgo 10mg


Escitalopram Oxalate equivalent to

Escitalopram…10mg

-do-

263. 054628 Spanor 80mg Tablets


Drotaverine HCL……80mg

-do-

264. 054852 Persolon 60ml Syrup

Prednisolone….15mg/5ml

Deferred for following: Section

approval letter is not submitted for

steroid oral liquid formulation.

Inspection report submitted does not

indicate aforesaid manufacturing

facility. The registration may be

suspended till clarification from the

firm.

M/s. PharmaWise Labs. (Pvt) Ltd., 25-M Industrial Estate KotLakhpat, Lahore

265. 022808 Rifacin 300mgs


Rifampicin….300mg





Valid DML. Evidence of



Licensing DivisionLatest cGMP




Stamp Papar).An undertaking









manufactured.Transfer of

registration in name of M/s

PharmaWise Labs to M/s Fakma

Pharma Lahore.

M/s. Pliva Pakistan (Pvt) Ltd., Plot No. B-77, Hub Industrial Trading Estate Hub, Balochistan

266. 050380 Plimaltos Tablet



Complex eq.to Elemental

Iron…100mg


submission of last renewal as last

Renewal application was submitted

through TCS.

267. 050381 Plimaltos-F Tablets




Iron…100mg

Folic Acid……0.35mg

-do-

268. 050382 Plimaltos Syrup

Each 5ml Contain:



Iron…50mg

-do-

M/s. MBL Pharma, Plot No. B-77/A, Hub Industrial Trading Estate, Balochistan

269. 053457 Betamethasone Eye Ear Drops

Each ml contain:

Betamethasone sodium




Phosphate…….0.1% under: Latest GMP inspection report

Valid DML

270. 053458 Betamethasone N Eye Ear Drops

Each ml contain:

Betamethasone Sodium

Phosphate……0.1%w/v Neomycin

Sulphate…….0.5% w/v

-do-

271. 055083 Justopain 10mg Tablet


Hyoscine-N-Butylbromide….10mg

-do-

272. 055084 Justopain 20mg/ml Injection

Each ml contain:

Hyoscine-N-Butyl bromide…20mg

-do-

M/s. Novins International (Pvt) Ltd., Plot No. E-37&38, Port Qasim Authority, Karachi

273. 053360 Alfuprozin SR 5mg Tablet


Alfuzosin HCL……5mg






renewal. Section approval letter

issued by Licensing Division for

product at Sr. No. 589 being

steroidal dosage form. Latest

cGMP Inspection Report.An



registered (on Stamp Papar).An








(on Stamp Papar).Brief report of

last batch manufactured.Evidence



274. 053361 Prostryl Tablet 5mg


Finasteride …..5mg

-do-

M/s. Hizat Pharmaceutical Industry, 170 Industrial Estate Hayatabad, Peshawar

275. 022862 Oprazole Capsules


Omeprazole….20mg





Source fixation approval for

pellets/ An undertaking that the




submitted documents are true








M/s. Zafa Pharmaceutical Laboratories (Pvt) Ltd., L-4/1, A&B, Block-21, Federal-B Industrial Area,

Karachi

276. 055546 Vofloza Tablet 500mg


Levofloxacin as

Hemihydrate…500mg


submission of renewal in DRAP

having endorsement of R&I has not

been submitted.

M/s. Bloom Pharmaceuticals (Pvt) Ltd., Plot No. 30, Phase-I & II Industrial Estate, Hattar

277. 022577 Cyten 10mg Tablet

Each tAblet contain:

Cetirizine Dihydrochloride BP.10mg





Differential fee required as

renewal of year 2013 was


sixty days. Evidence of approval


agencies.

278. 022576 Piroc-20mg

Capsules


Piroxicam BP…20mg

-do-

279. 022578 Zonid 400mg Tablet


Metronidazole BP…400mg

-do-

280. 022579 ZonidSuspension 60ml

Each 5ml contain:

Metronidazole BP….200mg

-do-

281. 022580 Zyvit Syrup 120mg

Each 5ml contain:

Eiastase........135mg

Pepsin……..50mg

Papine…….50mg

Vitamin B1... 5mg

Vitamin B2... 2mg

Vitamin B6... 2mg

Vitamin B12. 5mcg Nicotinamide…

20mg

Cal. Pantothenate…..1mg

-do-

M/s. Meditech Pharmaceuticals, 15-D Industrial Estate, Jamrud Road, Peshawar

282. 54616 Benzil emulsion

Each contains:

Benzyl Bezoate..25% w/v (USP

Specification)





Valid DML. Notarized copy of

initial registration letter. Evidence

of submission of last

renewal.Section approval letter


















283. 54614 Betzil suspension

Each 5ml contains:

Metronidazole Bernzoateeq to

Metronidazole ..200mg

(B.P Specification)

-do-

M/s. Nawabsons Laboratories (Pvt) Ltd., JiaBagga Off Raiwind Road, Lahore

284. 014793 Dexamethasone Tablet


Dexamethasone….0.5mg






renewal.Section approval letter

issued by Licensing Division for

steroidal dosage form at Sr. No.

537. Latest cGMP Inspection
















285. 014794 FurazolidoneSusp

Each 5ml contain:

Furazolidone….25mg

-do-

286. 014795 Cimetidine Tablets


Cimetidine…..200mg

-do-

M/s. Wnsfeild Pharmaceuticals, Plot No. 122, Block-A, Phase-V, Industrial Estate, Hattar

287. 078427 Haglox CR 12.5mg Tablet

Each controlled release coated tablet

contains:

Paroxetine HCL Hemihydrate

Paroxetine…..12.5mg
















laws (on Stamp Papar).Evidence



M/s. Z.Jans Pharmaceuticals (Pvt) Ltd., 148-A Industrial Area Hayatabad, Peshawar

288. 054569 Oxa-Z Tablets 500mg


Levofloxacin (as



submission of last renewal is not

submitted by the firm.

289. 054570 Oxa-Z Tablets 250mg


Levofloxacin (as


-do-

290. 054571 Ibo-Z Suspension

Each 5ml Contain:

Ibuprofen……100mg

-do-

291. 054572 GirestSuspension

Each 5ml contain:

Simethicone….50mg

Dicyclomine HCL……5mg

-do-

292. 054573 Cim-Z Susp

Each 5ml contain:

Cimetidine……100mg

-do-

M/s Medera Pharmaceuticals (Pvt) Ltd, 249/A, Industrial Triangle, Kahuta Road, Islamabad

293. 024750 Amazole Capsule 20mg


Omeprazole Pellets 235mg


Source: M/s Vision Pharmaceuticals

Plot No. 22-23 Industrial Triangle

Kahuta Road Islamabad.

Deferred for issuance of final reminder

for following: Differential fee for the

year 2013 and 2018 because the source

was changed from import to local on

17-06-2019.

M/s. Remington Pharmaceutical Industries (Pvt) Ltd., 18-Km Multan Road Lahore

294. 052653 Esler 20mg

Capsules.



Trihydrate….20mg.

Deferred for following: Differential

Fee is required as the product is

imported pellets for the renewal of

year 2013 & 2018.

295. 052654 Esler 40mg

Capsules.




Deferred for following: Differential

Fee is required as the product is

imported pellets for the renewal of

year 2013 & 2018.

296. 051013 Diarid 1/500 Tablets.


Glimepiride……………1 mg.

Metformin HCl………..500 mg.

Defered for status of showcause issued

by the concerned section for same

formulation.

M/s. Brookes Pharma Private Limited,58-59 Sector 15,Korangi Industrial Area, Karachi

297. 009128 Phlogin-50 Capsules



Deferred for confirmation of transfer

of registration from M/s Brooks

Laboratories to M/s Broks Pharma Pvt

Limited from the concerned section.

298. 009129 Phlogin-SR-100 Capsule



-do-

299. 009529 Pyodine Gargle & Mouth Wash


Polyvinylpyrolidine I odine

-do-

300. 009528 Pyodine Solution


Polyvinylpyrrolidine Iodine

-do-

301. 009031 Hepa-Merz Syrup

Each ml contains:-

Ornithine Asparate….60mg

Nicotinamide….4.8mg

Riboflavin-5-Phosphate

Sodium….0.153mg

Sodium Benzoate…1.2mg

Potassium Sorbate…1.2mg

Citric Acid…6.0mg

-do-

302. 009939 Sterile Water for InjectionContains:-


-do-

303. 022304 Ponsac Tablets


Mefenamic Acid….250mg

-do-

M/s. Reliance Pharma, Plot No. 8, Street No. S-8 , RCCI Industrial Estate, Rawat.

304. 072164 Genbet Cream 30gm contains:-

Betamethasone as DP 0.05%

Gentamycin as Sulphate

Deferred for final reminder for


shortcomings: Initial registration and

evidence of last renewal.

305. 075076 Religent-B Ointment

Each gm contains:-

Gentamycin (as sulphate)…0.1%,

Betamethasone (as dipropionate) …

0.05%

-do-

306. 075077 Religent-SB Ointment -do-

Each gm contains:-

Betamethasone (as

dipropionate)…0.5 mg, Salicylic

acid … 30 mg

307. 072951 Relaxipain 20mg

Capsule


Piroxicam…20mg

-do-

M/s Nawabsons Laboratories, Jia Bagga Off Raiwind Road, Lahore

308. 030320 Hemasol Syrup

Each 5ml Contains:-


Ascorbic Acid…5mg

Deferred for The product was deferred

in 288th meeting of Registration Board

clarification of following:i.

Reference formulation of BPC

is provided which is 30g/1000ml i.e.

150mg/5ml.ii. Section approval

letter.Now the has informed that the

formulation approved by then MOH

was in reference BPC 1973.This is

brand of firm and concentration of

ferrous is reduced fron 150mg

to 100mg

due to astringent property of API.

M/s. Alfalah Pharma (Pvt.) Ltd. 12 Km,Sheikhupura Road,Lahore



Glimepiride….1mg


for rectification of following

shortcomings: Latest GMP report and

evidence of submission of last renewal.



Glimepiride….2mg

-do-

311. 051112 Methoxine Tablet


Sulfadoxine….500mg

Pyrimethamine…25mg

-do-

312. 051113 Benbit Tablet 5mg



-do-

313. 051114 Pyomic Tablet 25mg



-do-

314. 051115 Alfakalium Tablet 50mg



-do-

315. 051116 Mczole Tablets 400mg



-do-




-do-




-do-

318. 051119 Zolo Tablets


-do-


Sesquihydrate)….40mg

M/s. MBL Pharma, Plot No. B-77/A, Hub Industrial Trading Estate, Baluchistan

319. 050384 MB Stine Tablet 10mg


Ebastine…10mg


for rectification of following

shortcomings: Evidence of submission

of last renewal.

320. 050385 MB Cobal Tablet 500mcg



-do-

321. 050386 MB Cobal Injection 500mcg

Each 1ml Contains:


-do-



Piroxicam…10mg

-do-



Piroxicam…20mg

-do-

324. 050389 Anbox 0.5% Gel

Each gm Contains:

Piroxicam…5mg

-do-

325. 050390 Xaser Tablet 10mg



-do-

326. 050391 Xaser 1mg/ml Syrup

Each ml Contains:


-do-

M/s. Usawa Pharmaceuticals, 146-Special Zone, (Export Processing Zone) Risalpur

327. 50826 Quinspar Tablet




for submission of evidence of


M/s. Wilson’s Pharmaceuticals, 387-388, I-9, Industrial Area, Islamabad

328. 031083 Gem-SR Tablet



Sesquihydrate)……40mg

Deferred for clarification required that

last renewal of 2015 is submitted and

renewal is applied in 2018 as per initial

letter

329. 031082 Reset-SR Tablet


Lansoprazole…….30mg

Deferred for clarification required that

last renewal of 2015 is submitted and

renewal is applied in 2018 as per initial

letter

330. 010029 Slepam Capsule 15mg


Tenazepam.....15mg



M/s. Wise Pharmaceuticals, Plot No. 3-A, Street No. S-1, RCCI Industrial Estate, Rawat, Rawalpindi


Capsule




Deferred for submission of source

fixation approval for pellets.


Capsule



Deferred for submission of source

fixation approval for pellets.


M/s. AGP Limited, B-23-C, S.I.T.E., Karachi.

333. 024881 Novafol 250mg

Capsules




of registration from concerned section.

334. 024882 Novafol 500mg

Capsules



-do-

335. 024883 Novafol Suspension

Each 5ml Contains:-


-do-

336. 024884 Novafol 250mg

Suspension

Each 5ml contains:-


-do-

337. 024878 Novafol 250mg

Injection (IM/IV)



Defferred for issuance of showcause

under and section 42 of Drug Act 1976

read with Schedule B-I (5.2) of Drug

(LRA) Rules 1976 to the firm


Cephalosporins.




-do-



Cephradine…..1gm

-do-


IM/IV


Cefoperazone…..250mg

-do-


IM/IV


Cefoperazone…..500mg

-do-

342. -do- Tecadin Injection 1gm

IM/IV


Cefoperazone…..1gm

-do-

343. 018070 Kefadim 1gm

Injection


Ceftazidime Sterile…..1.00gm

-do-

344. 018069 Kefadim 500mg

Injection


Ceftazidime Sterile…….500mg

-do-

345. 036178 Kefadim 250mg

Injection


Ceftazidime Pentahydrate eq. to

-do-

Ceftazidime…..250mg

346. 021640 Phyllocontin 100mg Tablet


Aminophylline Hydrate……100mg

Deferred for final clarifaction

regarding Brand name from the firm.



Bromazepam…..6mg

Deferred for issuance of reminder for

opinion from Legal Affairs division



Bromazepam…..3mg

-do-

M/s Nexus Pharma Pvt Limited, Plot No. 4/19 Sector 21, Korangi Industrial Area Karachi

349. 039557 Nettle Capsules 250mg


Cefaclor…..250mg


of registration from M/s Pride


21, Korangi Industrial Area Karachi to

M/s Nexus Pharma Pvt Limited, Plot

No. 4/19 Sector 21, Korangi Industrial

Area Karachi from concerned section.

350. 039558 Nettle capsules 500mg


Cefaclor……500mg

-do-


Each 5ml contains:-

Cefaclor…….125mg

-do-

352. 039561 Nitaxim 250mg

Injection


Cefotaxime (as Sodium)….250mg

-do-

353. 039563 Nitaxim Injection 1gm


Cefotaxime (as Sodium)….1gm

-do-

354. 039562 Nitaxim Injection 500mg


Cefotaxime (as Sodium)……500mg

-do-

355. 039529 Flur Tablet 100mg


Flurbiprofen …..100mg

-do-

356. 039633 Coozip Capsules 20mg


Omeprazole…..20mg

-do-

M/s. GlaxoSmithKline Pakistan Limited F-268, S.I.T.E. ,Karachi



Paracetamol…500mg

Caffeine…65mg

Deferred for clalrifcation from the firm

for complete details regarding transfer

of registration and sections since initial

regsitation.


Each 5ml Contains:

Paracetamol…250mg

-do-


Each 5ml Contains:

Paracetamol…120mg

-do-



Paracetamol…500mg

-do-


Each gm Contains:



-do-


Each 5ml Contains:


-do-


Each 5ml Contains:


-do-


Each 5ml Contains:

Metoclopramide HCl eq. to

Anhydrous Sustance…5mg

-do-


Each 5ml Contains:

Mebendazole…100mg

-do-



Mebendazole…100mg

-do-



Mebendazole…500mg

-do-

M/s. GlaxoSmithKline Pakistan Limited,35- Dockyard Road, West Wharf, Karachi


Contains:





regsitation.


Contains:



Nystatin…100,000 Units per gm

-do-


Contains:


-do-


Contains:


-do-



Exsiccated Ferrous

Sulphate…150mg

Folic Acid…0.5mg

-do-



Exsiccated Ferrous

Sulphate…150mg

Zinc Sulphate

Monohydrate…61.8mg

-do-

374. 020543 Fefol Z Spansule Pellets




-do-

22.5mg


Folic Acid…0.5mg


Each 2ml Contains:


-do-


Each gm Contains:





-do-


Each 2ml Contains:


-do-



Digoxin…0.5mg

-do-


Each ml Contains:




-do-


Each ml Contains:




-do-


Contains:


Base…0.2%w/w

-do-

M/s. GlaxoSmithKline Pakistan Limited,Plot 5,Sector 21,Korangi Industrial Area,Karachi




Cephalexin)…250mg




regsitation.




Cephalexin)…500mg

-do-



Cephalexin…125mg

-do-


Each 5ml Contains:


Cephalexin)…125mg

-do-


Each 5ml Contains:


Cephalexin)…250mg

-do-

M/s. GlaxoSmithKline Pakistan Limited

387. 68 Furadantin Tablet Deferred for clalrifcation from the firm





regsitation.

M/s Pantex Pharmaceutica 26 Abbot Road Lahore

388. 049736 Doxycyclin 500 Water Solube

Powder

Each gm contains:-

Doxycycline Hyclate….500mg

Manufactured by:M/s Pantex

Holland B.V., Holland


for submission of CoPP.

389. 049735 Amoxy C Water Soluble Powder

Each gm contains:-

Colistin as base (as sulphate)…50mg

Amoxicillin base as

trihydrate….200mg

Manufactured by:M/s Pantex

Holland B.V., Holland

-do-




Steroidal Sapoginins

13600ppmManufactured by:M/s.


Incorporated,USA




Anti-germ 77


Terramycin(Oxytetyracycline

Chlorhydrate) 5.6gm


chloride)5.5gm

Manufactured by:M/s. Laboratories

Pfizer Ltd.,Brazil

-do-

M/s Prix Pharmaceutica 26 Abbot Road Lahore.

392. 049578 Oxtra Effervescent Tablets


Oxytetracycline hydrochloride eq. to

Oxytetracycline …..1gm

Manufactured by:M/s Fatro S.p.A

Italy.



393. 021492 Aminolife Poultry W/S

PowderManufactured by:M/s Fatro

S.p.A Italy.

-do-

394. 049579 Micospectone

Each ml contains:-

Lincomycin 50mg

as Lincomycin HCL 56070mg

Spectinomycin 100mg

as Spectinimycin HCl 150mg

Manufactured by:M/s Fatro S.p.A

Italy.

-do-

M/s. Atco Pharma International (Pvt) Ltd., B-18, S.I.T.E., Karachi 395. 047676 Femizet Tablets 1mg

Each film coated tablets

Deferred for further evaluation.

contains:

Anastrozole IH*…1mg

(In House)Manufactured by: Nil

M/s. Medinet Pharmaceuticals Building No.601, Lane. No. 5, Main Peshawar Road, Rawalpindi

396. 028482 Hydra Capsule


Hydroxyurea……….500mg

Manufactured by:M/s Dae Han New


1-gil, Hyangnam-eup,Hwaseog-si,

Gyeonggi-do,Republic of Korea.

i. Deferred for issuance of final


following: Valid Legalized CoPP

397. 028482 DAC Injection

Each vial

contain:Dacarbazine……...200mg

Manufactured by:M/s Dae Han New

Pharm. Co., Ltd. 904-3 Shangshin-

ri, Hyangnam-myun, Hwasung-si,

Kyunggi-do Republic of Korea.




398. 028491 Etoside Injection


Etoposide….100mg

Manufactured by:M/s. Laboratorio

Varifarma S.A. Argentina







10mg


by:M/s. Laboratorio Varifarma S.A.

Argentina







20mg


by:M/s. Laboratorio Varifarma S.A.

Argentina




401. 028493 Progace Tablet


Megestrol Acetate…160mg

Manufactured by:M/s. Laboratorio

Varifarma S.A. Argentina




M/s Alina Combine Pharmaceuticals Pvt Limited Karachi

402. 48183 Oxytetracycline 10% Injectable

Solution

Each ml Contains:

Oxytetracycline HCl…100mg

Manufactured by:M/s Alfasan

International BV The Netherlands


for confirmation of transfer of

registration of M/s Alina Combine

from import to local from concerned

section.

403. 48184 Tylosin 20% Injectable Solution

Each ml Contains:

Tylosin (as Tartrate)…200mg


-do-


404. 48180 Alfamec 1% Injectable Solution

Each ml Contains:

Ivermectin…10mg



-do-

405. 48181 Xylazine 2% Injectable Solution

Each ml Contains:

Xylazine (as HCl)…20mg



-do-

406. 48182 Lincomycine-Spectinomycin 5/10

Injectable Solution

Each ml Contains:

Lincomycin (as HCl)…50mg

Spectinomycin (as HCl)…100mg



-do-

407. 48185 Multivitamin Injectable Solution

Each ml Contains:

Vitamin A (as Synthetic Concentrate

Oily Form)…15,000IU

Cholecalciferol (as Concentrate Oily

Form)…1000IU

Alpha tocopheryl Acetate…20mg

Thiamine HCl…10mg

Riboflavine Sodium

Phosphate…6.85mg

Pyridoxine HCl…3mg


Nicotinamide…35mg

Dexpanthenol...25mg



-do-

M/s. Legacy Pharmaceuticals (Pvt) Limited, 111-A Industrial Estate Hayatabad, Peshawar

408. 50092 Lesozol 20mg

Capsule



Trihydrate…20mg


fixation letter.

409. 50093 Lesozol 40mg

Capsule



Trihydrate…40mg


fixation letter.





fixation letter.





fixation letter.

412. 50096 Lanso Capsule Deferred for confirmation of source


Lansoprazole…30mg

fixation letter.

413. 50097 Legofen Capsule


Diclofenac Sodium Pellets…50mg


fixation letter.

414. 50098 Legofen-P Capsule


Diclofenac Potassium Pellets…50mg

Defered for confirmation of evidence

of approval of formulation in reference

drug agencies.

M/s. Genome Pharmaceuticals (Pvt) Ltd, Plot No. 16/1, Phase-IV, Industrial Estate, Hattar, Haripur,

KPK

415. 053576 Atractin-10 capsule Each capsule contains:-

Isotretinoin……………..10mg

Deferred for clarification of type of

capsule ( Soft or Hard gelatin)

416. 053577 Atractin-20 capsule Each capsule contains:-

Isotretinoin……………..20mg

Deferred for clarification of type of

capsule ( Soft or Hard gelatin)

417. 078425 Osicap-D Capsule Each capsule contains:-

Vitamin D……200IU,

Hydroxyapatite compound….830mg,

Ossein mineral complex

eqto.177.6mg,

Phosphorus…….82.2mg, Residual

minerals salts….24.9mg,

collagen……224mg, other rotein

66.4mg

Deferred for confirmation of Atomic

Absorption in Quality Control.

M/s. Abbott Laboratories Pakistan, Opp. Radio Pakistan Transmission Centre, Hyderabad Road,

Landhi, Karachi

418. 006894 Tronolane Cream

Each gm contains:-

Promoxine HCl……10mg

A letter of shortcoming was sent to

clarify their address at P.O Box 7229,

Karachi. Firm replied that this is their

mailing address and still mentioned on

their letterhead.

419. 006979 Entamizole Suspension


DilexanideFuroate B.P…….250mg,

Metronidazole Benzoate…320mg

eq to Metronidazole B.P…200mg

A letter of shortcoming was sent to

clarify their address at P.O Box 7229,

Karachi. Firm replied that this is their

mailing address and still mentioned on

their letterhead.

M/s Metro Pharmaceuticals, Plot No. 14, Street No. SS-2, National Industiral Zone, Rawat, Rawalpindi.

420. 75470 Pebtrin 20mg Tablet


Piroxicam as Beta

Cyclodextrin…20mg

a) Deferred for following

shortcomings. Shortcoming

communicated on 1st July, 2019

Notarized copy of last submitted

renewal application along with fee

or renewal certificate.Notarized

copy of valid Drug Manufacturing

License.Notarized copy of last

inspection report conducted by

DRAP.Notarized copy of

registration letter for confirmation

of brand name and strength.An

undertaking on stamp paper that

the applied products has never

been de-registered duly

notarized.An undertaking on

stamp paper that submitted







duly notarized.Last batch

manufactured record.

M/s Highnoon Laboratories Limited, 17.5 Km, Multan Road, Lahore.

421. 000033-EX Acetazolamide 500mg Tablet


Acetazolamide…500mg

a) Deferred for Shortcoming

communicated on 1st July,

2019Registration letters were

issued on 71-B, C/2 Gulberg-III,

Lahore whereas, your

manufacturing site is at 17.5 Km,

Multan Road, Lahore. Please

clarify. In case of change of

address, Please provide Notarized

Copy of approval of change of

address.Record of last

manufactured batch

422. 000031-EX Xamig Tablet 500mg



Deferred for Shortcoming


2019Registration letters were issued on

71-B, C/2 Gulberg-III, Lahore

whereas, your manufacturing site is at

17.5 Km, Multan Road, Lahore. Please

clarify. In case of change of address,

Please provide Notarized Copy of

approval of change of address.Record

of last manufactured batch

423. 000032-EX Rifampicin 500mg

Capsule


Rifampicine 500mg

a) Deferred for Shortcoming



issued on 71-B, C/2 Gulberg-III,








manufactured batch

424. 4496 Hi-Togan Drops (For Ear)

Contains:-

Benzocaine…1%Phenazone…5%Gl

ycerin qs to 100%"

a) Deferred forShortcoming



issued on 38-M, Gulberg-III,








manufactured batch

425. 14348 Xamig Capsule 250mg



Deferred forShortcoming


2019Notarized copy of registration

letter for confirmation of brand name

and strength.

426. 14349 Xamig Capsule 500mg



Shortcoming communicated on 1st

July, 2019Notarized copy of

registration letter for confirmation of

brand name and strength.

M/s Akhai Pharmaceuticals Pvt. Limited, Plot No. A-248 & A-256 to A-259, Hub Industrial Trading


427.

50794

Sycozip 20mg

Capsule


Ziprasidone (as HCl)..…..20mg


communicated on 3rd July,

2019Notarized copy of last submitted

renewal application along with fee or

renewal certificate.Notarized copy of

valid Drug Manufacturing



DRAP.Notarized copy of registration


and strength.An undertaking on stamp

paper that the applied products has

never been de-registered duly

notarized.An undertaking on stamp

paper that submitted documents are

true copy of the originals and that, if at


misinformation is detected / observed

the firm/company will be held

responsible as per relevant laws duly

notarized.Last batch manufactured

record.

428.

50795

Sycozip 40mg

Capsule


Ziprasidone (as HCl)..…..40mg

-do-

429.

50796

Benlon Syrup

Each 5ml contains:-

Piracetam……1gm

(BP Specification)

-do-

430.

50797

Sursyp Syrup

Each 5ml contains:-

Cetirizine Dihydrochloride 5mg

-do-

431.

50798

Akicol Syrup

Each 5ml contains:-

Simeticone….50mg

Dicyclomine…..5mg

-do-

432.

50799

Ronymose Syrup

Each 5ml contains:-

Iron (III) Hydroxide Polymaltose

Complex eq. to Elemental Iron

50mg

-do-

433.

50800

Enalbin Syrup

Each 5ml contains:-

Ibuprofen…..100mg

-do-

M/s Spencer & Company Pvt.Limited, D-105, SITE, Karachi.

434. 75987 Levos 500mg

Infusion


Levofloxacin ………500 mg

a) Deferred for following

shortcomings. Shortcoming

communicated on 3rd July,

2019Notarized copy of valid Drug

Manufacturing License.Notarized

copy of last inspection report

conducted by DRAP.Notarized

copy of registration letter for

confirmation of brand name and

strength.An undertaking on stamp

paper that the applied products

has never been de-registered duly









duly notarized.Last batch


435. 75988 Moxilox 400mg

Infusion


Moxifloxacin HCl BP ….400 mg

-do-

M/s. Semos Pharmaceuticals Pvt. Limited, Plot No. 11, Sector 12-A, North Karachi industrial Area,

Karachi

436. 14377 Mefalgic Tablet




communicated on 22-07-2019 reply

not yet received.Notarized copy of last


DRAP.Notarized copy of last

submitted renewal application along

with fee challan or renewal

certificate.An undertaking on stamp










notarized.Status of products

availability in reference regulatory

authority.

437. 14379 Pyrol Suspension

Each 5ml Contains:-

Paracetamol…120mg

-do-

438. 14381 Semotox Tablet


Attapulgite…500mg

-do-

439. 14382 Semo-C Tablet



-do-

440. 14385 Semo-Rex OintmentContains:-

Iodine…4% w/w

Methyl Salicylate…5% w/w

-do-

441. 14387 Semoquine Tablet


Amodiaquine…150mg

-do-

442. 14389 Semorfen Suspension

Each 5ml Contains:-

Ibuprofen…100mg

-do-

443. 14390 Semozol Tablet


Trimethoprim…80mg

Sulphamethoxazole…400mg

-do-

444. 14391 Semozol Suspension

Each 5ml Contains:-

Sulphamethoxazole…200mg

Trimethoprim…40mg

-do-

445. 14393 Neocin Skin Ointment

Each gm Contains:-


-do-

446. 14395 Semocof Syrup

Each 5ml Contains:-



Ephedrine HCl…7mg

-do-

447. 14386 Semodazol Tablet 400mg



-do-

M/s. Akhai Pharmaceuticals Pvt. Limited, Plot No. A-248 & A-256 to A-259, Hub Industrial Trading


448. 53001

Ebrantil Syrup

Each 5ml contains:-

Acefyllin……..125mg



not yet received.Notarized copy of

last submitted renewal application

along with fee or renewal

certificate.Notarized copy of valid

Drug Manufacturing















notarized.Last batch manufactured

record.

449. 53002 Ebrantil EXP Syrup

Each 5ml contains:-

AcefyllinPiprazine……..45mg

Diphenhydramine……….8mg

-do-

450. 53003 Comitril Cream


Clotrimazole……………..1%w/w(B

P Specification)

-do-

451. 53004 Ademac Cream


Terbinafine (as HCl)….…1%w/w

-do-

452. 53005 Antiburn Cream


Silver Sulphadiazine(as

HCl)……………….....1%w/w(USP

Specification)

-do-

453. 53006 Aprical Cream


Mupirocin….….2%w/w(BP

Specification)

-do-

454. 53007 Xesity Capsule


Orlistat………..120mg

-do-

M/s. Hicon Pharmaceuticals, 131 Industrial Estate Hayatabad, Peshawar

455. 77433 Artil Dry Powder Suspension

Each 5ml contains:-

Artemether……15 mg

Lumefantrine….90 mg

Deferred for following shortcomings.

Shortcoming communicated on 22-07-

2019 reply not yet

received.Application for renewal is

applied after due date, please deposit

differential fee Please provide approval

of dry powder suspension section.An

undertaking on stamp paper that the

applied products has never been de-

registered duly notarized.An


submitted documents are true copy of

the originals and that, if at any stage

any discrepancy / misinformation is

detected / observed the firm/company

will be held responsible as per relevant

laws duly notarized.Last batch


M/s. Helix Pharma, A/56, S.I.T.E., Monghopir Road, Karachi

456. 53014 Hidilol 6.25mg Tablets


Carvedilol……6.25mg



not received yet.Signature on the

covering letter and undertaking on

Form 5-B should be from Chief

Executive Officer/ Managing

Director / Director / Authorized

Officer not below the manager

level. In case of authorized person,

authority letter shall be submitted

along with application.An undertaking

on stamp paper that the applied

products has never been de-registered

duly notarized.An undertaking on



originals and that, if at any stage any

discrepancy / misinformation is



laws duly notarized.

457. 53012 Lowseiz 25mg Tablets


Topiramate….25mg

-do-

458. 53013 Lowseiz 50mg Tablets


Topiramate….50mg

-do-

459. 76128 Nurosa 200mg Tablet


Lacosamide…….200 mg

-do-



Lacosamide…….100 mg

-do-



Lacosamide….….50 mg

-do-

M/s. Epla Laboratories, D-12, Estate Evenue, S.I.T.E, Karachi, 75700

462. 76082 Pregrose-F Tablet


Iron (lll) Hydroidepolymaltose

complex eq. to Elemental

Iron.…………………....100 mg

polymaltose complex) Folic

Acid………..……0.35 mg


communicated on 22-07-2019 Application for renewal is applied after

due date 25-09-2018, please deposit


Each product mentioned An










laws duly notarized.Notarized Last

Inspection Report

463. 76083 Pregrose Syrup

Each 5ml contains:-

Iron (lll) Hydroidepolymaltose


Iron………………….…..50 mg

-do-

464. 76084 Ulcez 20mg Tablet



Trihydrate ………..…….20 mg

-do-




Trihydrate …………40 mg

-do-

466. 22048 Mecol Injection

Each ml Contains:-

Mecobalamin…500mcg imported in

bulk vials from Panbiotic Taiwan

and repacked locally.



not received yet.Please Clarify source

of vials along with pack size

imported.Please Clarify that imported

vial is labelled or not.Please provide

approval of section for repacking.An










laws duly notarized.Notarized Last

Inspection Report

M/s. Genix Pharma Pvt Limited, 44-45-B, Korangi Creek Road, Karachi

467. 53388 Dimis 50/200 Tablet


"Diclofenac Sodium ………….50mg

Misoprostol ……….…200mcg(BP

Specifications)"

Shortcoming communicated on 22-

07-2019 reply not received

yet.Please clarify the dosage form

description of formulation (each tablet

contains).Please provide evidence of

formulation in reference regulatory

authority.

M/s. Macter International Limited, E-40 SITE Karachi.

468. 037769 Benza L-A 0.6MIU Injection


Benzathine Penicillin

G….600,000units


communicated reply not received

yet. Confirmation is required

regarding penicillin manufacturing

facility. 469. 037770 Benza L-A 1.2MIU Injection -do-


Benzathine Penicillin

G..1,200,000units 470. 010133 Maccillin capsule 250mg


Ampicillin (as

trihydrate)……250mg

-do-

471. 010530 Maccillinforte 250mg/5ml dry

susp

Each 1.25ml contains:-

Amoxycillin (as

trihydrate)…..125mg

-do-

472. 026275 Maccillin Injection 250mg


Ampicillin sodium eq to

Ampicillin..250mg

-do-

473. 026276 Maccillin Injection 500mg


Ampicillin sodium eq to

Ampicillin..500mg

-do-

474. 010528 Maciclox capsule 500mg


Ampicillin (as

trihydrate)…..250mg, Cloxacillin

(as Sodium)……250mg

-do-

475. 009766 Maciclox 60mg+125mg/5ml

drops

Each 0.6ml Contains:- Ampicillin (as trihydrate)……60mg

Cloxacillin (as sodium)……30mg

-do-

476. 007906 Maciclox 125mg+125mg/5ml dry

susp

Each 5ml contains:-

Ampicillin………………………

125mg

-do-

M/s. Zafa Pharmaceuticals Laboratories (Pvt) Ltd, L-4/1, A&B, Block 21, Federal B Industrial Area,

Karachi

477. 007154 Furatop Cream 0.2%Contains:-

Nitrofurazone USP/ BP.0.2%w/w

Deferred for Clarification of

specification either Following BP or

USP.Undertakings are not notarized.

478. 006926 Naptrol 250mg Tablet


Naproxen B.P……..250mg

Deferred for Proof of formulation in

RRALast inspection

reportUndertakings are not notarized.

