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wxl 2144$20 - 2019 Tlaf;dan¾ ui 09 jeks nodod - 2019'10'09No. 2144/20 - WEDNESDAY, OCTOBER 9, 2019
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(Published by Authority)
PART I : SECTION (I) — GENERALGovernment Notifi cations
The Gazette of the Democratic Socialist Republic of Sri LankaEXTRAORDINARY
This Gazette Extraordinary can be downloaded from www.documents.gov.lk1A—PG 4679 - 257 (10/2019)
Order No. 01
NATIONAL MEDICINES REGULATORY AUTHORITY ACT, NO. 5 OF 2015
Order under section 60 (2)
BY VIRTUE of the powers vested in me by section 60 (2) of the National Medicines Regulatory Authority Act, No. 5 of 2015, I, Prof. Asita De Silva, Chairman of the National Medicines Regulatory Authority, do by this Order, inform the public that the medicines specifi ed in the Schedules here to have been registered with the National Medicines Regulatory Authority.
Prof. ASITA DE SILVAChairman,
(For and on behalf of) National Medicines Regulatory Authority
Colombo August 8, 2019
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SCHEDULE - I
COLUMN-I COLUMN-II COLUMN-III
COLUMN-IV COLUMN-V COLUMN-VI
COL-UMN-VII
COL-UMN-VIII
Offi cial Name Brand Name Dosage Form
Importer Name
Manufacturer Man-Country
Issue Date
Reg. Type
1 BENZALKONIUM CHLORIDE,CETRIMID 0.01%,0.2% DRAPOLENE CREAM GlaxoSmithkiline Pharmaceuti clas (Pvt) Ltd
Glaxo Smithkiline Pharmaceuti clas
POLAND 24-Mar-14
Full
2 CHLORHEXIDINE GLUCONATE 2.5%+ISOPROPYL ALEOHOL BP 70%
SANISCUB C SOLUTION Ceyoka (Pvt) Ltd Sirmaxo Chemicals Pvt Ltd
INDIA 07-Jan-15 Full
3 CHLOROXYLENOL LIQUID 4.8% APPLICATION DETTOL LIQUID N/A CDDEF Manu-facturers & Mer-chants for Rekitt Benkiser
SRI LANKA 01-Jan-18 Provisional
4 DICHLOROBENZYL ALCOHOL 1.2mg (2,4)+AMYLMETACRESOL 0.6m+ LOZENGES
STREPSILS HONEY & LEMON
LOZENGES Reckitt Benckiser (Lanka) Ltd
Reckitt Benckser Healthcare
THAILAND 28-Apr-15 Full
5 DICHLOROBENZYL ALCOHOL 1.2mg (2,4)+AMYLMETACRESOL 0.6m+ LOZENGES
STREPSILS COOL LOZENGES Reckitt Benckiser (Lanka) Ltd
Reckitt Benckiser Healthcare UK Ltd
THAILAND 28-Apr-15 Full
6 DICHLOROBENZYL ALCOHOL 1.2mg (2,4)+AMYLMETACRESOL 0.6m+ LOZENGES
STREPSILS ORIGINAL
LOZENGES Reckitt Benckiser (Lanka) Ltd
Reckitt Benckser Healthcare
THAILAND 28-Apr-16 Full
7 DICHLOROBENZYL ALCOHOL 1.2mg (2,4)+AMYLMETACRESOL 0.6m+ LOZENGES
THERASIL LOZENGES George Steuart Health (Pvt) Ltd
Plethico Pharma-ceuti cals Ltd
INDIA 05-Apr-15 Full
8 GLIPE MIXTURE WITH OIL OF AMITHI B PBCO 1% SODIUM BICARBONATE 1.0% & ZIMGIBAR OFFICINALE (GINGER) EXTRACT 0.48% FOR CHILDREN 4
MORISON S GRIPE MIXTURE
SYRUP N/A M S J Industries (Ceylon) (Pvt) Ltd
SRI LANKA 14-Jun-17 Two Years
9 INFANT CARMINATIVE SYRUP OIL OF ANETHI BPC 0.1% SODIUM BICARBONATE BP 1%
MORISON S GRIPE MIXTURE
SYRUP N/A M S J Industries (Ceylon) (Pvt) Ltd
SRI LANKA 19-Oct-14 Full
10 INFANT CARMINATIVE SYRUP SODIUM BICARBONATE +DIL OIL BP 0.1%
GAMMA'S GRIPE MIXTURE
MIXTURE N/A Gamma Pharma-ceuti cals Pvt Ltd
SRI LANKA 16-May-14
Full
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11 METHYL SALICYLATE 10.2% + MENTHOL 5.44% + EUGENOL 1.36%
FLANIL CREAM George Steuart Health (Pvt) Ltd
Biolab Co Ltd THAILAND 24-May-14
Full
12 METHYL SALICYLATE 6.3% ,MENTHOL 5.7% ,CAMPHAOR 1. 2% & TOCOPHEROL ACETATE
SALONPAS PATCH Akbar Pharmaceuti cals (Pvt) Ltd
Hisamitsu Phar-maceuti cals Co Inc
JAPAN 06-Apr-15 Full
13 METHYL SALICYLATE 6.3% ,MENTHOL 5.7% ,CAMPHAOR 1. 2% & TOCOPHEROL ACETATE
SALONPAS PATCH Akbar Pharmaceuti cals (Pvt) Ltd
Hisamitsu Pharmaceuti cals Co Inc
JAPAN 06-Apr-15 Full
14 METHYL SALICYLATE COMPOUND GEL WINTERPAN GEL N/A Akbar Pharmaceuti cals (Pvt) Ltd
SRI LANKA 11-Apr-14 Full
15 ORAL REHYDRATION SALTS BP 21.5G MINERVA ORAL POWDER
Emar Pharma (Pvt) Ltd
Unicure Ramadies (Pvt) Ltd
INDIA 04-Jun-16 Full
16 PARACETAMOL (PAEDIATIC) ORAL SOLUTION B.P 120MG/5ML
PARACETOL LIQUID N/A Gamma Pharmaceuti cals Pvt Ltd
SRI LANKA 22-Oct-14 Full
17 PARACETAMOL (PAEDRIATIC) ORAL SOLUTION B.P 120MG/5ML
PANADOL SYRUP
SYRUP N/A Glaxo Wellcome (Ceylon) Ltd
SRI LANKA 16-Jun-18 Full
18 PARACETAMOL (PAEDRIATIC) ORAL SUSPENSION B.P 120MG/5ML-Elixir
***** ORAL SOLUTION
N/A M S J Industries (Ceylon) (Pvt) Ltd
SRI LANKA 08-Feb-18 Two Years
19 PARACETAMOL TABLETS 500MG PANADOL TABLETS N/A Smithkline Beecham (Pvt) Ltd
SRI LANKA 17-Oct-16 Full
20 PARACETAMOL TABLETS BP 500MG ACETAMIN TABLETS Citi health Imports (Pvt) Ltd
Incepta Pharmaceuti cals Ltd
15-Aug-17 Two Years
21 PARACETAMOL TABLETS BP 500MG MAXMOL TABLETS George Steuart Health (Pvt) Ltd
Shefa Healthcare (Pvt) ltd
INDIA 18-Jan-14 Full
22 PARACETAMOL TABLETS BP 500MG RAPISOL TABLETS N/A Astron (Pvt) Ltd SRI LANKA 13-Nov-15 Full
23 PEDIATRIC PARACETAMOL ORAL SOLUTION B.P 120MG/5ML
MAXMOL ORAL SUSPENSION
George Steuart Health (Pvt) Ltd
Shefa Healthcare (Pvt) ltd
INDIA 10-Jun-15 Full
SCHEDULE - I
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SCHEDULE - II (GROUP A) (Contd.)
COLUMN-I COLUMN-II COLUMN-III COLUMN-IV COLUMN-V COLUMN-VI
COLUMN-VII
COLUMN-VIII
Offi cial Name Brand Name Dosage Form Importer Name Manufacturer Man-Country
Issue Date Reg. Type
1 ALBENDAZOLE TABLETS USP 400MG ALBEZIM TABLETS Tabrane Phar-maceuticals (Pvt) Ltd
Zim Laboratories Ltd
INDIA 03-Oct-14 Full
2 ALUM.HYDR. DRIED GEL 300MG+MAG.ALUM.SILICATE HYDR 50MG+MAG.HYDR. 25MG SIMETHICONE 25MG
DIGENE MINT FLAVOUR
TABLETS Sunshine Healthcare lanka Ltd
Abbott India Ltd INDIA 01-Jan-18 Provisional
3 ALUM.HYDR.306MG+MAG.HYDR 100MG+SIMETHICONE 25MG/5ML
VISCID ORAL SUSPENSION
Hemas Pharma-ceuticals (Pvt) Ltd
Indoco Remedies India
INDIA 18-Jan-17 Full
4 ALUM.HYDR.GEL 400MG+MAG.HYDR 400MG+SIMETHICONE 50MG/5ML
ANTAGTT DS ORAL SUSPENSION
Ceyoka (Pvt) Ltd Leben Laboratories (Pvt) Ltd
INDIA 28-May-14 Full
5 ALUMINIUM +MAGNESIUM & SIMETHICONE TABLETS USP (LEMON Flavour)
GASTRIL-LEMON
TABLETS Inter Pharm (Pvt) Ltd
Inter Pharm (Pvt) Ltd
SRI LANKA 27-Sep-17 Full
6 ALUMINIUM +MAGNESIUM & SIMETHICONE TABLETS USP (Mint Flavour)
GASTRIL-MINT TABLETS Inter Pharm (Pvt) Ltd
SRI LANKA 27-Sep-15 Full
7 ALUMINIUM 400MG+MAGNESIUM 400MG)HYDROXIDE+SIMETHICONE 50MG
ANTAGIT TABLETS Ceyoka (Pvt) Ltd Leben Laboratories (Pvt) Ltd
INDIA 02-Mar-14 Full
8 ALUMINIUM HYD.GEL. BP 200MG+MAGNESIUM HYD.100MG+MAGNESIUM TRISLICATE BP 200MG+SODIUM ALGINATE BP 100MG
CATOXYMAG-N ORAL SUSPENSION
Pharma Associates
Raptakos Brett & Company Ltd
INDIA 05-Dec-14 Full
9 ALUMINIUM HYDROXIDE 8OOMG+MAGNESIUM HYDROXIDE 800MG+SIMETHICONE
ZELLOX -11 ORAL SUSPENSION
Indoscan (Pvt) Ltd
Hoe Pharmaceuticals SDN BHD
MALAYSIA 28-May-14 Full
10 ALUMINIUM HYDROXIDE 960MG+MAGNESIUM HYDROXIDE 330MG+ SIMETHICONE 60MG
ANTACIL GEL GEL Sonali & Sudesh Thai Nakorn Patana Co Ltd
THAILAND 19-Aug-15 Full
11 ALUMINIUM HYDROXIDE B.P 500MG ***** CHEWABLE TABLETS
State Phar-maceuticals Manufacturer Corporation
State Pharmaceuticals Manufacturer Corporation
SRI LANKA 22-Dec-14 Full
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SCHEDULE - II (GROUP A) (Contd.)