479. 007153 Furatop Powder Contains:-

Nitrofurazone USP/BP.0.2%w/w

Deferred forClarification of

specification either Following BP or

USP.Undertakings are not notarized.

M/s. Zafa Pharmaceuticals Laboratories (Pvt) Ltd, L-1/B, A&B, Block 22, Federal B Industrial Area,

Karachi

480. 007130 Adicos-M Syrup

Each 5ml contains:-

DextrometherphanHdrobromide



not received yet.Proof of formulation

B.P……6.5mg, Diphenhydramine

Hydrochloride B.P……….14mg

Pseudoephedrine Hydrochloride

B.P…….22.5mg, Menthol

B.P.1.75mg

in RRALast Inspection

ReportUndertakings are not notarized.

M/s. Safe Pharmaceuticals (Pvt) Ltd, Plot No. C-I-20, Sector 6-B, North Karachi Industrial Area,

Karachi

481. 053051 Neboross 400mg


Norfloxacin…….400mg

i. Deferred forShortcoming

communicated on 23-07-2019

reply not received yet.Signature

on the covering letter and

undertaking on Form 5-B

should be from Chief Executive

Officer/ Managing Director /

Director / Authorized Officer

not below the manager level. In

case of authorized person,


along with application.Notarized

copy of any change in

particulars of registration of

these products.An undertaking

on stamp paper that the

applied products has never been

de-registered duly




originals and that, if at any




be held responsible as per

relevant laws duly

notarized.Notarized copy of

approval of change of brand

name of safedime 500 mg

ii. and 1 g injections. 482. 053052 Muzelus 400mg


Moxifloxacin…….400mg

-do-

483. 053053 Hynidate 10mg


Methylphenidate HCl….10mg

-do-

484. 053054 Ploxen 400mg


PefloxacinMesylate

Dihydrate….….400mg

-do-

485. 053055 Soxacin 400mg


Enoxacin….….400mg

-do-

486. 053056 Nebedox 500mg -do-


Nalidixic Acid….….500mg

487. 053057 Xanker 500mg


Naproxen….….500mg

-do-

488. 053058 Xanthma 10mg


Zafirlukast….….10mg

-do-

489. 053059 Xanthma 20mg


Zafirlukast….….20mg

-do-

490. 053060 Monte-safe 4mg


Montelukast (as Sodium)….…4mg

-do-




-do-




-do-

493. 053063 Risdon 1mg


Risperidone….…1mg

-do-

494. 053064 Risdon 2mg



-do-

495. 053065 Risdon 3mg



-do-

496. 053066 Risdon 4mg



-do-

497. 053067 Lomef 200mg


Lomefloxacin HCl…200mg

-do-

498. 053068 Saferol 120mg



-do-

499. 053069 Lymocin 500mg


Lincomycin (as HCl Monohydrate)

….500mg

-do-

500. 053070 Phynoline 250mg


Aminophylline…..250mg

-do-

501. 053071 Ostig 0.5mg/ml

Each ml contains:-

Neostigmine..…..0.5mg

-do-

502. 053072 Ostig 2.5mg/ml

Each ml contains:-

Neostigmine..…..2.5mg

-do-

503. 053073 Escape 25mg/ml

Each ml contains:-

Promethazine HCl…….25mg

-do-

504. 053074 Safedime 250mg


Ceftazidime (as

Pentahydrate)…..250mg

-do-

505. 053075 Safedime 500mg

Each vial contains Ceftazidime

(as Pentahydrate)…..500mg

-do-

506. 053076 Safedime 1mg


Ceftazidime (as

Pentahydrate)…..1gm

-do-

507. 053077 Tixac 250mg


Ceftizoxime (as Sodium).…..250mg

-do-

508. 053078 Tixac 500mg


Ceftizoxime (as Sodium).…..500mg

-do-

509. 053079 Tixac 1g


Ceftizoxime (as Sodium)..…..1gm

-do-

510. 053080 Safoper 250mg


Cefoperazone (as

Sodium)..….250mg

-do-

511. 053081 Safoper 500mg Each vial contains:-

Cefoperazone (as

Sodium)..….500mg

-do-

512. 053082 Safoper 1g


Cefoperazone (as Sodium)..….1gm

-do-

513. 053083 Safoper 2g


Cefoperazone (as Sodium)..….2gm

-do-

514. 053084 Opirocef 500mg

Each vial contains Cefpirome

(as Sulphate)...….500mg

-do-

515. 053085 Opirocef 1g


Cefpirome (as Sulphate)...….1gm

-do-

516. 053086 Zolpro 20mg


Omeprazole enteric coated

pellets…….20mg

-do-

517. 053087 Lanspro 15mg


Lansoprazole..….15mg

-do-

518. 053088 Lanspro 30mg


Lansoprazole Pellets..….30mg

-do-

519. 053089 Pep-Ease 20mg



(as Magnesium

Trihydrate)....….20mg

-do-

520. 053090 Pep-Ease 40mg



(as Magnesium

Trihydrate)....….40mg

-do-

521. 053392 Bunex 0.3mg

Each ml contains:-

Buprenorphine (as HCl)…....0.30mg

-do-

522. 053393 Laxum 3mg


Bromazepam…………………...3mg

-do-

523. 053394 Pantasafe 25mg


Pentazocine..……25mg

-do-

524. 053395 Bunex 0.2mg


Buprenorphine HCl..……….0.2mg

-do-

525. 053396 Ambien 10mg


Zolpidem Tartrate…10mg

-do-

526. 053397 Pantasafe 30mg

Each ml contains:-

Pentazocine (as Lactate)...........30mg

-do-

527. 053398 Nubagesic 10mg

Each ml contains:-

Nalbuphine (as HCl

Dihydrate)…10mg

-do-

528. 053399 Nubagesic 20mg

Each ml contains Nalbuphine

(as HCl Dihydrate)...20mg

-do-

529. 053407 Daz 10mg/2ml


Diazepam……..…10mg

-do-

M/s. English Pharmaceuticals, Link Kattar Bund Road, ThokarNiazBaig, Multan Road, Lahore

530. 052921 Ironone Syrup

Each 5ml contains:-

Iron Polysaccharide Complex

217.4mg

equivalent to elemental

Iron…..100mg











along with application. Form-5B

should not be printed on company

letterhead.An undertaking on stamp








detected / observed the



duly notarized.Please provide

evidence of availability of formulation

in reference regulatory authority.Last

Inspection ReportRecord of Last Batch

manufactured. 531. 052922 Enxamin 250mg

Capsule


Tranexamic Acid………250mg

-do-

532. 052923 Enxamin 500mg

Capsule



-do-

533. 052924 Enxamin 250mg

Injection

Each 5ml contains:-


-do-

534. 052925 Enxamin 500mg

Injection

Each 5ml contains:-


-do-

535. 052926 Etar 10mg Tablet


Atorvastatin Calcium (Trihydrate)

equivalent to Atorvastatin

……...10mg

-do-

536. 052927 Etar 10mg Tablet


Atorvastatin Calcium (Trihydrate)

equivalent to Atorvastatin

………..20mg

-do-

537. 052928 Medex 20mg Tablet


Piroxicam Beta cyclodextrin eq. to

Piroxicam…20mg

-do-

538. 001875-Ex Amborox 150mg Tablet


Roxithromycin USP…..150mg

-do-

539. 001876-EX Hoxidal 200mg Tablet


Ofloxacin…200mg

-do-

540. 077034 Jeta 15mg Tablet


Mirtazapin.15mg

-do-

541. 077035 Jeta 30mg Tablet


Mirtazapin.30mg

-do-

542. 014707 Enmol Cough Syrup

Each 5ml contains:-

Amonium Chloride

-do-

100mg,Ephedrine

HCl……….7mg,Chlorpheniramine

Maleate…….2mg

M/s. PDH Laboratories (Pvt) Ltd, 9.5 Km, Sheikhupura Road, Lahore

543. 022560 Silvin Cream Contains

Silver

sulphadiazineUsp……1%



not received yet.Firm has approval

of Cream Ointment section for

pharmacological category of

Steroidal preparations. However,

this formulation is non-steroidal.

Please clarify?

M/s Opal Laboratories Pvt. Limited LC-41, L.I.T.E, Landhi Karachi

544. 031270 Revloc Plus Tablet


Amlodipine Besylate ……5mg,

Hydrochlorothiazide………12.5mg











along with application.Please provide

evidence of availability of formulation

in reference regulatory authority. 545. 053372 Malther DS Tablet


Artemether…40mg


-do-

M/s. Searle Company Limited, F-319, S.I.T.E, Karachi

546.

053340

Alpent 20mg

Injection

Each 2ml contains:-

FlupentixolDecanoate….20mg











along with application.Approval of

sections for manufacturing of these

drugs. 547.

053341

Alpent 100mg

Injection

Each ml contains:-

Flupentixol Decanoate.100mg

-do-

548.

053342

Atrium Injection 10mg

Each ml contains:-

Atracurium Besylate….10mg

-do-

549. 053338 Defnac 75mg/3ml Injection -do-

Each 3ml contains:-

Diclofenac sodium…….75mg

550.

053344

Relispa 40mg/2ml Injection

Each 2ml contains:-

Drotaverine HCl…40mg

-do-

551.

053327

Rotec-50mg Tablet


Diclofenac sodum…50mg,

Misoprostol 200mcg

-do-

552.

076184

Ropion 100mg Tablets


Bupropion HCl…100mg

-do-

553.

076185

Ropin SR 150mg Tablet

Each sustained lealease tablet

contains Bupropion

HCl…..150mg

-do-

554.

076186

Ropin SR 300mg Tablet

Each sustained lealease tablet

contains:-

Bupropion HCl …..300mg

-do-

555.

076187

Olesta-AM 5/20mg Tablet


Amlodipine as besylate….5mg,

Olmesartan Medoxomil20mg

-do-

556.

076188





-do-

557.

076189





-do-

558.

076190





-do-

559.

076191

Beslol 2.5mg Tablet

Each film coated tablet contains

Bisoprolol

Fumarate….2.5mg

-do-

560.

076192

Beslol 10mg Tablet


Bisoprolol

Fumarate….10mg

-do-

561.

053340

Alpent 20mg

Injection

Each 2ml contains:-

FlupentixolDecanoate….20mg

-do-

M/s. Mediceena Pharma Pvt, Limited, 27 Km Raiwind Road, Lahore

562. 052855 Amlanic Tablets 1gm


Amoxycillin (as Sodium

salt)…..875mg,Clavulanic Acid (as

Potassium salt)………125mg











along with application. Form-5B

should not be printed on company

letterhead.Copy of NOC of Central

Research Fund (CRF) as required

by Budget & Accounts

DivisionNotarized copy of last

submitted renewal application



Drug Manufacturing

License.Notarized copy of

approval of sections for

manufacturing of said

drugs.Notarized copy of last




of brand name and

strength.Notarized copy of any

change in particulars of registration

of these products.An undertaking


products has never been de-









laws duly notarized. 563. 052856 Medioxil-F Capsules 500mg


Amoxycillin (as sodium)

….250mg,Flucloxacillin (as Sodium)

…250mg

-do-

564. 052857 Medioxil-F Syrup 250mg

Each 5ml contains:-

Amoxycillin (as sodium)

….125mg,Flucloxacillin (as Sodium)

…125mg

-do-

M/s. Mass Pharma (Private) Limited ,17 Km Ferozpur Road, Lahore

565. 022460 Mazivit Injection

Each 3ml ampoule contains

Thiamine




Hcl……100mg,Pyridoxine

HCl…….100mg,

Cyanocobalamine………..1000mcg








along with application. Application

for renewal of drug registration of

Mazivit Injection is submitted late.

Please deposit differential Fee.


renewal application along with fee

or renewal certificate.Notarized


License.Notarized copy of

approval of sections for

manufacturing of said

drugs.Notarized copy of last




of brand name and

strength.Notarized copy of any

change in particulars of registration

of these products.An undertaking


products has never been de-









laws duly notarized. 566. 030871 Clobetrex Ointment Contains:-

Cloobetazole Propionate….0.05%

-do-

567. 030872 Clobetrex cream Contains:-

Cloobetazole Propionate….0.05%

-do-

568. 030873 Lotricot CreamContains:-

Betamethasone

Dipropionate…..0.05%

Clotrimazole…..1%

-do-

M/s Alina Combine Pharmaceuticals (Pvt) Ltd, A-127, S.I.T.E., Super Highway, Karachi.

569. 022529 Vitamin E Capsule


Alphatocopheryl Acid

succinate…..400IUImported in bulk

from M/s Amco Pharmaceuticals Inc.



not received yet.Notarized copy of



Canada and repacked certificate.Notarized copy of valid

Drug Manufacturing



DRAP.An undertaking on stamp paper

that the applied products has never

been de-registered duly notarized.An







laws duly notarized.Legalized CoPP

as per WHO’s Format or Legalized

free sale certificate and GMP

certificateNotarized Copy of Approval

of sections for repacking. 570. 022530 EpilonaGelcap Capsule


Evening prime rose oil……..500mg

(9.5% Gamma Linolenic acid)

Vitamin E … 15 IUImported in bulk

from M/s Amco Pharmaceuticals Inc.

Canada and repacked

-do-

571. 022526 Pizofen Syrup

Each 5ml contains:-

Pizotifen (as hydrogen

maleate)…….0.25mg



renewal certificate. Notarized copy of













laws duly notarized.Availability of

formulations in reference regulatory

authority.Notarized Copy of Approval

of sections. 572. 022527 PiZofen Tablet



maleate)…….0.5mg

-do-

573. 022528 Pizofen V Syrup

Each 5ml contains:-


maleate)…….0.25mg, `Thiamine

HCl……0.875mg, Riboflavin 5

phosphate sodium 1.31mg,

-do-

Pyridoxine HCl….0.77mg,

Nicotinamde.5.25mg

574. 004338-EX Salgicef Suspension

Each 5ml contains:-

Cefixime Trihydrate eq to Cefixime

anhydrous……………..100mg

-do-


575. 052842 Nomilex Tablets 0.5mg


Alprazolam.0.5mg






Executive Officer/ Managing Director

/ Director / Authorized Officer not

below the manager level. In case of

authorized person, authority letter shall

be submitted along with

application.Notarized Copy of NOC of

Central Research Fund (CRF) as

required by Budget & Accounts

DivisionNotarized copy of valid Drug

Manufacturing License along with

letter of approved sections.in case of

renewal, notarized copy of receipt of

application for renewal of licence

along with fee challan. Notarized


conducted by DRAP.Notarized copy

of registration letter for confirmation

of brand name.An undertaking on

stamp paper that the applied products









notarized. 576. 052843 Tanil Tablet 3mg


Bromazepam...3mg

-do-

M/s. Helicon Pharmaceuticals Pakistan Pvt. Limited, Model Town Road, Faisalabad

577. 031294 Hepasil Suspension

Each 5ml contains:-

Simlmarin..100mg



not received yet.Notarized Copy of

NOC of Central Research Fund (CRF)

as required by Budget & Accounts

DivisionNotarized copy of valid Drug

Manufacturing License along with

letter of approved sections.in case of





conducted by DRAP.Notarized copy












notarized.Proof of availability of these

medicines in reference regulatory

authority

M/s. Sanofi-aventis Pakistan Limited, Plot No. 23, Sector 22, Korangi Industrial Area, Karachi

578. 053206 lignocaine 1% Injection

Each ml contains:-

Lignocaine HCl………1%(2 ml)



not received yet.Please provide recent

inspection report based on GMP

Certificate.An undertaking on stamp












authority 579. 053205 lignocaine 1% Injection

Each ml contains:-

Lignocaine HCl………1%(3.5 ml)

-do-

M/s. Hizat Pharmaceuticals Industries Pvt Limited, 170 Industrial Estate, Jamrud Road, Peshawar

580. 078410 Hizedol CF Tablet


Paracetamol…… 500mg,

Caffeine….65mg, Chlorpheniramine

Maleate…..2mg




valid Drug Manufacturing License

along with letter of approved

sections.in case of renewal, notarized

copy of receipt of application for

renewal of licence along with fee

challan. Notarized copy of last


DRAP.Notarized Copy of NOC of



Division.Notarized copy of


brand name.Source of Pallets, in case

of imported source, please deposit

differential fee. An undertaking on












authority. 581. 078408 lanzprazole capsule


contains:-

lansoprazole enteric coated pellets

8.5% Lansoprazole… 30mg

-do-

582. 014711 Surfadine Syrup

Each 5ml contains:-

Ammonium chloride…..100mg,

Ephedrine HCl……….7mg,

Diphenhydramine HCl……8mg

-do-

583. 078407 Essozat Capsule


contains:-

Esomeprazole eneric coated pellets

22.5% Esomeprazole….. 40mg

-do-

584. 078410 Disenite Tablet


Diloxanidefurate….500mg,

Metronidazole ….400mg

-do-

M/s. Rehmat Pharma, 10.5 Km, Sheikhupura Road, Lahore

585. 032040 Gentian Violet Solution


Gentian violet…….1gm




valid Drug Manufacturing License

along with letter of approved









Division.Notarized Copy of Last

Renewal Application Receipt along

with Fee challan. Notarized copy of


brand name.An undertaking on stamp












authority 586. 032042 Benzyl Benzoate lotion


Benzyl Benzoate….25gm

-do-

587. 032043 Ichthammol Glycerin BPC


Icthammol….10gm,

Glycerin….90gm

-do-

M/s. Aptcure Pvt. Ltd, 8- Pharma City, 30 km, Multan Road, Lahore

588. 053583 Neuripen 100mg

Capsule


Gabapentin……..100mg










be submitted along with

application.Notarized copy of














authority. Record of last batch

manufactuered. 589. 053584 Neuripen 300mg

Capsule


Gabapentin……..300mg

-do-

590. 053585 Aptimac Capsule 250mg


Azithromycin as dihydrate

USP……250mg

-do-

591. 053586 Prelap Capsule 5mg


Olanzapine Citrate eq to.

Olanzapine……….5mg

-do-

592. 053587 Prelap Capsule 10mg


Olanzapine Citrate eq to.

Olanzapine……….5mg

-do-

593. 053588 Aptex 120mg

Capsule



-do-

594. 053589 Celmatic 200mg

Capsule


Celecoxib………………….200m

g

-do-

595. 053590 Oxidex 20mg Tablet


Piroxicam-beta-cyclodextrin

191.2mg

eq.to Piroxicam…..20mg

-do-

596. 053592 Thymin 10mg Tablet


Escitalopram as oxalate……10mg

-do-

597. 053594 Aptizid 80mg Tablet

Each un-coated tablet contains:-

Gliclazide……..80mg

-do-

598. 053595 Artimal 20/120mg Tablet


Artemether……….20mg,

Lumefantrine………120mg

-do-

599. 053596 Apticip 250mg Tablet


Ciprofloxacin (as hydrochloride

monohydrate)…………250mg

-do-

600. 053597 Apticip 500mg Tablet


Ciprofloxacin (as hydrochloride

monohydrate)…………500mg

-do-

601. 053598 Apticlar 250mg Tablet



-do-

602. 053599 Cinax 200mg Tablet


Ofloxacin…………..200mg

-do-

M/s. Caraway Pharmaceuticals, Plot No. 12, Street No. N-3, National Industrial Zone RCCI, Rawat,

,Islamabad

603. 052845 Fexicame capsule 120mg

Each capsule contains:- a) Deferred forShortcoming


Fexofenadine as HCL……..120mg reply not received yet.Notarized


License Notarized copy of last






Renewal Application Receipt

along with Fee challan. Notarized


confirmation of brand name.An












duly notarized.Proof of

availability of these medicines in

reference regulatory authority.

604. 053706 Modivid Injection


Piroxicam ….20mg

-do-

M/s. Wise Pharmaceuticals, Plot No. 3-A, Street S-1, RCCI Industrial Area, Rawat, Rawalpindi

605. 052851 Feltose Capsule


Iron as (Iron III Hydroxy

Polymaltose

complex)…100mg,Folic

acid………..0.35mg



reply not received yet.Notarized


License along with letter of

approved sections.in case of

renewal, notarized copy of receipt

of application for renewal of

licence along with fee challan.

Notarized copy of last inspection

report conducted by






















reference regulatory authority.

606. 052852 Betoxi 20mg

Capsule


Piroxicam as beta

cyclodextrin…..20mg

-do-

607. 052853 E-Rest 10mg Tablet


Escitalopram as oxalate……10mg

-do-

608. 052854 Saliar 200mg

Capsule


Cefixime as trihydrate…200mg

-do-

M/s. Novamed Pharmaceuticals (Pvt) Ltd, 28 Km, Ferozpur Road, Lahore

609. 052929 Diabryl Tablet 1mg


Glimepiride 1mg



not received yet.An undertaking on





authority. 610. 052930 Diabryl Tablet 2mg


Glimepiride 2mg

-do-



Glimepiride 3mg

-do-



Glimepiride 4mg

-do-

M/s. Indus Pharma (Pvt) Ltd, Plot No. 65, Sector 27, Korangi Industrial Area, Karachi

613. 004339-Ex Bioran Injection

Each 3ml contains:-

Diclofenac Sodium ……..75mg



not received yet.An undertaking on










notarized.

614. 000037-Ex Erythrocin Granules 125mg/5ml

Each 5ml contains:-

Erythromycin as (Erythromycin

Ethyl succinate)……….125mg

-do-

615. 053450 Indomal Tablet 20mg+120mg


Ondaserton (as HCL)…….4mg

-do-



Artemether……..40mg,

Lumefantrine…………..240mg

-do-

617. 014823 Oflox Tablet 200mg



-do-

618. 053448 Onseron 4mg Tablet



-do-




-do-

620. 053452 Onseron Injection 2ml

Each 2ml contains:-


-do-

M/S. High-Q Pharmaceuticals, Plot No. 224, Sector 23, Korangi Industrial Area, Karachi

621. 053318 Brexxel 3mg Tablet


Bromazepam…………………...3

mg



not received yet. Please provide

approval of section for manufacturing

of said drugs. An undertaking on












authority 622. 053319 Shenlax 0.25mg

Tabet


Alprazolam………0.25mg

-do-

623. 053320 Shenlax 0.5mg

Tabet


Alprazolam………0.5mg

-do-

624. 053328 Brendel 0.2mg Tablet


-do-

Buprenorphine…..0.2mg 625. 053329 Dormex 7.5mg Tablet


Midazolam…………….7.5mg

-do-

626. 053330 Pentagin 25mg Tablet


Pentazocin……..25mg

-do-

627. 053331 Klotril 0.5mg Tablet


Clonazepam…………….0.25mg

-do-

628. 053332 Klotril 2mg Tablet


Clonazepam…………….2mg

-do-

629. 052291 Alphaferon 3MIU Injection


Human Recombinant Interferon

Appha 2b 3MIU

-do-

M/s. Mediate Pharmaceuticals (Pvt) Ltd. 150-151, Sector 24, Korangi Industrial Area, Karachi


Each 5ml contains:-

water for injection


communicated on 19th August,

2019.Notarized copy of valid

Drug Manufacturing License along

with letter of approved sections.in

case of renewal, notarized copy of

receipt of application for renewal

of licence along with fee challan.


report conducted by










the applied products have never












reference regulatory authority. 631. 053241 Lignocaine 2% Injection


-do-

Lignocaine HCl………20mg 632. 053240 Tramorhage 500mg

Injection

Each 5ml contains:-

Tranexamic Acid …. 500 mg

-do-

633. 053237 Medifenac 75mg

Injection

Each 3ml contains:-


-do-

M/s. Macter International Limited, E-40 SITE Karachi.

634. 010367 Maccillin capsule 500mg

Ampicillin (as

trihydrate)…500mg




initial registration letter for


strength. 635. 007699 Maccillin 125mg/5ml dry

suspAmpicillin (as

trihydrate)…125mg

-do-

636. 010132 Maciclox capsule 250mg Each capsule contains:-

Ampicillin (as Trihydrate

)……125mg, Cloxacillin (as

sodium)….125mg

-do-

637. 010131 Maxil capsule 250mg


Amoxycillin (as

trihydrate).250mg

-do-

638. 010527 Maxil capsule 500mg Each capsule contains:-

Amoxycillin (as Trihydrate .500mg

-do-

639. 010130 Maxil drops 125mg/1.25ml

Each 5ml contains:-

Ampicillin (as trihydrate).250mg

-do-

640. 007829 Maxil 125mg/1.25ml dry susp

Each 5ml contains:-

Amoxycillin …125mg

-do-

641. 010529 MaxilFotre 250mg/5ml dry susp

Each 5ml contains:-

Amoxyxillin (as trihydrate)….250mg

-do-

642. 026273 Maxil Injection 250mg Each vail contains:-

Amoxycillin sodium eq to

Amoxyxillin…….250mg

-do-

643. 026274 Maxil Injection 500mg Each vail contains:-

Amoxycillin sodium eq to

Amoxyxillin…….500mg

-do-

M/s Bio-Labs Pvt. Limited, Plot No. 145, Industrial Triangle, Kahuta Road, Islamabad.

644. 14535 U-Vit Forte Soluble Powder

Each 100gm contains:- a) Deferred forShortcoming



Vitamin B1…550mg

Vitamin B2 2,500mg

Vitamin B6 1,500mg

Vitamin B12…7mg

Vitamin C 22,000mg

Vitamin D3…1,200,000IU

Vitamin E…7,300mg

Vitamin K3 1,700mg

Biotin 2%...80mg

Choline Chloride 100,000mg"

reply not received yet. Also

applied for renewal on 01-11-2013


report conducted by DRAP. An

undertaking on stamp paperthat


been de-registered duly notarized.

An undertaking on stamp paper







laws duly notarized.

645. 23408 Helminpipra Powder Powder

Contains:-

PiprazineAdipate 100% W/W

-do-

646. 23416 Ciproxacin 20% Liquid


Ciprofloxacin 20gm

-do-

647. 25346 U-Dek Powder


Vitamin A 30,000,000 IU,

Vitamin D3 …25,00,000 I.U.

Vitamin E 5000mg,

Vitamin K3…6000mg

-do-

648. 25769 Amoxacin-50 Powder

Each 100gm contains: Amoxicillin

Trihydrate Eq To 50gm

Amoxicillin Base



not received yet. Also applied for

renewal on 01-11-2013 Letter for

renewal of Drug Manufacturing

Licence (DML) does not contains:-

word “VET” against Penicillin oral

powder section however, product is

for veterinary use. Clarification seeks.


report conducted by DRAP. An



registered duly notarized. An







laws duly notarized. M/s SB Pharma, Plot No. 5-E, Industrial Triangle, Kahuta Road, Islamabad.

649. 48220 Sb Tiamulin 12.5% Oral Solution

Each 100 Ml Contains: Tiamulin

Hydrogen Fumarate…12.5 g





along with fee or renewal certificate.

Notarized copy of valid Drug

Manufacturing License. Notarized


conducted by DRAP. Notarized copy


of brand name and strength. An



registered duly notarized. An







laws duly notarized. Last batch

manufactured record. M/s Attabak Pharmaceuticals, 5-C I-10/3, Industrial Estate, Islamabad.

650. 049773 Oxyfen Injection

Each ml contains:-

Oxytetracycline HCl………..50mg,

Mepyramine Maleate…….25mg



not received yet. Signature on the







be submitted along with application.

Notarized Copy of NOC of Central

Research Fund (CRF) as required by

Budget & Accounts Division

Notarized copy of valid Drug

Manufacturing License. In case of





conducted by DRAP. Notarized copy


of brand name. Notarized copy of

approval of sections for manufacturing

of these drugs. Proof of availability of

these medicines in reference regulatory

authority. An undertaking on stamp



notarized. An undertaking on stamp







notarized.

651. 049774 Clozanide suspension

Each ml contains:-

Oxyclozanide BP…….46.875mg,

Oxfendazole BP……….16.9875mg

-do-

652. 049775 Tylofenta Injection

Each ml contains:-

Tylosin Tartrate BP…….50mg,

Gentamycin Sulphate BP……25mg

-do-

653. 049776 Biotic Plus Powder Each 100g

Contains Tylosin Tartrte

BP…5gm, Doxycycline HCL

BP……10gm, Gentamycin Sulphate

BP…..25mg

-do-

654. 049777 Tydox Gold Powder


Tylosine Tartrate BP…..100g,

Doxyccline HCl BP…..200g,

Bromohexine HCl (B.P)…….5g

-do-

655. 049779 Mexibak 8mg

Injection

Each ml contains:-

Meloxicam BP…….8mg

-do-

656. 049780 Norbak 20mg

Liquid


Norfloxacin HCl…..20gm

-do-

657. 049781 MexigoldInjecion

Each ml contains:-

Meloxicam BP….5mg

-do-

658. 049782 Claratin Powder


Chloretracycline HCl (BP)…..200gm

-do-

659. 049783 Coliser Water soluble powder

Each 100g Contains:-

Colistin Sulphate BP….400000000

IU

-do-

660. 049784 Colibak Forte Powder


Colistin Sulphate BP….500000000

IU

-do-

661. 049785 ECA Mix Powder


Enrofloxacin………20% Colistin

Sulphate…3.5%,

Amantadine……4%

-do-

662. 049786 Bromohexine 5% Solution

Each ml contains:-

Bromhexine HCl….50mg

-do-

663. 049787 Doxycol Powder


Doxycycline HCl BP…..10gm,

Colistin Sulphate BP……20MIU

-do-

664. 049788 Bromodox Powder

Each 1000gm contains:- -do-

Tylosin tartrate BP……100gm,

Doxycycline HCL BP….200gm,

Colistin Sulphate BP…..400IU,

Bromhexine HCl…….3gm

665. 049789 Darvicox Powder


Sodium Sulphaquinoxaine

BP….200mg, Sodium

Sulphadimidine BP Vet……82.5gm,

Diaveridine BP Vet…..50mg,

Vitamin A………2.5MIU,

Vitamin K3 BP, …2gm, Colistin

Sulphate….500IU

-do-

666. 049790 Disulph D Powder


Sodium Sulphaquinoxaine

BP….200mg, Sodium

Sulphadimidine BP Vet……82.5gm,

Diaveridine BP Vet…..50mg,

Vitamin A………2.5MIU,

Vitamin K3 BP, …2gm, Colistin

Vitamin E BP….500mg

-do-

667. 049791 Oxyneomicina Powder


Oxytertracycline HCl…….190gm,

Neomycin Sulphate….190gm

-do-

668. 049792 Flushbak Powder


Methenamine……955gm,

Vitamin B2 (BP)…..10gm, Calcium

Pantothenate….6gm, Nicotinamide

BP…….25gm

-do-

669. 049793 Enrotin Solution


Enrofloxacin……10gm, Colistin

sulphate……50MIU

-do-

M/s Global Pharmaceuticals Pvt Ltd. Plot # 204-205, Industrial Triangle, Kahuta Road, Islamabad 670. 32038 Glosil Tablet With Enzymes


Pancreatin … 210 FIP

P.U.Bromelain …35000

P.UDimethylpolysilaxane…

50mg.Sodium dehydrocholate

…20mg

Metoclopramide … .6mg.

Deferred for Confirmation of API

Source.

M/s. S.N.B Pharma (Pvt) Ltd, Plot No. 142, Industrial Estate, Hayatabad, Peshawar 671. 078411 SN Clar 125mg

Drops

Each 5ml contains:-


Deferred for Confirmation of granules

source.

M/s Nabiqasim Industries Ltd, 17/24, Korangi Industrial Area, Korangi Highway, Korangi, Karachi. 672. 053138 Clarithro 125mg/5mg

Oral Drops

Each 5ml contains:-

Deferred for confirmation of Source of

granules.

Clarithromycin …125mg

M/s Trigon Pharmaceuticals Pvt Limited. 8 km, Thoker Raiwind Road, Lahore 673. 52756 Testine Tablets


Ebastine …10mg

i. Deferred for the rectification of

following shortcomings: Form 5-

B has not been submitted along

with dossier. Form 5-B is

required for consideration of

renewal application.An



registered. (On Stamp Papar).An




any discrepancy /



be held responsible as per

relevant laws. (On Stamp

Papar).Evidence of submission

of last renewal duly endorsed by

R&I, DRAP, Islamabad and

STO.Shortcoming letter issued

on 02/08/2019 vide letter F.No.

1-65/ 2018 (RRR). 674. 52757 Trinate Tablets 70mg


Alendronate Sodium Eq. to

Alendronate Acid …70mg

-do-

675. 52758 Trinate Tablets 10mg


Alendronate Sodium Eq. to

Alendronate Acid …10mg

-do-

676. 52759 Syndronil Tablets


Tizanidine as HCl …2mg

-do-

677. 52760 Tripofen Tablets


Flurbiprofen … 100mg

-do-

678. 52761 Mounteez Chewable Tablets


Montelukast …4mg

-do-

679. 52762 Tefloxin Tablets


Pefloxacin …400mg

-do-

680. 52763 Fastin Tablets


Famotidine…40mg

-do-

M/s.Welwink Pharmaceuticals G.T Road, Industrial Estate, Gujranwala 681. 77654 Nektrol 1mcg Injection



following shortcomings: An

Calcitriol ….. 1mcg undertaking that the applied products

has never been de-registered. (on







laws. (on Stamp Papar).Shortcoming

letter issued on 02/08/2019 vide letter

F.No. 1-65/ 2018 (RRR). M/s. Xenon Pharmaceuticals (Pvt) Ltd, 9.5km, Sheikhupura Road, Lahore.

682. 32009 Salinase Drops


Sodium Chloride …0.65%


following shortcomings: Latest cGMP

Inspection Report having conclusive

recommendations regarding cGMP.An

undertaking that the applied products










F.No. 1-65/ 2018 (RRR). M/s Ipram International, Plot # 26, S.S 3, National Industrial Zone Rawat, Islamabad.