12 ALUMINIUM HYDROXIDE B.P 500MG **** TABLETS Kamazu (Pvt) Ltd
B D H Industries Ltd
INDIA 07-Nov-14 Full
13 ALUMINIUM HYDROXIDE GEL 918MG+MAGNESIUM HYDROXIDE 300MG+ SIMETHICONE 60MG
BELCID ORAL SUSPENSION
George Steuart Health (Pvt) Ltd
Biolab Co Ltd THAILAND 15-Oct-18 Full
14 ALUMINIUM oxide 570MG+MAGNESIUM hydrox 300MG & SIMETHICONE 60MG ORAL SUSPENSION USP
ADMAG ORAL SUSPENSION
Medinex (Pvt) Ltd
T P Drugs Laboratories
THAILAND 07-Dec-14 Full
15 ALUMINUM HYDROXIDE DRIED GEL 500MG,MAGNESIUM TRISILICATE 240MG +MAGNESIUM HYDROXIDE 240MG IN10ML
GASTROGEL ORAL SUSPENSION
Sonali & Sudesh Aspen Pharma (Pvt) Ltd
AUSTRA-LIA
08-May-16 Full
16 AQUEOUS CREAM WITH GLYCERINE D-AQUA CREAM Panacea Medicals
Panacea Medicals
SRI LANKA 01-Jun-17 Two Years
17 AQUEOUS CREAM WITH GLYCERINE D-SOFT CREAM CREAM Panacea Medicals
Panacea Medicals
SRI LANKA 25-Apr-17 Two Years
18 AQUEOUS CREAM WITH GLYCERINE 2% AQUARIN CREAM Panacea Medicals
Panacea Medicals
SRI LANKA 27-Jun-17 Two Years
19 ASCORBIC ACID TABLETS BP 100MG C-TABS TABLETS Unical Ceylon (Pvt) Ltd
Unical Ceylon (Pvt) Ltd
SRI LANKA 18-Jul-16 Full
20 ASCORBIC ACID TABLETS BP 100MG ***** TABLETS Inter Pharm (Pvt) Ltd
Inter Pharm (Pvt) Ltd
SRI LANKA 11-May-17 Two Years
21 ASCORBIC ACID TABLETS BP 100MG ***** TABLETS M S J Industries (Ceylon) (Pvt) Ltd
M S J Industries (Ceylon) (Pvt) Ltd
SRI LANKA 01-Jan-17 Full
22 ASCORBIC ACID TABLETS BP 250MG CHEWCE TABLETS Darley Butler & Co Ltd
Navana Pharmaceuticals Ltd
BANGLA-DESH
30-Nov-16 Full
23 ASCORBIC AICD CHEWABLE TABLETS USP 100MG
SHINE Vit. C 100 TABLETS Y S P Lanka (Pvt) Ltd
l(Pvt) Ltd.
Y S P Industries /SDN BHD
MALAYSIA 30-Apr-17 Full
24 ASPIRIN GASTRO RESISTANT TABLETS BP 75MG
CARVA TABLETS (EN.COA.)
PharmAce (Pvt) Ltd
Square Pharmaceuticals Ltd
BANGLA-DESH
27-Nov-14 Full
25 CALAMINE BP 4%+WITCH HAZEL BPC 5%+PHENOL 0.2%+SODIUM BENZOATE 0.1%
CALAMINE LOTION
LOTION M S J Industries (Ceylon) (Pvt) Ltd
SRI LANKA 29-Oct-15 Full
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SCHEDULE - II (GROUP A) (Contd.)
26 CALCIUM CARBONATE 1500MG +VIT. D3 200IU(Equivalent to calcium 600mg)
CALCIVITA FORTE
SOFT GELETIN CAPSULES
A Baur & Co (Pvt) Ltd
Mega Lifesciences (Pvt) Ltd
THAILAND 24-Feb-14 Full
27 CALCIUM CARBONATE TABLETS USP 1250MG
ROCAL TABLETS Citihealth Imports (Pvt) Ltd
Healthcare Pharmaceuticals
18-Aug-16 Full
28 CHLORHEXIDINE GLUCONATE 2% MOUTHWASH
CLINICA MOUTH WASH CIC Holdings PLC
Platinum Pharmaceuticals (Pvt) Ltd
PAKISTAN 03-Feb-18 Full
29 CHLORHEXIDINE DIAGLUCONATE MOUTHWASH 0.2% W/V
CORSODYL MINT
MOUTH WASH-SOLUTION
Glaxo Wellcome (Ceylon) Ltd
Glaxo Wellcome (Ceylon) Ltd
SRI LANKA 15-Feb-17 Full
30 CHLORHEXIDINE GLUCONATE 1.5% CETRIMIDE 15%
**** SOLUTION M S J Industries (Ceylon) (Pvt) Ltd
M S J Industries (Ceylon) (Pvt) Ltd
SRI LANKA 01-Jan-17 Full
31 CHLORHEXIDINE GLUCONATE GEL 1.0%W/W HEXIGEL COLLAPSIBLE TUBES
George Steuart Health (Pvt) Ltd
ICPA Health Products Ltd
INDIA 06-Feb-14 Full
32 CHLORPHENAMINE ORAL SOLUTION BP 2ML/5ML (CHLORPHENIRAMINE)
CHLOFEN ORAL SOLUTION
Inter Pharm (Pvt) Ltd
Inter Pharm (Pvt) Ltd
SRI LANKA 11-Feb-15 Full
33 CHLORPHENIRAMINE MALEATE 2MG/5ML SYRUP
PIRITON SYRUP Glaxo Wellcome (Ceylon) Ltd
Glaxo Wellcome (Ceylon) Ltd
SRI LANKA 16-Mar-17 Full
34 CONTAINING LIQUID EXTRACT OF GLYCERRHI 4%,LIQUID EXTRACT OF COCILLANE 1% MENTHOL 0.05%
VALMELIX SYRUP M S J Industries (Ceylon) (Pvt) Ltd
M S J Industries (Ceylon) (Pvt) Ltd
SRI LANKA 01-Jan-18 Two Years
35 CYANOCOBALAMINE (VITAMIN B12, 35MCG/5ML SYRUP
CYTACON SYRUP Glaxo Wellcome (Ceylon) Ltd
Glaxo Wellcome (Ceylon) Ltd
SRI LANKA 12-Sep-17 Two Years
36 DEQUALINIUM CHLORIDE LOZENGES 0.25MG
DEXXON LOZENGES Delmege Forsyth & Co Ltd
Kotra pharma (M) Ltd
MALAYSIA 26-Apr-18 Full
37 DICHLOROBENZYL ALCOHOL 1.2mg (2,4)+AMYLMETACRESOL 0.6m+ LOZENGES
SUPERIL LOZENGES (ORANGE)
LOZENGES George Steuart Health (Pvt) Ltd
Unique Pharmaceutical Labs
INDIA 08-May-15 Full
38 DICHLOROBENZYL ALCOHOL 1.2mg (2,4)+AMYLMETACRESOL 0.6m+ LOZENGES
SUPERIL LOZENGES George Steuart Health (Pvt) Ltd
Unique Pharmaceutical Labs
INDIA 08-May-15 Full
39 DICHLOROBENZYL ALCOHOL 1.2mg (2,4)+AMYLMETACRESOL 0.6m+ LOZENGES
SUPERIL LOZENGES (LEMON)
LOZENGES George Steuart Health (Pvt) Ltd
Unique Pharmaceutucal Laboratories
INDIA 28-May-15 Full
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SCHEDULE - II (GROUP A) (Contd.)
40 DICHLOROBENZYL ALCOHOL 1.2mg (2,4)+AMYLMETACRESOL 0.6m+ VITAMIN C 100mg LOZENGES
STREPSILS ORIGINAL
LOZENGES Reckitt Benckiser (Lanka) Ltd
Reckitt Benckser Healthcare
THAILAND 28-Apr-15 Full
41 DICLOFENAC GEL BP 1% DICLOMOL GEL Robert Hall & Co Ltd
G S Pharmabutor (Pvt) Ltd
INDIA 13-Jul-18 Full
42 DIMETHICONE 50MG ACTIVATED+MAGNESIUM HYDROXIDE 250MG+ALUMINIUM HYDROXIDE 250MG
DIGUSIL MPS ORAL SUSPENSION
Breathe Free Lanka (Pvt) Ltd
Cipla Ltd INDIA 21-Jul-18 Two Years
43 DRIED ALUM.HYDROX.GEL 250MG,MAGNE HYDRA 250MG+SIMETHICONE 50MG
ACIFREE SUSPENSION Sunshine Healthcare lanka Ltd
Sai Mirra Innopharm (Pvt) Ltd
INDIA 19-Nov-14 Full
44 DRIED ALUMINIUM HYDROXIDE 400MG+DRIED MAGNESIUM HYDROXIDE 400MG
AGIFLUX CHEWABLE TABLETS
Citihealth Imports (Pvt) Ltd
Agio Pharmaceuticals Ltd
INDIA 03-Nov-16 Full
45 DRIED ALUMINIUM HYDROXIDE GEL 300MG,MAGNESIUM HYDROXIDE SILICATE HYDRATE 50MG+MAGNESIUM HYDROXIDE 25MG, SIMETHICONE 25MG CHEWABLE TABLETS
DIGENE MIXED FRUIT FLAVOUR
CHEWABLE TABLETS
Sunshine Healthcare lanka Ltd
Abbott India Ltd INDIA 21-Jul-15 Full
46 FERROUS GLYCINE SULPHATE EQUIVALENT TO 60MG,NIACINAMIDE BP 50MG+PYRIDOXINE HYDROCHLORIDE BP 3MG,CYANOCABALAMINE BP 15MG +FOLIC ACID 1MG+ZINC SULPHATE BP ZINC 5
FERIGEN XT SUGAR COATED TABLETS
Lifeline Pharmaceuticals (Pvt) Ltd
Nem Laboretories (P) Ltd
INDIA 29-May-18 Full
47 FERROUS SULPHATE 150MG+FOLIC ACID 500MCG
FEFOL CAPSULES A Baur & Co (Pvt) Ltd
The United Pharmaceutica Manufacturer
JORDAN 07-Aug-16 Full
48 FISH OIL CONCENTRATED SOFT GELATINE CAPSULES 1000MG
MAXX OMEGA 3 SOFT GELETIN CAPSULES
A Baur & Co (Pvt) Ltd
Mega Lifesciences Public Company (Pvt) Ltd
THAILAND 24-Mar-14 Full
49 FOLIC ACID TABLETS BP 1MG **** TABLETS Inter Pharm (Pvt) Ltd
Inter Pharm (Pvt) Ltd
SRI LANKA 14-Oct-14 Full
50 FOLIC ACID TABLETS BP 1MG F-A-One TABLETS Markss HLC (Pvt) Ltd
MMC Healthcare Ltd
INDIA 12-Jan-18 Two Years
51 IRON & B COMPLEX FERRA B SYRUP Glaxo Wellcome (Ceylon) Ltd
Glaxo Wellcome (Ceylon) Ltd
SRI LANKA 02-Dec-17 Full
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SCHEDULE - II (GROUP A) (Contd.)
52 IRON & VITAMIN ZINCOFER LIQUID A Baur & Co (Pvt) Ltd
Apex Laboratories Ltd
INDIA 29-Oct-14 Full
53 IRON (III) HYDROXIDE POLYMALTOSE 100MG+FOLIC ACID CHEWABLE TABLETS 0.35MG
RBC-F CHEWABLE TABLETS
Ceyoka (Pvt) Ltd Genix Pharma (Pvt ) Ltd
PAKISTAN 23-Apr-14 Full
54 IRON (III) HYDROXIDE POLYMALTOSE COMPLEX SYRUP 50MG/5ML
RBC Syrup SYRUP Ceyoka (Pvt) Ltd Genix Pharma (Pvt ) Ltd
PAKISTAN 02-Jun-15 Full
55 IRON WITH FOLIC ACID VIT.C & VIT. B COMPLEX
DUMASULES CAPSULES Astron (Pvt) Ltd Astron (Pvt) Ltd SRI LANKA 24-Sep-16 Full
56 IRON+ VITAMIN B OMPLEX CAPSULES SANGOBION CAPSULES Emerchemie NB (Ceylon) Ltd
Martin Daw Pharmaceuticals Ltd
PAKISTAN 23-Oct-16 Two Years
57 IRON+ VITAMIN B OMPLEX CAPSULES SANGOBION CAPSULES Emerchemie NB (Ceylon) Ltd
Merck (Pvt) Ltd PAKISTAN 23-Oct-16 Two Years
58 ISPAGHULA HUSK I.P 4.8G/5G W/W CREMADIET POWDER CIC Holdings PLC
Tirupathi Medicare Ltd
INDIA 29-Jul-16 Full
59 ISPAGULAR HUSK GRANULES BP 3.75G/4.8G FIBEREX GRANULES SMM Halcyon (Pvt) Ltd
Meyer Organics (Pvt) Ltd
INDIA 20-Oct-14 Full
60 KETOPROFEN GEL 2.5% (KETOPROFEN 2.5% W/W ,METHYL SALICYLATE 8.5% W/W MENTHOL 4% W/W)
RELEEV GEL Astron (Pvt) Ltd Astron (Pvt) Ltd SRI LANKA 09-Oct-17 Two Years
61 LEVONORGESTREL TABLETS 0.75MG MADONNA TABLETS George Steuart Health (Pvt) Ltd
Biolab Co Ltd THAILAND 20-Aug-18 Two Years
62 LEVONORGESTREL TABLETS 0.75MG POSTINOR TABLETS The Family fl anning associatio
Gedeon Richter Ltd
HUNGARY 28-Jan-15 Full
63 LIGHT LIQUID PARAFFIN 6% + WHITE SOFT PARAFFIN 15% CREAM
OILATUM CREAM
CREAM Glaxo Wellcome (Ceylon) Ltd
Glaxo Operations UK Ltd
UNITED KINGDOM
20-Sep-14 Full
64 MAGNESIUM HYDROXIDE 185 SIMETHICONE 50MG,DRIED ALU.HYD GEL 830MG +CARBOXYMETHYLCELLULOSE 100MG/10ML ORAL SUSPENSION
DIGENE GEL ORANGE FLAVOUR
ORAL SUSPENSION
Sunshine Healthcare lanka Ltd
Abbott India Ltd INDIA 23-Mar-18 Full
65 MAGNESIUM HYDROXIDE 185 SIMETHICONE 50MG,DRIED ALU.HYD GEL 830MG +CARBOXYMETHYLCELLULOSE 100MG/10ML ORAL SUSPENSION
DIGENE MINT FLAVOUR- GEL
ORAL LIQUID Sunshine Healthcare lanka Ltd
Abbott India Ltd INDIA 16-May-18 Full
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SCHEDULE - II (GROUP A) (Contd.)
66 MAGNESIUM HYDROXIDE IP 185 SIMETHICONE IP50MG,DRIED ALU.HYD GEL IP 830MG+CARBOXYMETHYL IP 100MG/10ML
DIGENE GEL MIXED FRUIT FLAVOUR
ORAL SUSPENSION
Sunshine Healthcare lanka Ltd
Abbott India Ltd INDIA 23-Mar-18 Full
67 MANGESIUM TRISILICATE 350+ DRIED ALUMINIUM HYDROXIDE GEL 250MG +KAOLIN
ANTACIL TABLETS Sonali & Sudesh Thai Nakorn Patana Co Ltd
THAILAND 16-Oct-15 Full
68 MEBENDAZOLE ORAL SUSPENSION USP 100MG/5ML
AGOBEN ORAL SOLUTION
lifeServ (Pvt) Ltd Agog Pharma Ltd INDIA 04-May-14 Full
69 MEBENDAZOLE TABLETS 500MG BENHOL 500 CHEWABLE TABLETS
Kalpentyn Syndicats (Pvt) Ltd
Pure pharma Ltd INDIA 04-Jun-16 Full
70 MEBENDAZOLE TABLETS U.S.P 100MG MEBFIL TABLETS Sunshine Healthcare lanka Ltd
Fourrts (India) Laboratories Ltd
INDIA 11-Feb-18 Two Years
71 MEBENDAZOLE TABLETS U.S.P 100MG MEBFIL TABLETS Sunshine Healthcare lanka Ltd
Fourrts (India) Laboratories Ltd
INDIA 11-Feb-18 Two Years
72 MEBENDAZOLE TABLETS U.S.P 500MG ***** TABLETS Chamee Chemist
Bajaj Healthcare Ltd
INDIA 20-Jun-14 Full
73 METHYL SALICYLATE 12.5%,MENTHOL 3%, THYMOL 10.5%,EUCALYPTUS OIL 0.5%,CAPSIUM 0.5%
TRANSPAIN CREAM
CREAM Panacea Medicals
Panacea Medicals
SRI LANKA 27-Jun-17 Full
74 METHYL SALICYLATE 2% ,MENTHOL 5% ,CAMPHAOR 2%
SALONPAS SPRAY
AEROSOL SPRAY
Akbar Pharmaceuticals (Pvt) Ltd
Hisamitsu Pharmaceuticals Co Inc
JAPAN 14-Mar-14 Full
75 METHYL SALICYLATE AEROSOL 60G WINSPAY 60 AEROSOL SPRAY
Emerchemie NB (Ceylon) Ltd
Shandong Jewim Pharmaceutical Co. Ltd
CHINA 08-Mar-14 Full
76 METHYL SALICYLATE BP 8% ,MEPHENESIN BPC 5%,METHYL NICOTANATE BP 1% MENTHOL USP 2%W/W CREAM
FLAMAR CREAM Hemas Pharmaceuticals (Pvt) Ltd
Indoco Remedies India
INDIA 08-Aug-16 Full
77 METHYL SALICYLATE COMPOUND CREAM METHYL SALICYLATE 12.5% MENTHOL 2.5%,OLEORESIN CAPSICUM 0.25, THYMOL 0.12% EUCALYPTUS OIL 0.2%
WINCREAM CREAM Falcon Pharmaceuticals (Pvt) Ltd
Falcon Pharmaceuticals (Pvt) Ltd
SRI LANKA 13-Sep-17 Two Years
78 METHYL SALICYLATE OINTMENT RELAXON PLUS OINTMENT Neon Pharmaceuticals (Pvt) Ltd
Neon Pharmaceuticals (Pvt) Ltd
SRI LANKA 23-Jun-16 Full
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A - 09.10.2019
10SCHEDULE - II (GROUP A) (Contd.)
79 METHYL SALUCYLATE,COMPOUND OINTMENT METHYL SALICYLATE MENTHOL 2.2% EUCALYPTUS OIL 0.12%,THYMOL 0.12% ,CAMPHOR 1%
PRINCE WINTERGREEN
OINTMENT Prince Marketing Service
Prince Marketing Service
SRI LANKA 09-Oct-16 Full
80 MULTIVITAMIN & MINERALS CAPSULES MINTERRA CAPSULES Astron (Pvt) Ltd SRI LANKA 11-Feb-15 Full
81 MULTIVITAMIN & MINERALS CHEWABLE TABLETS
VITA-KID CHEWABLE TABLETS
Alaris Lanka (Pvt) Ltd
Contract Manufacuring & Packging Services pty Ltd
20-May-14 Full
82 MULTIVITAMIN & MINERALS SOFT GELATIN CAPSULES VIT. A USP 1.5MG,VIT. D3, USP 0.4MG,VIT. B1 1.50MG,VIT. B2,1.70MG USP,VIT B6 2.00MG,VIT, CBP 60MG,NICOTI
STANO-M CAPSULES Tabrane Healthcare (Pvt) Ltd
Globe Pharmaceuticals Ltd
24-Oct-15 Full
83 MULTIVITAMIN & MINERALS TABLETS ONE A DAY TABLETS CCL Pharmaceuticals Lanka (Pvt) Ltd
CCL Pharmaceuticals (Pvt) Ltd
PAKISTAN 11-Mar-14 Full
84 MULTIVITAMIN CAPSULES MULTIFORTE CAPSULES Astron (Pvt) Ltd Astron (Pvt) Ltd SRI LANKA 20-May-16 Full
85 MULTIVITAMIN SYRUP GROVIT SYRUP Hemas Pharmaceuticals (Pvt) Ltd
U S V Ltd INDIA 25-Oct-15 Full
86 MULTIVITAMIN SYRUP HOVITE SYRUP SYRUP Pharma Associates
Raptakos Brett & Company Ltd
INDIA 28-Jul-15 Full
87 MULTIVITAMIN SYRUP VITALISE SYRUP Astron (Pvt) Ltd Astron (Pvt) Ltd SRI LANKA 03-Feb-15 Full
88 MULTIVITAMINS & MINERALS CAP GUARDIAN CAPSULES Sunshine Healthcare lanka Ltd
Catalent Australia (Pvt) Ltd
13-Oct-14 Full
89 NEOMYCIN SULPHATE 5MG + BACITRACIN ZINC 500IU/G OINTMENT
NEBANOL OINTMENT PharmAce (Pvt) Ltd
Square Pharmaceuticals Ltd
28-Jan-15 Full
90 OMEGA 3 FISH OIL CAPSULES 1000MG SOLOMEGA SOFT GELETIN CAPSULES
Alaris Lanka (Pvt) Ltd
Contract Manufacuring & Packging Services pty Ltd
20-May-14 Full
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A - 09.10.2019
11
SCHEDULE - II (GROUP A) (Contd.)