683. 52799 D-Drop Injection

Each ml contains:-

Cholecalciferol (Vitamin D3) eq to

…5mg


following shortcomings: Late

submission of last renewal fee for

Dekat Injection (Reg#49049).Late

submission of renewal fee Dekat

Injection (Reg#49049).Undertakings

not submitted.Latest GMP inspection

report.Shortcoming letter issued on

02/08/2019 vide letter F.No. 1-65/

2018 (RRR). 684. 49049 Dekat Injection


Ketamine as HCI …50mg

-do-

M/s. Focus &Rulz Pharmaceuticals (Pvt) Ltd, 44-Industrial Triangle, Kahuta Road, Islamabad 685. 77658 Tenv 300mg Tablet


Tenofovir Disoproxil

Fumarate….300mg, (Eq to 245mg

of Tenofovir disproxil)


following shortcomings: Renewal fee

was submitted after the due date,

therefore, differential fee is

required.Shortcoming letter issued on

02/08/2019 vide letter F.No. 1-65/

2018 (RRR). M/s. Reko Pharmacal(Pvt) Ltd, 13Km Multan Road ,Lahore

686. 001662 Encore Ointment

Each gm contains:-

Betamethasone

Dipropionate…0.64mg















F.No. 1-65/ 2018 (RRR). 687. 001663 Encore Cream

Each gm contains:-

Betamethasone

Dipropionate…0.64mg

-do-

688. 019105 Loc-H Capsule


Omeprazole…….20mg

-do-

689. 022011 Encore-G Ointment

Each gm contains:-

Betamethasone

Dipropionate…0.64mg, Gentamicin

sulphate …1.7mg

-do-

690. 022012 Encore-G Cream

Each gm contains:-

Betamethasone

Dipropionate…0.64mg, Gentamicin

sulphate …1.7mg

-do-

691. 024689 Encore Lotion


Betamethasone dipropionate….16mg

-do-

692. 024690 Encore S Lotion


Betamethasone

dipropionate….12.5mg, Salicylic

Acid………….500mg

-do-

693. 024691 Trio Cream

Each gm contains:-

Isotretinoin………..0.5mg

-do-

694. 027190 Encore-S Ointment

Each gm contains:-

Betamethasone

Dipropionate….0.64mg, Salicylic

Acid……..30mg

-do-

695. 077033 Vivox 50mg

Tabet


Naltrexone HCl …50mg

-do-

M/s Bio-Labs (Pvt) Ltd,Plot # 145, Industrial triangle, Islamabad. 696. Ex-003090 Amwarm Syrup

Each 5ml contains:-

Aminophylline …32mg,

Diphenydramine HCl

…8mg,Ammonium Chloride


following shortcomings: An




…30mg,Menthol …5mg submitted documents are true copy of





laws. (on Stamp Papar).Source of

pellets for Esmepra Capsule (Reg# Ex-

003093) &Esophil Capsule (Reg# Ex-

003094) and differential fee in case of

imported pellets.Shortcoming letter

issued on 02/08/2019 vide letter F.No.

1-65/ 2018 (RRR). 697. Ex-003091 Fexguard-180 Tablet


Fexofenadine HCl …180mg

-do-

698. Ex-003092 PV-Koff Syrup

Each 5ml contains:-

Diphenhydramine HCl …13.5mg

Ammonium Chloride …131.5mg

-do-

699. Ex-003093 Esmepra Capsule


Esomeprazole Magnesium Dihydrate

eq to Esomeprazole…..40mg

(Enteric coated pellets)

-do-

700. Ex-003094 Esophil Capsule




(Enteric coated pellets)

-do-

701. Ex-003095 Mersum Syrup

Each 5ml contains:-

Calcium lactate gluconate …40mg,

Vitamin A …1200IU,

Vitamin D3…..100IU,

Vitamin B1 Hydrochloride …1mg,

Vitamin B2 5-sodiumPhosphate

…1mg,

Vitamin B6 hydrochloride

…0.5mg,Nicotinamide …5mg,

Dexpanthenol …2mg,

Vitamin C……….50mg,

Vitamin E Acetate.....1mg,

-do-

702. Ex-003096 Himzian syrup

Each 5ml contains:-

Aminophylline …32mg,

Diphenhydramine HCl …8mg,

Ammonium Chloride …30mg,

Menthol …5mg

-do-

703. Ex-003097 Fexguard-120 Tablet


Fexofenadine HCl …120mg

-do-

704. Ex-003098 Sulivit Syrup

Each 5ml contains:-

Calcium lactate gluconate…..40mg,

-do-

Vitamin A …1200IU,

Vitamin D3 …100IU,

Vitamin B1 Hydrochloride …1mg,

Vitamin B2 5-sodium Phosphate

…1mg,

Vitamin B6 hydrochloride

…0.5mg,Nicotinamide

…5mg,Dexpanthenol …2mg,

Vitamin C …50mg,

Vitamin E Acetate …1mg,

705. Ex-003099 Esmezin Tablet




-do-

706. Ex-003100 Nopitam Solution for Infusion

Each ml contains:-

Paracetamol …10mg

-do-

M/s Pliva Pakistan (Pvt) Ltd, B-77, Hub Industrial Trading Estate, Hub, Baluchistan. 707. 022180 Gentamycin Injection

Each ml contains:-

Gentamycin Sulphate eq. to 40mg

Gentamycin base


following shortcomings: Evidence of

submission of last renewal duly

endorsed by R&I, DRAP, Islamabad

and STO.Latest cGMP Inspection

Report having conclusive

recommendations regarding

cGMP.Notarized copy of Section

approval letter issued by Licensing

Division.Shortcoming letter issued on

02/08/2019 vide letter F.No. 1-65/

2018 (RRR). 708. 014717 Vitamin B Compound Injection

Each 3ml contains:-

Thiamine Hcl …100mg,Pyridoxine

HCl…100mg, Cyanocobalamine

…1000mcg

-do-

709. 014718 Neoplex Super Injection

Each ml contains:-

B1……….100mg, B2…….5mg,

B6…….5mg,

Nicotinamide…..75mg, Pantothenic

Acid…….5mg

-do-

710. 014719 Neoplex Plain Injection

Each ml contains:-

B1 …10mg, B2 …2mg, B6 …5mg,

Nicotinamide …75mg,Pantothenic

Acid …5mg

-do-

M/s Nexus Pharma Pvt Limited, Plot No. 4/19 Sector 21, Korangi Industrial Area Karachi 711. 039530 Nex Meco Tablet 500mcg


Mecobalamin …500µg







Division.An undertaking that the

applied products have never been de-

registered. (on Stamp

Papar).Renewal fee is submitted after

the due date, therefore, differential fee

is required for Nettle Suspension

250mg/5ml .(Reg#039554), Nettle

Drop 50mg/1ml.

(Reg#039556)Shortcoming letter


1-65/ 2018 (RRR). 712. 039531 Nex Meco injection 500mcg/ml

Each ml contains:-

Mecobalamin …500µg

-do-

713. 039332 Nexbon Tablet 0.5mcg


Alfacalcidol …0.5mcg

-do-

714. 039331 Nexbon Tablet 0.25mcg



-do-


Each 5ml contains:-

Cefaclor …250mg

-do-

716. 039543 Nadium SR 100mg

Capsule


Diclofenac Sodium …100mg

-do-

717. 039546 Zefung Capsules 150mg


Fluconazole …150mg

-do-

718. 039556 Nettle Drop 50mg/1ml

Each ml contain Cefaclor

50mg.

-do-

719. 031945 Eftax Injection 1gm


Ceftazidime (as Pentahydrate) …1g

-do-

720. 031947 Eftax Injection 500mg


Ceftazidime (as Pentahydrate)

…500mg

-do-

721. 031946 Eftax Injection 250mg


Ceftazidime (as Pentahydrate)

…250mg

-do-

M/s. Venus Pharma, 23 KM, Multan Road, Lahore 722. 14721 B complex Injection

Each 1ml contains:-

B1 ….. 10mg

B2 …. 2mg

B6 ….. 5mg

Nicotinamide …. 75mg

Pantothenic Acid …. 5mg










Papar).Evidence of submission of last

renewal duly endorsed by R&I, DRAP,

Islamabad and STO.Evidence of

approval of formulation in Reference

Drug Agencies.Shortcoming letter


1-65/ 2018 (RRR). M/s Global Pharmaceuticals Pvt Ltd. Plot # 204-205, Industrial Triangle, Kahuta Road, Islamabad

723. 16831 Fadiphine Tablet 40mg


Famotidine ...40mg


following shortcomings: Last renewal

for Fericard 5mg Tablet (Reg#25195),

Fadiphine Tablet 40mg

(Reg#16831) & Gloxil 250mg

Injection(Reg#030533) was valid till

29/04/2013as per letter No.F.11-

16/2007-RRR (Vol-I) issued on

02/11/2011, but the firm applied for

renewal on 05/12/2013 with 20,000/-

fee each.Last renewal of Clopirine

Tablet (Reg#52507) was due on

16/09/2013 but the firm applied for

renewal on 05/12/2013 with 20,000/-

fee.Shortcoming letter issued on

02/08/2019 vide letter F.No. 1-65/

2018 (RRR). 724. 25195 Fericard 5mg Tablet


Warfarin Sodium …5mg

-do-

725. 52507 Clopirine Tablet


Clopidogrel ……. 75mg

Aspirin …………… 75mg

-do-

726. 30533 Gloxil 250mg

Injection


Amocycillin (as sodium) …250mg

-do-

M/s. Biorex Pharma, Plot No. 251-A, Industrial Triangle, Kahuta Road, Islamabad. 727. 75496 Neusec Forte Capsules 40 mg

Each Capsule Contains:Omeprazole

Pellets (Enteric coated) eq. to

Omeprazole….. 40 mg.M/s Vision

Pharmaceuticals, Islamabad.



was submitted after the due date;



02/08/2019 vide letter F.No. 1-65/

2018 (RRR).

M/s. Hizat Pharmaceutical Industry, 170 Industrial Estate Hayatabad, Peshawar 728. 13877 Zapex Syrup

Each 28.4ml contains:-

Vit. A …14000 I.UVit. D2 …1400

I.UThiamine HCI …2.8mg

Riboflavine …3.4mg

Nicotinamide …28.4mg

Ascorbic Acid …85.2mg





cGMP.Brief report of last batch

manufactured.Notarized copy of


Licensing Division. Notarized copy of

Valid Drug Manufacturing

License.Evidence of approval of

formulation in Reference Drug

Agencies.Shortcoming letter issued on

02/08/2019 vide letter F.No. 1-65/

2018 (RRR). 729. 13878 Zarsine Syrup


Thiamine HCI …. 2.5mg

Riboflavine …. 10mg

Pyridoxine HCI …. 6mg

Cyanocobalamine ….. 50mcg

Cal.D Pantothenate …. 15mg

Lysine Monohydro Chloride ….

200mg

Inositol …. 30mg

Niacinamide ….. 108mg

Ascorbic Acid …. 450mg

-do-

M/s. Tagma Pharma (Pvt) Ltd, 12.5 Km Raiwind Road, Lahore 730. 31787 Metomet Tablets



Di-Iodohydroxyquinolone … 325mg








Licensing Division.Evidence of




1-65/ 2018 (RRR). M/s. Pharmatec Pakistan (Pvt) Ltd, D-86/A, S.I.T.E., Karachi

731. 009266 Acetal Tablet


Spray dried sodium polyhydroxy

aluminium monocarbonate hexitol

complex 360mg

(eq. to 216mg

aluminium hydroxide)


following shortcomings: For the

product Isomon CR Capsule

(Reg#022468) pellets are imported as

per Initial registration letter. Firm is

required to pay differential fee for last

renewal and also for current

renewal.Evidence of approval of

formulations in Reference Drug


02/08/2019 vide letter F.No. 1-65/

2018 (RRR). 732. 022468 Isomon CR Capsule


Isosorbide-5-mononitrate …50mg

-do-

733. 030732 Nalacid 1g Caplet


Nalidixic acid …1000mg

-do-

734. 001122-EX Flu-Gone Cough expectorant

Syrup

Each 5ml contains:-

Ammonium chloride …100mg

-do-

Guaiphensin …100mg

Pseudoephedrine HCl …30mg

Chlorpheniramine Maleate …2mg

M/s. Panacea Pharmaceuticals, Plot No. 4, Street No. S-6, National Indutrial Zone, Rawat, Islamabad 735. 052800 Monteser 5mg

Chewable tablet


Montelukast as sodium …5mg


following shortcomings: Form 5-B has

not been submitted along with dossier.

Form 5-B is required for consideration

of renewal application.Differential fee

for import of pellets for Tasium

Capsule 75mg

(Reg#052803) for last renewal as well

as latest renewal

application.Shortcoming letter issued

on 02/08/2019 vide letter F.No. 1-65/

2018 (RRR). 736. 052801 Dewfer-F Chewable tablet


Iron Polymaltose complex eq to.

Elemental Iron……100mg, Folic

acid…….0.35mg

-do-

737. 052802 Moads 10mg

capsule


Escitalopram oxalate …10mg

-do-

738. 052803 Tasium Capsule 75mg


Diclofenac Potassium (as enteric

coated pellets)……….75mg

M/s Spansules Pharma (Pvt) Ltd,

Subash Nagar IDA Jeedimetla

Hyderabad, India. (Pellets source)

-do-

M/s. MKB Pharmaceuticals (Pvt) Ltd, Plot# 66, Hayatabad Industrial Estate, Peshawar 739. 052793 Cetamol Oral Liquid

Each 5ml contains:-

Paracetamol …160mg

Renewal submitted on 11/07/2017 with

20,000/- fee. And then on 09/11/2017

with 10,000/- additional fee.

740. 052794 Rinsora Mouth Wash

Each 5ml contains:-

Chlorhexidine Gluconate….0.2%,

Benzydamine HCl…..0.15%

Renewal submitted on 29/09/2017 with

20,000/- fee. And then on 09/11/2017

with 10,000/- additional fee.

M/s Festel Laboratories, Jinnah Industrial Estate, Link Kattarband Road, Thokar Niaz Baig, Multan

Road, Lahore. 741. 052771 Nozin SR 100mg Tablet


Diclofenac Sodium ….100mg





cGMP.Shortcoming letter issued on

02/08/2019 vide letter F.No. 1-65/

2018 (RRR). 742. 052772 Fentolin 2mg Tablet


sulbutamol as sulphate…..2mg

-do-

743. 052773 Festofen 200mg Tablet

Each tablet contains:- -do-

Ibuprofen …200mg

744. 052774 Feridone 10mg Tablet


Domperidone …10mg

-do-

745. 046369 Fesodamint 300mg Tablet


Sodium Bicarbonate …300mg

-do-

M/s Sapient Pharma,123/S Industrial estate, Kot Lakhpat, Lahore 746. 052826 Sapizine Syrup

Each 5ml contains:-

Cetirizine 2HCl …5mg








Licensing Division.Shortcoming letter


1-65/ 2018 (RRR). 747. 052827 Alersap Suspension

Each 5ml contains:-

Loratadine …5mg

-do-

M/s. Ahsons Drug Company, T/1, S.I.T.E., Tando Adam, Sindh 748. 004420 Vitamin B Complex Lysine Syrup

Each 5ml contains:-

Thiamine HCl …4.16mg, Riboflavin

5 phosphate Sodium …1.66mg,

Pyridoxine HCl …1mg,

Cynocobalamin …8.33mcg,

Calcium D-Pantothenate …2.5mg,

Lysine Monohydrate …33.33mg,

Ascorbic Acid ….75mg, Inositol

…5mg, Nicotinamide ….18mg








Licensing Division.Notarized copy of


License.Evidence of submission of last


Islamabad and STO.Evidence of




1-65/ 2018 (RRR). 749. 004421 Diphenhydramin cough syrup

Each 5ml contains:-

Diphenhydramin HCl

…13.5mg,Ammonium Chloride B

…131.5mg

Sodium Citrate …55mg,Menthol

…1.00mg

-do-

M/s. Star Laboratories (Pvt) Ltd., 23-Km Multan Road (Chung), Lahore 750. 022536 Anvil Injection

Each ml contains:-

Pheniramine Maleate……..25mg






02/08/2019 vide letter F.No. 1-65/

2018 (RRR). M/s. Imco Pharmaceuticals Laboratories, 73-Industrial Estate, Hayatabad, Peshawar

751. 014821 Imoquin Syrup

Each 5ml contains:-

Chloroquin Phosphate eq to 50mg

Chloroquine








Licensing Division. Notarized copy of


License.Evidence of approval of



02/08/2019 vide letter F.No. 1-65/

2018 (RRR). 752. 014822 Gargoral Solutin


Carbolic Acid…….0.4%,

Menthol……0.035%,

Thymol……..0.075%,

Sod.Phenolate…..1%,

Glycerine….10%, Apple

Green….0.001%,Citric

Acid….0.01%

-do-

753. 014771 Imco Tuss Syrup

Each 5ml contains:-

Dextromethorphan HBr…6.25mg,

Diphenhydramine HCl …5mg

-do-

M/s. CSH Pharmaceuticals-North (Pvt) Ltd, 38-A, Industrial Estate, Hayatabad, Peshawar 754. 030733 Heldex Suspension

Each 5ml contains:-

Albendazole …..100mg


following shortcomings: Notarized

copy of Initial Registration

Letter.Latest cGMP Inspection Report

having conclusive recommendations

regarding cGMP.Brief report of last

batch manufactured.Notarized copy of


Licensing Division.An undertaking


been de-registered. (on Stamp

Papar).An undertaking that submitted








F.No. 1-65/ 2018 (RRR). 755. 030734 Heldex Tablets 200mg


Albendazole …..200mg

-do-

756. 030735 Dopin Tablets


Domperidone ……10mg

-do-

757. 030736 Dopin Suspension

Each ml contains:-

Domperidone ……1mg

-do-

758. 030737 Molid Suspension

Each 5ml contains:-

Paracetamol ……..120mg

-do-

759. 030738 Molid Forte Suspension

Each 5ml contains:-


-do-

760. 030739 Molid Drops

Each 5ml contains:-


-do-

761. 030740 Molid Tablets



-do-

762. 030741 Decos Syrup


Diphenhydramine

…8mg,Aminolphylline

….32mg,Ammonium Chloride

….30mg,Menthol ………0.98mg

-do-

763. 030744 Zotrim DS Suspension

Each 5ml contains:-

Sulphamethaxole

…400mg,Trimethoprim …80mg

-do-

764. 030745 Trocodex Syrup

Each 5ml contains:-

Triclofos Sodium ..500mg

-do-

765. 030746 Fured Tablets


Diloxanide Furoate

...250mg,Metronidazole …200mg

-do-

766. 030747 Fured Suspension


Diloxanide Furoate ……250mg,

Metronidazole (as

benzoate)….200mg

-do-

767. 030748 Lyodex Syrup

Each 5ml contains:-

Vitamin B1 ……..4.16mg,

Vitamin B2..1.66mg,

Vitamin B6 .. 1mg,

Vitamin B12 .. 8.33mcg,

Vitamin C ……. 75mg,Calcium D

Pentothenate …..2.5mg,Inositol

….5mg,Niacinamide …18mg,Lysine

Monohydrochloride.33.33mg

-do-

768. 030749 Apidol Tablet


Aspirin…………..300mg,Paracetam

ol…….200mg,Caffeine………….30

mg

-do-

769. 030752 Napred Tablets


Naproxen Sodium 550mg

eq. to Naproxen…500mg

770. 030753 Glucotrol Tablet


Glibenclamide……..50mg

-do-

771. 030754 Myzid Dry Suspension

Each 5ml contains:-

Azithromycin (as

dihydrate)…..200mg

-do-

772. 030755 Zotrim Tablets


Sulphamethoxazole……….400mg,T

rimethoprim……..80mg

-do-

773. 030756 Zotrim DS Tablets


Sulphamethoxazole…..800mg,Trime

thoprim…..160mg

-do-

774. 030757 Zotrim Suspension

Each 5ml contains:-

Sulphamethoxazole……..200mg,Tri

methoprim…..400mg

-do-

775. 030761 Spired Tablet


Spiramycin…….500mg

-do-

776. 030762 Spired Forte Tablet


Spiramycin…….1000mg

-do-

777. 030763 Mycin Tablets 250mg


Clarithromycin ………250mg

-do-

778. 030764 Mycin Tablets 500mg


Clarithromycin ………500mg

-do-

779. 030765 Mycin Dry Suspension

Each 5ml contains:-


-do-

780. 030766 Mycin Drops

Each 5ml contains:-


-do-

781. 030767 Myzid Capsule


Azithromycin (as

dihydrate)….250mg

-do-

782. 030768 Nagid Tablets 10mg


Piroxicam …….10mg

-do-

783. 030769 Nagid Tablets 20mg


Piroxicam …….20mg

-do-

784. 030770 Besipine Tablets


Amlodipine Besylate …5mg

-do-

785. 030771 Napred Tablets 250mg


Naproxen Sodium 275mg

eq. to Naproxen …250mg

786. 031754 Spocef Capsule


Cefadroxil …….500mg

-do-

787. 031755 Spocef Dry Suspension

Each 5ml contains:-

Cefadroxil …….125mg

-do-

788. 031756 Spocef Forte Dry Suspension

Each 5ml contains:-

Cefadroxil …250mg

-do-

M/s.Popular Chemical Works (Pvt) Ltd, 9-km, Sheikhupura Road, Lahore 789. 031851 Atronil 10mg Tablet


Atorvastatin……10mg

(as calcium trihydrate salt)






manufactured.Shortcoming letter


1-65/ 2018 (RRR). 790. 031852 Atronil 20mg Tablet




791. 031853 Atronil 40mg Tablet




M/s Scotmann Pharmaceuticals. 5-D, I-10/3, Industrial Area, Islamabad 792. 040678 Dune Tablet 5mg


Montelukast (as sodium)…..5mg


following shortcomings: Initial

registration letter issued on 08/07/2005

mentions the name of applied product

as ‘Montescot Tablets 5mg’ whereas

firm has applied for ‘Dune Tablets

5mg’ with same composition.

Evidence of change of brand name, if

any, is therefore required.Shortcoming


F.No. 1-65/ 2018 (RRR). M/s W.Woodward Pakistan (Pvt) Ltd, F-275,S.I.T.E, Karachi

793. 003540 Doltee Drops

Each Drops contains:-

Lignocaine HCl Monohydrate

…0.37%, Methyl Salicylate

…0.02% Phenyl Carbinol …0.20%,

Menthol …0.06%






1-65/ 2018 (RRR). M/s Medipak limited 132/1,Industrial Estate, Kot Lakhpat, Lahore

794. 014775 Chloroquine Phosphate Injection

Each 5ml contains:-

Chloroquin Phosphate eq to 200mg

Chloroquine base

Evidence of approval of formulation

for Chloroquine Phosphate Injection

(Reg. No. 014775) in Reference Drug


02/08/2019 vide letter F.No. 1-65/

2018 (RRR).

M/s Eros Pharmaceuticals Pvt Ltd 94-95/23, Korangi Industrial Area, Karachi. 795. 004443 Eropyrin Tablet


Paracetamol …200mg, Aspirin

…300mg, Caffeine …30mg,

Phenobarbitone …15mg


following shortcomings: Transfer of

registration to new address for

Eropyrin Tablet (Reg#004443) &

Paracetamol suspension

(Reg#004443).Evidence of approval of



02/08/2019 vide letter F.No. 1-65/

2018 (RRR). 796. 004444 Paracetamol suspension

Each 5ml contains:-

Paracetamol …120mg

-do-

797. 014706 Pholtex Syrup

Each 5ml contains:-

Pholcodine ….10mg, Ephedrine HCl

…7mg, Chlorpheniramine Maleate

…2mg

-do-

M/s Navegal Laboratories. 41/1-A2, Phase-1, Industrial Estate, Hattar 798. 078405 Movez SR Capsule 100mg

Each Prolonged-release capsule

contains:-

Diclofenac sodium prolonged release

pellets eq to Diclofenac

sodium……….100mg

M/s Vision Pharmaceuticals,

Islamabad.





and STO for Adevox 10mg

Tablet(Reg#052858).Brief report of

last batch manufactured.An


have never been de-registered. (on









F.No. 1-65/ 2018 (RRR).

799. 052858 Adevox 10mg Tablet


Adefovir Dipivoxil …10mg

M/s. Mediate Pharmaceuticals (Pvt) Ltd. Plot No. 150-151 Sector 24 Korangi Industrial Area, Karachi. 800. 053273 Mediprzole 40mg

Capsule


Omeprazole (enteric coated

pellets)……...40mg

M/s Spansulex Pharmatech Phase-I

IDA (Pvt) Plot No. 153 gubhash

Nagar Jeedimetla, Hderabad, India.


following shortcomings: Differential

fee is required as according to

registration letter, pellets are

imported.Shortcoming letter issued on

26/08/2019 vide letter F.No. 1-65/

2018 (RRR).

M/s. Noa Hemis Pharmaceuticals,Plot No. 154 Sector 23 Korangi Industrial Area Karachi. 801. 032165 Flamar Tablet








1-65/ 2018 (RRR).

802. 032166 Flamar Forte Tablet



-do-

803. 032172 Neporex Tablet 250mg


Naproxen …250mg

-do-

804. 032173 Neporex DS Tablet 500mg


Naproxen …500mg

-do-

805. 032175 Fastmov creamContains:-

Methl Salicylate …20.0%, Menthol

…8.0%,Camphor …4.0%

-do-

M/s. Amarant Pharmaceuticals Pvt, Ltd,158-D Den Toro Gadap Road Super Highway Karachi. Karachi

806. 075883 Limgit 50mg Tablet


Lamotrigine …50mg


following shortcomings: Complete

description of tablet dosage form i.e.

Film Coated or Plain etc for Esorant

40mg Tablet (Reg#075882), Esorant

20mg Tablet (Reg#075884) &Peprant

40mg Tablet (Reg#075887)Renewal

fee was submitted after the due date,



26/08/2019 vide letter F.No. 1-65/

2018 (RRR).



Lamotrigine …25mg

-do-



Lamotrigine …100mg

-do-

809. 075888 Cilosta 100mg Tablet


Cilostazol …100mg

-do-

810. 075889 Amlepo 25mg Tablet


Clozapine …25mg

-do-

811. 075882 Esorant 40mg Tablet


Esomeprazole Magnesium eq to

Esomeprazole …40mg

-do-

812. 075884 Esorant 20mg Tablet


Esomeprazole Magnesium eq to

Esomeprazole …20mg

-do-

813. 075887 Peprant 40mg Tablet


Pantoprazole as sodium …40mg

-do-

814. 076127 Amprexa-F 6mg/25mg

Capsule


-do-

Olanzapine …6mg, Fluoxetine HCl

…25mg

815. 076131 Cyclorant 250mg

Capsule


Cycloserine …250mg

-do-

M/s. Bio-Labs,Plot No.145 Kahuta Triangle Industrial Estate Islamabad.

816. 054777 Biodine Dry Suspension 125mg

Each 5ml contains:-

Cephradine …125mg




Reference Drug Agencies.Evidence

of approval of Alfacalcidol 0.5mcg

hard gelatin capsule in Reference

Drug AgenciesShortcoming letter

issued on 26/08/2019 vide letter

F.No. 1-65/ 2018 (RRR). 817. 054778 Biodine Dry Suspension 250mg

Each 5ml contains:-

Cephradine …250mg

-do-

818. 054760 Biodol 0.5mcg Capsule



-do-

M/s. Mehran International, JM-498/D, Hume Road, Quaideen Colony, Opposite: World Map, Near 3

Star Hall, Karachi. 819. 052273 Vinblastine Sulfate for injection

5mg


Vinblastine Sulfate …5mg

Manufactured by: M/s Zhejiang

Hisun Pharmaceutical Co. Ltd,

China.


following shortcomings: Address of

DSL varies from the address

mentioned on registration

letter.Original, valid and legalized

CoPP as per WHO’s format or

original, valid and legalized free sale

certificate and GMP certificate.Copy

of attested invoices for respective

applied products.DRAP’s attested

invoice of last import.Evidence of



and STO.Shortcoming letter issued on

02/08/2019 vide letter F.No. 1-65/

2018 (RRR). 820. 052274 Vinblastine Sulfate for injection

10mg


Vinblastine Sulfate …10mg



China.

-do-

821. 052275 Vincristine Sulfate for injection

2mg


Vincristine Sulfate …2mg



-do-

China.

822. 052271 Granisetron Hydrochloride

Injection

Each 3ml vial contains:-

Granisetron Hydrochloride….3mg



China.

-do-

M/s. Angelini Pharmaceuticals (Pvt) Ltd, 221 Block CCA, Phase-4, DHA, Lahore 823. 022663 Monurol Sachets

Each 3gm

sachet contains:-

Fosfomycin Tremethamol 5.631gm

(eq to

Fosfomycin….3gm)Manufactured

by: M/s InpharzamSA,

(ZambonGroup),Switzerland


following shortcomings: Original,

valid and legalized CoPP as per

WHO’s format or original, valid and

legalized free sale certificate and GMP

certificate.Shortcoming letter issued on

02/08/2019 vide letter F.No. 1-65/

2018 (RRR). 824. 021174 Fluimucil 200mg

Sachet

Each 1gm

sachet contains:-

Acetylcysteine ..200mg

Manufactured by: M/s InpharzamSA,

(ZambonGroup),Switzerland

-do-

M/s Novartis Pharma (Pakistan) Limited, 15 West Wharf Road, Karachi 825. 04458 Ritalin Tablet 10mg


Methylphenidate HCl

…10mg,Manufactured by: M/s

Novartis Farmaceuutica S.A, Spain


following shortcomings: Notarized and

valid copy of DSL.Original, valid and

legalized CoPP as per WHO’s format

or original, valid and legalized free

sale certificate and GMP

certificateCopy of attested invoices for

respective applied

productsShortcoming letter issued on

26/08/2019 vide letter F.No. 1-65/

2018 (RRR).

826. 31327 Co-Diovan Film Coated Tablets

(160/12.5mg)


Valsartan …160mg.

Hydrochlorothiazide

…12.5mg.Manufactured by: M/s

Novartis Farma S.p.A, Torre

Annunziata, Italy

-do-

827. 78105 Afinitor 2.5 mg Tablets


Everolimus …2.5mg

MA Holder:M/s Novartis

Europharm Limited, Wimblehurst

Road, Horsham, West Sussex, RH12

5AB, UK.Mfgd by:M/s Novartis

Pharma Stein AG,

Schaffhauserstrasse 4332 Stein AG,

Switzerland.

-do-

828. 52256 Tasigna 200mg

Capsules.

Each hard gelatin capsule contains:-

Nilotinib…..200mg.Manufactured

by: M/s Novartis Pharma Stein AG,

Switzerland.

-do-

829. 78106 Galvus Met 50/500mg Tablets


Vildagliptin …50mg.Metformin

hydrochloride …500mg.MA

Holder:M/s Novartis Pharma,

GmbH, Roonstrasse 25, 90429

Nurnberg, Germany.Mfgd by:M/s

Novartis Pharma Produktions

GmbH, Oflinger Str.44, 79664 Wehr,

Baden- Wurttemberg, Germany.

-do-

830. 52230 Diovan Film Coated Tablets

320mg


Valsartan …320mg.Manufactured

by: M/s Novartis Pharma Stein AG,

Switzerland.

-do-

M/s AJM Pharma (Pvt) Ltd 1st Floor, Shafi Court, Merewether Road, Civil Lines, Karachi.

831. 72596 Cytabine Injection 1000mg/10ml.


Cytarabine …1000mg.Manufactured

by: M/s Cipla Limited (Unit-V),

Verna Industrial Estate, Verna,

Salcette, Goa, India








respective applied products.An

undertaking that the applied product










F.No. 1-65/ 2018 (RRR).

832. 72595 Cytabine Injection 500mg/5ml.






-do-

833. 72594 Cytabine Injection 100mg/ml.






-do-

834. 72593 Capegard-500mg

Film Coated Tablets.


Capecitabine

…500mg.Manufactured by: M/s

Cipla Limited (Unit-VI), Verna

Industrial Estate, Verna, Salcette,

Goa, India

-do-

M/s Bayer Pakistan (Pvt) Limited, Bahria Complex II, 4th Floor, M.T. Khan Road, Karachi.

835. 52224 Nexavar 200mg Tablets

Each tablet contains: Sorafenib

(as tosylate)

…200mg.Manufactured by:M/s

Bayer Pharma AG, 51368,

Leverkusen, Germany.Product

License Holder:M/s Bayer Pharma

AG, 13342, Berlin, Germany.


following shortcomings: Firm has not

submitted renewal for applied product

since its registration. Furthermore, firm

has stated that last renewal date for

product was 09/08/2010 at the time of

approval of company name

change.Notarized and valid copy of

DSL.Original, valid and legalized

CoPP as per WHO’s format or

original, valid and legalized free sale

certificate and GMP certificateCopy of

attested invoices for respective applied

products.An undertaking that the

applied product has never been de-

registered. (on Stamp Papar).An

undertaking that submitted documents

are true copy of the originals and that,

if at any stage any discrepancy /



responsible as per relevant laws. (on

Stamp Papar).Shortcoming letter


1-65/ 2018 (RRR).

M/s. Al Habib Corporation, Abdullah House, 81 Block-B, S.M.C.H.S., Karachi.

836. 31334 Ucetam Injection 1gm


Piracetam …1000mg

Manufactured by: M/s Korea United

Pharm. Inc., Korea



required regarding the transfer of

registration to new address of firm as

the address on Initial Registration

Letter is different from that of Drug

Sale License.Original, valid and



sale certificate and GMP certificateAn









laws. (on Stamp Papar).

837. 22622 Etopul Injection

Each ampoule 5ml contains:-

Etoposide …100mg


Pharm. Inc., Korea

-do-

838. 22623 Vinracine Injection


Vincristine sulphate …2mg


Pharm. Inc., Korea

-do-

839. 22624 K.U Dactinomycin Injection


Dactinomycin …0.5mg


Pharm. Inc., Korea

-do-

840. 22625 Hydrine Capsule


Hydroxyurea …500mg


Pharm. Inc., Korea

-do-

841. 22626 Unitexrate Injection 25mg/ml

Each 1ml contains:-

Methorrexate …25mg


Pharm. Inc., Korea

-do-

842. 22637 K.U Thioguanine Tablet


Thioguanine …40mg


Pharm. Inc., Korea

-do-

M/s. Pharmevo (Pvt) Ltd., A-29, North Western Industrial Zone, Port Qasim, Karachi

843. 78103 Anazole 1mg Tablet


Anastrazole …1mg

Manufactured by: M/s Hetero Labs

Limited, Unit-VI APIIC Formulation

SEZ, Polepally Village, Jadcherla

Mandal, Mahaboob Nagar (Dist)

509301, Andhra Pradesh, India.








respective applied products.An











F.No. 1-65/ 2018 (RRR).

844. 78104 Letzole 2.5mg Tablet


Letrozole …2.5mg

Manufactured by: M/s Hetero Labs

-do-

Limited, Unit-VI APIIC Formulation

SEZ, Polepally Village, Jadcherla

Mandal, Mahaboob Nagar (Dist)

509301, Andhra Pradesh, India.

M/s. Atco Laboratories (Pvt) Ltd,B-18 S.I.T.E Karachi.

845. 31333 Pentasa 500mg Tablet


Mesalazine …500mg

Manufactured by: M/s Feering A/s

Denmark







certificateShortcoming letter issued on

26/08/2019 vide letter F.No. 1-65/

2018 (RRR).

M/s. Angelini Pharmaceuticals (Pvt) Ltd, 221 Block CCA, Phase-4, DHA, Lahore

846. 43074 Brumixol Cream


Ciclopiroxolamine …1gm

Manufactured by: M/s Bruschettini

s.r.l., Italy.






certificate.Renewal fee was submitted

after the due date; therefore,

differential fee is


26/08/2019 vide letter F.No. 1-65/

2018 (RRR).

847. 43075 Brumixol Ovules

Each ovule contains:-

Ciclopiroxolamine …0.1gm

Manufactured by: M/s Bruschettini

s.r.l., Italy.

-do-

M/s. Decent Pharma Plot No. 30, Street SS 3, National Industrial Zone, Rawat 848. 75779 Nortrim-s oral liquid

Each ml contains:-

Norfloxacin …10%

Sulphamethoxypyridazine …15%

Trimethoprim …03%



was submitted after the due date,



02/08/2019vide letter F.No. 1-65/ 2018

(RRR).