91 OMEGA 3 FISH OIL SOFT GEL CAPSULS 750MG
HAPPY KIDS SOFT GELETIN CAPSULES
Alaris Lanka (Pvt) Ltd
Contract Manufacuring & Packging Services pty Ltd
27-Apr-15 Full
92 ORAL REHYDRATION ELECTROLYTE SOLUTION ORANGE FLAVOUR
PAEDICARE ORAL SOLUTION
Markss HLC (Pvt) Ltd
Woodward Pakitan (Pvt) Ltd
PAKISTAN 14-Dec-17 Full
93 ORAL REHYDRATION ELECTROLYTE SOLUTION ORANGE FLAVOUR
PAEDICARE ORAL SOLUTION
Markss HLC (Pvt) Ltd
Woodward Pakitan (Pvt) Ltd
PAKISTAN 14-Dec-17 Full
94 ORAL REHYDRATION SALT IP PROLYTE POWDER Breathe Free Lanka (Pvt) Ltd
Cipla Ltd INDIA 31-Jan-15 Full
95 ORAL REHYDRATION SALTS BP (O.R.S) ORSAL POWDER Associated Laboratories (Pvt) Ltd
Well & Well Pharma (Pvt) Ltd
PAKISTAN 30-Mar-16 Full
96 ORAL REHYDRATION SALTS FOR SOLUTION (SODIUM CHLORIDE 2.6G,POTASIUM CHLORIDE 1.5MG,DEXTROSE ANHYDROUS 12.5G)PEDITRAL (LOW OSMOLARITY- O.R.S)
PEDITRAL LOW ORAL SOLUTION
Morison PLC Searle-Pakistan PAKISTAN 09-Feb-15 Full
97 ORAL REHYDRATION SOLUTION (FLAVOUR STRAWBERRY)
PEEDICARE ORAL SOLUTION
Markss HLC (Pvt) Ltd
Woodward Pakistan (Pvt) Ltd
PAKISTAN 10-Jun-16 Full
98 PARACETAMOL (PAEDIATIC) ORAL SOLUTION B.P 120MG/5ML
ARCET ORAL SOLUTION
Pharma Associates
Central drugs and Pharmaceutical
INDIA 12-May-17 Two Years
99 PARACETAMOL (PAEDRIATIC) ORAL SUSPENSION B.P 120MG/5ML
PARACIL SYRUP
ORAL SOLUTION
Sunshine Healthcare lanka Ltd
Fourrts (India) Laboratories Ltd
INDIA 05-Feb-15 Full
100 PARACETAMOL (PAEDRIATIC) ORAL SUSPENSION B.P 120MG/5ML
***** ORAL SOLUTION
Chamee Chemist
Gopaldas Visram & Co Ltd
INDIA 16-Sep-14 Full
101 PARACETAMOL (PAEDRIATIC) ORAL SUSPENSION B.P 120MG/5ML
PARAFIL ORAL SOLUTION
Sunshine Healthcare lanka Ltd
Fourrts (India) Laboratories Ltd
INDIA 16-Aug-16 Full
102 PARACETAMOL (PAEDRIATIC) ORAL SUSPENSION B.P 120MG/5ML
ANODYNE-P ORAL SOLUTION
Pharma Associates
Bafna Pharmaceuticals Ltd
INDIA 30-Apr-15 Full
103 PARACETAMOL 120MG/5ML SYRUP CETAPYRIN SYRUP Glaxo Wellcome (Ceylon) Ltd
Glaxo Wellcome (Ceylon) Ltd
SRI LANKA 10-Feb-16 Full
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A - 09.10.2019
12SCHEDULE - II (GROUP A) (Contd.)
104 PARACETAMOL SYRUP USP 120MG/5ML RAPISOL SYRUP
SYRUP Astron (Pvt) Ltd SRI LANKA 03-Feb-16 Full
105 PARACETAMOL TABLETS BP 500MG PACETOL TABLETS ABC Pharma Services Pvt. Ltd
Magbro Healthcare
INDIA 28-Feb-18 Full
106 PARACETAMOL TABLETS BP 500MG *** TABLETS Morison PLC Morison PLC SRI LANKA 16-Aug-18 Two Years
107 PARACETAMOL TABLETS BP 500MG **** TABLETS P Jayanetti & Sons Pvt Ltd
Kausikh Therapeutics (Pvt) Ltd
INDIA 04-Jan-14 Full
108 PARACETAMOL TABLETS BP 500MG ***** TABLETS Astron (Pvt) Ltd Astron (Pvt) Ltd SRI LANKA 08-Oct-14 Full
109 PARACETAMOL TABLETS BP 500MG AZICOT 500 TABLETS Alaris Lanka (Pvt) Ltd
Scottish Pharma INDIA 28-Jun-14 Full
110 PARACETAMOL TABLETS BP 500MG UNIMOL TABLETS Unical Ceylon (Pvt) Ltd
Unical Ceylon (Pvt) Ltd
SRI LANKA 18-Feb-16 Full
111 PARACETAMOL TABLETS BP 500MG SPMC TABLETS State Pharmaceuticals Manufacturer Corporation
State Pharmaceuticals Manufacturer Corporation
SRI LANKA 06-Jun-16 Full
112 PARACETAMOL TABLETS BP 500MG ASTAMOL TABLETS Associated Pharma Celyon (Pvt) Ltd
Astamed Healthcare (Pvt) Ltd
INDIA 28-Nov-14 Full
113 PARACETAMOL TABLETS BP 500MG **** TABLETS SPMC/State Pharmaceuticals Manufacturing COP
SPMC/State Pharmaceuticals Manufacturing COP
INDIA 26-Apr-18 Provisional
114 PARACETAMOL TABLETS BP 500MG ZIFAM TABLETS Alaris Lanka (Pvt) Ltd
Adore Pharmaceuticals (Pvt) Ltd
INDIA 23-Jun-17 Full
115 PARACETAMOL TABLETS BP 500MG REGAMOL TABLETS Harcourts (Pvt) Ltd
Bal Pharma Ltd INDIA 23-May-18 Two Years
116 PARACETAMOL TABLETS BP 500MG KELVIN TABLETS Ceyoka (Pvt) Ltd Leben Laboratories (Pvt) Ltd
INDIA 17-Nov-17 Full
117 PARACETAMOL TABLETS BP 500MG MEDMOL TABLETS Akbar Pharmaceuticals (Pvt) Ltd
Medopharm (PVT Ltd
INDIA 20-Oct-17 Two Years
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RATIC
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A - 09.10.2019
13
SCHEDULE - II (GROUP A) (Contd.)
118 PERMETHRIN CREAM 5% W/W GLENPER CREAM Sunshine Healthcare lanka Ltd
Glenmark Pharmaceuticals Ltd
INDIA 11-Sep-18 Two Years
119 PERMETHRIN HEAD LOTION 0.5% W/V LYCINE LOTION M W L De Silva & Co
M W L De Silva & Co
SRI LANKA 07-Jun-15 Full
120 PERMETHRIN LOTION 2% W/V (A-Scaba) A-SCABS LOTION Indoscan (Pvt) Ltd
Hoe Pharmaceuticals SDN BHD
MALAYSIA 24-Oct-17 Full
121 POLYETHYLENE GLYCOL 59.0G,SODIUM SULPHATE 5.685G SODIUM BICA
KLEAN PREP POWDER ORAL SOLUTION
Hemas Pharmaceuticals (Pvt) Ltd
Helsinn Birex Pharmaceuticals Ltd
IRELAND 11-Jun-18 Two Years
122 POVIDONE IODINE 10% TOPICAL SOLUTION NOVASEPT TOPICAL SOLUTION
ABC Pharma Services Pvt. Ltd
Navketan Research & Labo. (Pvt) Ltd
INDIA 23-Jul-15 Full
123 POVIDONE IODINE 10% TOPICAL SOLUTION USP
APODINE Solution
SOLUTION Tabrane Healthcare (Pvt) Ltd
Globe Pharmaceuticals Ltd
28-Feb-14 Full
124 POVIDONE IODINE CLEANSING SOLUTION USP 7.5%
SANIQUAD PVP 7.5%
SOLUTION Ceyoka (Pvt) Ltd Sirmaxo Chemicals (Pvt) Ltd
INDIA 13-Jul-15 Full
125 POVIDONE IODINE CLEANSING SOLUTION USP 7.5%
NOVASEPT SURGICAL SCRUB
ABC Pharma Services Pvt. Ltd
Nawketan Resarch & Laboratories
INDIA 24-Jul-15 Full
126 POVIDONE IODINE CLEANSING SOLUTION USP 7.5%
SETADINE TOPICAL CREAM
Suraksa Pharma (Pvt) Ltd
Suraksa Pharma (Pvt) Ltd
SRI LANKA 06-Apr-18 Full
127 POVIDONE IODINE CLEANSING SOLUTION USP 7.5%
BETADINE SURGICAL SCRUB
SOLUTION Robert Hall & Co Ltd
G S Pharmabutor (Pvt) Ltd
INDIA 05-Nov-17 Full
128 POVIDONE IODINE CLEANSING SOLUTION USP 7.5%
PYODINE SOLUTION Hemas Pharma-ceuticals (Pvt) Ltd
Brookes Pharma (Pvt) Ltd
PAKISTAN 02-Jan-16 Full
129 POVIDONE IODINE CLEANSING SOLUTION USP 7.5%
BETADINE SURGICAL SCRUB
SOLUTION Robert Hall & Co Ltd
G S Pharmabutor (Pvt) Ltd
INDIA 05-Nov-17 Full
130 POVIDONE IODINE OINTMENT USP 5% SURGIDENE OINTMENT Gamma Phar-maceuticals Pvt Ltd
Gamma Pharmaceuticals Pvt Ltd
SRI LANKA 11-Jul-14 Full
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A - 09.10.2019
14SCHEDULE - II (GROUP A) (Contd.)
131 POVIDONE IODINE OINTMENT USP 5% VIODIN OINTMENT PharmAce (Pvt) Ltd
Square Pharmaceuticals Ltd
BANGLA-DESH
03-Oct-17 Full
132 POVIDONE IODINE SOLUTION BP 10% HEMITADINE SOLUTION Himata (Pvt) Ltd Himata (Pvt) Ltd SRI LANKA 17-Sep-18 Provisional
133 POVIDONE IODINE SOLUTION BP 10% ZYLO-P SOLUTION Ceyoka (Pvt) Ltd Leben Laboratories (Pvt) Ltd
INDIA 19-Mar-15 Full
134 POVIDONE IODINE TOPICAL SOLUTION USP 10% W/V
BETADINE SOLUTION Robert Hall & Co Ltd
G S Pharmabutor (Pvy) Ltd for Win Medical (Pvt) Ltd
INDIA 12-Feb-14 Full
135 POVIDONE IODINE U.S.P 5% HEALZ OINTMENT Pharma Associates
Central drugs and Pharmaceutical
INDIA 06-May-17 Full
136 PROPANOL-2 45G+PROPANOL-1 30G+MECETRONIUM ETHYLSULFATE 0.2G/100G SOLUTION
STERILLUM ANTISEPTIC SOLUTION
Mamro (Pvt) Ltd Raman & Weil (Pvt) Ltd
INDIA 12-Aug-16 Full
137 PYRANTEL PAMOATE 125MG TABLETS **** TABLETS M S J Industries (Ceylon) (Pvt) Ltd
M S J Industries (Ceylon) (Pvt) Ltd
SRI LANKA 10-Sep-14 Full
138 PYRANTEL PAMOATE 125MG TABLETS COMBIFIL-125 TABLETS Sunshine Healthcare lanka Ltd
Fourrts (India) Laboratories Ltd
INDIA 18-Apr-16 Full
139 SALBUTAMOL 1MG+BROMHEXINE HCL. 2MG+GUAIPHENESIN 50MG/5ML
BENOF SYRUP Inter Pharm (Pvt) Ltd
Inter Pharm (Pvt) Ltd
SRI LANKA 23-Aug-14 Full
140 SALICYLIC ACID 40% W/W DRESSINGS WITH CENTRE RING CONTAING ACID PASTE
CORN CAPS PLASTER Akbar Pharma-ceuticals (Pvt) Ltd
Cuxson Gerrard & Co Ltd
UNITED KINGDOM
17-May-17 Full
141 SIMETHICONE 50MG,MAGNESIUM HYDROXIDE 250MG & DRIED ALUMINUM HYDROXIDE GEL 250MG ORAL SUSPENSION
CORASIL ORAL SUSPENSION
Harcourts (Pvt) Ltd
Coral Laboratories Ltd
INDIA 08-Dec-17 Two Years
142 SIMETHICONE ORAL SUSPENSION 40MG/06ML DROPPERFUL
GAS-MED ORAL SUSPENSION
PharmAce (Pvt) Ltd
T Man Pharma Ltd.
THAILAND 03-Dec-17 Two Years
143 SIMETHICONE ORAL SUSPENSION 40MG/06ML DROPPERFUL
GAS-MED ORAL SUSPENSION
PharmAce (Pvt) Ltd
T Man Pharma Ltd.
THAILAND 03-Dec-17 Two Years
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A - 09.10.2019
15
SCHEDULE - II (GROUP A) (Contd.)
144 SODIUM ALGINATE 500MG+SODIUM BICARBONATE 267MG/10ML
GAVISCON ORAL SUSPENSION
Reckitt Benckiser (Lanka) Ltd
Reckitt Benckser Healthcare UK
UNITED KINGDOM
28-Jan-18 Full
145 SODIUM ALGINATE 500MG+SODIUM BICARBONATE 267MG/10ML
GAVISCON ORAL SUSPENSION
Reckitt Benckiser (Lanka) Ltd
Reckitt Benckser Healthcare UK
UNITED KINGDOM
28-Jan-18 Two Years
146 SODIUM CHLORIDE 1.75MG,POTASIUM CHLORIDE 7.5MG CITRATE DEHYDRATE 14.2G ,DEXTROSE 100MG /500ML LIQUED -BUBBLE GUM FLAVOUR
PEDITRAL LIQUID
ORAL SOLUTION
Morison PLC The Searle Company Ltd
PAKISTAN 24-Sep-14 Full
147 SODIUM CHLORIDE 2.6G+TRISODIUM CITRATE 2.9G+POTASSIUM CHLORIDE 1.5G GLUCOSE 13.5G/1000ML
PEDILIN ORAL ELECTROLY SOLUTION
PharmAce (Pvt) Ltd
Alina Combine Pharmaceuticals (Pvt) Ltd
PAKISTAN 21-May-14 Full
148 SODIUM CHLORIDE NASAL DROPS 0.9% NORSALINE P NASAL DROPS Morison PLC ATCO Laboratories (Pvt) Ltd
PAKISTAN 04-Apr-14 Full
149 SODIUM FLUORIDE AND ACIDULATED PHOSPHATE TOPICAL SOLUTION USP
FLUORITOP MOUTH WASH George Steuart Health (Pvt) Ltd
ICPA Health Products Ltd
INDIA 18-Sep-15 Full
150 TERBUTALINE SULPHATE BP 1.25MG BROMHEXINE HYDROCHLORIDE BP 4MG & GUAIPHENESIN SYRUP BP 50MG
LIBITUS PLUS SYRUP
SYRUP Ceyoka (Pvt) Ltd Leben Laboratories (Pvt) Ltd
INDIA 10-Oct-14 Full
151 THIAMINE HYDROCHLORIDE 10MG BP TABLETS
**** TABLETS Inter Pharm (Pvt) Ltd
Inter Pharm (Pvt) Ltd
SRI LANKA 28-Jul-17 Full
152 VIATMIN C 1000MG PLUS,LEMON FLAVONOID COMPLEX 71.45MG POWDER WITH ORANGE FLAVOUR
NAT-C ESTER POWDER A Baur & Co (Pvt) Ltd
Mega Lifesciences Public Company (Pvt) Ltd
THAILAND 28-Jan-16 Full
153 VIT.B COMPLEX ,THIAMINE 5MG.Ribofi avine 2mg Niacinamide 20mg BP
STANOVIT B TABLETS Tabrane Healthcare (Pvt) Ltd
Globe Pharmaceuticals Ltd
BANGLA-DESH
26-Apr-14 Full
154 VITAMIN B COMPLEX SANVITA -B SYRUP
SYRUP Lifeline Pharma-ceuticals (Pvt) Ltd
P T Sanbe Farma INDONESIA 19-Aug-14 Full
155 VITAMIN B COMPLEX **** TABLETS Sunshine Healthcare lanka Ltd
Axon Drugs (Pvt) Ltd
INDIA 01-Sep-15 Full
156 VITAMIN B COMPLEX & IRON DUROL FOR ADULTS
SYRUP Astron (Pvt) Ltd SRI LANKA 11-Dec-15 Full
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A - 09.10.2019
16SCHEDULE - II (GROUP A) (Contd.)
157 VITAMIN B COMPLEX AND IRON & ZINC SYRUP
BIZ SYRUP SYRUP Tabrane Healthcare (Pvt) Ltd
Globe Pharmaceuticals Ltd
02-Aug-14 Full
158 VITAMIN B COMPLEX FORTE+VITAMIN C+ZINC
BECOZINC CAPSULES Emerchemie NB (Ceylon) Ltd
Dr Reddy's Laboratories Ltd
INDIA 19-Nov-17 Two Years
159 VITAMIN B COMPLEX SYRUP POLYBION SYRUP Emerchemie NB (Ceylon) Ltd
Merck Limited INDIA 09-Mar-14 Full
160 VITAMIN B COMPLEX TABLETS (VIT. B1 1MG,B2 1MG & NICOTINAMIDE 10MG)
* TABLETS Sunshine Healthcare lanka Ltd
Axon Drugs (Pvt) Ltd
INDIA 29-Jun-18 Full
161 VITAMIN B COMPLEX WITH VITAMIN C ENERVON C FILMCAP
TABLETS George Steuart Health (Pvt) Ltd
United Laboratories
PHILIP-PINES
13-Oct-16 Full
162 VITAMIN B COMPLEX, VITAMIN B12 AND FOLIC ACID SYRUP
BECOSULES SYRUP Astron (Pvt) Ltd Astron (Pvt) Ltd SRI LANKA 29-Sep-15 Full
163 VITAMIN B COMPOUND TABLETS (THIAMIN HCL 1MG+RIBOFLAVIN 1MG NICOTINAMIDE 10MG)
* TABLETS Morison PLC Morison PLC SRI LANKA 01-Jan-18 Provisional
164 VITAMIN C SUSTAINED RELEASE TABLETS 500MG
VITACEE TABLETS Alaris Lanka (Pvt) Ltd
Contract Manufacuring & Packging Services pty Ltd
AUSTRA-LIA
29-Oct-14 Full
165 VITAMIN MINERAL &TRACE ELEMENTS CAPSULES
AVITONE CAPSULES Avenier Pharma (Pvt) Ltd
Triveni Formulations Ltd
INDIA 14-Mar-15 Full
166 WATER FOR INJECTION STERILISE SWFI INJECTION Chamee Chemist
Axa Parenterals Ltd
INDIA 02-Apr-15 Full
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17
SCHEDULE - II (GROUP B) (Contd.)
COLUMN-I COLUMN-II COLUMN-III COLUMN-IV COLUMN-V COLUMN-VI COLUMN-VII
COLUMN-VIII
Generic Name Brand Name Dosage Form Importer Name Manufacturer Country OF Manufactuer
Issue Date Reg. Type
1 ABACAVIR TABLETS 300MG ABAMUNE TABLETS Breathe Free Lanka (Pvt) Ltd
Cipla Ltd INDIA 06-Aug-18 Two Years
2 ABCIXIMAB INJECTION 10MG IN 5ML
REOPRO INJECTION Hemas Pharmaceuticals (Pvt) Ltd
Hospira Inc, USA for Cubist Pharmaceuticals Inc USA
SWITZERLAND 16-Jul-15 Full
3 ABCIXIMAB INJECTION 2MG/ML CLOTINAB TM INJECTION Pharma Associates ISU Abxis Co Ltd KOREA 16-Aug-17 Two Years
4 ABIRATERONE ACETATE TABLETS 250MG
ZYTIGA TABLETS Pettah Pharmacy (Pvt) Ltd
Patheon Inc.Canada (pack & Released by Janssen Cilag SPA Italy for Janssen Pharmaceuticals N V
BELGIUM 21-Feb-16 Full
5 ABIRATERONE ACETATE TABLETS 250MG
ABIRAGLOB 250 TABLETS PharmAce (Pvt) Ltd Gobela Pharma (Pvt) Ltd
INDIA 22-Feb-18 Two Years
6 ABIRATERONE ACETATE TABLETS 250MG
N/A TABLETS Yaden International (Pvt) Ltd
Centurion Laboratories Pvt Ltd
INDIA 09-Oct-17 Two Years
7 ABIRATERONE ACETATE TABLETS 250MG
ABIRON TABLETS Pharma Associates BDR Pharmaceuticals International (Pvt) Ltd
INDIA 20-Jan-16 Full
8 ABIRATERONE ACETATE TABLETS 250MG
AIZERONE TABLETS A V H Distributors (Pvt) Ltd
Aizant Drugs Research Solution Pvt Ltd
INDIA 11-Apr-18 Full
9 ABIRATERONE ACETATE TABLETS USP 250MG
N/A TABLETS R N Vision Pharma (Pvt) Ltd
Therdose Pharma (Pvt) Ltd
INDIA 06-Feb-18 Two Years
10 ABIRATERONE ACETATE TABLETS USP 250MG
ABIRATREP TABLETS Emerchemie NB (Ceylon) Ltd
Dr Reddy's Laboratories Ltd
INDIA 19-Feb-18 Two Years
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RT I : SEC. (I) - G
AZETTE EX
TRA
OR
DIN
ARY
OF TH
E DEM
OC
RATIC
SOC
IALIST R
EPUB
LIC O
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NK
A - 09.10.2019
18SCHEDULE - II (GROUP B) (Contd.)