M/s Elko Organization, Plot# 27 & 28, Sector 12/B, North Karachi, Industrial Area, Karachi.

849. 22155 EL-OXANIL SUSPENSION

Each ml contains:

Oxfendazole B.P...22.65mg










Papar).Evidence of submission of last


Islamabad and STO.Shortcoming letter

issued on 02/08/2019vide letter F.No.

1-65/ 2018 (RRR).

850. 22156 EL-LEVANIL SOLUTION

Each 100 ml contains: HCL B.P.

1.5% W/V

-do-

851. 22157 El-Clozanil Suspension


Oxyclozanide B.P …3.4% W/V

-do-

852. 22158 El-Levaclozanil Suspension

Each 100 ml contains: Levamisole

HCL B.P.1.5% W/V,Oxyclozanide

B.P.3.0% W/V

-do-

853. 22189 Elvomec Injection

Each ml contains:

IVERMECTIN 1.0% W/V

-do-

854. 22190 Elkosol Super Powder

Each 300gm contains

Vitamin …. 6,000,000 IU,

Vitamin D …. 1,200,000 IU,

Vitamin E …. 480 IU,

Vitamin K3 …. 2700mg,

Vitamin B1 …. 375mg,




Folic Acid …. 600mg

Nicotinic Acid .... 30,000mg

Calcium Pantothenate .... 9000mg

-do-

855. 31536 Distilled Water for

Injection(Distilled Water for Inj for

Poultry Vaccination)

-do-

M/s. Star Laboratories (Pvt) Ltd., 23-Km Multan Road (Chung), Lahore

856. 022185 Thiaprin Injection

Each ml contains:-

Vitamin B1 …5mg

Vitamin B2 sodium …2.5mg,

Vitamin B6 (HCl)

…2.5mg,Nicotinamide …37.5mg






02/08/2019vide letter F.No. 1-65/ 2018

(RRR).

M/s International Chempharma (Pakistan), House #397, Block B-1, Johar Town, Lahore

857. 14199 Amoxycillin 15% LA Injection

Each ml Contains:-

Amoxycillin Trihydrate eq. to

Amoxycillin …150mg

Manufactured by: M/s Franklin

Pharmaceuticals Irl Ltd, Meath,

Ireland







respective applied products.Evidence

of transfer of products from address on

Registration Letter to new address.An











F.No. 1-65/ 2018 (RRR). M/s. Better Traders International, 23-Z, Saifullah Shaheed Road, Madina Town, Faisalabad

858. 49737 Kepro Amoxy-Col WSP

Each gm Contains:-

Amoxycillin Trihydrate…200mg

Colistin

Sulphate…600,000IUManufactured

by: M/s Kepro B.V., Holland.






certificateAn undertaking that the

applied product has never been de-








Stamp Papar).Shortcoming letter


1-65/ 2018 (RRR).

859. 49738 Kepro Colistin 4800 WSP

Each gm Contains:-

Colistin (as Sulphate)

…4,800,000IUManufactured by: M/s

Kepro B.V., Holland.

-do-

M/s Marvi Pharmaceuticals Pvt Limited Karachi 860. 012777 Pain Gay Ointment

Each gm contains:-

Methyl Salicylate ……150mg

Menthol….100

Registration Board deferred above case

for deliberations in next (292nd )

meeting.

M/s. Vision Pharmaceuticals, Islamabad

861. 037784 Cibrotam Injection 1gm

Each 5ml contains:-

Piracetam …1gm

Registration Board deferred above case

for deliberations in next (292nd )

meeting. 862. 038900 Acetofeb Extra Tablet


Paracetamol … 500mg

Caffeine Anhydrous … 65mg

-do-

863. 041729 Adfin 400mg Tablet


Ibuprofen … 400mg

-do-

864. 041736 Inflanil Tablet 250mg


Mefenamic Acid … 250mg

-do-

865. 037563 Protozid Tablet


Metronidazole … 250mg

Di Iodohydroxyquinoline … 325mg

-do-

866. 037572 Epilax 200mg Tablet


Carbamazepine … 200mg

-do-

867. 056309 Fevonor Suspension

Each 5ml contains:-

-Paracetamol … 120mg

-do-

868. 056310 Fevonor Plus Suspension

Each 5ml contains:-


-do-

869. 050289 Coxyzin Syrup

Each 5ml contains:-

Cetirizine Dihydrochloride … 5mg

-do-

870. 037573 Epilax Syrup

Each 5ml contains:-

Carbamazepine … 100mg

-do-

871. 037554 Mycomide 500mg Tablet


-Pyrazinamide … 500mg

-do-

M/s Hoover Pharmaceuticals (Pvt.) Ltd.Plot # 16 Zain Park Industrial Area Saggian By Pass Road,

Lahore

872. 062474 Tretigen Capsules 20mg


Isotretinoin 20mg


formulation is not approved in RRA.

873. 062475 Pantomax Capsules 40mg



Sesquihydrate Pellets 40mg

Deferred for confirmation of source of

pellets.

874. 062476 Kaynac Capsule


Diclofenac Potassium Pellets eq.to

Diclofenac Potassium 75mg


pellets.

875. 062477 De-Artho Capsule


Diclofenac Sodium Enteric

CoatedPellets eq. to Diclofenac

Sodium…50mg


pellets.

876. 062478 Fungex Capsule


Itraconazole Pellets eq. to

Itraconazole 100mg


pellets.

877. 062479 De-Artho Capsule


Diclofenac Sodium Enteric

CoatedPellets eq. to Diclofenac

Sodium…100mg


pellets.

878. 062480 Peptomet Capsules 40mg




Esomeprazole ...40mg


pellets.

879. 062481 Peptomet Capsules 20mg




Esomeprazole ...20mg


pellets.

M/s Berlex Lab International, Multan

880. 062608 BS Zole capsule 20mg


fixation letter

881. 062606 BS Zole capsule 20mg Deferred for confirmation of source

fixation letter

882. 062607 Diclotal capsule 50mg Deferred for confirmation of source

fixation letter

883. 062609 Diclotal SR Capsule 100mg Deferred for confirmation of source

fixation letter

884. 062605 Lamizol Capsule 20mg Deferred for confirmation of source

fixation letter

Deferred Cases of 292ndMeeting of Registration Board (RRR-Section)


No.

Product Name DecisionRegistration Board deferred

for

M/s. Medisure Laboratories Pakistan (Pvt) Ltd., A-115 S.I.T.E, Super Highway, Karachi

1. 1147-EX Axadol Plus Tablet


PARACETAMOL... 500MG

Caffeine ... 65MG

Chloropheniramine maleate…2mg

Differential fee is required as



M/s. Macter International Limited, F-216, S.I.T.E., Karachi

2. 055842 Maxima 200mg Tablet


Cefixime (as trihydrate) ….200mg

Shortcomings:-Following

shortcomings were communicated vide

letter dated: 19-09-2019Evidence of

last renewal required.Copy of brand

name change letter required.Approval

status of products in Reference Drug

AgenciesSection approval letter issued

by Licensing Division

3. 055752 Mac-Mether Plus


Artemether………..20mgLumefantri

ne…….120mg

4. 055845 Heptrol 10mg Tablet


Adefovir Dipivoxil……....10mg

M/s. Davis Pharmaceutical Laboratories, Plot 121, Industrial Triangle Kahuta Road, Islamabad

5. 032088

Opza Capsule


Omeprazole (coated pellets) 225mg

eq. to Omeprazole………20mg



letter dated: 19-09-2019Original

legalized lasted GMP certificate is

copy required.

M/s. Helicon Pharmaceutek Pakistan (Pvt) Ltd., Model Town Road, Faisalabad

6. 032146 Slide Tablets


Nimesulide..... 100mg




last renewal required.Attested copy of


License.Section approval letter issued

by Licensing DivisionOriginal

legalized lasted GMP certificate is

copy required.

M/s. Espoir Pharmaceutical, Plot No. TBIC-II PCSIR Laboratory Complex, Shahrah-e-Dr. Salim-uz-

Zaman Siddiqui off. University Road, Karachi

7. 076258 Haito 5mg/5ml Syrup

Each 5ml contains:-

Domperidone maleate eq to

Domperidone…...5 mg



letter dated: 19-09-2019Attested copy

of valid Drug Manufacturing

License.Original legalized lasted GMP

certificate is copy required

M/s. Popular Chemical Works (Pvt) Ltd., 9-Km Sheikhupura Road, Lahore

8. 32259 Obexil Tablets 20mg


Paroxetine HCl …….20mg



letter dated: 19-09-2019Initial

Registration letter required.Attested


License.Original legalized lasted GMP

certificate is copy required.

9. 32256 Mincole 10mg Tablets


Simvastatin …..10mg

10. 32255 Savelox Tablets 250mg


Levofloxacin (as hemihydrate)..

..250mg







M/s. Pakistan Pharmaceutical Products (Pvt) Ltd., D/122, S.I.T.E. Karachi

13. 4856 Theoron Capsules


Theophylline …150mg

Guaifenesin….90mg



letter dated: 19-09-2019Transfer of

Registration to current site copy

required Approval status of products in

Reference Drug AgenciesAttested


LicenseOriginal legalized lasted GMP

certificate is copy required.

14. 4857 Theoron Syrup


Theophylline …150mg

Guaifenesin …90mg

M/s. Elko Organization (Pvt) Ltd., Plot No 27 & 28, Sector 12-B, North Karachi, Industrial Area Karachi

15. 55128 Seasol 5mg Tablet


Montelukast (as

Sodium)......……..5mg



letter dated: 24-09-2019Approval

status of products in Reference Drug

Agencies.Evidence of last renewal

required.Last Inspection

ReportAttested copy of valid Drug

Manufacturing License.Section


DivisionAn undertaking that the


registered (on Stamp Paper).An






responsible as per relevant laws (on

Stamp Paper).

16. 55129 Seasol 10mg Tablet


Montelukast (as

Sodium)………..10mg

17. 55130 Ronate 10mg Tablet


Alendronate (as

Sodium)………..10mg

18. 55131 Ronate –OW Tablet


Alendronate (as

Sodium).………..70mg

19. 55132 Dinerve 500mcg Tablet


Mecobalamin…..500mcg

20. 39210 Elfar 100mg Tablets


Sparfloxacin….100mg

M/s. Alkemy Pharmaceutical Laboratories (Pvt) Ltd., P-9 S.I.T.E., Hyderabad

21. 022996 Kemyclox Suspension

Each 5ml contains:-


Amoxycillin base… 125mg



letter dated: 24-09-2019Copy of valid

Drug Manufacturing License.Evidence

of last renewal required.Section


Division.Latest GMP certificate is

copy required.Brief detail of last batch

manufacturedDifferential fee as the


due date.

M/s. Pulse Pharmaceuticals (Pvt) Ltd., Mozay Badoke, Raiwind Road (Sua Asil Road), Lahore

22. 046715 Gutsy 20mg Tablet


Esomeprazole … 20mg




last renewal required (as submitted

document shows that application is

received after expiry of registration).

23. 046714 Gutsy 40mg Tablet


Esomeprazole … 40mg



Water for injection

M/s. Shaigan Pharmaceutical (Pvt) Ltd., 14-Km Adyala Road, Post Office Dahgal, Rawalpindi

25. 054490 Esso-40 Injection IV


Esomeprazole Sodium eq. to

Esomeprazole…40mg



letter dated: 24-09-2019Copy GMP

certificate required.

26. 054491 Antimin D Tablet


Desloratadine… 5mg

27. 054492 Glykin 500mg

Injection


Amikacin as Sulphate…. 500mg

28. 054493 Glykin 250mg

Injection



29. 054494 Glykin 100mg

Injection



30. 054495 Iroton-F Chewable Tablet


Iron (III) Hydroxide Polymaltose

Complex eq. to Elemental Iron …

100mg


M/s. Indus Pharma (Pvt) Ltd., Plot No. 26, 27, 63, 64, 65, 66 & 67, Sector 27, Korangi Industrial Area

Karachi

31. 53492 Nixpro 40mg

Capsule


Pantoprazole (as Sodium)

Susquihydrate Pellets ...............40mg



letter dated: 24-09-2019Undertaking

on Stamp paper required.Imported

Pellets fee required for year

(2014)Imported Pellets fee required for

year (2019)An undertaking that the








32. 53493 Dyclo GR-50 Capsule


Diclofenac Sodium Enteric Coated

Pellets …………. …50mg


33. 36589 Xed 500mg

Capsules


:Tranexamic Acid……500mg responsible as per relevant laws (on

Stamp Paper). Source fixation letter

required Last Inspection report

required

34. 14584 cimetamat (injection)

Each ml contains:-

Cimetidine…100mg

M/s. Better Traders International, 24-Z/E Saif Ullah Shaheed Road, Madina Town, Faisalabad

35. 14562 KeproTylo-Dox Extra W/S


Tylosin tartrate…50gm




letter dated: 24-09-2019Drug Sale

License as per WHO format

required.Copy GMP Certificate

required.COPP required. 36. 14563 Kepro Gentaject 10% Injection

Each ml contains:-

Gentamycine sulphate eq. to 100mg

Gentamycine base. M/s. Venus Pharma, 23 Km Multan Road Lahore

37. 015111 Viocin Injection

Each ml contains:-

Lincomycin HCl eq. to 300mg

Lincomycin Base




last renewal required.Copy of valid

Drug Manufacturing License.Section


DivisionOriginal legalized latest GMP

certificate copy required.An


have never been de-registered (on

Stamp Paper).An undertaking that






laws (on Stamp Paper).

M/s. Panacea Pharmaceuticals, Plot No. 4, Street No. S-6, National Industrial Zone, Rawat, Islamabad

38. 056339 Fenum SR 100mg

Capsule


Diclofenac Sodium (as enteric coated

Pellets)…100mg




last renewal required.Original

legalized latest GMP certificate copy

required.Imported Pellets differential

fee required.Source of Pellets letter

required. An undertaking that the








responsible as per relevant laws (on

Stamp Paper).

M/s. Pharmacare Laboratories (Pvt) Ltd., 129/1 Industrial Estate Kot Lakhpat, Lahore

39. 14852 Bactacin Tablets

Each TABLET CONTAINS:-

Ofloxacin...200mg




last renewal required.Section approval 40. 14853 Pharmic Forte Tablets


Mefenamic acid…500mg

letter issued by Licensing


certificate copy required.Valid Drug

Sale License is required.An


have never been de-registered (on

Stamp Paper).An undertaking that






laws (on Stamp Paper).

M/s. Spencer & Company (Pvt) Ltd., D-105 S.I.T.E., Karachi

41. 15057 Spencidine SolutionContains:-

Povidone Iodine… 10 %




last renewal required.Copy of valid

Drug Manufacturing License.Section



certificate copy requiredBrief detail of

last batch manufactured

42. 15058 Spencidine GargleContains:-

Povidone Iodine… 1% w/v

43. 15059 Spencidine Surgical ScrubContains:-

Povidone Iodine… 7.5 % w/v

M/s. Mediate Pharmaceuticals (Pvt) Ltd., Plot No. 150-151, Sector 24, Korangi Industrial Area, Karachi

44. 078406 Fentolit-100 mg

SR Capsules

Each prolonged-release capsule

contains

Diclofenac Sodium Prolonged

Release Pellets ≡

Diclofenac…….100 mg

Approval of source of pellets is

required.

45. 52727 Ronset SR Tablets.


Diclofenac Potassium……100mg.

(B.P Specs)

The registration of product was

granted with condition that you will

submit comparative dissolution profile

with innovator before marketing. Copy

of approval of comparative dissolution

profile is required.

M/s Allied Distributors Akhai Arcade 1st Floor, 103K Block-2 PECHS Shahra-e-Quaideen Karachi

46. 021969 CEREBOLIN 250mg/2ml Injection

Each 2ml contains:-

Citicoline……250mg

M/s Myungmoon

Pharmaceutical,Co., Ltd., 26

Jeyakgongdan 2-gil Hyangnam –eup

Hwaseong-si Gyeonggi-do-Republic

of Korea

Legalized CoPP vide No. 2018-DI-

1577 dated 03-07-2018 issued by

Ministry of Food and Drug Safety has

been submitted.

47. 021970 CEREBOLIN 500/2ml Injection

Each 2ml contains:-

Citicoline……500mg

M/s Myungmoon

Pharmaceutical,Co., Ltd., 26

Jeyakgongdan 2-gil Hyangnam –eup

Hwaseong-si Gyeonggi-do-Republic

of Korea

Legalized CoPP vide No. 2018-DI-

2335 dated 16-10-2018 issued by

Ministry of Food and Drug Safety has

been submitted.


48. 6983 ULCEDINE 400MG

TAB


Cimetidine ……400mg

Letter of following shortcomings was

issue to the firm vide letter dated 20th

September, 2019Latest GMP

Inspection report.

49. 14313 Neclof Tablet 100mg

(S/R)

Each S/R Tablet Contains


M/s. Caylex Pharmaceuticals (Pvt) Ltd., 27-Km Mian Raiwind Road, Lahore

50. 029125 Calotren Cream

Contains

Clotrimazole…1%


issue to the firm vide letter dated 02nd

September, 2019The copy of

registration letter indicates the

permission of toll manufacturing from

M/s Mass Pharma Lahore for period of

three years. Approval of

manufacturing at your premises is

required.Evidence of submission of

last renewal i.e. 2013Moreover the

application under consideration is also

submitted after due date of renewal i.e.

19-01-2018. Differential fee as SRO

1005 (I) / 2017 needs to be

submitted.Valid DLM.Section


Division.Brief report of last batch

manufactured.Latest GMP report in

compliance to report dated: 20-10-

2017.The above inspection report

submitted indicates that the firm didn’t

possess dedicated manufacturing

facility for Cephalosporin products.

The production was also stopped in

said facility. Latest status is required.

51. 029126 Betasporin Cream

Contains

Betamethasone

Dipropionate…0.05%

52. 029127 Germi Cream

Contains

Gentamycin Sulphate…0.3%

53. 029128 Cayzon 0.25gm

Injection

Each Vial Contains

Ceftazidime (as

Pentahydrate)…0.25gm

54. 029129 Cayzon 0.5gm

Injection

Each Vial Contains

Ceftazidime (as

Pentahydrate)…0.5gm

55. 029130 Cayzon 1gm

Injection

Each Vial Contains

Ceftazidime (as Pentahydrate)…1gm

M/s. Albro Pharmaceutical (Pvt) Ltd., 340-S, Industrial Area, Kot Lakhpat, Lahore

56. 004378 Torant Expectorant

Each 5ml Contains


…………………..2mg, Ephedrine

HCl…. 7mg, Ammonium Chloride

…………………...100mg, Sodium

Citrate …..60mg, Terpin Hydrate

……5mg, Menthol ……………1mg,



September, 2019Differential fee is

required as application for the renewal

of 2013 was submitted after due

date.Details of last batch

manufactured.Product composition is

not mentioned on the initial

registration letter, approval of

composition if any.Latest GMP

inspection report.Approval of


agencies.Copy of approval of last

quota allocation.Brief report of last

batch manufactured.

M/s. Hansel Pharmaceuticals (Pvt) Ltd., Plot No. 2, Pharma City, 30-Km Multan Road, Lahore

57. 76979 Taricin Eye Drops Letter of following shortcomings was

Each ml of solution contains:-

Ofloxacin…3mg

issue to the firm vide letter dated

02ndSeptember, 2019Differential fee is

required as application is submitted

after due date but within sixty

days.Latest GMP inspection

report.Brief details of last batch

manufacturedSection approval letter

issued by Licensing DivisionValid

DML.

58. 76980 Q-Mox Eye Drops

Each ml of solution contains:-

Moxifloxacin HCl eq. to

Moxifloxacin…5mg

59. 76981 Timodor Eye Drops

Each ml contains:-

Timolol maleate eq. to

Timolol…5mg

Dorzolamide HCl eq. to

Dorzolamide…20mg

60. 76982 Poly Tears Eye Drops

Each ml of ophthalmic solution

contains:-

Polyethylene Glycol 400…4mg

Propylene Glycol…3mg

61. 76983 Eyepat 0.2% Eye Drops

Each ml contains:-

Olopatadine HCl eq. to Olopatadine

…2mg

62. 76984 Ternafine Cream


Terbinafine (as HCl) ……10mg

63. 76985 Fungtel Cream


Clotrimazole …10mg

64. 76986 Futril Cream


Fusidic Acid …20mg

65. 76987 Painnil Gel

Each 100 g Gel contains:-

Diclofenac Di-ethyl amine …1.16g

(eq. to Diclofenac Sodium…1g)

M/s. Weather Folds Pharmaceuticals, Plot No. 69/2, Phase-II, Industrial Area, Hattar

66. 77488 Olpine 10 mg Tablets


Olanzapine Citrate ≡

Olanzapine…..……10 mg



September, 2019:Latest GMP

inspection report

M/s. Medisure Laboratories Pakistan (Pvt) Ltd., A-115 S.I.T.E, Super Highway, Karachi

67. 4242-EX Rahmacin Dry Suspension 125mg

Each 5ml contains

Clarithromycin as dihydrate ….

125mg


issue to the firm vide letter dated 3rd

September, 2019:Source of granules

for Rahmacin Dry Suspension 125mg

and 250mg

and in case of imported the differential

fee thereof.Evidence of approval of

formulation of Citide 1mg Tabletin

reference drug agencies.Differential

fee for Quopine Tablet 100mg

& 200mg

and Moment Tablet 10mg

as application is submitted after due

date but within sixty days.

68. 4243-EX Rahmacin Dry Susp 250mg

Each 5ml contains

Clarithromycin as dihydrate ….

250mg

69. 76123 Citide 1mg Tablet


Cinitapride as acid Tartrate.1 mg



Quetiapine (as fumarate) …100mg



Quetiapine (as fumerate) ...200mg

72. 50775 Moment 10mg

Tab


Memantine HCl…..10mg

M/s. WelMark Pharmaceuticals, Plot No. 122, Block-B, Phase-V, Industrial Estate, Hattar

73. 52708 Elzed 20mg

Capsule


Omeprazole pellets eq. to

Omeprazole …20mg

M/s Murli Krishna Pharma Pvt

Limited, Shop No. 08 Pearl Building

Powai Vihar Complex Powai India.



September, 2019:Section approval

letter issued by Licensing

Division.Latest GMP inspection

report.Evidence of submission of last

renewal for Gentamark 20mg

InjectionApproval of change of brand

name for Topmark 50mg

& 100mg TabletsApproval of change

of brand name for Topmark 50 and

100mg Tablet. Differential fee for

imported pellets.

74. 52709 Brince 20mg

Capsule


Esomeprazole pellets eq.to

Esomeprazole...20mg

75. 77462 Carbawel 200 mg Tablets


Carbamazepine…200 mg

76. 77463 Topmark 50mg Tablets


Topiramate…….50 mg

77. 77464 Topmark 100mg Tablets


Topiramate………….100 mg

78. 77465 Schizolan 10 mg Tablets


Olanzapine Citrate ≡ Olanzapine

………….….10 mg

79. 77466 Seizoram 250 mg Tablets


Levetiracetam……250 mg

80. 77467 Seizoram 500 mg Tablets


Levetiracetam……500 mg

81. 77468 Lupin 50 mg Tablets


Lamotrigine……….50 mg

82. 77469 Lupin 100 mg Tablets


Lamotrigine…….100 mg

83. 52847 Gentamark 20mg

Injection

Each 2ml Contains:

Gentamycin……20mg

(BP Specs)

M/s. Aims Pharmaceuticals, Plot No.291 Industrial Triangle Kahuta Road Islamabad

84. 52643 Cefaim 400mg

Capsules


Cefixime…….400mg

(USP Specs)



September, 2019:Evidence of

submission of last renewal i.e.

2013.Section approval letter issued by

Licensing Division. 85. 52646 Cef-P Injection


Cefepime as …..1.0gm

(USP Specs)

86. 52649 Cefaim D Suspension

Each 5ml contains:-

Cefixime….…100mg

(USP Specs)

M/s Nabiqasim Industries (Pvt) Ltd., 17/24, Korangi Industrial Area, Karachi

87. 53115 Ognis-D Tablet


Vitamin D…… 400 IU

Ossein Mineral Complex…830mg*

corresponding to:

Calcium…….177.6 mg

Phosphorus… 82.2 mg

Residual Mineral Salts 24.9 mg

Collagen……..224 mg

Other Proteins…….66.4 mg

Trace elements F, Mg, Fe, Zn, Cu,

Ni

* Corresponding to approx. 440mg

Hydroxyapatite



September, 2019:Evidence of approval


agencies.Details of manufacturer of

API along with certificate of analysis

of latest batch of API imported.

88. 53116 Ognis-D Suspension

Each 5ml contains:

Vitamin D…….. 400 IU

Ossein Mineral Complex…250mg

corresponding to:

Calcium………. 53.5 mg

Phosphorus…… 24.8 mg

Residual Mineral Salts...7.5 mg

Collagen……..67.5 mg

Other Proteins….20 mg

Trace elements F, Mg, Fe, Zn, Cu,

Ni

89. 53117 Ognis 400mg/5ml Suspension

Each 5ml contains:

Ossein Mineral Complex…400mg

Corresponding to:

Calcium……..85.59mg*

Phosphorus……….39.61mg

Residual Mineral Salts……12mg

Collagen…..107.95mg

Other Proteins……32mg

Trace Elements F, Mg, Fe, Zn, Cu,

Ni

*Corresponding to approx.

Hydroxyapatite..212mg

M/s. Spencer & Company (Pvt) Ltd., Formerly: Spencer & Co. (Pakistan) Ltd., D-105, S.I.T.E., Karachi

90. 30857 Lostaz 50mg Tablets


Cilostazol…….50mg




submission of last renewal i.e.

2013Latest GMP inspection

reportSection approval letter issued by

Licensing DivisonValid

DML.Approval of last quota allocation

of Ephedrine HCl for Spensid Cough

SyrupDetails of last batch

manufactured.Evidence of approval of


91. 30858 Lostaz 100mg Tablets


Cilostazol…….100mg

92. 4482 NEO-FERILEX SYP

Each 4ml Contains:

Iron Choline Citrate ……0.2gm, L-

Lysine Mono-HCl ….25mg,

Cyanocobalamin …5mcg, Folic

Acid ….5mg, Thiamine HCl …2mg,

Riboflavin ….0.5mg, Nicotinamide

…15mg, Pyridoxine HCl ..0.25mg,

Di-Pantothenyl Alcohol…..2mg

93. 53033 Polygard Infusion


Ciprofloxacin Lactate eq. to

Ciprofloxacin……….200mg

94. 14715 Spensid Cough Syrup

Each 5ml Contains

Dextromethorphan HBr…10mg


Ephedrine HCl…7mg

M/s. Welwrd Pharmaceuticals, Plot No 3 Block–A Phase-I-II Industrial Estate Hattar

95. 052629 Welmadol Injection

Each 2ml contains:-

Tramadol HCl…....100mg




inspection reportEvidence of

submission of last renewal

M/s. Barrett Hodgson Pakistan (Pvt) Ltd., F/423, S.I.T.E., Karachi

96. 30970 Opticef Tablets 100mg


Cefpodoxime Proxetil eq. to

Cefpodoxime …….100mg



September, 2019:Approval of

manufacturing facility for Dry Powder

Injections and Cephalosporin Tablets 97. 30983 Megaklar I.V Injection


Clarithromycin Lactobionate eq. to

Clarithromycin …….500mg

M/s. Biogen Pharma, 8-Km, Chakbeli Road, Rawat Rawalpindi

98. 75491 Alendrogen 70mg Tablet


Alendronate (as Sodium)…70mg




inspection re[portEvidence of approval

pof formulation for Melif-D Tablets 99. 75492 Dexipro 400mg Tablet


Dexibuprofen…400mg

100. 75493 Melif-D Tablet


Melitracen (HCl)…10mg

Flupenthixol (HCl and

Decanoate)…0.5mg

M/s. Lisko Pakistan (Pvt) Ltd., L-10/D Block 21 Federal B Industrial Area Karachi.

101. 004508 LYSOL LIQUID

Each 100ml Contains

Cresol…50ml

Sodium Hydroxide…5gm

Cotton Seed Oil…30ml





agencies.

102. 004425 MULTIMIN MULTIVITAMIN

PEAD DROPS

Each 0.6ml Contains

VITAMIN A 6000Units

VITAMIN D 1000Units

Vitamin B1…1mg

Vitamin B2…1mg

Vitamin B6…1mg

Nicotinamide…10mg

Calcium D Pentothenate…2mg


M/s. Venus Pharma, 23 Km Multan Road Lahore

103. 49755 XYLEX 2% + AD INJECTION.

Each ml contains:

LIGNOCAINE HCH (B.P) 2% W/V.

ADRENALINE 0.0005% W/V.





agencies.Evidence of submission of

last renewalValid DMLSection


DivisionDetails of last batch

manufactured

104. 49756 VITAMIN B COMPLEX

INJECTION.

Each ml contains:

THIAMIN HCL 5MG.

RIBOFLAVIN SODIUM

PHOSPHATE 2.5MG.

PYRIODOXINE HCL 2.5MG.

NICOTINAMIDE 37.5MG.

105. 31295 Vepressor Injection

Each ml Ampoule Contains

Ephedrine (As Sulphate)…50mg

M/s. Mass Pharma (Pvt) Ltd., 17 Km Ferozpur Road Lahore

106. 30859 Celicob Capsule 200mg


Celecoxib……..200mg




inspection report Source of pellets

Itranex Capsule 100mg

and in case of imported pellets the

differential fee thereof.Approval of

manufacturing facility for the steroidal

injectable formulations.Approval of

section / manufacturing facility for the

Topical solutions

107. 30860 Seroless Tablet 20mg


Paroxetine (as HCl)…20mg

108. 30865 Synalar C Ointment

Contains:-

Fluocinolone

Acetonide……0.025%w/w

Clioquinol………3.0%w/w

109. 30866 Synalar C Cream

Contains:-

Fluocinolone

Acetonide……0.025%w/wClioquino

l…3.0%w/w

110. 30870 Tretinex Cream

Contains:-

Tretinoin……..0.05%

111. 30875 Aerius Tablets 10mg


Ebastine…….10mg

112. 30876 Dinaphin Injection 500mg



Ceftriaxone ……..500mg

113. 30877 Itranex Capsule 100mg


Itraconazole……..100mg

114. 30880 Probase Tablets 5mg


Bisoprolol Fumarate……..5mg

115. 30881 Probase Tablets 10mg


Bisoprolol Fumarate…….10mg

116. 26126 Triton Injection 40mg

Each ml Contains

Triamcinolone Acetonide…40mg

117. 51159 Procon Tablets 10mg.


Rabeprazole


118. 51160 Procon Tablets 20mg.


Contains:-

Rabeprazole


119. 52469 Hyseke Solution

Each Bottle Contains

Ketoconazole ..... 2% w/v

M/s. Alkemy Pharmaceutical Laboratories (Pvt) Ltd., P-9 SITE Hyderabad.

120. 50328 Pantacool 40mg Tablet


Pantoprazole (as

Sesequihydrate)…40mg



September, 2019:Differential fee needs

to be submitted under SRO 1005 (I)/

2017 as application of renewal is

submitted after due date.Description of

all applied tablet dosage

forms.Evidence of approval of

formulation for Sonomycin Dry

syrupLatest GMP inspection

reportSection approval letter issued by

Licensing DivisionValid

DMLEvidence of submission of last

renewalSource of pellets for Omzole

Capsules and in case of imported

pellets differential fee thereof.

121. 50329 Levofam 250mg Tablet


Levofloxacin (as


122. 50330 Kemipan Plus Tablet


Diclofenac Potassium………75mg

123. 50331 Tarithrocid 250mg Tablet


Clarithromycin…….250mg

124. 50332 Tarithrocid 500mg Tablet


Clarithromycin……500mg

125. 50333 Kemyceph Suspension

Each 5ml contains:-

Cephradine….…..250mg

126. 50335 FB-Said Tablet


Flurbiprofen……..100mg

127. 50336 Zaridine Tablet


Loratadine………..10mg

128. 50338 Biodine Tablet


Ranitidine (as HCl)………150mg

129. 30842 Sonomycin Dry Syrup

Each 5ml contains:-

Fosfomycin……..250mg

130. 30841 Omcool Capsule 20mg


Omeprazole USP…..20mg

M/s. Alina Combine Pharmaceuticals (Pvt) Ltd., Plot No. A-127 SITE Super Highway Karachi.

131. 014081 Ultec 150mg Tablet


167.4mg

Ranitidine HCl eq. to 150mg

Ranitidine



September, 2019:Approval of Change

of name of manufacturer from M/s

Alina Combine Pakistan (Pvt) Karachi

to M/s M/s. Alina Combine

Pharmaceuticals (Pvt) Ltd

Karachi.Approval of transfer of

registration from M/s Alina Combine

Pakistan (Pvt) Karachi to M/s M/s.

Alina Combine Pharmaceuticals (Pvt)

Ltd Karachi.Evidence of submission of

last renewal i.e. 2013.Latest GMP

inspection report.

132. 014082 Ultec 300mg Tablet


Ranitidine HCl eq. to 300mg

Ranitidine

M/s. Lahore Pharma, 9-Km Sheikhupura Road Lahore

133. 14438 Cetrimide Solution

Contains:-

Cetrimide…15gm

Chlorohexidine…1.5gm




inspection report.Valid DML.Section

approval letter issued by licensing

division.Brief details of last batch

manufactured.

134. 14439 Chloroxylenol Solution


Chloroxylenol…50gm

M/s. Nawabsons Laboratories (Pvt) Ltd., Jia Bagga off Raiwind Road Lahore

135. 14334 Nobstan Tablet


Mefnamic Acid…250mg




submission of renewal of 2013.Latest 136. 14335 Metronidazole Tablet 200mg



GMP inspection report.Description of

all applied tablet dosage form.

137. 14336 Metronidazole Tablet 400mg



138. 14337 Ibuprofen Tablet 200mg


Ibuprofen…200mg

139. 14338 Ibuprofen Tablet 400mg


Ibuprofen…400mg

140. 14339 Ibuprofen Suspension 90ml

Each 5ml Contains

Ibuprofen…100mg

M/s. Nawal Pharmaceuticals, Plot No. 11-A Punjab Small Industrial Estate, Taxila

141. 75750 Bella Raft Oral Powder


Furosemide…2gm

Belladonna Extract…0.2gm




inspection report.

M/s. Macter International (Pvt) Ltd., F-216, S.I.T.E., Karachi

142. 22825 Midolam Inj 1mg

Each ml contains

Midazolam as HCI …. 1mg



September, 2019:Approval

manufacturing facility for psychotropic

Injectable products.