11 ACARBOSE TABLETS 100MG GLUCOBAY TABLETS Hemas Pharmaceuticals (Pvt) Ltd
Bayer Pharma A G GERMANY 18-Mar-18 Full
12 ACARBOSE TABLETS 100MG ACARB TABLETS Euro Asian Pharma (Pvt) Ltd
Orchid Healthcare INDIA 26-Feb-14 Full
13 ACARBOSE TABLETS 50MG GLUCONAY 50 TABLETS Hemas Pharmaceuticals (Pvt) Ltd
Bayer Pharma A G GERMANY 18-Mar-18 Full
14 ACARBOSE TABLETS 50MG ABACUS TABLETS Pharma Associates The Madras Pharmaceuticals
INDIA 20-Jul-14 Full
15 ACARBOSE TABLETS 50MG GLUCAR TABLETS Hemas Pharmaceuticals (Pvt) Ltd
Glenmark Pharmaceuticals Ltd
INDIA 21-Nov-16 Full
16 ACARBOSE TABLETS 50MG DIABOSE 50 TABLETS Micro Mega Lanka (Pvt) Ltd
Micro Labs Ltd INDIA 20-Feb-16 Full
17 ACECLOFENAC CAPSULES 200MG SR
FECK SR CAPSULES Tabrane Lanka (Pvt) Ltd
Zim Laboratories Ltd
INDIA 30-Oct-14 Full
18 ACECLOFENAC CAPSULES 200MG SR
ACHAID CAPSULES Emerchemie NB (Ceylon) Ltd
Inventia Healthcare (Pvt) Ltd
INDIA 08-May-18 Full
19 ACECLOFENAC CONTROLLED RELEASE TABLETS 200MG
ZERODOL-CR TABLETS Hemas Pharmaceuticals (Pvt) Ltd
IPCA Laboratories INDIA 14-Jun-17 Two Years
20 ACECLOFENAC ENTERIC COATED TABLETS 100MG
ATOACE TABLETS Salveo Pharma (Pvt) Ltd
Pell Tech Health Care (Pvt) Ltd
INDIA 06-Feb-18 Two Years
21 ACECLOFENAC ENTERIC COATED TABLETS 10MG
ATOACE TABLETS Salveo Pharma (Pvt) Ltd
Pell Tech Health Care (Pvt) Ltd
INDIA 08-Feb-18 Two Years
22 ACECLOFENAC FILM COATED TABLETS 100MG
ACENORM 100 TABLETS Darley Butler & Co Ltd
Sterling Lab INDIA 09-Apr-14 Full
23 ACECLOFENAC GEL 1% W/W ACELODON GEL GEL PharmAce (Pvt) Ltd Swiss Garnier Life Scences
INDIA 09-Jan-17 Full
24 ACECLOFENAC SUSTAINED RELEASE TABLETS 200MG
DOLOWIN-SR TABLETS SMM Halcyon (Pvt) Ltd
Micro Labs Ltd INDIA 17-Jan-18 Two Years
25 ACECLOFENAC SUSTAINED RELEASE TABLETS 200MG
RIHA-SR 200 FILM COA TABLETS
Ceyoka (Pvt) Ltd Leben Laboratories (Pvt) Ltd
INDIA 09-Nov-17 Two Years
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AZETTE EX
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OR
DIN
ARY
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E DEM
OC
RATIC
SOC
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EPUB
LIC O
F SRI LA
NK
A - 09.10.2019
19
SCHEDULE - II (GROUP B) (Contd.)
26 ACECLOFENAC TABLETS BP 100MG
CECLOFEN TABLETS Emerchemie NB (Ceylon) Ltd
Renata Limited BANGLADESH 19-Jan-17 Full
27 ACECLOFENAC TABLETS BP 100MG
CELOFEN TABLETS CIC Holdings PLC Advanced Chemical Industries
BANGLADESH 14-Jun-17 Two Years
28 ACECLOFENAC TABLETS 100MG TUFFOX TABLETS Sunshine Healthcare lanka Ltd
Eskayef Bangladesh Ltd
BANGLADESH 07-Jul-18 Two Years
29 ACECLOFENAC TABLETS 100MG MOBENAC TABLETS Emerchemie NB (Ceylon) Ltd
Alkem Laboratories Ltd
INDIA 14-Oct-18 Full
30 ACECLOFENAC TABLETS 100MG OSICLO TABLETS RS Biogenics (Pvt) ltd
Oasis Laboratories (Pvt) Ltd
INDIA 11-Mar-16 Full
31 ACECLOFENAC TABLETS 100MG MERVAN TABLETS Hemas Pharmaceuticals (Pvt) Ltd
Aristopharma Ltd BANGLADESH 30-May-14 Full
32 ACECLOFENAC TABLETS 100MG TERNILLA TABLETS Citihealth Imports (Pvt) Ltd
Healthcare Pharmaceuticals
BANGLADESH 02-Oct-18 Two Years
33 ACECLOFENAC TABLETS 100MG ALFINAC TABLETS Harcourts (Pvt) Ltd Sai Mirra Innopharm (Pvt) Ltd
INDIA 10-May-18 Provisional
34 ACECLOFENAC TABLETS 100MG FECK TABLETS Tabrane Pharmaceuticals (Pvt) Ltd
Zim Laboratories Ltd
INDIA 01-Feb-15 Full
35 ACECLOFENAC TABLETS 100MG ZERODOL TABLETS Emar Pharma (Pvt) Ltd
IPCA Laboratories INDIA 17-Feb-14 Full
36 ACECLOFENAC TABLETS 100MG ACECLODEAL TABLETS Radiant Health Care (Pvt) Ltd
Sava Healtheare Ltd
INDIA 21-Oct-15 Full
37 ACECLOFENAC TABLETS 100MG ZIX TABLETS Hemas Pharmaceuticals (Pvt) Ltd
Jenburkt Pharmaceuticals Ltd
INDIA 03-May-17 Two Years
38 ACECLOFENAC TABLETS 100MG ACEFLEX 100 TABLETS Darley Butler & Co Ltd
Navana Pharmaceuticals Ltd
BANGLADESH 23-Dec-17 Two Years
39 ACECLOFENAC TABLETS 100MG ACEFEN TABLETS Lifeline Pharmaceuticals (Pvt) Ltd
Synmedic Laboratories (Pvt) Ltd
INDIA 14-Oct-16 Full
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DIN
ARY
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RATIC
SOC
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EPUB
LIC O
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NK
A - 09.10.2019
20SCHEDULE - II (GROUP B) (Contd.)
40 ACECLOFENAC TABLETS 100MG ACLOFEN TABLETS Pharma Associates The Madras Pharmaceuticals
INDIA 18-Nov-14 Full
41 ACECLOFENAC TABLETS 100MG ACECLOFAR TABLETS Tropical Pharma (Pvt) Ltd
S J & G Fazul Ellahie (Pvt) Ltd
PAKISTAN 14-Aug-15 Full
42 ACECLOFENAC TABLETS 100MG ACTINAC 100 TABLETS A Baur & Co (Pvt) Ltd
Ajantha Pharma Ltd
INDIA 13-Oct-17 Two Years
43 ACECLOFENAC TABLETS 100MG AROFF TABLETS A Baur & Co (Pvt) Ltd
Unichem Laboratories
INDIA 23-Apr-14 Full
44 ACECLOFENAC TABLETS 100MG MERVAN TABLETS Hemas Pharmaceuticals (Pvt) Ltd
Aristopharma Ltd BANGLADESH 30-May-14 Full
45 ACECLOFENAC TABLETS 100MG CDFENAC TABLETS Lifeline Pharmaceuticals (Pvt) Ltd
G D Laboratories (India) Pvt Ltd
INDIA 28-Mar-14 Full
46 ACECLOFENAC TABLETS 100MG APITAC TABLETS Mega Pharma (Pvt) Ltd
The Acme Laboratories Ltd
BANGLADESH 06-Sep-17 Two Years
47 ACECLOFENAC TABLETS 100MG MOVIZ 100 TABLETS George Steuart Health (Pvt) Ltd
J.B.Chemicals & Pharmaceuticals
INDIA 01-Mar-18 Two Years
48 ACECLOFENAC TABLETS 100MG CECLOF TABLETS Ashland Associates Baader Schulz Laboratories
INDIA 01-Jan-14 Full
49 ACECLOFENAC TABLETS 100MG ALGIC TABLETS Axia (Pvt) Ltd MSN Laboratories Ltd
INDIA 09-Dec-14 Full
50 ACECLOFENAC TABLETS 100MG ACECLOFAR TABLETS PharmAce (Pvt) Ltd Medley Pharmaceuticals Ltd
INDIA 22-Mar-15 Full
51 ACECLOFENAC TABLETS 100MG CECLO TABLETS Ceyline Pharmaceuticals (Pvt) Ltd
Medizan Laboratories (Pvt) Ltd
PAKISTAN 13-Sep-14 Full
52 ACECLOFENAC TABLETS 100MG ACECLORIGHT TABLETS Chamee Chemist Alvita Pharma (Pvt) Ltd
INDIA 06-Jan-16 Full
53 ACECLOFENAC TABLETS 100MG OSICLO TABLETS Union Lanka Imports (Pvt ) Ltd
Oasis Laboratories (Pvt) Ltd
INDIA 11-Mar-16 Full
54 ACECLOFENAC TABLETS 100MG RUNN 100 FILM COA TABLETS
ABC Pharma Services Pvt. Ltd
Alice Pharma Private Ltd.
INDIA 18-Sep-16 Full
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ARY
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RATIC
SOC
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EPUB
LIC O
F SRI LA
NK
A - 09.10.2019
21
SCHEDULE - II (GROUP B) (Contd.)
55 ACECLOFENAC TABLETS 100MG RESERVIX TABLETS Citihealth Imports (Pvt) Ltd
Incepta Pharmaceuticals Ltd
BANGLADESH 15-Mar-17 Two Years
56 ACECLOFENAC TABLETS 100MG RIHA FILM COA TABLETS
Ceyoka (Pvt) Ltd Leben Laboratories (Pvt) Ltd
INDIA 25-Mar-15 Full
57 ACECLOFENAC TABLETS 100MG ACELODON 100 TABLETS PharmAce (Pvt) Ltd Swiss Garnier Life Scences
INDIA 16-Feb-17 Full
58 ACECLOFENAC TABLETS 100MG ACLOFRE TABLETS George Steuart Health (Pvt) Ltd
Fredun Pharmaceuticals Ltd
INDIA 11-Dec-14 Full
59 ACECLOFENAC TABLETS 100MG PRESERVIN TABLETS Medinex (Pvt) Ltd The IBN SINA Pharmaceuticals Industry Ltd
BANGLADESH 24-Nov-14 Full
60 ACECLOFENAC TABLETS 100MG RILIF 100 TABLETS Gamma Pharmaceuticals Pvt Ltd
Umedica Laboratories (Pvt) Ltd
INDIA 07-Nov-14 Full
61 ACECLOFENAC TABLETS 100MG SUPPAINS TABLETS Hemas Health Care Cadila Healthcare Ltd
INDIA 26-Sep-14 Full
62 ACECLOFENAC TABLETS 100MG DOLOWIN TABLETS SMM Halcyon (Pvt) Ltd
Micro Labs Ltd INDIA 14-Sep-17 Two Years
63 ACECLOFENAC TABLETS 100MG ZOFEN 100 TABLETS Trendz Healthcare (Pvt) LTD
Zota Healthcare Ltd
INDIA 08-Aug-17 Full
64 ACELAIC ACID CREAM 20% AZIDERM CREAM Mega Pharma (Pvt) Ltd
Micro Labs Ltd INDIA 11-May-14 Full
65 ACETAMINOPHEN SUPPOSITORIES USP 125MG
RECTOL 125 Sunshine Healthcare lanka Ltd
Bliss GVS Pharma Ltd
INDIA 05-May-18 Full
66 ACETAMINOPHEN SUPPOSITORIES USP 125MG
GALIPAR 125 Tropical Pharma (Pvt) Ltd
Galen Pharmaceuticals (Pvt) Ltd
INDIA 18-Mar-17 Full
67 ACETAZOLAMIDE TABLETS BP 250MG
N/A TABLETS Yaden International (Pvt) Ltd
Centurion Laboratories Pvt Ltd
INDIA 11-Apr-15 Full
68 ACETAZOLAMIDE TABLETS BP 250MG
N/A TABLETS Kamazu (Pvt) Ltd Micro Labs Ltd INDIA 22-Aug-15 Full
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AZETTE EX
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DIN
ARY
OF TH
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RATIC
SOC
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EPUB
LIC O
F SRI LA
NK
A - 09.10.2019
22SCHEDULE - II (GROUP B) (Contd.)
69 ACETAZOLAMIDE TABLETS BP 250MG
N/A TABLETS Ravilux Company (Pvt) Ltd
B D H Industries Ltd
INDIA 28-Oct-15 Full
70 ACETAZOLAMIDE TABLETS IP 250MG
ACETAMIDE 250 TABLETS SMM Halcyon (Pvt) Ltd
Micro Labs Ltd INDIA 08-Apr-14 Full
71 ACETAZOLAMIDE TABLETS USP 250MG
N/A TABLETS The Esses Pharmacy (Pvt) Ltd
SG Pharma (Pvt) Ltd
INDIA 10-Apr-16 Full
72 ACETYLCYSTEINE INJECTION BP 200mg/10ML
N/A INJECTION Pharma Associates Sreil-Gene Life Science P Ltd
INDIA 15-Feb-18 Two Years
73 ACETYLCYSTEINE SOLUTION USP 200MG
CIROCYST 200 INJECTION Ceyoka (Pvt) Ltd Ciron Drugs & PharmaceuticalS (Pvt) Ltd
INDIA 29-Jun-16 Full
74 ACETYLCYSTEINE SOLUTION USP 200mg/ml (2G/10ML)Sterile
MUCOTYLE SOLUTION The Esses Pharmacy (Pvt) Ltd
SG Pharma (Pvt) Ltd
INDIA 06-Feb-14 Full
75 ACICLOVIR 200MG BP TABLETS N/A TABLETS Akbar Pharmaceuticals (Pvt) Ltd
Medico Remedies (Pvt) Ltd
INDIA 12-Dec-17 Two Years
76 ACICLOVIR 200MG BP TABLETS HERPERAX TABLETS Micro Mega Lanka (Pvt) Ltd
Micro Labs Ltd INDIA 16-Jul-17 Two Years
77 ACICLOVIR 400MG TABLETS BP VIRUCID TABLETS Access International (Pvt) Ltd
Delobris Pharmaceuticals Ltd-AT 01.06.18 Yaden-LO42/17
CYPRUS 17-Sep-14 Full
78 ACICLOVIR CREAM BP 5%W/W VIREST CREAM Hadley Bevan Lanka (Pvt) Ltd
Hovid SDN Bhd MALAYSIA 10-Jun-18 Two Years
79 ACICLOVIR CREAM BP 5%W/W ACIHERPIN CREAM Citihealth Imports (Pvt) Ltd
Agio Pharmaceuticals Ltd
INDIA 03-Apr-15 Full
80 ACICLOVIR CREAM BP 5%W/W ACIRAX CREAM Lifeline Pharmaceuticals (Pvt) Ltd
Synmedic Laboratories (Pvt) Ltd
INDIA 16-Mar-16 Full
81 ACICLOVIR CREAM BP 5%W/W CYCLOZ CREAM Ceyoka (Pvt) Ltd Focus & Rulz Pharmaceuticals (Pvt) Ltd
PAKISTAN 23-Aug-17 Two Years
82 ACICLOVIR CREAM BP 5%W/W DECLOVIR CREAM Indoscan (Pvt) Ltd Hoe Pharmaceuticals SDN BHD
MALAYSIA 02-Feb-17 Full
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PA
RT I : SEC. (I) - G
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DIN
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OC
RATIC
SOC
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EPUB
LIC O
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NK
A - 09.10.2019
23
SCHEDULE - II (GROUP B) (Contd.)
83 ACICLOVIR EYE OINTMENT BP 3% STERILE
ACYVIR EYE OINTMENT Hemas Pharmaceuticals (Pvt) Ltd
Aristopharma Ltd BANGLADESH 02-May-14 Full
84 ACICLOVIR EYE OINTMENT BP 3% W/w
EYEVIR EYE OINTMENT George Steuart Health (Pvt) Ltd
Centaur Pharmaceutical (Pvt) Ltd
INDIA 16-Jul-16 Full
85 ACICLOVIR EYE OINTMENT BP 3% W/w
N/A OINTMENT Yaden International (Pvt) Ltd
Sunwaya Rohto Pharmaceutical Pvt Ltd
INDIA 21-Feb-18 Two Years
86 ACICLOVIR EYE OINTMENT USP 3.0%
LOVIR OINTMENT Chamee Chemist Indiana Opthalmincs
INDIA 05-Jun-14 Full
87 ACICLOVIR INJECTION 250MG ZOVIRAX INJECTION GlaxoSmithkiline Pharmaceuticlas (Pvt) Ltd
Glaxo Smithkiline Manufacturing SPA
ITALY 21-Mar-15 Full
88 ACICLOVIR OINTMENT USP 5% HERPERAX OINTMENT Micro Mega Lanka (Pvt) Ltd
Micro Labs Ltd INDIA 20-Feb-18 Full
89 ACICLOVIR OPTHALMIC OINTMENT USP 3% w/w
LOVIR EYE DROPS Delmege Forsyth & Co Ltd
Remington pharmaceutical Industries (Pvt) Ltd
PAKISTAN 05-Oct-17 Two Years
90 ACICLOVIR OPTHALMIC OINTMENT USP 3% w/w
SANTOVIR EYE OINTMENT Emerchemie NB (Ceylon) Ltd
Sante (Private) Limited
PAKISTAN 19-Apr-17 Two Years
91 ACICLOVIR SODIUM FOR INTRAVENOUS INFUSION 250MG TABLETS BP
CIROVIR INJECTION Ceyoka (Pvt) Ltd Ciron Drugs & PharmaceuticalS (Pvt) Ltd
INDIA 23-Jul-15 Full
92 ACICLOVIR SODIUM FOR INTRAVENOUS INFUSION BP 250MG
VIR INJECTION Slim Pharmaceuticals (Pvt) Ltd
Troikaa Pharmaceuticals Ltd
INDIA 04-Aug-17 Two Years
93 ACICLOVIR SODIUM FOR INTRAVENOUS INFUSION BP 250MG
VIR INJECTION Slim Pharmaceuticals (Pvt) Ltd
Troikaa Pharmaceuticals Ltd
INDIA 04-Aug-17 Two Years
94 ACICLOVIR TABLETS BP 200MG ACIHERPIN TABLETS Citihealth Imports (Pvt) Ltd
Agio Pharmaceuticals Ltd
INDIA 06-Feb-15 Full
95 ACICLOVIR TABLETS BP 200MG ACIRAX TABLETS Lifeline Pharmaceuticals (Pvt) Ltd
Synmedic Laboratories (Pvt) Ltd
INDIA 28-Mar-14 Full
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SOC
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EPUB
LIC O
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A - 09.10.2019
24SCHEDULE - II (GROUP B) (Contd.)
96 ACICLOVIR TABLETS BP 200MG OVIR TABLETS SMM Halcyon (Pvt) Ltd
XL Laboratories (Pvt) Ltd
INDIA 06-Aug-14 Full
97 ACICLOVIR TABLETS BP 200MG CYCLOVIR TABLETS Sunshine Healthcare lanka Ltd
Cadila Healthcare Ltd
INDIA 30-Nov-15 Full
98 ACICLOVIR TABLETS 200MG ZOVIRAX TABLETS GlaxoSmithkiline Pharmaceuticlas (Pvt) Ltd
Glaxo Wellcom S.A Aranda Spain /Glacosmithkline Australia Pty Ltd
SPAIN/AUSTRALIA
25-Nov-17 Full
99 ACICLOVIR TABLETS BP 200MG CYCLOZ TABLETS Ceyoka (Pvt) Ltd Focus & Rulz Pharmaceuticals (Pvt) Ltd
PAKISTAN 16-Aug-17 Two Years
100 ACICLOVIR TABLETS BP 200MG ACYCLOVIR-DENK 200
TABLETS Akbar Pharmaceuticals (Pvt) Ltd
Denk Pharma GmbH & Co.