M/s. Reckitt Benckiser Pakistan Ltd., F-18 S.I.T.E Karachi

143. 000484 Disprol Suspension

Each 5ml contains:

PARACETAMOL 120MG,



September, 2019:Copy of initial

registration letter of Disprol

Suspension & Polycrol Forte Gel 144. 000487 POLYCROL FORTE GEL

Each 5ml contains:

Simethicone …. 125mg

Magnesium Oxide B.P

………70mg

Aluminum Hydroxide B.P as

Aluminum Oxide …. 200mg

M/s. Harmann Pharmaceutical Laboratories (Pvt) Ltd., P.O. Chung, 16-Km Multan Road, Lahore

145. 003933 LYSOBEX SYP

Each 30ml Contains

Thiamine HCl…..25mg

Pyridoxine HCl……6mg

Riboflavin 5-Phosphate……10mg

Cyanocobalamin….50mcgCalcium

Pantothenate…….15mg

Lysine Monohydrochloride…200mg

Ascorbic acid……450mg

Inositol…..30mg

Nicotinamide…..108mg



September, 2019:Valid DML.Evidence

of submission of renewal of

2013.Approval of formulation in

reference drug agencies.Section


Division.Latest GMP inspection

report.

M/s. Pharmix Laboratories (Pvt) Ltd. , 21-Km Ferozepur Road, Lahore

146. 001840-EX Kwantadin Tab 10mg

Each tablet contains

Loratadine USP …. 10mg



September, 2019:Registration Letter

and evidence of renewal submitted is

of Lorate Tablets (022371) instead of

Kwantadin Tablets.

M/s. Sami Pharmaceuticals (Pvt) Ltd., F-95, Off Hub River Road, S.I.T.E., Karachi

147. 76174 Sitip 1mg Tablet


Cinitapride acid tartrate eq. to

cinitapride.. …………..… 1mg




submission of last renewal for Sitip

1mg TabletApproval of manufacturing

facility for penicillin oral syrup/

suspension.

148. 15062 Moxypen DS Syrup


Amoxicillin trihydrate eq. to 250 mg

Amoxicillin base

M/s. The Schazoo Pharmaceutical Laboratories (Pvt) Ltd., Kalalwala Stop, 20-Km Lahore-Jaranwala

Road, District Sheikhupura

149. 077030 Arify Tablets 15mg


Aripiprazole………….15mg




inspection report. 150. 077031 Arify Tablets 10mg


Aripiprazole………..10mg

M/s. Cherwel Pharmaceuticals (Pvt) Ltd., Plot No. 20, Phase-IV, Industrial Estate, Hattar

151. 52702 Cherose Capsules.


Iron III Hydroxy Polymaltose

complex eq. to elemental

Iron………….100mg.




inspection reportValid DML.

M/s. P.D.H Pharmaceuticals (Pvt) Ltd., 19-Km Ferozepur Road, Lahore

152. 14442 Hypnotil Capsule 15mg

Each Capsule Contains

Temazepam…….15mg



September, 2019:Transfer of

registration from Punjab Drug House

42 Nicholson Road Lahore to PDH

Pharmaceuticals Pvt Limited 19-Km

Ferozepur Road, Lahore.Approval of

psychotropic capsule section by

Licensing Division.Brief details of last

batch manufactured along with quota

allocation approval by Controlled

Drugs Division.Latest GMP inspection

report.

153. 14443 Hypnotil Capsule 30mg

Each Capsule Contains

Temazepam……30mg

154. 22378 Corinor Tablet 5mg


Amlodipine Besylate……5mg

155. 22379 Corinor Tablet 10mg


Amlodipine Besylate…….10mg

M/s. Getz Pharma (Pvt) Ltd., Plot No. 29-30, Sector 27, Korangi Industrial Area Karachi

156. 53280 Lanic Injection

Each ml contains:

Triamcinolone Acetonide..…40.0mg




September, 2019:Approval of

manufacturing facility for injectable

steroids as required under Schedule B

(1) (5.2) of Drug (LR&A) Rules

1976from Licensing Division.

M/s. Jawa Pharmaceuticals (Pvt) Ltd., 112/10 Quaid-e-Azam Industrial Estate, Kot Lakhpat Lahore

157. 52775 P-Lock Tablets 400mg.


Pefloxacin as Mesylate.…….400mg.

(B.P Specs)



September, 2019:Differential fee is

required as the renewal of 2013 was


sixty days.Evidence of submission of 158. 52776 J-Rox Tablets 150mg.


Roxithromycin……..150mg. renewal for Mfor Tablets 500mg

159. 52777 Typdex Tablets 500mg.


Nalidixic Acid ……..500mg. (USP

Specs)

160. 52778 Fanoxin Tablets 120mg.


Fexofenadine HCl…………120mg.

161. 52779 Fanoxin Tablets 60mg


Fexofenadine HCl…………60mg.

162. 52780 Jperidon Tablets 10mg


Domperidone ………..10mg. (BP

Specs)

163. 52781 Cholein Tablets 20mg.


Atorvastatin …………..20mg.

164. 52782 Cholein Tablets 10mg.


Atorvastatin …….……..10mg.

165. 52783 Jasartan Tablets 50mg.


Losartan Potassium………...50mg.

166. 52784 Mfor Tablets 500mg.


Metformin HCl …..………500mg.

(BP Specs)

167. 52785 Mntazole -DS Tablets


Metronidazole ….………..400mg.

Diloxanide Furoate …..…..500mg.

(B.P Specs)

168. 52786 Mntazole Tablets


Metronidazole ….………..200mg.

Diloxanide Furoate ……..250mg.

(B.P Specs)

169. 52787 Zenzol Tablets


Mebendazole ………..100mg. (USP

Specs)

M/s. Global Pharmaceuticals, Plot No 204-205, Industrial Triangle Kahota Road, Islamabad

170. 29501 Coasacort Ointment

Each gm Contains:

Strong CoalTar Solution..30mg

Hydrocortisone.10mg

Salicylic Acid…..30mg

Approval of formulation in RRA.

171. 30031 Doudcer-Nil Caps


Lansoprazole……30mg

Copy of approval of change of brand

name from Nevazole to Doudecer Nil

Capsules does not bear the date of

issuance of letter. Renewal letter dated

20-07-2009 indicates the brand name

Nevazole capsules however the brand

name was changed in 2007. Source of

pellets.

172. 052250 Opepzole 40mg

IV Injection


Omeprazole sodium eq. to

Omeprazole…..40mg

Manufactured by:M/s Habrin

Pharmaceutical Group

Bioengineering Co., Ltd China.

You have submitted Form-5B for local

manufacturing however the product is

registered as Finished import from

China. In case the product has been

transferred from import to local

manufacturing then approval of same

is required. Valid legalized CoPP/ FSC

and GMP DRAP attested last import

invoice. Differential fee applicable in

case of finished import.

173. 017488 Tobicon Capsules


Sodium Chondroitin

Sulphate…..100mg

Thiamine HCl…..20mg

Retinol

Palmitate….2500IURibofavin

….5mg

Hydrocholine tartrate…..25mg

Evidence of approval of formulation in

RRA.

M/s. Prix Pharmaceutica (Pvt) Ltd., 5-Pharmacity, 30-Km, Multan Road, Lahore

174. 49517 HEPAPRI ORAL SOLUTION


DL-METHIONINE…5GM

L-LYSINE

MONOHYDROCHLORIDE…10G

M

CHOLINE CHLORIDE…19GM

VITAMIN B12….1MG

SORBITOL…..10GM




inspection reportSection approval

letter issued by Licensing Division.

175. 49530 DOXIMAC-C WATER SOLUBLE

POWDER

Each gm Contains:

COLISTIN SULPHATE

BP…25,00,000IU, TYLOSIN (AS

TARTRATE)BP 100MG

DOXYCYCLINE (AS HYCALTE)

BP…100MG

BROMHEXINE (AS

HYDROCHLORIDE) BP 5MG

176. 75780 PRI-DIMIDINE 33.3% INJECTION

Each ml injection contains:-

SULPHADIMIDINE

SODIUM……………….333.3MG

177. 75781 PRI-DOLOCAM 7.5 INJECTION

Each ml contains:

MELOXICAM…………...…7.5MG

178. 75782 PRI-DEFLAME 5 INJECTION

Each ML INJECTION contains

FLUNIXIN

MEGLUMINE……..50MG

M/s. D-Marson Pharmaceuticals, Plot No. 17, SS-2, RCCI, Rawat, Rawalpindi

179. 75742 FLUSH B POWDER


FUROSEMIDE…………..2gm

BELLADONNA EXTRACT...0.2gm



16thSeptember, 2019:Latest GMP

inspection report.

180. 75743 RIZ ZAN PLUS SUSPENSION


OXYCLOZANIDE…….….3.0G

LEVAMISOLE HCL ….…1.5G

COBALT SULPHATE …0.382%

181. 75744 ALBENMARS SUSPENSION


ALBENDAZOLE………....2.5G

SODIUM SELENITE ....0.035%

COBALT CHLORIDE …0.075%

182. 75745 LEVAMARS SUSPENSION


LEVAMISOLE HCL ……1.5%

183. 75746 TOLMARS LIQUID


TOLTRAZURIL …………...25G

VITAMIN K3 ………...…3G

184. 75747 FENMARS SUSPENSION

Each ml contains:

OXFENDAZOLE …... 22.65MG

185. 75748 COL-PLUS ORAL LIQUID


FLORFENICOL……...… 20GM

186. 75749 MAXEN LIQUID.


ENROFLOXACIN ……....20GM

COLISTIN SULPHATE…50 MIU

M/s. Univet Pharmaceuticals, 14-Km, Adyala Road, Post Office Dahgal, Rawalpindi

187. 049799 Coxban Powder


SODIUM

SULPHAQUINOXALINE.20G

SODIUM

SULPHADIMIDINE….8.25MG

DIAVERIDINE…4.0G

Vitamin A….280,000IU

Vitamin K3….0.200G




inspection report.

188. 049800 ECBRO POWDER

Each 100GM

POWDER contains

ERTHROMYCIN BASE (AS

THIOCYANATE)…..5GMCOLICO

LISTIN SULPHATE…5,000,000

IUBROMHEXINE

HYDROCHLORIDE.0.375G

M/s. Symans Pharmaceuticals (Pvt) Ltd., 10-Km Sheikhupura Road, Lahore

189. 29700 Cholipol Powder


CHOLINE CHLORIDE … 500GM.

DL-METHIONINE …… 40GM. L-




inspection report.Section approval

LYSINE …………. 40GM. letter issued by Licensing

DivisionValid DML.Brief details of

last batch manufactured.

M/s Lundbeck Pakistan (Pvt) Ltd., 40 T/4 Blessing Street Block-6 P.E.C.H.S., Karachi

190. 028467 Cipralex 10mg Tablets.


Escitalopram Oxalate12.77mg

~Escitalopram 10mg.

M/s H. Lundbeck A/S Denmark

Valid legalized CoPP issued by Danish

Medicines Agnecy vide No.

2019010913 dated 09-01-2019,

Export License Holder (Name and

Address):M/s H. Lundbeck A/S

Ottiliavej 9, 2500 Valby, Denmark

M/s. Novartis Pharma (Pakistan) Limited, 15-West Wharf, Karachi

191. 052235 Lozal 40mg

Powder for Infusion.

Each vial of powder for solution for

infusion contains:

Omeprazole sodium eq. to 40mg

Omeprazole.

M/s Lek Pharmaceuticals d.d.

Slovenia



September, 2019:Copy of valid

DSL.Valid legalized CoPP/ FSC and


invoice.

M/s. Drug's Inn, 1-I, Park View Plaza, Sector F-10 Markaz, Islamabad

192. 21939 ZACIN TABLETS 250MG


CIPROFLOXACIN HCL 250MG

M/s Chengdu Second Pharmaceutical

Factory China Exported by M/s

Shanghai Pharmaceutical Co., Ltd

China



13thSeptember, 2019:Valid legalized

CoPP/ FSC & GMP.

M/s. Shaheen Agency, P.No.GK-3/13, Adamji Dawood Road, Karachi

193. 014602 GRANDAXIN TABLETS


TOFIZOPAM 50MG

M/s Egis Pharmaceutical Budapest

Hungary



17thSeptember, 2019:Evidence of

submission of renewal of 2013 having

endorsement of receiving in

DRAP.Valid legalized CoPP/ FSC and

GMP

M/s. Al Habib Pharmaceuticals, 81-B Block B, S.M.C.H.S, Karachi

194. 21955 UCETAM CAPSULES 400MG


PIRACETAM 400MG

M/s Korea United Pharm Inc., Korea



17thSeptember, 2019:Address of

Importer mentioned on DSL varies

with address on transfer of registration.

Approval letter for address as per DSL

is required.Valid legalized CoPP/ FSC

and GMP.DRAP attested invoice of

last imported batch.

195. 21956 UCETAM TABLETS 800MG


PIRACETAM 800MG

M/s. Prix Pharmaceutica (Pvt) Ltd., 26-Abbot Road, District Lahore

196. 12989 OXTRA LA (INJECTABLE SOL.)


OXYTETRACYCLINE

DIHYDRATE 20gm

M/s Fatro SPA Italy



04thSeptember, 2019:Valid legalized

CoPP/ FSC and GMP

197. 22175 Vitamin AD3E Injection

Each ml Contains

Retinyl Palmitate 80,000 IU

Cholecalciferol 40,000IU

A-Tocopherol Acetate 20mg

M/s Farvet Laboratories B.V.

Netherland

M/s. MeDLey Pharmaceuticals, 41-A, P.S.I.E. JhangBahtar Road, WahCantt. Rawalpindi

198. 075453 Le-Ride 100mg

Capsule



Registration Board in its 289th meeting

deferred the case for following: Latest

GMP report is not submitted.Valid

DML is not submitted.

The firm has now submitted the GMP

report dated 10-08-2018, 03-03-2019

and 15-05-2019 conducted by the

panel wherein the panel recommended

the issuance of GMP Certificate.

Moreover the firm has submitted the

application for renewal of DML dated

27-06-2019 which is before the due

date as required under rules. The firm

also submitted that due date was on

Sunday and fee was submitted on

Saturday, however application was

submitted on Monday i.e. 23-07-2018.

199. 075454 Arte-M Capsule 20/120


Artemether…20mg


200. 075455 Arte-M Capsule 40/240


Artemether…40mg


201. 075456 Z-Cin 250mg

Capsule



202. 075457 Mexo120mg

Capsule



203. 075458 MecoCap 500mcg Capsule



204. 075459 Meroxi 20mg

Capsule


Piroxicam as Beta-

Cyclodextrin…20mg

205. 075460 Medifos 500mg

Capsule



Fosfomycin…500mg

206. 075461 Maltoley Syrup

Each ml Contains:


Complex…100mg

Folic Acid…0.35mg

Sugar Free Syrup

207. 075462 Letose Syrup

Each 5ml Contains:


Complex…50mg

208. 075463 Medfir 10mg Tablet


Adefovir Dipivoxil…10mg

209. 075464 Medcavir 0.5mg Tablet


Entecavir as Monohydrate…0.5mg

210. 075465 T-Poxi 20mg Tablet


Paroxitine (as HCl)…20mg

211. 075466 Ice 30 Capsule


Lansoprazole (Pellets)…30mg


Islamabad.

212. 075467 Olx 20mg

Capsule




Islamabad.

213. 075468 D-Lox 40mg

Capsule


Duloxetine as HCl (Pellets)…40mg


Islamabad.

214. 075469 Kanamed 1gm

Injection


Kanamycin Sulphate eq. to

Kanamycin Base…1000mg

215. 075472 Medka 100mg

Injection

Each Vial Contains:


216. 075473 Medka 250mg

Injection

Each Vial Contains:


217. 075474 Medka 500mg

Injection

Each Vial Contains:


M/s. Medisure Laboratories Pakistan (Pvt) Ltd., A-115, S.I.T.E, Super Highway, Karachi


Injection

Each 5ml contain:


Deferred for in 291st meeting of RB for


reference agencies.


Injection

Each 5ml contain:




reference agencies.

220. 076147 Suregine Oral Solution

Each ml contain:

Co-degrocrinemesylate……1mg



reference agencies.


reference agencies is not submitted.

221. 032033 Clarocin Granules

Each 5ml contain:





under:Approval of source of granule

and in case of imported granules the

differential fee thereof.

The firm mentioned they are

purchasing granules from M/s Surge

Laboratories Pvt Limited Sheikhupura.

However the source fixation letter is

not submitted.

222. 076160 Colistat Powder for injection

Each vial contain:

Colistimethate

sodium………1million I.U




under:Clarification of formulation as

the formulation approved in the

reference agencies is lyophilized


doesn’t indicate the availability of

lyophilizer. Brief details of last batch

manufactured.

Clarification of formulation is not

provided as the formulation approved

in the reference agencies is lyophilized


doesn’t provide the availability of

lyophilizer.







under:Differential fee required as


due date.Section approval letter issued

by Licensing

Clarification of formulation is not

provided as the formulation approved

in the reference agencies is lyophilized


doesn’t provide the availability of

lyophilizer.

M/s. Paramount Pharmaceuticals, 36-Industrial Triangle, Kahuta Road, Islamabad

224. 050285 Respimet Syrup.

Each 1ml contains:

Ketotifen as Fumarate…0.2mg.

Deferred in 289th meeting for approval

status of tablet section by CLB

The firm submitted a panel inspection

report dated 08-02-2019 wherein the

panel recommended the regularization

Tablet General section and accordingly

the firm submitted letter in Licensing

Division on 25-02-2019.

225. 050286 Silicur Tablets.


Silymarin………………….200mg.

226. 050287 Sycon Tablet 3mg.


Risperidone………………………3

mg.

227. 050288 Sycon Tablets 4mg.


Risperidone………………………4

mg

228. 050986 Polymat Syrup

Each 15ml contains:

Iron Protein

Succinylate……...800mg

(eq to 40mg

elemental iron)

M/s Tabros Pharma (Pvt) Ltd, L-20/B, Sector-22, F.B. Industrial Area, Karachi






(RRR) dated 1-3-2019 which has not

yet been responded by the firm and

accordingly deferred in 289th meeting

of RB.

The firm has now submitted the GMP

report dated 24 & 25 October 2018

wherein the GMP was rated as GOOD.




231. 014345 Hemsamic Injection 250mg/5ml

Each 5ml Contains:


M/s. English Pharmaceutical Industries, Link Kattar Bund Road, ThokarNiazBaig, Multan Road,

Lahore



Atenolol ..50mg

Deferred for following in 291st meeting

of RB: Latest GMP inspection

reportAs per letter dated 09-03-2015

regarding renewal of DML, your

Tablet section (General) was not

renewed, therefore clarification in this

respect is needed Evidence of approval

of formulation on reference drug

agencies for products at Sr. No.

269&270

Firm informed that Tablet General

section is not renewed but they have

another section Tablet General &

antibiotics. However as per Licensing

Division letter the section is “Tablet

General Antibiotics”Evidence of

approval of RRA submitted for Ardi-

75 Tablet &Ornivit Syrup is

insufficient.



Atenolol…...100mg

234. 022928 Ardi-75 Tablet


Diclofenac Sodium 75mg

235. 022929 Ornivit Syrup

Each 5ml contains:

L-Ornithine L-Aspartate 300mg

Nictinamide.24mg

Riboflavin-5 phosphate Sodium

0.76mg

236. 022930 Cezen Tablets


Cetrizine Dihydrochloride 10mg

237. 022931 F-100 Tablet


Flurbiprofen 100mg

M/s Medisure Laboratories Pakistan Pvt Limited Karachi

238. 028462 Hyal Prefilled Injection

Each ml contain:

Sodium hyaluronate…10mg

M/s Shin Poong Pharmaceuticals

Co., Ltd Seoul Korea.


following shortcoming in 291st

meeting of RB:Approval of



last renewal. Differential fee as per

SRO 1005 (I)/ 2017.Valid legalized

CoPP/ FSC and GMPLast DRAP

attested import invoice.Valid Drug

Sale License

Reply of the firm: The firm

informed that they are no longer

interested in the in the above products

and same may kindly be deregistered.

239. 014004 Trizoline 400mg Tablet Deferred for the rectification of


Norfloxacin USP….400mg

M/s RemedicaAhmon Street

Limassol Cyprus

following shortcoming in 291st

meeting of RB:Approval of



last renewal. Differential fee as per

SRO 1005 (I)/ 2017.Valid legalized

CoPP/ FSC and GMPLast DRAP

attested import invoice.Valid Drug

Sale License.

Reply of the firm: The firm

informed that they are no longer

interested in the in the above products

and same may kindly be deregistered.

M/s. Pharmix Laboratories (Pvt) Ltd. , 21-Km Ferozepur Road, Lahore

240. 053784 Alide Capsule 500mg

Each capsule contains

Azithromycin as Dihydrate ….

500mg

ShortcomingsFollowing shortcoming

has been observed:Evidence of last

renewal is required

M/s. Amros Pharmaceuticals, A-96 S.I.T.E., North Karachi

241. 004051-EX Mediquin Tablet


Quinine Sulphate …. 300mg

Shortcomings:Following shortcoming

has been observed:Latest cGMP

inspection letter required.Section

approval letter issued by licensing

division is required for confirmation of

steroidal (tablet) section.

242. 004052-EX Haemoforte Syrup

Each 100ml contains

Ferric Ammonium Citrate …. 1g

Folic Acid …. 11mg




243. 004053-EX Regogent Eye/Ear Drops

Each 10ml contains

Gentamycin Sulphate eq. to

Gentamycin Base …. 0.3% w/v

244. 004054-EX Regozone Tablet


Dexamethasone …. 0.5mg

M/s. Sante (Pvt) Ltd., A/97 S.I.T.E Super Highway, Karachi

245. 075812 Softeal 0.3% Eye Drops

Each ml contains

Hydroxypropylmethyl Cellulose ….

3mg


has been observed:Approval status of

product in Reference Regulatory

Agency is required.

M/s. Hilton Pharma (Pvt) Ltd., Plot No. 13 - 14, Sector 15, Korangi Industrial Area, Karachi

246. 001000-EX Tramin 250mg

Capsule




has been observed:Differential fee

required for regularization of renewal

of year 2013 in the light of SRO

1117/2012.Renewal of year 2013 was

submitted on 27-08-2012 with fee of

Rs.4000/-.Detail of manufacturing

facility of Lyophilized Saccharomyces

Boulardii is required.Approval status

of product in RRA is required.

247. 000997-EX Tramin 250mg

Injection

Each 5ml contains


248. 009730 Transamin Capsule 500mg



249. 000999-EX Tramin 500mg

Capsule



250. 009816 Anapaz Drops

Each ml contains

Hyoscyamine Sulphate …. 0.125mg

251. 001000-EX Tramin 250mg

Capsule



252. 010103 Disal Powder

Each sachet contains

Sodium Chloride …. 3.5g

Potassium chloride …. 1.5g

Sodium Bicarbonate …. 2.5g

Dextrose Anhydrous ….. 20g

Flavour Banana, Strawberry, Lime,

Mango and Orange.

253. 000998-EX Tramin Injection 500mg

Each 5ml contains


254. 021667 Amovac 10mg Tablet


Amlodipine Besylate …. 10mg

255. 021668 Eknit Tablet


Scenidazole …. 500mg

256. 022071 Enflor Sachet 250mg


Lyophilised Saccharomyces

Boulardii 282.5mg

corresponding to …. 250mg

of yeast

257. 022072 Enflor Capsule 250mg


Lyophilised Saccharomyces

Boulardii 282.5mg

corresponding to …. 250mg

of yeast (Biological)

The Central Licensing Board vide

letter date 11-04-2018 considered and

approved the grant of amendment /

expension to the firm in partial

modification of their letter dated 04-

12-2014 for sachet probiotics. The

Borad further requrested that the Drug

Registration Board may decide the

matter in the light of the decision of

the DRAP Policy Board.











258. 021874 Stimol Oral Liquid Shortcomings:Following shortcoming

Each 100ml contains

Citrulline Maleate (50% Citrulline

Maleate Solution) …. 10g










M/s. Epla Laboratories (Pvt) Ltd., D-12, Estate Avenue, S.I.T.E. Karachi

259. 003912 Eplacin Tablet


Aspirin …. 200mg



has been observed:Transfer of

registration of product in the name of

M/s. Epla Laboratories is

required.Approval status of product in

RRA

M/s. Wilson’s Pharmaceuticals, Plot No. 387-388, Sector I-9, Industrial Area, Islamabad

260. 075373 Stay-H Tablet


Aliskirin …. 300mg

Hydrochlorothiazide …. 12.5mg


has been observed:Detail of chemical

composition of Aliskirin is required as

it is in the form of Aliskirin

Hemifumarate in reference regulatory

agencies.

M/s. Ferozsons Laboratories Ltd., Amangarh Nowshehra, Khyber Pakhtunkhwa

261. 021203 HelicureContains:

Clarithromycin Tablet 250mg


to Omeprazole capsule …. 20mg

Metronidazole Tablet…. 400mg



formulation in RRA is

required.Section approval letter issued

by Licensing Division for product

being steroidal dosage form.

Approval status of formulation in RRA

262. 021204 Genesis Tablet


Finasteride …. 1mg



formulation in RRA is

required.Section approval letter issued

by Licensing Division for product

being steroidal dosage form.

M/s. Regent Laboratories, C-20, S.I.T.E., Super Highway, Karachi

263. 030102 Roral Syrup

Each 5ml contains

Loratadine …. 5mg


has been observed:Evidence of


requiredLatest cGMP report

requiredSection approval letter issued

by Licensing Division is requiredBoth

Undertaking as per approved SOP is

required.Valid DML requiredApproval

status of formulation in RRASource

fixation letter required for pellets of

Omeprazole and in case of imported

pellets prescribed fee required for

renewal of year 2013 &2018.Source

fixation letter of bulk importer of

Lactulose related to Looslac Syrup and

prescribed fee required for

264. 030103 Roral Tablet


Loratadine …. 10mg

265. 030106 Cipronet 250mg Tablet



266. 030107 Cipronet 500mg Tablet



267. 030108 Revonil 250mg Tablet


Levofloxacin as Hemihydrate ….

250mg

268. 030109 Revonil 500mg Tablet


Levofloxacin as Hemihydrate ….

500mg

regularization of renewal of year 2013

& 2018.

269. 030110 Azelide 250mg Tablets


Azithromycin as Dihydrate ….

250mg

270. 030111 Azelide 200mg

Suspension

Each 5ml contains


271. 030112 Remoxy 250mg

Capsule


AmoxycillinTrihydrate eq. to

Amoxycillin Base …. 250mg

272. 030113 Remoxy 500mg

Capsule




273. 030114 Remoxy 125mg

Suspension

Each 5ml contains



274. 030115 Remoxy 250mg

Suspension

Each 5ml contains



275. 030116 Pencil 250mg

Capsule


Ampicillin Trihydrate eq. to

Ampicillin …. 250mg

276. 030117 Pencil 500mg

Capsule




277. 030118 Pencil 125mg

Suspension

Each 5ml contains



278. 030119 Recard 150mg Tablet

Each enteric coated tablet contains

Aspirin …. 150mg

279. 030120 Rentolin 2mg Tablet


Salbutamol Sulphate eq. to

Salbutamol …. 2mg

280. 030122 Rentolin Syrup

Each 5ml contains

Salbutamol Sulphate eq. to

Salbutamol …. 2mg

281. 030123 Recid Tablet



282. 030124 Recid Syrup

Each 5ml contains


283. 030125 Regopyrin 50mg Tablet



284. 030128 Regoclox Suspension

Each 5ml contains



Cloxacillin Sodium eq. to

Cloxacillin base …. 125mg

285. 030129 Megodine Tablet


Metronidazole .… 250mg

Di-Iodohydroxyquinoline ….

325mg

286. 030130 Megodine Suspension

Each 5ml contains

Metronidazole Benzoate … 321.6mg

Di-Iodohydroxyquinoline ….

200mg

287. 030131 Mycef 100mg

Suspension

Each 5ml contains

Cefixime Trihydrate …. 100mg

288. 030132 Mycef 400mg

Capsule


Cefixime Trihydrate …. 400mg

289. 030133 Prodral 10mg Tablet


Propranolol as HCI …. 10mg

290. 030134 Prodral 40mg Tablet


Propranolol as HCI …. 40mg

291. 030135 Doprine 5mg Tablet



292. 030136 Doprine 10mg Tablet



293. 030137 Pril 5mg Tablet


Enalapril Maleate …. 5mg

294. 030138 Pril 10mg Tablet


Enalapril Maleate …. 10mg

295. 030139 Colexib 100mg Tablet



296. 030140 Colexib 200mg Tablet



297. 030141 Rusort 50mg Tablet


Losartan Potassium …. 50mg

298. 030142 Monorid 20mg Tablet


Isosorbide Mononitrate …. 20mg

299. 030143 Monorid 40mg Tablets


Isosorbide Mononitrate …. 40mg

300. 030144 Racor 10mg Tablet


Simvastatin …. 10mg

301. 030145 Racor 20mg Tablet


Simvastatin …. 20mg

302. 030148 Ompizol 20mg

Capsule


Omeprazole …. 20mg



Naproxen …. 250mg



Naproxen …. 500mg

305. 030151 Orphadine Tablet


Orphenradine Citrate …. 35mg


306. 030152 Randazol Tablet


Albendazole …. 200mg

307. 030153 Randazol Suspension

Each 5ml contains

Albendazole …. 100mg

308. 030154 Pancare Tablet


Piroxicam …. 20mg

309. 030155 Rivid 200mg Tablet



310. 030156 Looslac Syrup

Each 5ml contains

Lactulose …. 3.35g

311. 030158 Pheno Tablet


Phenobarbitone …. 30mg

312. 030159 Benovate-In Cream

Contains

Betamethasone as Valerate …. 0.1%

neomycin Sulphate …. 0.5%

313. 030160 Kanarod-N Cream

Contains

Dexamethasone …. 0.1%

Neomycin Sulphate …. 0.5%

314. 030161 Regofax Skin Ointment

Each gm contains

Polymyxin B Sulphate …. 10,000

Units Bacitracin Zinc …. 500

Units

315. 030162 Pancare Gel

Each 100gm contains

Piroxicam …. 500mg

316. 030163 Regofenac Gel

Each 100gm contains

Diclofenac Diethylamonium Salt

1.16g eq. to Diclofenac Sodium ….

1g

317. 030164 Wellcef 125mg

Suspension

Each 5ml contains


318. 030165 Wellcef 250mg

Suspension

Each 5ml contains


319. 030166 Wellcef 500mg

Capsule



320. 030167 Tencid 100mg Tablet


Flurbiprofen …. 100mg

321. 030168 Hylin-Plus Syrup

Each 5ml contains

Aminophyline …. 32mg



Menthol …. 0.98mg

322. 030169 Amonil Syrup

Each 5ml contains




Menthol …. 1mg

323. 030171 Alumico Suspension

Each 5ml contains

Aluminium Hydroxide …. 215mg


Simethicone …. 25mg

324. 030172 Resil Tablet


Magnesium Tricyclate …. 250mg

Dried Aluminium Hydroxide ….

120mg

Peppermint oil …. 03ml

325. 030173 Resil Suspension

Each 5ml contains


Aluminium Hydroxide …. 215mg

326. 030174 Protozol 200mg Tablet


Metronidazole …. 200mg

327. 030175 Protozol 400mg Tablet


Metronidazole …. 400mg

328. 030178 Citrolyte Syrup

Each 5ml contains

Sodium Acid Citrate …. 1.25g

329. 030179 Regocof Cough Syrup

Each 5ml contains





Menthol …. 1mg

330. 030180 Carminative Mixture

Each 100ml contains

Soda Bi-Carbonate …. 5mg

Tr.Card Co …. 6.5ml Spirit

Ammonia Aromatic …. 6.5ml Tr.

Zingiberis Forte …. 0.4ml Aqua

Menthapip …. 4.8ml

331. 030183 Regofid DM Cough Tablet


Triprolidine HCI …. 1.25mg

Pseudoephedrine HCI …. 30mg

Dextromethorphan HBr …. 10mg

332. 030176 Paracetamol Compound Tablet



Aspirin …. 300mg

Caffeine …. 10mg

333. 030177 Hylin Tablet



M/s. Delux Chemical Industries, Plot No. 26-A1 Landhi Karachi

334. 048573 Mega-III Syrup

Each 5ml contains


complex 400mg

eq. to Elemental Iron …. 50mg


has been observed:Evidence of


requiredLatest CGMP report

requiredSection approval letter issued

by Licensing Division is requiredBoth

Undertaking as per approved SOP is

required.Valid DML requiredApproval

335. 030190 Kidcold Syrup

Each 5ml contains


Pseudoephedrine HCI …. 15mg


status of formulation in RRA

336. 030076 Deemac Suspension

Each 5ml contains


337. 013944 Deemac Tablet



338. 013945 Deefol Tablet


Folic Acid …. 5mg

339. 013946 Deepol Tablet



340. 013947 Deemine Tablet 4mg



341. 013948 Deerin Tablet


Aspirin …. 300mg

342. 013950 Deeoxine Capsule


Oxytetracycline HCI …. 250mg

343. 013951 Deemycin Skin Ointment

Contains

Neomycin Sulphate …. 0.5%

M/s. Standpharm Pakistan (Pvt) Ltd., 20-Km Ferozepur Road, Lahore

344. 018659 Bludol Suspension

Each 5ml contains

Ibuprofen …. 100mg

Clarification required regarding the

renewal application submitted in

2018, according to the initial

registration date renewal is due on 05-

02-2016.Evidence of any post

registration variation Evidence of

renewal of year 2013.

345. 018655 Coldrex Syrup

Each 15ml contains


Dextromethorphan HBr …. 10mg


Clarification required regarding the

renewal application submitted in

2018, according to the initial

registration date renewal is due on 05-

02-2016.Evidence of any post

registration variation Evidence of

renewal of year 2013.

346. 074382 Viloc Suspension 250mg

Each 5ml contains

Ciprofloxacin as HCI …. 250mg

Firm is advised to comply the

decision of 290th meeting of

registration board regarding

Manufacturing Requirement of

Diluent for Ciprofloxacin Dry Powder

Suspension before further processing

the renewal of product.

347. 074383 Viloc Suspension 125mg Firm is advised to comply the

Each 5ml contains

Ciprofloxacin as HCI …. 125mg

decision of 290th meeting of

registration board regarding


Diluent for Ciprofloxacin Dry Powder


the renewal of product.

M/s. Humayun International Pharma (Pvt) Ltd., 20-Km Satiana Road, Faisalabad

348. 074325 Pakvit Injection 5mg

Each ml contains



has been observed:An undertaking that

the applied products have never been

de-registered.An undertaking that






laws.Attested copy of valid Drug

Manufacturing License.Attested copy

of last inspection report conducted by

DRAP.Approval of the section /

manufacturing facility (by Central

Licensing Board).Brief report of last

manufactured batch.Any post

registration variation since grant of

registration Approval status of

products in Reference Drug Agencies.


349. 030034 Elkopheniramine Tablet




has been observed:Renewal

application was submitted late but

within sixty days prescribed fee

required.An undertaking that the


registered.An undertaking that






laws.Approval of the section /



manufactured batch.Any post

registration variation since grant of

registration Approval status of

products in Reference Drug Agencies.

350. 030035 Elfolic Tablet


Folic Acid …. 5mg

351. 030036 Elkofur Tablet


Furazolidone …. 100mg

352. 008750 Dextrose 4.3% + Sodium Chloride

0.18% w/v Infusion

Each 100ml contains

Dextrose …. 4.3% Sodium

Chloride …. 0.18% w/v

M/s. Medicraft Pharmaceuticals (Pvt) Ltd., 126-B Industrial Estate Hayatabad, Peshawar

353. 028988 Clafax Tablet 250mg




has been observed:Renewal of year

2013 has been submitted late but


required for regularization.Latest GMP

inspection report required.An

354. 028989 Clafax Tablet 500mg




have never been de-registered.An






responsible as per relevant




manufactured batch.

M/s. Shaigan Pharmaceutical (Pvt) Ltd., 14-Km Adyala Road, Post Office Dahgal, Rawalpindi

355. 057267 Remet-5 Tablet


Ramipril …. 5mg


has been observed:Latest GMP













manufactured batch.

356. 057268 Remet-2.5 Tablet


Ramipril …. 2.5mg

357. 057269 Remet-1.25 Tablet


Ramipril …. 1.25mg

358. 049130 Mionex Tablet 400mg


Moxifloxacin as HCI …. 400mg

359. 049131 Fertab Tablet


Clomiphene Citrate …. 50mg

360. 049137 Cefdin Dry Suspension 125mg

Each 5ml contains

Cefdinir …. 125mg

361. 049138 Cefdin Dry Suspension 250mg

Each 5ml contains

Cefdinir …. 250mg

362. 049139 Cefdin Capsule


Cefdinir …. 300mg

363. 049140 Tepride Tablet


Itopride HCI …. 50mg

364. 049187 Tenocin Tablet


Minocycline as HCI …. 100mg

365. 057270 Dilgem Tablet 1mg












369. 057274 Dilgem Plus Tablet



Metformin HCI …. 500mg

(Show cause notice has been issued

to the formulation by the concerned

section.)

370. 057275 Gluzon Tablet 15mg


Pioglitazone as HCI …. 15mg

371. 057276 Gluzon Tablet 30mg



372. 057277 Gluzon Plus Tablet



Metformin as HCI …. 500mg

373. 049151 Ecad Tablet


Elemental Calcium …. 400mg

Vitamin D …. 100 I.U.

374. 049152 Gezlin Tablet


Gemifloxacin as Mesylate …. 320mg

M/s. English Pharmaceutical Industries, Link Katarband Road, Thokar Niaz Baig, Multan Road, Lahore

375. 074332 Biotic-P 1.20 M.I.U.

Injection

Each vial contains

Penicillin G Benzathine …. 1.20

M.I.U.



application has been submitted late but


required.

376. 074333 Biotic-P 0.60 M.I.U.

Injection

Each vial contains

Penicillin G Benzathine …. 0.60

M.I.U.

377. 074334 Enmox 250mg

Injection

Each vial contains

Amoxicillin Sodium eq. to

Amoxicillin …. 250mg

378. 074335 Zyncillin 500mg

Injection

Each vial contains

Ampicillin Sodium eq. to Ampicillin

…. 500mg

379. 074336 Zyncillin 250mg

Injection

Each vial contains


…. 250mg

380. 074337 Ampitan 750mg

Injection

Each vial contains


…. 500mg

Sulbactam Sodium eq. to Sulbactam

…. 250mg

381. 074338 Chroncef 2g Injection

Each ml contains

Ceftriaxone as Sodium …. 2g

382. 074339 Cefi 2g Injection

Each ml contains

Cefepime HCI with L-Arginine eq.

to Cefepime …. 2g

383. 074340 Xim DS Suspension

Each 5ml contains

Cefixime as Trihydrate …. 200mg

M/s. Macter International (Pvt) Ltd., F-216 S.I.T.E., Karachi

384. 029793 Ultima 125mg

Suspension

Each 5ml contains



has been observed:Clarification

required regarding the source of

granules of Clarithromycin and in case

of imported source differential fee


of year 2013 &2018.Approval of the

section / manufacturing facility of

cephalosporin (by Central Licensing

Board).

385. 029786 Maxima 400mg

Capsules

Each capsule contain

Cefixime …. 400mg

386. 029787 Maxima 100mg

Suspension


Cefixime …. 100mg

M/s. Getz Pharma (Pvt) Ltd., Plot No. 29-30, Sector 27, Korangi Industrial Area Karachi

387. 022019 Ceftazid 250mg

Injection

Each vial contains

Ceftazidime Pentahydrate, Sterile ….

29.5mg

Import in Bulk from M/s. LG

Chemical Ltd. Chun Buk-Do,

Korea and repack locally


has been observed:Detail required,

either the primary packaging,

secondary packaging and quality

release of product are done locally or

product is imported in finished

form.Free sale status of product in

market.Original legalized valid COPP

is required.Original legalized valid

GMP certificate is required as copy is

submitted.Latest DRAP attested

invoice.Prescribed fee required for

regularization of renewal of year 2013

as the products are imported in bulk

and locally repack.Clarification

regarding the manufacturing facility of

Dry Powder for inhalation, in the light

of decision of 290th meeting of

Registration Board.

388. 022020 Ceftazid 500mg

Injection

Each vial contains


59mg


Chemical Ltd. Chun Buk-

Do,Korea and repack locally

389. 022021 Ceftazid 1g Injection

Each vial contains


118mg


Chemical Ltd. Chun Buk-

Do,Korea and repack locally

390. 075970 Titro Powder for Inhalation 18mcg


Tiotropium Bromide Monohydrate

eq. to Tiotropium …. 18mcg


391. 003493 Cloramidina Eye Ointment

Each 10gm contains

Chloramphenicol …. 1% w/w


has been observed:Latest GMP













manufactured batch.Copy of Valid

DML.

392. 003489 Cloramidina Ear Drops

Each 100ml contains

Chloramphenicol …. 1g

393. 003495 Cloramidina Eye Drops

Each 100ml contains

Chloramphenicol …. 0.5g

394. 003491 Sa Cit Syrup

Each 5ml contains

Sodium Acid Citrate …. 1.25g

M/s. Espoir Pharmaceuticals PCSIR KLC, PCSIR Laboratories Complex, Shahrah-e-Dr. Salim-Uz-

Zaman Siddiqui off University Road, Karachi

395. 073821 Enfys Capsule 20mg



Trihydrate enteric coated pellets eq.

to Esomeprazole …. 20mg

Pellets will be purchased in bulk

from M/s.Vision Pharmaceuticals



application of year 2018 has been

receive late but within sixty days

prescribed fee required.Latest GMP

inspection report required.Approval of

the section / manufacturing facility (by

Central Licensing Board).-Brief report

of last manufactured batch.Copy of

Valid DML.

396. 073822 Enfys Capsule 40mg



Trihydrate enteric coated pellets eq.

to Esomeprazole …. 40mg



397. 073819 Refuge Capsule 20mg



to Omeprazole …. 20mg



398. 073820 Refuge Capsule 40mg



to Omeprazole …. 40mg



399. 073823 Pdif Capsule 40mg

Each enteric coated tab contains


eq. to Pantoprazole …. 40mg

400. 073824 Invicta 300mg Tablet


Dexibuprofen …. 300mg

401. 073825 Titlis 80/480 Tablet



Lumefantrine …. 480mg

402. 073826 Titlis 20/120 Tablet




403. 073827 invicta 400mg Tablet



404. 073828 Titlis 40/240 Tablet




405. 073829 RH-12 Sachet


Sodium Chloride …. 2.6g Tri

Sodium Citrate …. 2.9g Potassium

Chloride …. 1.5g Glucose

Anhydrous …. 13.5g

406. 073830 Wilten 100mg


Each 5ml contains

Nitazoxanide …. 100mg

407. 073831 Letob 125mg/5ml Dry Powder

Suspension

Each 5ml contains


Levofloxacin …. 125mg

408. 073832 Letob 250mg/5ml Dry Powder

Suspension

Each 5ml contains


Levofloxacin …. 250mg

409. 073833 Zimaze 20mg/5ml

Each 5ml contains

Zinc Sulphate Monohydrate eq. to

Elemental Zinc …. 20mg

410. 073834 Ijs Syrup

Each 5ml contains


complex eq. to Elemental Iron ….

50mg


411. 073835 Invicta 100mg/5ml Syrup

Each 5ml contains


412. 073847 Painflex 20mg

Capsule


Piroxicam as Beta Cyclodextrin

191.2mg

eq. to Piroxicam …. 20mg

413. 073848 Xclent 400mg Tablet


Moxifloxacin as HCI …. 400mg

M/s. S.J & G. Fazul Ellahie (Pvt) Ltd., E/46, S.I.T.E., Karachi

414. 075829 Despar MR Capsule


Mebeverine HCI extended release

pellets eq. to Mebeverine HCI ….

200mg

Pellets are imported in bulk from

R.A. Chem Pharma Ltd. Plot No.

A-19/C,Road No.18

,IDA,Nacharam,Hyderabad,India


has been observed:Prescribed fee

required as the pellets are imported

from India.You have submitted the

master formulation of product in which

Riboflavin -5Sodium Phosphate,

Pyridoxine HCl, Nicotinamide and

Dexpanthenol is use as an excipient.

Justification is required to use these as

an excipient and define their role as an

inactive in this formulation. Define the

role of Sodium Formaldehyde

Sulfoxylate in the formulation.-Further

complete Form 5-B is required as

incomplete form has been submitted

along with dossier.You have submitted

the master formulation of product in

which Pyridoxine HCl,

Cyanocobalamin is used as an

excipient. Justification is required to

use these as an excipient and define

their role as an inactive in the

formulation.

415. 004059 Rexaplex Injection

Contains:

Vitamin B complex

416. 004060 Vitamin B Compound Forte

Injection

Contains:

Vitamin B compound Forte

M/s. Zanctok Pharmaceutical Laboratories, F/5 S.I.T.E., Hyderabad

417. 021601 Zantazil Suspension

Each 10ml contains

Aluminium Hydroxide Gel ….

400mg


Shortcoming letter has been issued on

15-10-2018,reminder is communicated

to the firm dated 19-09-2019.

418. 021602 Zalomycetin Suspension

Each 5ml contains

Chloramphenicol Palmitate eq. to

Chloramphenicol Base …. 125mg

419. 021603 ZeoplexSyp

Each 15ml contains


Riboflavin …. 3mg



Mediate Pharmaceutical (Pvt) Ltd., Plot No. 150-151, Sector 24, Korangi Industrial Area, Karachi

420. 044104 Hilixophin 250mg

Dry Powder Injection


Ceftriaxone (as Ceftriaxone Sodium)

…..250mg


has been observed:Initial registration

letter requiredClarification required

regarding the address of firm on

change of brand name letter dated 04-

12-2017, address mentioned on said

letter is Sector C-14, Manghopir Road,

SITE Karachi. While address on DML

is Sector-24 Korangi Industrial Area

Karachi.

421. 044105 Hilixophin 500mg




…..500mg

422. 044106 Hilixophin 1g Dry Powder Injection



…..1g

423. 044107 Hitaxime 250mg



Cefotaxime (as Cefotaxime Sodium)

…..250mg

424. 044108 Hitaxime 500mg




…..500mg(Cephalosporin)

425. 044109 Hitaxime1g Dry Powder Injection



…..1g

426. 044110 Mediroxime 250mg



Cefuroxime(as Sodium)

427. 044111 Mediroxime 750mg



Cefuroxime (as Sodium) …..750mg

428. 044112 Mediroxime 1.5g Dry Powder

Injection


Cefuroxime (as Sodium) …..1.5g

429. 044113 Hitazidime 250mg

Injection

Each vial contains:

Ceftazidime……250mg

430. 044114 Hitazidime 500mg

Injection

Each vial contains:

Ceftazidime……500mg

431. 044115 Hitazidime 1g Injection

Each vial contains:

Ceftazidime……1g

432. 045297 CS-Sumbest 1gm

Dry Powder Injections


Cefoperazone (as Sodium)..500mg

Sulbactam(as Sodium)… 500mg

433. 045298 CS-Sumbest 2gm



Cefoperazone (as Sodium)..1000mg

Sulbactam(as Sodium)…1000mg

434. 045299 Opimed 500mg



Cefpirome……500mg

435. 045300 Opimed 1g Dry Powder Injections


Cefpirome……1g

436. 045301 Inzolir 250mg



Cefazolin (as Sodium)…250mg

437. 045302 Inzolir 500mg



Cefazolin (as Sodium)…500mg

438. 045303 Inzolir 1g Dry Powder Injections


Cefazolin (as Sodium)…1g

M/s. Hamaz Pharmaceuticals (Pvt) Ltd., 13-Km, Bosan Road, Lutfabad, Multan

439. 076988 Nixin Suspension 125mg

Each 5ml contains:

Ciprofloxacin HCI eq. to



has been observed:Firm is advised to

comply the decision of 290th meeting

of registration board regarding


Diluents for Ciprofloxacin Dry Powder


the renewal of product.Valid DML

required.

440. 076989 Nixin Suspension 250mg

Each 5ml contains:

Ciprofloxacin HCI eq. to


M/s. Poul Med Enterprises, 9 Amber Estate Building Baloch Colony, Shahra-e-Faisal, Karachi

441. 021230 Trimetoprim 40 Sulfadimetossina

200 Oral Solution

Each liter contains

Trimethoprim …. 40g

Sulphamethoxazole …. 200g

M/s Chemifarma S.P. Italy

Shortcomings:Letter of shortcoming

has been communicated to the firm


under:Drug Sale License (DSL) Free

sale status of product in





invoice.Both undertaking as per SOP.

M/s. ICI Pakistan Ltd.,5-West Wharf Road, Karachi

442. 017113 Systamex 200mg

Bolus

Each Bolus contains

Oxfendazole …. 200mg

M/s. Help Limited Athens, Greece



dated 17-10-2018, and reminder was

given on 13-09-2019 Details are as

under:Drug Sale License (DSL) Free

sale status of product in





invoice.Both undertaking as per

443. 028590 Tricure Injection

Each ml contains

Flunixin as Meglumine …. 50mg

M/s. Norbrook Laboratories Limited,

Northern Ireland

444. 020134 Spectrazole (Milking Cow Intra-

Mammary) Infusion

Each single dose syringe contains

Cefuroxime as Sodium Salt ….

250mg

M/s. Schering-Plough Animal Health

Corporation,UK

SOPInitial registration letter required

for product at sr.no.270Post

registration variation letter required

regarding toll manufacturing for

product at sr.no.269

445. 017112 Zaquilan Bolus

Each Bolus contains

Baquiloprim …. 0.8g

Sulphadimidine …. 7.2g

M/s. Schering-Plough Animal Health

Corporation,UK

M/s. Delux Chemical Industries, Plot No. 26-A1 Landhi Karachi

446. 029640 Reocin-TD

Each 100gm contains

Tylosin Tartrate …. 20g

Doxycycline HCI …. 40g


has been observed:Renewal of year

2013 has been submitted late but


required for regularization.Approval of

the section / manufacturing facility of

(by Central Licensing BoardAttested


License.Attested copy of last


DRAP.Both undertaking required as

per approved SOP.

447. 029626 Acipin Powder

Each kg contains

Procaine Pencillin …. 12g

Streptomycin Sulphate …. 36g

Zinc Bacitracin …. 52g

448. 029627 Normic Powder

Each gm contains

Oxytetracycline HCI …. 300mg

Neomycin Sulphate …. 150mg

Chlormaphenicol …. 300mg


449. 029631 Flumeg Injection

Each ml contains

Flunixin Melamine …. 50mg



application was submitted late but

within 60 days prescribed fee


last renewalLatest GMP inspection

reportDetail of post registration

variation (if any)Both undertakings (as

per SOP)Section approval letter issued


450. 029656 Brics Injection

Each vial contains

Ceftiofur Sodium …. 1g

M/s. Atco Pharma International (Pvt) Ltd., , B-18, S.I.T.E., Karachi

451. 021230 Diluent for Bemocin 15 Units

Injection

Each ampoule contains

Sterile Water for Injection USP

5.0ml

M/s. Fresenius Kabi Oncology

Limited, India




under:Original legalized valid COPP is

required.Original legalized valid GMP

certificate is required

M/s. Epla Laboratories, D-12, Estate Evenue, S.I.T.E, Karachi, 75700

452. 22048 Mecol Injection

Each ml Contains:-

Mecobalamin…500mcg imported in

bulk vials from Panbiotic Taiwan

and repacked locally.

Deferred in 291st meeting of DRB.


2019. Please Clarify source of vials

along with pack size imported.Please

Clarify that imported vial is labelled or

not.Please provide approval of section

for repacking.following reply

received:-Approved source is Ms.

Panbiotic Taiwan and the imported

pack size is 1mlx10’s and vial are

imported preprinted.Furthermore, firm

has no dedicated repacking area and

using the general packing area.

453. 76082 Pregrose-F Tablet


Iron (lll) Hydroide polymaltose


Iron.…………………....100 mg

polymaltose complex) Folic

Acid………..……0.35 mg


2019 Application for renewal is

applied after due date 25-09-2018,

please deposit differential fee for

Each product mentioned. Firm

responded that they have deposited Fee

on 14-09-2018. However, R&I receipt

is on 26-09-2018. Firm is One day late

in submission of Renewal application. 454. 76083 Pregrose Syrup

Each 5ml contains:-

Iron (lll) Hydroide polymaltose


Iron………………….…..50 mg




Trihydrate ………..…….20 mg

M/s. Zafa Pharmaceuticals Laboratories (Pvt) Ltd, L-4/1, A&B, Block 21, Federal B Industrial Area,

Karachi

456. 007154 Furatop Cream 0.2%Contains:-

Nitrofurazone USP/ BP.0.2%w/w

Deferred in 291st Meeting of DRB.

Firm Provided the shortcomings.

457. 006926 Naptrol 250mg Tablet


Naproxen B.P……..250mg

458. 007153 Furatop Powder Contains:-

Nitrofurazone USP/BP.0.2%w/w


459. 076960 Friendine Injection


Ranitidine (as HCl) ….. 25 mg

(B.P. Specs)

Deferred in 290th Meeting of DRB.



(RRR) dated 14-06-2019. However,

following deficiency is yet not

provided. Please provide Notarized

copy of approval of change of brand

name.Firm replied that they have

applied for correction in brand name

while issuance of registration letter.

However, approval of change name is

not provided.


2019 reply received. DML renewal is

460. 052842 Nomilex Tablets 0.5mg


Alprazolam.0.5mg

461. 052843 Tanil Tablet 3mg


Bromazepam...3mg

applied.

M/s. Vetcon Pharmaceutical Pvt. Ltd, Plot No. 7-10 B, Industrial Estate, Bhimbar, AJK.

462. 031499 Levacon-50 Liquid Solution.

Each ml contains:-

levamisole hydrochloride 500mg.

Deferred in 290th meeting of DRB.



(RRR) dated 14-06-2019. Firm has

provided following documents but not

duly notarized. last submitted renewal

application along with fee or renewal

certificate.Receipt of application for

renewal of Drug Manufacturing

License.registration letter for


strength.DRAP’s approval for

qualified staff or attested copy of

application submitted in DRAP.

463. 031500 Oxfendacon Liquid Suspension.

Each ml contains:-

Oxfendazole 22.65mg.

464. 031501 Clozacon Liquid Suspension.

Each ml contains:-

Oxyclozanide 34mg.

465. 031502 Ivercon-10 Injection

Each ml contains:-

Ivermectin 10mg.

466. 031503 Predcon-D Injection.

Each ml contains:-

Prednisolone acetate 7.5mg.

Dexamethasone sodium phosphate

2.5mg.

467. 031504 Gentacon-100 Injection.

Each ml contains:-

Gentamicin Sulphate (As Base)

100mg

468. 031505 Albacon-10% Liquid Suspension.

Each ml contains:-

Albendazole 100mg

M/s Amros Pharmaceuticals, A-96, S.I.T.E. North Karachi.

469. 031192 Amdik Tablets 50mg


Potassium…50mg

Deferred in 290th meeting of

DRB.Letter of shortcomings was

issued to the firm vide letter No. F.1-

65/ 2018 (RRR) dated 17-06-2019 firm

has provided shortcoming. However,

Notarized copy of Registration letter of

Amroton Syrup is not provided. Firm

has submitted differential fee of Rs.

10,000/- for late submisstion of

application for Amroton Syrup on 26-

06-2019. However, copy is provided

which is not notarized.

470. 031193 Amrofec Tablet 50mg


Sodium….50mg

471. 022565 Amroton Syrup


Ferric Ammonium Citrate…900mg

Folic Acid…10mg

Vitamin B1…20mg

Vitamin B6…40mg

Nicotinamide…20mg

Vitamin B12..360mcgD-

Panthenol…33mg

M/s. Indus Pharma (Pvt) Ltd, Plot No. 65, Sector 27, Korangi Industrial Area, Karachi

472. 004339-Ex Bioran Injection

Each 3ml contains:-

Diclofenac Sodium ……..75mg



2019 firm has replied with

shortcomings. However, undertakings

provided is not signed. 473. 000037-Ex Erythrocin Granules 125mg/5ml

Each 5ml contains:-

Erythromycin as (Erythromycin

Ethyl succinate)……….125mg






Artemether……..40mg,

Lumefantrine…………..240mg

476. 014823 Oflox Tablet 200mg









479. 053452 Onseron Injection 2ml

Each 2ml contains:-


M/s. Genix Pharma Pvt Limited, 44-45-B, Korangi Creek Road, Karachi

480. 53388 Dimis 50/200 Tablet


"Diclofenac Sodium ………….50mg

Misoprostol ……….…200mcg(BP

Specifications)"

Deferred in 291th meeting of

DRB.Shortcoming communicated on

22-07-2019. Form replied as under

against following deficiencies:Please

clarify the dosage form description of

formulation. firm replied that it is a

round biconvex film coated

tablet.Clarification is required for

availability of Tablet in Tablet

compression machine.

M/s Highnoon Laboratories Limited, 17.5 Km, Multan Road, Lahore.

481. 000033-EX Acetazolamide 500mg Tablet


Acetazolamide…500mg

Deferred in 291stmeeting of DRB.


July, 2019. Firm provided Notarized

Copy of DML. However, does not

provide approval of change of

manufacturing site. Registration letters

were issued on 71-B, C/2 Gulberg-III,

Lahore whereas, your manufacturing

site is at 17.5 Km, Multan Road,

Lahore. Please clarify. In case of

change of address, Please provide

Notarized Copy of approval of change

of address.

482. 000031-EX Xamig Tablet 500mg




July, 2019Firm provided Notarized



manufacturing site.Registration letters







of address.

483. 000032-EX Rifampicin 500mg

Capsule


Rifampicine 500mg


July, 2019. Firm provided Notarized










of address.

484. 4496 Hi-Togan Drops (For Ear)

Contains:-

Benzocaine…1%Phenazone…5%Gl

ycerin qs to 100%"

Deferred in 291st meeting of

DRB.Shortcoming communicated on

1st July, 2019. Firm provided Notarized




were issued on 38-M, Gulberg-III,






of address.Record of last manufactured

batch

M/s Harmann Pharmaceutical Laboratories Pvt. Limited, P.O Chung, 16 Km, Multan Road, Lahore.

485. 003612 Diazepam 2mg Tablet


Diazepam…2mg


Late renewal applied.


2019. Deferential fee was required for

late submission. Firm has deposited

Rs. 10,000/-

Each as differential fee for late

submission of renewal application for

5 products.Firm was advised to Please

provide notarized copy of approval of

section for psychotropic tablet

manufacturing. Firm replied that their

psychotropic drugs were registered in

1988 and at the time of registration,

there was no need of dedicated section.

486. 003664 Diazepam 5mg

Tab


Diazepam 5mg,


Tab


Paracetamol 500mg,


Elixer

Each 5ml Contains:-

Paracetamol 120mg,

489. 003932 Vitonol Syrup


Nicotinamide..23mg

Riboflavin…3mg

Thiamine Hcl 3mg

Pyridoxine Hcl 2mg

M/s. Medipak Limited, Plot No 132 Industrial Estate Kot Lakhpat Lahore. Lahore

490. 022594 Haes Steril 3% Intravenous infusion

Each 1 litre contains:-


2019 no reply received yet.Notarized

Poly(0-2 Hydroxyethyl)

starch= 60.0g

Molar Substition 0.40-0.55 (MS)

Average Molecular

weight Mv 200,000)

Sodium chlorid...9.0g

(Osmolarity = 309 mosm/1)

Water for injection to = 1000ml


License along with letter of approved

























authority.

491. 022583 Ciprofena Eye Drops

Each ml contains:-

Ciprofloxacin HCl eq

to.ciprofloxacin…….3mg

492. 014778 Medical BES Blance Electrolyte

Ophthalmic irrigation solution


Sodium chloride……0.64gm,

Potassium chloride…0.75gm,

Calcium chloride…..0.048gm,

Magnesium chloride……0.003gm,

Sodium Aetate….0.39gm, Sodium

citrate….0.17gm

M/s. Epla Laboratoies (Pvt) Ltd, D-12 Estate Avenue S.I.T.E Karachi

493. 014770 Ciprocide-500 Tablet


Ciprofloxacin HCl eq to…..500mg

Ciprofloxacin.


2019 no reply received yet.Application

on prescribed Form 5B along with

enclosures duly signed by Chief





be submitted along with application.

Please note that Prescribed form 5-B

should not be printed on company’s

letterhead.Notarized copy of last


DRAP.Notarized copy of approval of

Change of Technical Staff.

494. 014769 Ciprocide-250 Tablet


Ciprofloxacin HCl eq to…..500mg

Ciprofloxacin.

M/s. Danas Pharmaceuticals (Pvt) Ltd,Plot No .312-Industrial Triangle Kahuta Road Islamabad.

495. 053610 Cyclodan Capsule 50mg


Diclofenac sodium as pellets…50mg




License along with letter of approved






DRAP.Notarized Copy of Last

496. 053611 Danpep Capsule 40mg



eq. to Pantoprazole ……….40mg

497. 053612 Rumide Tablet 20mg


Leflunomide……………..20mg

498. 054591 Cyclodan SR capsule 100mg


Diclofenac sodium

(pellets)….100mg




brand name.

499. 054592 Cyclofen SR Tablets 100mg


Diclofenac sodium…..100mg

500. 054593 Vendep XR Tablet 75mg


Venlafaxine as HCl…….75mg

M/s. Elite Pharma (Pvt) Ltd, 9.5 Km, Sheikhupura Road, Lahore

501. 053733 Mavecef Cap.250mg

Each 5ml contains:-

Cephradine………….250mg


2019 no reply received

yet.Notarizedcopy of last inspection

report conducted by DRAP.Notarized

Copy of NOC of Central Research

Fund (CRF) as required by Budget &

Accounts Division.Notarized Copy of

Last Renewal Application Receipt

along with Fee challan. Notarized copy



stamp paper that submitted documents








authority.Notarized copy of approval

of section for manufacturing of these

drugs.

502. 053734 Mavecef Cap.500mg



503. 053735 Mavecef Dry susp 125mg

Each 5ml contains:-


504. 053736 Mavecef Dry susp 250mg

Each 5ml contains:-


505. 053721 Elexin Dry Suspension 125mg

Each 5ml contains:-

Cephalexin……..125mg

506. 053722 Elexin Dry Suspension 250mg

Each 5ml contains:-

Cephalexin……..250mg

507. 053725 Eliclor Dry Suspension 125mg

Each 5ml contains:-

Cefaclor (as monohydrate)…125mg

508. 053726 Eliclor Dry Suspension 250mg

Each 5ml contains:-

Cefaclor (as monohydrate)…250mg

509. 053718 Cefulite Injection 750mg


Cefuroxime (as Sodium) Sterile…

750 mg

510. 053731 Droxilite Dry Susp 125mg

Each 5ml contains:-

Cefadroxil (as

monohydrate)…….125mg

M/s. Alina Pharmaceuticals, Plot No. A-127 SITE Super Highway Karachi.

511. 052348 C-Pyrine Injection

Each ml contains:-

Methampyrone….200mg,

Aminopyrine……50mg,

Caffeine…..20mg, Chlorpheniramine

Maleate…….2mg



copy of last submitted renewal



Drug Manufacturing





512. 052349 Vitamin-SA Injection

Each ml contains:-

Vitamin E……70mg,

Vitamin B1……20mg,

Vitamin B12…..0.1mg, Sodium

selenite…0.5mg, Adenosine 5

monophosphate….5mg








laws duly notarized.Detail of last

manufactured batch.Proof of

availability of product in reference

regulatory authority. Notarized copy of

Approval of section for manufacturing

of these products.

513. 052350 Toldimfos Injection

Each ml contains:-

Toldimfos sodium……100mg

514. 052351 D-Methrin Solution

Each ml contains:-

Deltamethrin…..25mg

515. 052352 Almee oral Solution

Each ml contains:-

Ivermectin……………………..10m

g

516. 052353 Ciprolina 10% Injection

Each ml contains:-

Ciprofloxacin…………100mg

517. 052354 Chlorphen-P Injection

Each ml contains:-

Chlorpheniramine maleate…..4mg,

prednisolone…….10mg

518. 052355 S-Vit E Injection

Each ml contains:-

Vitamin E(Acetate)…..25mg,

Selenium……………2.2mg

519. 052333 Norlin Injection

Each ml contains:-

Norfloxacin……..100mg

Lincomycin

Hydrochloride……113.38mg

eq to Lincomycin base…..100mg

Amantadine Hydrochloride 49.6mg

eq to Amantadine base……40mg

520. 052334 Trichlor W.S. Powder

Each gm contains:-

Trichlorfon…………980mg

521. 052335 Clomix Plus Injection

Each ml contains:-

Cloxacillin sodium 136.25mg

eq to cloxacillin base……125mg

Amoxicillin trihydrate 143.75mg

eq to Amoxicillin base…….125mg

522. 052360 Analasone-C Injection

Each ml contains:-

Analgin…………………220mg

Vitamin C……………..20mg

Dexamethasone……..96mg

523. 052361 Vit-B Complex

Each ml contains:-

Vitamin B1………..0.2gm

Vitamin B6…………0.06gm

Vitamin B12………0.40gm

524. 052362 Multi vit injection

Each ml contains:-

Vitamin A Palmitate……5MIU

Vitamin D……….2.5MIU

Vitamin E…………2000IU

Vitamin B1…..0.2gm

Vitamin B6……….0.0gm

Vitamin B12………0.4gm

Nicotinamide……….0.06gm

525. 052363 S-Prim Injection

Each ml contains:-

Sulphamethoxypyridazine……200m

g

Trimethoprim…………40mg

526. 052356 Ascorlina Injection

Each ml contains:-

Ascorbic acid……………10mg

527. 052357 B.Hexine Injection

Each ml contains:-

Bromexine HCl………….3mg

528. 052358 Alverm Injection

Each ml contains:-

levamisol HCl……………75mg

529. 052359 Anagin-C Injection

Each ml contains:-

Analgin…………………220mg

Vitamin C……………..20mg

530. 052340 Licocin C W.s Powder

Each kg contains:-

Lincomycin HCl……..100gm

Colistin sulfate……800MIU

531. 052341 Calbor Injection

Each ml contains:-

Calcium Gluconate…..266mg

Boric Acid…………………..54mg

532. 052342 Nicofloxin Injection

Each ml contains:-

Norfloxacin……………100mg

Nicotinic Acid…………..40mg

533. 052343 Estropur Injection

Each ml contains:-

Cloprostenol Sodium…..263mg

534. 052344 Enflox Plus Powder

Each gm contains:-

Enrofloxacin…………………..100m

g

Colistin sulfate………………35mg

Amantdine HCl……………..40mg

535. 052345 Enflox-C Oral Suolution

Each ml contains:-

Enrofloxacin……………100mg

Colistin sulfate…………..48MIU

536. 052346 Vitamin ADE Injection

Each ml contains:-

Vitamin A………80000 IU

Vitamin D3………40000 IU

Vitamin E…………………..20mg

537. 052347 K.N.Dex Injection

Each ml contains:-

Kanamycin Sulfate…………..50mg

Neomycin sulfate…………….50mg

Colistin Sulfate…………10000IU

Dexamethasone sodium

Phosphate…………….0.5mg

538. 052337 Iverzole-F Suspension


Triclabendazole…….5mg

Ivermectin……………….1gm

Fenbendazole……………5gm

539. 052338 Levazole suspension


Triclabnedazole………………5gm

Levamisole

HCl……………..3.75gm

Albendazole…………………..10gm

540. 052339 Strepto-Pen Inectable solution

Each ml contains:-

Procaine pencillin………..200mg

streptomycin

sulfate…………..250mg

M/s. Nawan Laboratories (Pvt) Ltd,136 Sector 15 Korangi Industrial Area Karachi.

541. 014524 Nawazan SuspensionContains:-

Levamisole

hydrochloride………1.5%w/v,

Oxyclozanide……3.0% w/v


2019 no reply received yet.Please

Clarify the difference in dosage from

description as initial registration states

Drench and in change of brand name

suspension is written.

M/s. Care Pharmaceuticals,8-Km Thokar Raiwind Road Lahore.

542. 077044 Hysospas syrup

Each 5ml contains:-

Hysosine N-Butyl Bromide…..5mg

Please provide proof of availability in

Reference regulatory Authority.

543. 077045 Metocare Oral Drops

Each 5ml contains:-

Metoclopramide HCl eq to

Metoclopramide……….5mg

M/s. Glitz Pharma, Plot No 265 Industrial Triangle Kahuta Road Islamabad.

544. 054724 Ziglit Syrup

Each 5ml contains:-

Elemental zinc (as zinc sulphate

monohydrate)…….20mg


2019 no reply received yet.Please

provide proof of availability in

reference regulatory Authority. Please

confirm the availability of Atomic

Absorption for testing of these

products.

545. 077698 Osilex-D Tablet


Ossein Mineral complex…..830mg

eq to calcium……177.60mg

Phosphorous…………………82.20

mg

Residual mineral salts…..24.80mg

collagen…………………...……224

mg

Other

Proteins…………………88.4mg

Trace elements F1,Mg,Fe,Nim Cu

corresponding to

Approx…….440mg

Hydroxyapatitie

Vitamin D....................400IU

546. 077699 Osilex-D Suspension

Each ml contains:-

Vitamin

D……………………….400IU

Ossein mineral complex I,e

Hydroxyaoatite compound

(Anhydrous)…………….250mg

Eq to

calcium……………….53.50mg

Phosphorous…………..24.80mg

Residual Mineral salt………7.50mg

collagen……………8750mg

other protein……………….20mg

Trace element…..Fi, Mg, Zn, Fe, Ni,

Cu corresponding to

approx........132.53mg

hydroxyapatite

547. 077700 Osilex-D Suspension

Each 5ml contains:-

Vitamin

D……………………….400IU

Ossein mineral complex I,e

Hydroxyaoatite compound

(Anhydrous)…………….400mg

Eq to

calcium……………….85.59mg

Phosphorous…………..39.61mg

Residual Mineral salt………12mg

collagen……………107.95mg

other protein……………….32mg

Trace element…..Fi, Mg, Zn, Fe, Ni,

Cu corresponding to

approx........212mg

hydroxyapatite

M/s. Kohinoor Industries, 159-160/B Small Industrial Estate Sahiwal

548. 022436 Prodine Solution


10% w/v Providone iodine USP

eq.to. available iodine (1.0% w/v)


2019 no reply received yet.Last

renewal was applied after due date.

Differential fee required. Notarized




Drug Manufacturing

















of these products.

M/s. Bosch Pharmaceuticals, 221 Bosch House Sector 23 Korangi industrial Area Karachi.

549. 015112 Boschtamol Tablet 500mg


Paracetamol BP………….500mg


2019 Notarized copy of last submitted


renewal certificate.Notarized copy of


















of these products

550. 015113 Boshtan tablet


Mefenamic Acif BP………..250mg

551. 015114 Boschofen Tablet 200mg


Ibuprofen BP……………..200mg

552. 015115 Boschofen Tablet 400mg


Ibuprofen BP……………..400mg

553. 015118 Ulceloc tablet 200mg


Cimetidine …………….…200mg

554. 015119 Ulceloc tablet 400mg


Cimetidine …………….…400mg

555. 015120 Nulcer Tablet 150mg


Ranitidine (as HCl) ………150mg

556. 015121 Norocin Tablet 400mg


Norfloxacin

USP……………..400mg

557. 015122 Omezol capsule 20mg


Omeprazole………………20mg

558. 015123 Cefrinex Capsule 250mg


Cephradine……………..250mg

559. 015124 Cefrinex Capsule 500mg



560. 015125 Cefrinex Suspension 125mg/5ml

Each 5ml contains:-


561. 015126 Cefrinex Suspension 125mg/5ml

Each 5ml contains:-


562. 015127 Cefrinex vial 250mg









565. 015130 Cefotax Inj 250mg


Cefotaxime sodium……250mg

566. 015131 Cefotax Inj 1000mg


Cefotaxime sodium……1000mg

567. 015132 Dexamex Eye Drops 0.1% w/v

Each ml contains:-

Dexamethasone doidum phosphate

eq to 1mg

dexamethasone


1ml,2ml,3ml,5ml, and 10mlSterile

distilled water for injection

569. 023015 Dolo-K 50mg


Diclofenic potassium……50mg

570. 023020 Quinflox Infusion 100mg


Ciprofloxacin………………….100

mg

571. 023021 Quinflox Infusion 200mg


Ciprofloxacin………………….200

mg

572. 023018 Lorefect 10mg Tablet


loratadine…10mg

573. 055017 Zezot 500mg

Injection


Azithromycin (as

Dihydrate)…500mg

574. 055018 Q-Pro 30mg

Injection


Lansoprazole30mg

575. 055540 Falgan 1gm/100ml infusion


Paracetamol……………..1000mg

576. 055541 Batro 10mg Tablet


Bambuterol HCl……………10mg

577. 055542 Batro 20mg Tablet


Bambuterol HCl……………20mg

578. 055638 Bvir 0.5mg Tablet


Entecavir……0.5mg

579. 055639 Bvir 1mg Tablet


Entecavir…..1mg

580. 055909 Demtrat 10mg Tablet


Zolpidem Tartrate………10mg

581. 055910 Etidron 200mg Tablet


Etidronate Disodium200mg

582. 055911 Octorin 0.1mg Tablet


Desmopressin Aetate……0.1mg

583. 055912 Octorin 0.2mg Tablet


Desmopressin Aetate……0.2mg

584. 055913 Cefxone 2gm

Injection


Ceftriaxone (as Sodium)……..2gm

585. 055314 Zolrest 200mg/100ml Infusion


Linzezolid….200mg



Linzezolid400mg



Linzezolid….600mg

588. 055850 Zion 150mg Tablet


Bupropion HCL…………150mg

589. 055851 Proart 50/200 Tablet


Diclofenac sodium (In eneric coated

core)…..50mg

Misoprostol………………200mcg

590. 000221-EX Baxidyme 1gm

Injection


Ceftazidime (as

pentahydrate)….1000mg

591. 001192-EX Fixcef 400mg

Capsule


Cefixime…..400mg

592. 001193-EX Diflan 75mg/3ml Injection

Each 3ml contains:-

Diclofenac sodium (Bromide

free)…..75mg

593. 001194-EX Clovax 75mg Tablet


Clopidogrel (as Bisulphate) 78.76mg

eq to clopidogrel…75mg

594. 002157-EX Cefxone-S 375mg

Injection


Ceftriaxone (as Sodium)…..250mg

Sulbactam as doium……….125mg

595. 002158-EX Cefxone-S 750mg

Injection


Ceftriaxone (as Sodium)…..500mg

Sulbactam as doium…….250mg

596. 002159-EX Cefxone-S 1500mg

Injection


Ceftriaxone (as Sodium)……..1g

Sulbactam as doium……….500mg

M/s. Axis Pharmaceuticals,3-B Value Addition City 1.5 Km Khurrianwala – Sahanwala Road

Faisalabad.

597. 077074 Megrofen Suspension

Each 5ml contains:-

Ibuprofen……………100mg


2019. Reply yet not received.Notarized




Drug Manufacturing

















of these products.

598. 077073 Magnicon Oral Suspension

Each 5ml contains:-

Aluminium hydroxide…215mg,

Nmagnesium Hydroxide….80mg

Simethicone 25mg

599. 077075 Amclomide Syrup

Each 5ml contains:-

Metoclopramide (as Hcl)…..5mg

600. 077066 Genifer-F- Syrup

Each 5ml contains:-

Iron (III) hydroxide polymaltose

complex eq to elemental

iron…..50mg

601. 077068 Ceridal Syrup

Each 5ml contains:-

Cetirizine

Di Hydrochloride ……….…5mg

602. 077069 Dypin Oral Suspension

Each 5ml contains:-

Domperidone……………5mg

603. 077072 Deltalin Syrup

Each 5ml contains:-

Ammonium chloride……..30mg

Aminophylline…………………32m

g

Diphenhdramine HCl………..8mg

Menthol…0.98mg

M/s. Zanctok Pharmaceutical Laboratories, F/5 SITE Hyderabad

604. 022586 Zalovit Syrup


Vitamin A……….14000IU

Vitamin D…….1400IU

Vitamin B1……..2.8mg





certificate.Notarized copy of last

Nicotinamide…………….28.4mg

Vitamin C………….82.2mg


DRAP.Proof of availability of product

in reference regulatory authority. 605. 022587 Zufen Suspension

Each 5ml contains:-

Ibuprofen BP…………100mg

606. 022588 Zyfuron Suspension

Each 5ml contains:-

Furazolidone………………25mg

M/s. Epharm Laboratories, A-40, Road No. 1, S.I.T.E. Super Highway Industrial Area, North Karachi

607. 075826 Eptrim M 20/120mg Tablet


Artemether…………..20mg,

Lumefantrine…………………..120

mg















laws duly notarized.Notarized copy of


brand name.Detail of last





of these products.





mg





mg

610. 076485 Eptrim 20mg

Injection

Each ml contains:-

Artemether…………….20mg

611. 076486 Eptrim 40mg

Injection

Each ml contains:-


612. 076487 Eptrim 80mg

Injection

Each ml contains:-


M/s. Shawan Pharmaceuticals, Plot No. 37 Road NS-1 National Industrial Zone Rawat Rawalpindi

613. 052671 Shawbal Capsule


Mecobalamin …………...500mcg

Shortcomings:-Notarized copy of













laws duly notarized.Notarized copy of


brand name.Detail of last


614. 052672 Xegtin Capsule


Piroxicam as beta cyclodextrin

…..20mg




of these products.Xegtin Capsule name

is hand written without signature of

issuing authority, please clarify?

M/s. Martin Dow Limited, F-126 SITE Karachi.

615. 076142 Cal One-D Suspension

Each 5ml contains:-

Vitamin D…………….400IU

Ossein Mineral complex…..400mg

Corresponding to

Calcium….85.59mg

Phosphorous………………………3

9.61mg

Residual Mineral

Salt…………..12mg

Collagen 107.95mg

other proteins…….32mg

Trace elements F1, Mg, Zn, Fe, Ni,

Cu,)corresponding to Approximate

212mg

hydroxyapatite.


2019. Reply yet not received.Proof of


regulatory authority.Please clarify and

justify manufacturing of Stronsha

Sachet 2 gm

as no sachet section is approved in

letter for approval of amendments/

regularization of sections.

616. 076141 Salvaj-DS 30mg/180mg

Dry powder suspension

Each 5ml contains:-

Artemether………..30mg

Lumefantrine…………180mg

617. 076140 Stronsha Sachet 2gm


Storntium renelate……….2gm

M/s. Fassgen Pharmaceuticals, Plot No. 67/1 Block-A Phase-III Industrial Estate Hattar.

618. 053504 Artegen 140mg


Artemether………….20mg

Lumefantrine ………120mg


2019. Reply yet not received.Signature

on the covering letter and undertaking

on Form 5-B should be from Chief



below the manager level. In case

ofauthorized person, authority letter

shall be submitted along with

application. Form-5B should not be

printed on company letterhead.Copy of

NOC of Central Research Fund (CRF)

as required by Budget & Accounts

DivisionNotarized copy of last


with fee or renewal


Drug Manufacturing

License.Notarized copy of approval of

sections for manufacturing of said

drugs.Notarized copy of last inspection

report conducted by DRAP.Notarized

619. 053505 Atregen 280


Artemether………..40mg

Lumefantrine……240mg

620. 053506 Cebect 250


Ciprofloxacin HCl equivalent to

Ciprofloxacin………250mg

621. 053507 Ceftagen 250mg

Inj


Ceftazidime as Sodium…….250mg

622. 053508 Cefigen 500mg

Inj


Cefipime……….500mg

623. 053509 Cefrafass 1.0 inj


Cephradine with L-Arginine...1.0gm



strength.Notarized copy of any change

in particulars of registration of these

products.An undertaking on stamp










notarized.Proof of availability of

product in reference regulatory

authority.

624. 053510 Cefrafass 500 inj


Cephradine with L-Arginine...500mg

625. 053511 Ceftagen 1.0 Inj


Ceftazidime …………1gm

626. 053512 Ceftagen 500 inj


Ceftazidime …………500mg

627. 053513 Dezatax 1.0 inj


Cefotaxime as Sodium………1gm

628. 053514 Dezatax 500 inj


Cefotaxime Sodium equivalent to

Cefotaxime…..500mg

629. 053515 Dezatax 250 inj


Cefotaxime Sodium equivalent to

Cefotaxime ……250mg

630. 053516 Fabstin 10


Ebastine ……10mg

631. 053517 Famycin capsule 500mg


Azithromycin as

Dihydrate…..500mg

632. 053518 Fasidex Tablet 20mg


Piroxicam B Cyclodextrin……20mg

633. 053519 Fasmont Tablet 5mg


Montelukast as Sodium……..5mg

634. 053520 Faspirome 1g Inje


Cefpirome as Sulphate equivalent to

Cefpirome………..1gm

635. 053521 Cefigen 1 inj


Cefepime ……..1gm

636. 053522 Faspirome 500mg

Inj


Cefpirome as sulphate……..500mg

637. 053523 Fastrixone 1.0 Inj


Ceftriaxone as Sodium…….1gm

638. 053524 Fastrixone 250 Inj


Ceftriaxone Sodium equivalent to

Ceftriaxone……….250mg

639. 053525 Fastrixone 500 Inj


Ceftriaxone as Sodium……..500mg

640. 053526 Fasxime 100 susp

Each 5ml contains:-


641. 053527 Fasxime 200 DS susp

Each 5ml contains:-


642. 053528 Fasxime 400 Cap


Cefixime…………400mg

643. 053529 Fasxime 200 Cap


Cefixime…………200mg

644. 053530 Ironex Tablet 100mg


Iron polymaltose complex equivalent

to

elemental Iron…..100mg

645. 053531 Kanagen Tablet 200mg


Ketoconazole……….200mg

646. 053532 Levotar 500


Levofloxacin Hemihydrate

equivalent to

Levofloxacin………500mg

647. 053533 Mecobon Tablet 0.5mg


Mecobalamine……….500mcg

648. 053536 Sulbacef 1.0 Inj


Cefoperazone Sodium equivalent

to Cefoperazone………..500mg

Sulbactum…………..500mg

649. 053537 Sulbacef 2.0 Inj


Cefoperazone Sodium equivalent

to Cefoperazone………..1000mg

Sulbactum….………..1000mg

650. 053538 Sulpride 25


Levosulpride………25mg

651. 053539 Sulpride 50


Levosulpiride…….50mg

652. 053540 Levotar 250


Levofloxacin as

Hemihydrate….250mg

653. 053630 Mepragen 20 cap


Omperazole Pelelts……..20mg

654. 053631 Essofas 20 Caps


Esomeprazole Pellets ……20mg

655. 053632 Essofas 40 Caps


Esomeprazole Pellets ……40mg

656. 053633 Mepragen 40 cap


Omeprazole Pelelts………40mg

M/s. Novartis Pharma (Pakistan),15-West Wharf Dockyard Road Karachi.

657. 024660 Annuva Tablet Each Tablet

Contains 46.50 Diclofenac

Free Acid eq. to 50mg

of Diclofenac Salt

Shortcomings:-Notarized copy of last


with fee or renewal


Drug Manufacturing















regulatory authority. In address of

manufacturer, M/s GSK OTC Pvt. Ltd

is mentioned. Please Clarify?Notarized





products.

M/s. Pharmedic Laboratories Pvt. Ltd, 16 Km Multan Road Lahore

658. 052634 Plaxinol-50mg

Injection


Oxaliplatin……………50mg.

Shortcoming:-Notarized copy of last


with fee or renewal


Drug Manufacturing



DRAP.Detail of last manufactured

batch.Proof of availability of product

in reference regulatory authority.

Notarized copy of registration letter for




products.

659. 006923 Diaben 500mg

Tab


Metformin Hcl………..500mg

M/s. English Pharmaceuticals Industries, Indus Link Katarband Road Thokar Niaz Beg, Multan Road

Lahore.

660. 001857-EX Ketanov-EP Tablet

Each Film Coated Tablet Contains

Ketorolac

Trometamol…10mg


2019. Reply yet not received.An



registered duly notarized.Detail of last

manufactured batch. 661. 001858-EX Ketanov-EP Injection

Each ml Contains:-

Ketorolac Trometamol…30mg

662. 001859-EX Inzagi 250mg

Dry Suspension

Each 5ml Contains:-

Fosfomycin…250mg

663. 001860-EX Inzagi 500mg

Capsule


Fosfomycin…500mg

664. 001861-EX E-SPA Injection

Each Ampoule (4ml)

Contains"Phloroglucinol

Hydrate…40mg

Trimethylphloroglucinol…0.04mg"

665. 001862-EX Ecam Capsule 20mg


Piroxicam…20mg

666. 1863-EX Loprid 75mg Tablet

Each Film Coated Tablet Contains

Clopidogrel Hydrogen

Sulfate eq. to 75mg

Clopidogrel

M/s. Lahore Chemical & Pharmaceutical Works, 137-Shahrah-e-Moulana Jalal Ud din Roomi Lahore.

667. 14431 Riacen Cream Contains:-

Piroxicam…1%w/w

Shortcomings:-Notarized copy of last


with fee or renewal


Drug Manufacturing















regulatory authority.Notarized copy of


brand name and strength.

668. 14432 Fluibron Syrup


Ambroxol HCl…300mg

669. 14433 Fluibron Tablet


Ambroxol HCl…30mg

M/s. Aims Pharmaceutical, Plot No.291 Industrial Triangle Kahuta Road Islamabad. (VET)

670. 054804 Roxaim 20mg

Capsule


2019. No reply received yet. Notarized


Piroxicam … 20mg




Drug Manufacturing















notarized.Detail of last manufactured



671. 054802 Alexicam 15mg Tablet


Meloxicam … 15mg

672. 054801 Moxiaim 400mg Tablet


Moxifloxacin (as HCl) … 400mg

673. 054800 Amidic 50mg Tablet


Diclofenac Sodium … 50mg

674. 054803 Dexpir 20mg Tablet


Piroxicam -beta-cyclodextrin

191.2mg

eq. to Piroxicam … 20mg

675. 054806 Aimpram 10mg Tablet


Escitalopram (as Oxalate) … 10mg

676. 054805 Lotdis 5mg Tablet


Desloratidine … 20mg

M/s. Zakfas Pharmaceutical (Pvt) Ltd, 12-Km Bosan Road Lutafabad Multan (vet)

677. 057077 Albentex Oral Suspension


Albendazole … 2.5mg


2019. No reply received yet.

Notarized copy of last


with fee or renewal


Drug Manufacturing


















678. 057068 Oxfoban Suspension

Each ml contains:-

Oxfendazole … 22.65mg

679. 057073 Coliran-60 Injection


Colistin Sulphate … 60MIU

680. 057071 Enras -20 Injection

Each ml contains:-

Enrofloxacin … 20mg

681. 057072 CD Raas Powder

Each kg contains:-

Tylosin Tartrate … 100gm

Doxycycline Hyclate … 200gm

Colistin Sulphate … 50gm

Bromhexine HCl … 5gm

682. 057074 Coli Raas Powder

Each gm contains

Colistin Sulphate … 600,000IU

683. 057076 O.C Raas Plus Powder

Each kg contains:-

Oxytetracycline HCl … 100gm

Colistin Sulphate …80000000IU

Vitamin A … 2100000IU

Vitamin D3…420,000IU

Vitamin E…. 6500mg

Vitamin K3… 750mg

Vitamin B2… 300mg

Vitamin B12… 8300mcg

Nicotinic Acid … 15000mg

Calcium Pantothenate … 6000mg

684. 057078 Broncofas Powder

Each kg contains:-



Colistin Sulphate … 500MIU

Phenylbutazone … 12gm

Bromhexine HCl … 5gm

685. 048156 Tylozak Plus Powder

Each kg contains:-


Furaltadone … 75gm

Colistin Sulphate .. 300MIU

M/s. Indus Pharma (Pvt) Ltd, Plot No. 26, 27, 63, 64, 65, 66 & 67 Sector 27 Korangi Industrial Area

Karachi.

686. 053489 Cidpro 20mg

Capsule


Omeprazole enteric coated pellets …

20mg


2019. No reply received yet.Pallets are

imported from India, therefore,

additional Fee is required for renewal

of application. An undertaking on












authority.

687. 053490 Cidpro 40mg

Capsule


Omeprazole enteric coated pellets …

40mg

688. 032068 Copamol Tablet



Codeine Phosphate … 15mg

689. 053491 Indpro 30 mg

Capsule


Lansoprazole pallets… 30

mg.Source of pallets:M/s Pell Tech

Health Care Private Limited, Plot

No. 20-B, Tansa Farm Estate,

Village Met-Gonsai, Bhiwani-Wada

Road, Wada, Dist-Thane,

Maharashtra-421312- India.

690. 036588 Xed 500mg

Injection

Each 5ml contains:-

Tranexamic Acid… 500mg

691. 014855 Bromalex 3mg Tablet


Bromazepam …. 3mg

692. 04470-Ex Bioran Neo Injection

Each 3ml contains:-


M/s. Ophth Pharma, Plot No. 241 Sector 24 Korangi Industrial Area Karachi.

693. 032399 Lincom Injection Shortcomings Notarized copy of last

Each ml contains:-

Lincomycin HCl. Eq. to Lincomycin

base … 300mg


with fee or renewal


Drug Manufacturing


















M/s. Geofman Pharmaceutica, 20-23 Korangi Industrial Area Karachi.

694. 04410 Betamethasone Tablet


Betamethasone … 0.5mg

ShortcomingsPlease provide notarized

copy of last submission of renewal

application submitted after 2010 for

availing opportunity under SRO

1005(i)/2017. Please provide Notarized

copy of leter of approval of Tablet

section (Steriod) for manufacturing of

said product.Proof of availability of

product in reference regulatory

authority.

M/s. Olive Laboratories, Plot No.52-S-6 National Industrial Zone Rawat Rawalpindi.

695. 079408

Nofaveer Tablet

Each film coated Tablet contains:-

Tenofovir Disrpoxil Fumarate …

300mg

ShortcomingsNotarized copy of last


with fee or renewal


Drug Manufacturing
















batch.

M/s. Shrooq Pharmaceutical,21-Km Ferozepur Road, Lahore.

696. 040298 Lortin D Tablet


Loratadine …. 10mg

ShortcomingsNotarized copy of last


with fee or renewal


Drug Manufacturing
















batch.

M/s. Sami Pharmaceutical (Pvt) Ltd,F-129 SITE Karachi.

697. 022420 Sterile Distilled Water for Injection


Sterile distilled water for injection

containing no antimicrobial agent or

other added substance

Shortcoming was communicated on

23rd September, 2019. Reply yet not

received An undertaking on stamp










notarized.

698. 076308 Izato 500mg Tablet


Nitazoxanide … 500mg

699. 076309 Izato 100mg/5ml Suspension

Each 5ml of reconstituted suspension

contains:-

Nitazoxanide … 100mg

700. 076310 Nixaf 200mg Tablet


Rifaximin … 200mg

701. 076311 Mevulak Sachet

Each Sachet contains:-

Mebeverin HCl … 135mg

Ispaghulla Husk … 3.5g

702. 076306 Gpride-M SR 1/500mg Tablet

Each bilayered tablet contains:-

Glimepiride … 1mg

Metformin Hcl (as sustained release)

… 500mg

703. 076307 Gpride-M SR 2/500mg Tablet

Each bilayered tablet contains:-

Glimepiride … 2mg

Metformin Hcl (as sustained release)

… 500mg

M/s. Flow Pharmaceutical (Pvt) Ltd, 17-Km Sheikhupura Road Lahore.

704. 022924 IAN Tablet Shortcoming was communicated on


Clomiphene Citrate… 50mg

24th September, 2019. Reply yet not

received Notarized copy of last


with fee or renewal


Drug Manufacturing
















batch.

705. 022925 Bacty Forte Tablet


Sulphamethoxazole … 800mg

Trimethoprim … 160mg

706. 022922 Xany Dipersable Tablet



707. 022450 Floret Tablet


Lortatidine … 10mg

708. 022932 Oracap-T Tablet


Vitamin A… 5000IU

Vitamin D … 500IU

Vitamin B1… 10mg

Vitamin B2… 10mg

Vitamin B6… 4mg

Vitamin B12… 5mcg

Vitamin E … 50IU

Vitamin C…. 300mg

Calcium Pantothenate … 20mg

Folic Acid … 1mg

Biotin … 300mg

Nicotinamide … 50mg

Iron … 50mg

Iodien … 100mcg

709. 022919 Opain Tablet



710. 022452 OX-600 tablet


Oxaprozin … 600mg

711. 022451 Bescard Tablet 5mg


Amlodipine (as besylate) … 5mg

712. 022921 Ulcenor Tablet


Ranitidine (as HCl) … 150mg

713. 022920 Troloc Capsule


Omeprazole … 20mg

714. 022923 Gyny Viginal Tablet


Clotrimazole … 500mg

715. 022453 Bescard tablet 10mg


Amlodipine (as besylate) … 10mg

Meditech Pharmaceuticals, 15-D, Industrial Estate, Jamrud Road, Peshawar.

716. 056803 Med Enema

Each ml contains:-

Dibasic Sodium Phosphate (Sodium



received Renewal application of Metzil

Phosphate) … 6.00gm

Mono Basic Sodium Phosphate

(Sodium Biphosphate) …16.00gm

Suspension is applied after due date as

per letter No. F. No. 3-1/2018-RRR

(M-277) dated 5th October, 2018 for

regularization of said product till 23-

12-2018. Please deposit differential fee

as per SRO 1005(I)/2017. Notarized




Drug Manufacturing
















batch.

717. 056804 Medicol Suspension

Each 5ml contains:-


718. 060820 Medinase Drops

Each 5ml contains:-

Sodium Chloride … 32.5mg

(0.65%)

719. 056123 Metzil Suspension


Metronidazole Benzoate eq. to


Diloxanide Furoate … 250mg

720. 033828 Gelcid Suspension

Each 5ml cotains:-

Aluminium Hydroxide Gel (Dried)

… 215mg

Simethicon… 25mg

Magnesium Hydroxide … 80mg

721. 033829 Cotazole Suspension

Each 5ml cotains:-



722. 033830 Cotazole DS Suspensio

Each 5ml cotains:-

Sulphame thoxazole … 400mg


723. 033831 Hydil Syrup

Each 5ml cotains:-

Aminophyline ... 32mg

Diphenhydramine … 8mg

Ammonium Chloride … 30mg

Menthol … 0.98mg

724. 033832 Hydil DM Syrup

Each 5ml cotains:-

Diphenhydramine HCl … 5mg

Dextromethrphan … 6.25mg

725. 033833 Mefar Suspension

Each 5ml cotains:-

Mefenamic Acid … 50mg

726. 033834 Mebz Suspension

Each 5ml cotains:-

Mebendazole … 100mg

727. 033836 Histor Syrup

Each 5ml cotains:-

Lotratadine … 5mg

728. 033837 Zenest Syrup

Each 5ml cotains:-

Cetirizine Dihydrochloride … 5mg

729. 033838 Domitech Suspension

Each 5ml cotains:-

Domperidone … 5mg

730. 033576 HB Malt Syrup

Each 5ml cotains:-

Iron (III) Hydroxide Polymatose

Complex eq. to Elemental Iron …

50mg

731. 033827 Fevernil Suspension



M/s. Polyfine Chem Pharma, 51 Industrial Estate Hayatabad, Peshawar.

732. 032077 Pantulcer Tablet


Pantoprazole Sodium sesquihydrate

.. 45.1mg



received.Notarized copy of last


with fee or renewal


Drug Manufacturing
















batch.

733. 032078 Simtas 10mg Tablet


Simvastatin … 10mg

734. 032079 Simtas 20mg Tablet


Simvastatin … 20mg

735. 032081 Kaylan Capsules


Lansoprazole … 30mg

736. 032082 Tricosten 1 tablet



737. 032083 Tricosten 6 Tablet



738. 032084 Monocare Capsule


Fluconazole … 150mg

739. 032085 Polyxil Forte Suspension

Each 5ml contains:-


Amoxycillin base … 250mg

740. 032086 Tonek Tablet 75mg



741. 032080 Polylact Syrup

Each 5ml contains:-

Lactulose … 3.35gm

M/s. Atco Laboratories, B-18 S.I.T.E Karachi.

742. 07124 Primox DS Suspension

Each 5ml contains:-

Trimethoprim ….80mg


Sodium Citrate … 100mg

Availability in reference regulatory

authority.

M/s. Noa Hemis Pharmaceutical, Plot No. 154 Sector 23 Korangi Industrial Area Karachi.

743. 055560 Uflo Capsule


Tamsulosin HCl … 0.4mg

Please Clarify source of pallets.

M/s. Werrick Pharmaceuticals, 216-217,I-10/3, Industrial Area Islamabad

744. 54914 Linderm Cream


Shortcomings:Evidence of approval

of formulation in Reference

Lindane(Gamma Benzene

Hexachloride) …1%w/w

Regulatory Authorities i.e. . Linderm

Cream (Reg No. 54914), Caltab

Tablets (Reg No. 23061) & Co-

Cardiovasc Tablets 5/12.5mg

(Reg No. 56348).Source of pellets for

Meprazol 40mg

Capsules (Reg. No. 23060) and

differential fee in case of imported

pellets.

745. 23061 Caltab Tablets


Calcium Carbonate 1250mg

(eq. to 500mg

Elemental calcium)

746. 23060 Meprazol 40mg

Capsules

EachCapsule contains:-

Omeprazole(Coated granules) eq to

Omeprazole Activity …40mg

747. 56348 Co-Cardiovasc Tablets 5/12.5mg


Amlodipine(as Besylate) …5mg

Hydrochlorothiazide …12.5mg

M/s Dr. Raza Pharma, Plot # 44- C, Industrial Estate, Hayatabad, Peshawar.

748. 32102 Dicfin 75mg Tablets


Diclofenac Potassium …75mg



Regulatory Authorities i.e. . Dicfin

75mg Tablets (Reg No. 32102).Source

of pellets for Klary 125mg

Dry Suspension (Reg. No. 32104) and

Lapizole 20mg

Capsules (Reg No. 28914) and


pellets.Last renewal fee for CLA 1gm

Tablets (Reg No. 35289), CLA 625mg

Tablets (Reg No. 35290) & Mezonil

Suspension (Reg No. 35497) was

submitted after the due date, therefore,

differential fee is required.An










749. 32104 Klary 125mg

Dry Suspension

Each 5ml contains:-


750. 28914 Lapizole 20mg

Capsules

Each Capsules contains:-

Omeprazole Pellets eq. to of

Omeprazole ...20mg

751. 35289 CLA 1gm Tablets


Amoxicillin(as Trihydrate) …875mg

Clavulanic Acid (as Potassium salt)

…125mg

752. 35290 CLA 625mg Tablets


Amoxicillin(as Trihydrate) …500mg

Clavulanic Acid (as Potassium salt)

…125mg

753. 35497 Mezonil Suspension

Each 5ml contains:-

Mebendazole …100mg

M/s. Tabros Pharma (Pvt) Ltd, Plot No. L-20/B Karachi Industrial Area Sector-22 Federal B Area

Karachi.

754. 55456 Zirith Cream

Each gm contains:-

Bufexamac …50mg

Neomycin Sulphate …2500IU

Nystatin …100000IU



Regulatory Authorities.

M/s. Tagma Pharma (Pvt) Ltd, 12.5 Km Lahore Raiwind Road Lahore.

755. 32036 Spactrum Tablets 100mg


Sparfloxacin …100mg



Regulatory Authorities.Latest cGMP

Inspection Report having conclusive 756. 32037 Spactrum Tablets 200mg


Sparfloxacin …200mg

recommendations regarding cGMP.

757. 22500 Trovit F Tablets


Ferrous Fumarate …250mg

Thiamine Mononitrate …3.3mg

Riboflavin …3.3mg

Nicotinamide ..33.3mg

Pyridoxine HCl …3.3mg

Cyanocobalamine …50mcg

Ascorbic Acid …100mg

Folic Acid …1mg

Manganese Chloride …0.2mg

Copper Chloride …0.5mg

M/s. Xenon Pharmaceuticals (Pvt) Ltd, 9.5-Km Sheikhupura Road Lahore.

758. 24782 Xetac Tablets 150mg

Each Film Coated tablet contains:-

Ranitidine (as HCl) …150mg

Shortcomings:Copy of evidence of

Change of brand name for Xetac

Tablets 150mg

(Reg. No. 24782).Evidence of


Regulatory Authorities i.e. . Respirate

DM Syrup (Reg No. 24783), Respirate

E Syrup (Reg No. 24784) & Multifax

Ointment (Reg No. 32328).For

imported pellets of Somepra 20mg

Capsule (Reg No. 57498), Somepra

40mg

Capsule (Reg No. 57499) & Omrazo

40mg

Capsule (Reg No. 57511) differential

fee is required for last as well as latest

renewal for regularization.

759. 24783 Respirate DM Syrup

Each 5ml contains:-

Phenylpropanolamine HCl ..12.5mg

Dextromethophan HBr …10mg

760. 24784 Respirate E Syrup

Each 5ml contains:-

Phenylpropanolamine HCl …12.5mg

Guaifenesin …100mg

761. 32328 Multifax Ointment

Each gm contains:-

Polymycin B Sulphate …10,000unit

Zinc Bacitracin …500unit

762. 57498 Somepra 20mg

Capsule


Esomeprazole magnesium trihydrate

eq to Esomeprazole(Pellets) …20mg

M/s Cornileus Pharmaceuticals (Pvt)

ltd, Plot No. 43H..NO 7-1-414/43,

Santosh Mansion srinivas colony

(EAST) S.R, Hyderabad-500038

Andhra Pradesh, India.

763. 57499 Somepra 40mg

Capsule


Esomeprazole magnesium trihydrate

eq to Esomeprazole(Pellets) …40mg

M/s Cornileus Pharmaceuticals (Pvt)

ltd, Plot No. 43H..NO 7-1-414/43,

Santosh Mansion srinivas colony

(EAST) S.R, Hyderabad-500038

Andhra Pradesh, India.

764. 57511 Omrazo 40mg

Capsule


Omeprazole (pellets) …40mg

M/s Ravoos Laboratories Ltd H. No

5-35/234/4 Plot No.6 Mythri Nagar,

IDA Kukatpally Hyderabad-500072,

India.

M/s.Polyfine Chem Pharma, 51 Industrial Estate Hayatabad Peshawar

765. 32426 Antinaus Injection


Prochlorperazine Maleate …

12.50mg

Shortcomings:Evidence of submission

of last renewal duly endorsed by R&I,

DRAP, Islamabad and STO.Evidence

of approval of formulation for Lexhal

500mg

Injection (Reg. No. 32430), Polygenta

40mg

Injection (Reg. No. 32432), Ceframed

Injection 250mg

(Reg. No. 32440), Ceframed Injection

500mg

(Reg. No. 32441), Ceframed Injection

1gm

(Reg. No. 32442), Kanan Injection

1gm

(Reg. No. 32450), Cromosol Eye

Drops 4% (Reg. No. 32455), Polypred-

S Eye Drops (Reg. No. 32458),

Polypred-C Eye Drops (Reg. No.

32459) &Sterifin Eye Drops (Reg. No.

32462) in Reference Drug

Agencies.Evidence of approval of

formulation for Fazim Injection 250mg

(Reg. No. 32427), Fazim Injection

500mg

(Reg. No. 32428), Fazim Injection

250mg

(Reg. No. 32429) in Reference Drug

Agencies as Ceftazidime Sodium eq. to

Ceftazidime.

766. 32431 Polygenta 80mg

Injection

Each 2ml contains:-


Gentamycin …. 80mg

767. 32433 Fendic S. Injection



768. 32434 Polytax Injection 250mg


Cefotaxime Sodium eq. to

Cefotaxime … 250mg

769. 32435 Polytax Injection 500mg



Cefotaxime … 500mg

770. 32436 Polytax Injection 1gm



Cefotaxime … 1gm

771. 32437 Moklin Injection 250mg


Cefoperazone Sodium eq. to

Cefoperazone … 250mg

772. 32438 Cefrozil Injection 500mg



Cefoperazone … 500mg

773. 32439 Cefrozil Injection 1gm



Cefoperazone … 1gm

774. 32443 Ceftrex Injection 250mg



Cefriaxone … 250mg

775. 32444 Ceftrex Injection 500mg



Cefriaxone … 500mg

776. 32445 Ceftrex Injection 1gm



Cefriaxone … 1gm

777. 32447 Matric Injection



778. 32448 Piroflam Injection


Piroxicam … 20mg

779. 32449 Linco-Plus Injection

Each 2ml contains:-

Lincomycin (as Hcl)… 600mg

780. 32451 Silzolin Injection 500mg


Cephazolin Sodium eq. to

Cephazilon… 500mg

781. 32453 Water for Injection 5ml

contains:-

water for injection

782. 32454 Maxaclor Injection


Metoclopramide Hcl… 10mg

783. 32456 Optibram Eye Drops

contains:-

Tobramycin …. 0.3%

784. 32457 Cromosol Eye Drops 2%

contains:-

Sodium Cromoglyeate … 2%

785. 32460 Polypred Eye Drops

contains:-

Prednisolone Acetate… 1%

786. 32461 Naloroptic Eye Drops

contains:-

Naphazoline HCl… 0.025%

Pheniramine Maleate …0.3%

787. 32463 Polygenta Eye Drops

contains:-

Gentamycin (as Sulphate) … 0.3%

788. 32464 Fendic-S Eye Drops

contains:-

Diclofenac Sodium … 0.1%

789. 32465 Milosol Eye Drops

contains:-

Timolol (as maleate) … 0.5%

790. 32430 Lexhal 500mg

Injection


Cephalexin Sodium eq. to

Cephalexin … 500mg

791. 32432 Polygenta 40mg

Injection

Each 1ml contains:-


Gentamycin …. 40mg

792. 32440 Ceframed Injection 250mg


Cephradine …250mg

793. 32441 Ceframed Injection 500mg


Cephradine …500mg

794. 32442 Ceframed Injection 1gm


Cephradine … 1gm

795. 32450 Kanan Injection 1gm

Each ml contains:-

Kanamycin Sulphate eq. to

Kanamycin …1gm

796. 32455 Cromosol Eye Drops 4%

contains:-

Sodium Cromoglycate … 4%

797. 32458 Polypred-S Eye Drops

contains:-

Prednisolone Acetate … 0.25%

Sulphacetamide … 10%

798. 32459 Polypred-C Eye Drops

contains:-

Prednisolone Acetate … 0.2%

Sulphacetamide … 0.5%

799. 32462 Sterifin Eye Drops

contains:-

Zinc Sulphate…. 0.25%

Phenylephrine HCl … 0.12%

800. 32427 Fazim Injection 250mg


Ceftazidime Sodium eq. to

Ceftazidime … 250mg

801. 32428 Fazim Injection 500mg



Ceftazidime … 500mg

802. 32429 Fazim Injection 1.0gm



Ceftazidime … 1gm

M/s. Maple Pharmaceutical, Plot No. 147 Sector 23 Korangi Industrial Area Karachi.

803. 86240 Mefsunate Tablet

Each co-blister tablet,

Each contains:-

Mefloquine HCl … 250mg

01 film coated tablet,

Each contains:-

Artesunate … 100mg


of formulation in Reference Drug

Agencies.

M/s. Amros Pharmaceutical, A-96 SITE Karachi.

804. 23033 Tobcin 20mg

Injection

Each 2ml contains:-

Tobramycin Sulphate … 20mg

Shortcomings:Latest cGMP









805. 23034 Tobcin 80mg

Injection

Each 2ml contains:-

Tobramycin Sulphate … 80mg








M/s. Trigon Pharmaceutical (Pvt) Ltd, 8- Km Thoker Raiwind Road Lahore.

806. 14328 Trisamin Injection

Each 5ml contains:-

Tranexamic Acid … 250mg


Change of brand name.Last renewal

fee was submitted after the due date,

therefore, differential fee is required.

M/s. Global Pharmaceuticals (Pvt) Ltd, Plot No 204-205 Industrial Triangle, Kahuta Road, Islamabad.

807. 26986 Rama-D Capsule 50mg


Tramadol HCl ….. 50mg


Change of brand name.Evidence of

transfer of registration from 224, Street

No.1, I-10/3, Industrial Area,

Islamabad to Plot No 204-205

Industrial Triangle, Kahuta Road,

Islamabad.

808. 26987 Rama-D Injection 100mg

Each ml contains:-

Tramadol HCl ….. 100mg

M/s. English Pharmaceuticals Industries, Link Kattar Bund Road, Thokar Niaz Beg, Multan Road

Lahore.

809. 77087 Urimax 0.4mg

Capsules


Tamsulosin HCl eq. to Tamsulosin

…0.4mg

M/s Disto Pharmaceuticals (Pvt) lTd,

Plot No. 22, Phase-I, IDA,

Cherlapally, Hyderabad-500 051,

A.P, India.

Shortcomings:Differential fee is

required as Urimax 0.4mg

Capsules (Reg#77087) has imported

pellets.Evidence of approval of

formulation for Vit-K 1 Injection (Reg.

No. 77088) in Reference Drug

Agencies.

810. 77088 Vit-K 1 Injection

Each ml contains:-

Phytomenadione (Vitamin K1) ….

2mg

M/s. Zafa Pharmaceutical Laboratories (Pvt) Ltd, A-46, S.I.T.E, North Karachi

811. 32543 Emkit DS Tablet


Levonorgestrel … 1.5mg

Shortcomings:Evidence for approval

of Tablet (Hormone) section.

M/s. Zafa Pharmaceutical Laboratories (Pvt) Ltd, L-4/1, A&B Block 21, Federal B Industrial Area

Karachi

812. 23542 Debridat Tablet 200mg


Trimebutine Maleate … 200mg



Agencies.

M/s. Sapient Pharma, 123-S Industrial Area Kot Lakhpat Lahore.

813. 06939 Sevtol Lotion


Castor oil …6.3gm,Chloroxylenol

…5gm

Pot. Hydroxide … 1.36gm

Spit.Methy …20ml



Agencies.Evidence of Transfer of

registration of product from 123-S

Industrial Area Kot Lakhpat Lahore to

157- Abdul Hameed Scheme,

Samanabad, LahoreLatest cGMP












M/s. Reckitt Benckiser Pakistan Limited, F-18 S.I.T.E Karachi.

814. 24262 Disprin CnF Tablet


Aspirin …. 300mg

Paracetamol DC (Starch/pvp)

…210mg

eq. to Paracetamol … 200mg



Agencies.

M/s. Obsons Pharmaceuticals, 209-S Industrial Estate Kot Lakhpat Lahore.

815. 54153 Levortizin Tablet 5mg


Levocetirizine Dihydrate … 5mg

Shortcomings:For imported pellets of

Obpra 20mg

Capsule (Reg No. 54165) &

Obpra40mg

Capsule (Reg No. 54166) differential


renewal for regularization.Source of

pellets for Klario 125mg

Suspension (Reg. No. 54449) and


pellets.Evidence of approval of


Agencies for Obfosfo Suspension

(Reg#54448).Latest cGMP Inspection





Division.Notarized copy of Valid Drug

Manufacturing License.

816. 54154 Bonion Tablet 0.5mcg


Alfacalcidol … 0.5mcg

817. 54155 Klario Tablet 500mg


Clarithromycin … 500mg

818. 54156 Klario Tablet 250mg



819. 54157 Ob-Flox Tablet 500mg



Levofloxacin … 500mg

820. 54158 Cipcin Tablet 500mg


Ciprofloxacin HCl … 500mg

821. 54159 Obkast Tablet 5mg

Each chewable tablet contains:-

Montelukast Sodium eq. to

Montelukast Base … 5mg

822. 54160 Vomson Tablet 10mg


Domperidone … 10mg

823. 54161 Obkast Tablet 10mg


Montelukast Sodium eq. to

Montelukast Base … 10mg

824. 54448 Obfosfo Suspension

Each 5ml contains:-


Fosfomycin …. 250mg

825. 54449 Klario 125mg

Suspension

Each 5ml contains:-


826. 54165 Obpra Capsules 20mg


Enteric coated pellets of

Esomeprazole Magnesium trihydrate

eq. to Esomeprazole … 20mg

M/s Smilax Labs, Ltd. Plot# 88-A,

Flat# 401, Sarala Nivas, Street No.1,

Sagar Society, Road # 2, Banjara

Hills, Hyderabad, India.

827. 54166 Obpra Capsules40mg


Enteric coated pellets of

Esomeprazole Magnesium trihydrate

eq. to Esomeprazole … 40mg

M/s Smilax Labs, Ltd. Plot# 88-A,

Flat# 401, Sarala Nivas, Street No.1,

Sagar Society, Road # 2, Banjara

Hills, Hyderabad, India.

M/s. Saturn Pharmaceutical (Pvt) Ltd, 23-Km Thokar Raiwind Road Lahore.

828. 71278 Satafenac Injection

Each 3ml contains:-




DRAP, Islamabad and STO.Evidence

of approval of formulation for Kanasat

Injection IM (Reg. No. 71285) in

Reference Drug Agencies.Latest

cGMP Inspection Report having

conclusive recommendations regarding

cGMP.Notarized copy of Valid Drug

Manufacturing License.

829. 71279 Metroin Infusion IV



830. 71280 Levosat Infusion IV


Levofloxacin (as hemihydrate) …

500mg

831. 71281 Vortex Injection IV

Each 5ml contains:-

Iron Sucrose complex eq. to

Elemental Iron … 100mg

832. 71282 Domax Infusion IV


Ciprofloxacin (as Lactate) … 200mg



Water for injection … 5ml

834. 71284 Satamin Injection

Each ml contains:-


835. 71285 Kanasat Injection IM

Each 2ml contains:-

Kanamycin …. 500mg

836. 71286 Satacin Infusion IV Injection


Ofloxacin … 200mg

837. 71287 Ketalin Injection


Ketamin … 500mg

M/s. Abbott Laboratories (Pakistan) Limited, Opposite Radio Pakistan Transmission Centre Hyderabad

Road Landhi Karachi.

838. 15104 Klaricid Granules

Each 5ml contains:-


Shortcomings:Source fixation letter of

granules of Clarithromycin Suspension

is required.Evidence of approval of

formulation for Somogel (Reg. No.

07083) in Reference Drug Agencies. 839. 07083 Somogel

contains:-

Lignocaine (Base) ... 0.6 w/w

Cetylpyridinium Chloride … 0.02%

w/w

Menthol … 0.06w/w

Eucalyptol …. 0.1%v/w

Ethanol … 33%v/w

M/s. Lawari International Pharmaceutical, Gulkada Saidu Sharif Swat

840. 54933 Cipwari 250mg Tablet



Ciprofloxacin … 250mg

Shortcomings:For imported pellets of

Lesomep 40mg

Capsules (Reg No. 54935) Omepak

20mg

Capsules (Reg No. 54936) differential


renewal for regularization.Latest





Division. Notarized copy of Valid

Drug Manufacturing License.

841. 54934 Cipwari 500 mg Tablet



Ciprofloxacin … 500mg

842. 54937 Livle 250mg Tablet




843. 54938 Livle 500mg Tablet




844. 54939 Piroxibet 20mg Tablet


Piroxicam as Beta Cyclodextrin …

20mg

845. 54935 Lesomep 40mg

Capsules


Esomeprazole pellets eq. to

Esomeprazole activity … 40mg

M/s Murli Krishna Pharma (Pvt)

Limited, Shop No. 08, Pearle

Building Powai Vihar Complex

Powai, India

846. 54936 Omepak 20mg

Capsules


Omeprazole Pellets eq. to of

Omeprazole Activity … 20mg

M/s Murli Krishna Pharma (Pvt)

Limited, Shop No. 08, Pearle

Building Powai Vihar Complex

Powai, India

M/s. Seatle (Pvt) Ltd, 45 KM Multan Road Lahore.

847. 32494 Dowfen Gel 2.5%w/w

Each gm contains:-

Ketoprofen …25mg

Shortcomings:Renewal application has

been received late but within 60 days.

Therefore, prescribed late fee is


last renewal duly endorsed by R&I,

DRAP, Islamabad and STO.

M/s. Flow Pharmaceuticals (Pvt) Ltd, 17-km Sheikhupura Road, Lahore.

848. 23044 Ficloran Injection



Shortcomings:Evidence of change of

brand name for Flozid Capsule

(Reg#23098) &Flozid Suspension

(Reg#23099) from ‘Fixime Capsule &

Fixime Suspension’ to ‘O-Fix Capsule

& O-Fix Suspension’

respectively.Latest cGMP Inspection




Manufacturing License.Notarized copy

of Section approval letter issued by











849. 23098 Flozid Capsule


Cefixime Trihydrate …400mg

850. 23099 Flozid Suspension

Each 5ml contains:-

Cefixime Trihydrate…100mg

M/s. Venus Pharma, 23 Km Multan Road Lahore.

851. 30758 Angilock Tablets


Losartan Potassium …50mg
















laws. (on Stamp Papar).Brief report

of last batch manufactured.Complete

description of tablet dosage form i.e.

Film Coated or Plain etc.Approval of

technical staff issued by Licensing

Division.Evidence of submission of

last renewal duly endorsed by R&I,

DRAP, Islamabad and STO.

M/s. Bayer Pakistan (Pvt) Ltd, Plot No. 108, Kot Lakhpat Industrial Estate, Lahore.

852. 00697 Proviron Tablet


Mesterolone …25mg

Shortcomings:Notarized copy of

Initial registration letter for Proviron

Tablet (Reg#00697), Nerisone

853. 05829 Travogen Cream

Each gm contains:-

Isoconazole Nitrate …10gm

Cream,Ointment & Fatty Ointment

(Reg# 04105), Nerisone C Cream

(Reg# 04104) & Primolut N Tablets

(Reg#00677)Evidence of transfer of

registrations from M/s Medipharm to

new title i.e. M/s. Bayer Pakistan (Pvt)

Ltd, C-21, S.I.T.E, Karachi .Notarized

copy of Valid Drug Manufacturing

License of M/s. Bayer Pakistan (Pvt)

Ltd, C-21, S.I.T.E, Karachi.Notarized

copy of Section approval letter issued

by Licensing Division.Evidence of

approval of Tablet (Hormone) section

by Licencing Board.`Latest cGMP



854. 04105 Nerisone Cream,Ointment & Fatty

Ointment

Each gm contains:-

Diflucortolone Valerate …1mg

855. 05830 Travocort Cream

Each gm contains:-

Isoconazole Nitrate …1%

Diflucortolone Valerate …0.1%

856. 04104 Nerisone C Cream

Each gm contains:-

Diflucortolone Valerate …1mg

Chlorquinoldol …10mg

857. 0677 Primolut N Tablets


Norethisterone …5mg

M/s.Medicraft Pharmaceuticals (Pvt) Ltd, 126-B Industrial Estate Hayatabad, Peshawar.

858. 51085 Sefitime 1gm

Injection


Cefoperazone(as

Sodium)…………500mg

Sulbactum (as

Sodium)…………….500mg

Shortcomings:Evidence of change of

brand name from Bacticef to Cefopar

for applied products.

859. 56360 Sefitime 2gm

Injection


Cefoperazone(as

Sodium)…………1000mg

Sulbactum (as

Sodium)…………….1000mg

M/s. Glitz Pharma, Plot No 265 Industrial Triangle Kahuta Road Islamadad.

860. 54725 Usid-B Cream 2%w/w

Each gm contains:-

Fusidic Acid …20mg

Shortcomings:Renewal application

for Usid-B Cream 2%w/w

(Reg#54725) has been received late

but within 60 days. Therefore,

prescribed late fee is

required.Evidence of approval of

formulation G-Toco Tablet 100mg

(Reg#54926) in Reference Drug

Agencies.Latest cGMP Inspection



861. 54926 G-Toco Tablet 100mg


Vitamin E Acetate…100mg

M/s. Karachi Chemical Industries (Pvt) Ltd, F-25 Estate Avenue, SITE, Karachi.

862. 22959 Xylometazoline Nasal Spray

contains:-

Xylometazoline HCL …0.1%w/v



DRAP, Islamabad and STO.Notarized

copy of Valid Drug Manufacturing

License.Latest cGMP Inspection




863. 22960 Iqanol Tablets 50mg


Atenolol …50mg

864. 22961 Iqanol Tablets 100mg


Atenolol …100mg approval letter issued by Licensing










Stamp Papar).

865. 22958 Clotrimazole Solution 1%w/v

contains:-

Clotrimazole …1%w/v

M/s.Novartis Pharma (Pakistan) Ltd, 15-West Wharf Dockyard Road Karachi.

866. 78120 Jakavi 15mg Tablet


Ruxolitinib…15mg

Mfgd by:M/s Novartis pharma Stein

AG, Schaffhausestrasse, 4332 Stein,

SwitzerlandMA Holder:Novartis

Europharm Ltd., Wimblehurst Road,

Horsham, West Sussex, RH12 5AB,

United Kingdom.

Shortcomings:Original, valid and



sale certificate and GMP certificate.

867. 078119 Jakavi 5mg Tablet


Ruxolitinib…5mg

Mfgd by:M/s Novartis pharma Stein

AG, Schaffhausestrasse, 4332 Stein,

SwitzerlandMA Holder:Novartis

Europharm Ltd., Wimblehurst Road,

Horsham, West Sussex, RH12 5AB,

United Kingdom.

868. 23119 Exelon Capsules 1.5mg


Carbamoylatine as hydrogen

tartrate…..1.5mg

M/s Novartis Farmaceutica S.A.,

Spain.

869. 23120 Exelon Capsules 3.0mg


Carbamoylatine as hydrogen

tartrate…..3mg

M/s Novartis Farmaceutica S.A.,

Spain.

M/s B.Braun Pakistan (Pvt) Ltd, Khayaban-e- Jami, Block No.9, The Forum, Suite 216, 75600, Clifton,

Karachi

870. 33126 Propofol-Lipuro 1%

Each ml contains:-

Propofol … 10mg

M/s B.Braun Melsungen AG, Carl-

Braun-Strabe 1, 34212 Melsungen,

Germany.

Shortcomings:Differential fee is

required for late submission of renewal

application for latest and last renewal

of Propofol-Lipuro 1%

(Reg#33126).Notarized copy of initial

registration letter of Diazole Injection

(Reg#10053), Lipofundin MCT/LCT

20% (Reg#11084) & Gelofusine

(Reg#10222).Evidence of change of

manufacturing site from B.Braun

871. 59042 Aminoplasmal B-Braun 10% E

Solution for Infusion


Isoleucine …5gm

Leucine …8.9gm

Lysine HCl …8.56gm

(eq. to Lysine 6.85gm)

Methionine …4.4gm

Phenylalanine …4.7gm

Threonine …4.2gm

Tryptophan …1.6gm

Valine …6.2gm

Arginine …11.5gm

Histidine …3gm

Alanine …10.5gm

Glycine …12gm

Aspartic Acid …5.6gm

Glutamic Acid …7.2gm

Proline …5.5gm

Serine …2.3gm

Tyrosine …0.4gm

Sodium Acetate Trihydrate

…2.858gm

Sodium Hydroxide …0.36gm

Potasium Acetate …2.453gm

Magnasium Chloride Hexahydrate

…0.508gm

Disodium Phophate dodecahydrate

…3.581gm



Germany.

Switzerland to B.Braun Malysia for

Gelofusine (Reg#10222).Original,




certificate.Copy of Valid Drug Sale

License.

872. 10222 Gelofusine


Modified Fluid

Gelatin………….4.00gm

Weight average molecular

weight(Mw)….30000

Number average molecular

weight(Mw)………….23200

Sodium

Chloride……………..0.701gm

Sodium

Hydroxide……………..0.136gm

Water for Injections

to…………..100ml

Na…………154

Cl………..120

M/s B.Braun Medical AG,

Switzerland.

873. 23619 Etomidate-Lipuro Emulsion for

Injection

Each 10ml emulsion contains:-

Etomidate…20mg



Germany.

874. 11084 Lipofundin MCT/LCT 20%


Soybean Oil …100gm

Medium Chain Triglycerides

…100gm

Glycerol …25gm

Egg Yolk PhoPhelpids …12gm



Germany.

875. 59041 Aminoplasmal B-Braun 5% E

Solution for Infusion


Isoleucine …2.5gm

Leucine …4.45gm

Lysine HCl …4.28gm

(eq to lysine 3.43gm)

Methionine …2.2gm

Phenylalanine …2.35gm

Threonine …2.1gm

Tryptophan …0.8gm

Valine …3.1gm

Arginine …5.75gm

Histidine …1.5gm

Alanine …5.25gm

Glycine …6gm

Aspartic Acid …2.8gm

Glutamic Acid …3.6gm

Proline …2.75gm

Serine…1.15gm

Tyrosine …0.40gm

Sodium Acetate Trihydrate

…1.361gm

Sodium Hydroxide …0.14gm

Potasium Acetate …2.453gm

Sodium Chloride …0.964gm

Magnesium Chloride Hexahydrate

…0.508gm

Disodium Phophate dodecahydrate

…3.581gm



Germany.

876. 10053 Diazole Injection


Meronidazole …500mg

M/s B.Braun Medical Industries

SDN BHD, Bayan Lepas Free

Industrial Zone, 11900 Bayan Lepas,

Pulau Pinang, Malaysia.

M/s Zam Zam Corporation, 205- 206, Beaumont Plaza 6-CL-10 Beaumont Road Karachi.

877. 15726 Daivonex Ointment

Each gm contains:-

Calcipotrilol …50mcg

Mfgd by:M/s Leo Laboratories Ltd,

Shortcomings:Copy of Valid Drug

Sale License.

285 Cashel Road, Crumlin Dublin

12, D12 E923, Ireland MA

Holder:M/s Leo Pharma A/S,

Industriparken 55, DK-27500

Ballerup, Denmark.

878. 31379 Daivobet Ointment

Each gm contains:-

Calcipotrilol (as monohydrate)

…50mcg

Betamethasone (as

dipropionate)…0.5mg

Mfgd by:M/s Leo Laboratories Ltd,

285 Cashel Road, Crumlin Dublin

12, D12 E923, Ireland MA

Holder:M/s Leo Pharma A/S,

Industriparken 55, DK-27500

Ballerup, Denmark.

M/s. Manhattan Pharma, 209/B, Sector-5 (Green Belt) Korangi Industrial Area Karachi.

879. 14574 Furazone-M Feed Supplement

Powder

Each 1000gm

powder contains:-

Furazolidone … 244gm







Licensing Division.Notarized copy of


License.Evidence of submission of last


Islamabad and STO.An undertaking










880. 14575 Terra-M 200 Feed Supplement

Powder

Each 1000gm

powder contains:-

Oxytetracycline HCl… 200gm

M/s. Amros Pharmaceutical, A-96 SITE Karachi. Veterinary local

881. 22711 Chlorophenaramine Maleate

Injection

Each ml contains:-

Chlorpheniramine Maleate … 10mg

















M/s. Bio-Labs Research Lab, Plot No.145 Kahuta Triangle Industrial Estate Islamabad.

882. 14534 Biolyte Water Soluble Powder

Each 1000mg

contains:-

Vit A … 11,500,000IU

Vit D 1,800,000IU

Vit E… 5,200IU

Vit B2… 1200mg

Cal. D. Pantothenate … 10,000mg,

Folic Acid … 200mg,

Biotine … 10mg,

Sodium Chloride … 1600mg,

Zinc Sulphate … 10,000.00mg,

Magnanese Sulphate …10, 000mg,

L-Lysine Hcl … 10,000mg

DL-Methionine .... 10,000mg

Shortcomings:Clarification required

regarding the address of firm as the

address on Initial Registration Letter is

different from Drug Manufacturing

License.Clarification required

regarding date of initial registration for

Bio-HS Bacterin Injection (Reg No.

14536) as it is not mentioned on

registration letter.Evidence for

approval for injectable section

(Veterinary).

883. 14536 Bio-HS Bacterin Injection

Methionine … 60,000mg,

Lysine … 100,000mg,

Folic Acid … 550mg,

Nicotinic Acid … 25000mg,

Cal. Pantothenate … 4,500mg,

Arginine … 800mg,

Tryptophan … 350mg

Cysteine … 350mg,

Manganese … 1,500mg,

Iron Sulphate … 25,000mg

M/s. Noble Pharma, Plot No. B-1 Old Industrial Area Mirpur Azad Kashmir. Veterinary Local

884. 58728 Nobivet Oral Powder


Spiramycin Adipate … 2.50gm

Chlortetracycline Hydrochloride …

7.50gm

Shortcomings:Last renewal

application of products was received

late but within 60 days. Therefore,

prescribed late fee is required.Latest



cGMP.An undertaking that the applied









Stamp Papar).Any post registration

variation since grant of registration

885. 58729 Nobi- Spectin Powder


Lincomycin Hydrochloride

….33.3gm

Spectinomycin Sulphate … 66.7gm

886. 58730 Nobinor Solution

Each 1000ml Solution contains:-

Norfloxacin …. 250gm

887. 58731 Nobitylox -60 Powder


Tylosin Tartrate… 20gm

Doxycycline Hydrochloride…. 40gm

888. 58732 Nobi-Enro 10% Oral Solution

Each ml contains:-

Enrofloxacin … 100mg

889. 58733 Nobioxy-200 Powder

Each kg contains:-

Oxytetracycline Base …. 222gm

890. 58734 Nobi-Esb3 Powder


Sulphachlorpyridazine … 30%

891. 58735 Nobi-Cina TS Oral Solution

Each ml contains:-

Cenoxine … 75mg

Sulphamethoxypridazine … 75mg

Sulphamethazine … 50mg


892. 58736 Nobi-Trime Suspension


Sulphadiazine … 80gm

Trimethoprim …. 16gm

Tylosin Tartate …. 2gm

893. 58737 Nobi-Dvd Oral Solution


Sulphaquinoxaline … 2.56%w/v

Diaveridine … 0.64%w/v

894. 58738 Colisel 200 Solution


Colistin Sulphate …

2,000,000,000IU

895. 58739 Freecox Oral Powder


2,4-diamino-5

Veratrylpyrimidine … 25gm

Sulphabenzypyrazine … 100gm

Vitamin A … 1.25MIU

Menadione Sulphate Sodium

(Vitamin K3) … 2.5gm

896. 58740 Nobi-Dine Oral Powder


Sodium Sulphadiamidine … 80gm

Diaveridine … 8gm

897. 58741 Coccizole Plus Oral Powder


Sulphaquinoxaline Sodium… 200gm

Sulphadimidine Sodium … 82.5gm

Diaveridine …. 2.5MIU

Vitamin A …5000mg

Vitamin E … 5000mg

898. 58743 Nobiquin Oral Powder


Trimethoprim ... 4.62gm

Sulphaquinoxalline Sodium

…15.02gm

899. 58744 Tigercin TD Powder



Doxycycline HCl … 20gm

Colistine Sulphate … 3gm

Bromhexine … 1gm

900. 58720 Nobicholivet Powder


Colistine Sulphate ….

5,00,000,000IU

901. 58721 Nobicen Oral Liquid

Each ml contains:-

Tylosin Tartrate … 55mg

Sulfadiazine … 175mg


902. 58722 Nobidar Oral Powder


Amprollium Hydrochloride … 30gm

Sulphaquinoxaline Sodium … 20gm

Vitamin K3… 0.6gm

903. 58724 Nobillin-S Oral Solution

Each ml contains:-

Spiramycin Adipate … 12.5w/v

Lincomycin Hydrochloride …

7.5w/v

904. 58725 Nobi PSBC Powder


Procain Penicillin ... 12gm

Streptomycin Sulphate … 36gm

Zinc Bacitracin … 52gm

Colistin Sulphate … 60IU

905. 58726 Nobineo Oral Powder


Neomycin Sulphate … 720gm

906. 58727 Nobicycline 50% Oral Powder

Each kg contains:-


M/s. Alina Combine Pharmaceuticals (Pvt) Ltd, Plot No. A-127 SITE Super Highway Karachi.

Veterinary Local

907. 52336 Colitylo Plus Injection


Colistin sulphate …1250mg

Tylosin tartarate …10mg

Bromhexine HCl …100mg

Dexamethasone …50mg







Licensing Division.

M/s. Pantex Pharmaceutica, 26-Abbott Road, Lahore.

908. 29650 Tylin 20% Injection

Each ml contains:-

Tylosin (as Tartrate) … 200mg

M/s Pantex Holland B.V.,

Smaragdweg 15, 5527 LA Hapret,

The Netherlands





909. 26651 Gentalin 10% Injection

Each ml contains:-

Gentamycin (as Sulphate) …. 100mg



The Netherlands

910. 22778 Streptopen 25/20 Injection

Suspension

Each ml contains:-

Procaine Pencillin G… 200,000IU

Dihydrostreptomycin Sulphate …

250mg



The Netherlands

Mustafa Brothers, 186-D, Peoples Colony No.1, Faisalabad.

911. 53953 Aminoplex Forte Injection

Solution


Dextrose … 5.5gm

Calcium Chloride … 15mg

Potassium Chloride …20mg

Magnesium Sulphate … 20mg

Sodium Acetate Trihydrate …250mg

L-Histidine Hydrochloride … 34mg

DL-Methionine … 34mg

DL-Tryptophane …34mg

L-Threonine …. 68mg

L-Cysteine Hydrochloride …. 34mg

DL-Isoleucine.... 68mg

L-Arginine Hydrochloride ... 85mg

DL-Phenylalanine ... 102mg

M/s Laboratorio HOFARM S..A.C.

(for Agrovert Market S.A.),

Carretera Central Km 3.7, Santa

Anita, Lima, Peru.





912. 53951 Bovimec LA Injectable Solution


Ivermectin …1gm




Anita, Lima, Peru.

913. 52399 Acemav Injection 10mg/ml

Each ml contains:-

Acepromazine…………10mg

M/s Mavlab Pty Ltd., Australia.

914. 53955 Cefa Milk Fort Intramammary

Suspension


Cephalexin Monohydrate eq to base

…200mg

Gentamycin Sulphate eq to

base…100mg

Dexamethasone 21

Phosphate…0.750mg

Vitamin A…10000IU




Anita, Lima, Peru.

915. 53952 Hematofos B12 Injectable Solution


Vitamin B12(cyanocobalamine)

…0.0011gm

Tetrahydrate cobalt(ii)

acetate…0.05gm

L-tryptophan …0.25gm

Histidine…0.5gm

Citric Acid…0.5gm

DL Methionine …1 gm

Sodium Sulphate …1 gm

Ammoium Iron Citrate …2 gm

Sodium Cacodylate…3gm

Disodium Edetate…0.4gm

Riboflavin 5 phosphate…0.2gm

Nicotinamide…5gm

Pyridoxine HCl …1 gm

Sodium Glycerophosphate …1gm




Anita, Lima, Peru.

916. 52398 Flumav Flunixin Injection

Each ml contains:-

Flunixin Meglumine 83mg

eq to Flunixin …50mg

M/s Mavlab Pty Ltd., Australia.

917. 53950 Duramycin 300LA Injectable

Solution


Oxytetracycline Base …30gm




Anita, Lima, Peru.

918. 53954 Tri-ABZ Oral Suspension


Triclabendazole …50gm

Albendazole …37.5gm




Anita, Lima, Peru.

919. 53948 Tylo-Combisone Injectable Solution


Tylosin Tartrate Base …15gm

Gentamycin Sulphate Base …6gm

Dexamethasone 21 Phosphate

…0.0265gm

Chlorpheniramine Maleate …0.75gm

M/s. Atco Laboratories (Pvt) Ltd,B-18 S.I.T.E Karachi.

920. 31333 Pentasa 500mg

prolonged release Tablet

Each prolonged release tablet

contains:-

Mesalazine …500mg

M/s Feering Intrnational Center S.A.,

Chemin de la Vergognausaz 50 CH-

Evaluation by RRR:Now firm has

submitted following:Firm has

submitted commitment to submit

valid DSL upon receiving and have

submitted evidence of application

for renewal of DSL. Original, valid

and legalized CoPP as per WHO’s

1162 St. Prex, Switzerland format or original, valid and legalized

free sale certificate and GMP

certificate.

M/s Bayer Pakistan (Pvt) Limited, Bahria Complex II, 4th Floor, M.T. Khan Road, Karachi. (Import

human)

921. 52224 Nexavar 200mg Tablets

Each tablet contains: Sorafenib

(as tosylate) …200mg.

Manufactured by:M/s Bayer AG,

Kaiser-Wilhelm – Allee, 51368,

Leverkusen, Germany.Product

License Holder:M/s Bayer AG,

51368, Leverkusen, Germany

Evaluation by RRR:Now firm has

submitted following:Firm has stated

that they have submitted original

CoPP in Import section and have

submitted copy of CoPP in RRR

section.Firm has applied for renewal

in 25/09/2018 and initial Reg date is

25/09/2008. Last renewal was

submitted on 24/06/2015 keeping in

view the time of approval of

company name change of

09/08/2010.Copy of attested invoices

for respective applied products.An










M/s Marvi Pharmaceuticals Pvt Limited Karachi 922. 012777 Pain Gay Ointment

Each gm contains:-

Methyl Salicylate ……150mg

Menthol….100

The case is deferred in 291st meeting

for further delibration Submitted for

the consideration of Board

M/s. Ahad International Pharmaceuticals, Ltd., Dera Ismail Khan

923. 045824 Safemed Injection



Water for injection q.s tomake 100ml

letter has been communicated to the

firm. Shortcoming has been

rectified.Fee of Rs. 10,000/- has been

paid on 04-12-2017, differential fee of

Rs. 20,000/- paid on 27-07-2018Fee as

per S.R.O Required Initial Registration

letter required DML Required. In this

regard shortcoming

Submitted for the consideration of

Board

M/s. GlaxoSmithKline Pakistan Limited F-268, S.I.T.E. ,Karachi



Paracetamol…500mg

Caffeine…65mg




regsitation.


Each 5ml Contains:

Paracetamol…250mg

-do-


Each 5ml Contains:

Paracetamol…120mg

-do-



Paracetamol…500mg

-do-


Each gm Contains:



-do-


Each 5ml Contains:


-do-


Each 5ml Contains:


-do-


Each 5ml Contains:

Metoclopramide HCl eq. to

Anhydrous Sustance…5mg

-do-


Each 5ml Contains:

Mebendazole…100mg

-do-



Mebendazole…100mg

-do-



Mebendazole…500mg

-do-

M/s. GlaxoSmithKline Pakistan Limited,35- Dockyard Road, West Wharf, Karachi


Contains:





regsitation.


Contains:



Nystatin…100,000 Units per gm

-do-


Contains:


-do-


Contains:


-do-



Exsiccated Ferrous

Sulphate…150mg

Folic Acid…0.5mg

-do-



Exsiccated Ferrous

Sulphate…150mg

Zinc Sulphate

Monohydrate…61.8mg

-do-

941. 020543 Fefol Z Spansule Pellets -do-




22.5mg


Folic Acid…0.5mg


Each 2ml Contains:


-do-


Each gm Contains:





-do-


Each 2ml Contains:


-do-



Digoxin…0.5mg

-do-


Each ml Contains:




-do-


Each ml Contains:




-do-


Contains:


Base…0.2%w/w

-do-

M/s. GlaxoSmithKline Pakistan Limited,Plot 5,Sector 21,Korangi Industrial Area,Karachi




Cephalexin)…250mg




regsitation.




Cephalexin)…500mg

-do-



Cephalexin…125mg

-do-


Each 5ml Contains:


Cephalexin)…125mg

-do-


Each 5ml Contains:


-do-

Cephalexin)…250mg

M/s. GlaxoSmithKline Pakistan Limited

954. 000068 Furadantin Tablet






regsitation.

Documents

LIST OF RENEWAL APPLICATION OF YEAR 2018 DEFERRED BY ... of Deferred cases of renewal... · Colistin Sulphate …. 3gm Renewal granted in rd Meeting 53. 046678 Lincofas-44 Powder