GERMANY 04-Jul-14 Full
101 ACICLOVIR TABLETS BP 400MG ACIHERPIN TABLETS Citihealth Imports (Pvt) Ltd
Agio Pharmaceuticals Ltd
INDIA 17-Jan-17 Full
102 ACICLOVIR TABLETS BP 400MG HERPERAX 400 TABLETS Micro Mega Lanka (Pvt) Ltd
Micro Labs Ltd INDIA 16-Dec-17 Full
103 ACICLOVIR TABLETS BP 800MG CLOVIREX TABLETS Hemas Pharmaceuticals (Pvt) Ltd
Brookes Pharma (Pvt) Ltd
PAKISTAN 14-Sep-17 Two Years
104 ACiCLOVIR TABLETS BP 800MG N/A TABLETS Chamee Chemist Bajaj Healthcare Ltd
INDIA 02-May-15 Full
105 ACICLOVIR TABLETS BP 800MG ACIHERPIN 800 TABLETS Citihealth Imports (Pvt) Ltd
Agio Pharmaceuticals Ltd
INDIA 21-Jan-14 Full
106 ACICLOVIR TABLETS USP 800MG VIRLESS TABLETS Indoscan (Pvt) Ltd Y S P Industries /SDN BHD
MALAYSIA 11-May-17 Full
107 ACICLOVIR TABTET USP 200MG SIMPLOVIR TABLETS Citihealth Imports (Pvt) Ltd
Incepta Pharmaceuticals Ltd
BANGLADESH 21-Dec-17 Two Years
108 ACICLOVIR TABTET USP 200MG KAYVIR 200 TABLETS P Jayanetti & Sons Pvt Ltd
Kausikh Therapeutics (Pvt) Ltd
INDIA 23-Sep-15 Full
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RATIC
SOC
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EPUB
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A - 09.10.2019
25
SCHEDULE - II (GROUP B) (Contd.)
109 ACICLOVIR TABTET USP 200MG SIMPLOVIR TABLETS Citihealth Imports (Pvt) Ltd
Incepta Pharmaceuticals Ltd
BANGLADESH 21-Dec-17 Two Years
110 ACICLOVIR TABTETS USP 400MG N/A TABLETS Emerchemie NB (Ceylon) Ltd
Pharmaniaga Manufacturing berhand
MALAYSIA 15-Feb-18 Full
111 ACITRETIN CAPSULES 10MG NEOTIGASON CAPSULES Emerchemie NB (Ceylon) Ltd
Patheon Inc.Canada for F Hoffman La Roche ltd
CANADA 11-Dec-15 Full
112 ADALIMUMAB INJECTION 40MG/0.8ML
CINNORA SOLUTION FOR INJECTION
Slim Pharmaceuticals (Pvt) Ltd
CinnaGen Co IRAN 12-Mar-18 Two Years
113 ADALIMUMAB INJECTION 40MG/0.8ML (SINGLE DOSE)
EXEMPTIA PRE-FILLED SYRINGES
Sunshine Healthcare lanka Ltd
Cadila Healthcare Ltd
INDIA 16-Nov-18 Provisional
114 ADAPALENE 0.1%w/w+CLINDAMYCIN PHOSPATE 1% w/w
CLINALIN GEL PharmAce (Pvt) Ltd Aurochem Pharmaceuticals (India) Ltd
INDIA 21-Apr-15 Full
115 ADAPALENE 1MG+CLINDAMYCIN 10MG/G
DERIVA-C GEL GEL Sunshine Healthcare lanka Ltd
Glenmark Pharmaceuticals Ltd
INDIA 04-Jul-18 Provisional
116 ADAPALENE 1MG+CLINDAMYCIN 10MG/G
CALENE GEL GEL Bio Tech Pharma (Pvt) Ltd
Dupen Laboratories (Pvt) Ltd
INDIA 13-Jan-16 Full
117 ADAPALENE CREAM 0.1% w/w ADAPCO CREAM TOPICAL CREAM
Morison PLC ATCO Laboratories (Pvt) Ltd
PAKISTAN 01-Nov-17 Two Years
118 ADAPALENE CREAM 0.1% w/w FONA 0.1% CREAM
CREAM PharmAce (Pvt) Ltd Square Pharmaceuticals Ltd
BANGLADESH 08-Oct-17 Two Years
119 ADAPALENE GEL 0.1% ADAFERIN GEL GEL Sunshine Healthcare lanka Ltd
Laboratories Galderma
FRANCE 12-Aug-15 Full
120 ADAPALENE GEL 0.1% ACLENE GEL Hemas Pharmaceuticals (Pvt) Ltd
Brookes Pharma (Pvt) Ltd
PAKISTAN 13-Oct-17 Two Years
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A - 09.10.2019
26SCHEDULE - II (GROUP B) (Contd.)
121 ADAPALENE GEL 0.1% ADAPCO GEL GEL Morison PLC ATCO Laboratories (Pvt) Ltd
PAKISTAN 23-Mar-14 Full
122 ADAPALENE GEL 0.1% ACNEPALE GEL PharmAce (Pvt) Ltd Aurochem Pharmaceuticals (India) Ltd
INDIA 06-Jun-17 Full
123 ADAPALENE GEL 0.1% ADAFERIN GEL GEL Sunshine Healthcare lanka Ltd
Galderma Laboratories
FRANCE 12-Aug-15 Full
124 ADAPALENE GEL 0.1% DERIVA AQUEOUS GEL
AQUE GEL Sunshine Healthcare lanka Ltd
Glenmark Pharmaceuticals Ltd
INDIA 24-Jan-18 Two Years
125 ADAPALENE GEL BP 0.1% ADCEPT GEL Softcare International (Pvt) Ltd
Concept Pharmaceuticals Ltd
INDIA 12-Sep-17 Two Years
126 ADAPALENE GEL MICROSPHERES 0.1%w/w
DERIVA Ms GEL Sunshine Healthcare lanka Ltd
Glenmark Pharmaceuticals Ltd
INDIA 16-Dec-18 Full
127 ADAPALENE MICROSPHERES 0.1%w/w+CLINDAMYCIN 1.0% W/W GEL
APLENE-C GEL Harcourts (Pvt) Ltd Parmax Labo. Ltd
INDIA 03-Apr-14 Full
128 ADENOSINE INJECTION USP 3MG/ML
SOLADENO INJECTION The Esses Pharmacy (Pvt) Ltd
SG Pharma (Pvt) Ltd
INDIA 16-Oct-14 Full
129 ADRENALINE (EPINEPHRINE) INJECTION BP 1 IN 1000 (IMG IN 1ML)
N/A INJECTION Akbar Pharmaceuticals (Pvt) Ltd
Hameln Pharmaceuticals GmbH Germany Mayne Pharma (Pvt) Ltd
UNITED KINGDOM
01-Jun-17 Full
130 ADRENALINE INJECTION BP 0.1MG (1,1000)
N/A INJECTION Yaden International (Pvt) Ltd
Kwality Pharmaceuticals Pvt Ltd
INDIA 02-Jul-18 Provisional
131 ADRENALINE INJECTION BP 1,1000 N/A SOLUTION FOR INJECTION
Niix Holdings (Pvt) Ltd
Macarthys Laboratories Ltd T/A Martindale Pharmaceuticals
UNITED KINGDOM
06-Oct-17 Two Years
132 ADRENALINE INJECTION BP 1MG IN IML
N/A INJECTION Ceyoka (Pvt) Ltd Ciron Drugs & PharmaceuticalS (Pvt) Ltd
INDIA 25-Nov-18 Full
I fl
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DIN
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RATIC
SOC
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EPUB
LIC O
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A - 09.10.2019
27
SCHEDULE - II (GROUP B) (Contd.)
133 ADRENALINE INJECTION BP 1MG IN IML
N/A INJECTION Pharma Associates Steril Gene Life Sciences (Pvt) Ltd
INDIA 26-Apr-18 Two Years
134 ADRENALINE INJECTION BP 1MG IN IML
ADEVER INJECTION Leader Pharma Agency Pvt Ltd
Verve Human Care Laboratories
INDIA 09-Nov-17 Two Years
135 ADRENALINE INJECTION BP 1MG IN IML
ADEVER INJECTION Leader Pharma Agency Pvt Ltd
Verve Human Care Laboratories
INDIA 09-Nov-17 Two Years
136 ADRENALINE INJECTION BP 1MG IN IML
N/A INJECTION Novachem Lanka (Pvt) Ltd
Pharmafabrikon Unit
INDIA 18-Oct-17 Full
137 ADRENALINE INJECTION BP 1MG IN IML
N/A INJECTION Yaden International (Pvt) Ltd
Atlantic Laboratories Corporation Ltd
THAILAND 26-Nov-14 Full
138 ADRENALINE INJECTION SYRINGE AUTO INJECTION 0.15MG/0.3ML
EPIPEN Jr SOLUTION FOR INJECTION
Emerchemie NB (Ceylon) Ltd
Meridian Medical Technologies In Colombia
UNITED STATES
06-Oct-17 Full
139 ADRENALINE INJECTION SYRINGE AUTO INJECTION 0.15MG/0.3ML
EPI PEN SOLUTION FOR INJECTION
Emerchemie NB (Ceylon) Ltd
Meridian Medical Technologies In Colombia
UNITED STATES
06-Oct-17 Full
140 ALBENDAZOLE CHEWABLE TABLETS 400MG
ENDANIL TABLETS SMM Halcyon (Pvt) Ltd
XL Laboratories (Pvt) Ltd
INDIA 27-Oct-17 Full
141 ALBENDAZOLE CHEWABLE TABLETS 400MG
OLWORM 400 TABLETS Lifeline Pharmaceuticals (Pvt) Ltd
Synmedic Laboratories (Pvt) Ltd
INDIA 14-Oct-15 Full
142 ALBENDAZOLE CHEWABLE TABLETS 400MG
ALZEN 400 TABLETS Softcare International (Pvt) Ltd
Ankur Drugs & Pharma (Pvt) Ltd
INDIA 09-Oct-17 Two Years
143 ALBENDAZOLE CHEWABLE TABLETS USP 400MG
ESTAZOLE 400 TABLETS Medinex (Pvt) Ltd The IBN SINA Pharmaceuticals Industry Ltd
BANGLADESH 21-Dec-17 Two Years
144 ALBENDAZOLE ORAL SUSPENSION USP 200MG/5ML
LOKABEN ORAL SUSPENSION
Slim Pharmaceuticals (Pvt) Ltd
J Duncan Healthcare (Pvt) Ltd
INDIA 12-Feb-14 Full
145 ALBENDAZOLE TABLETS 200MG CHAMPS-D WORMS
TABLETS Lifeline Pharmaceuticals (Pvt) Ltd
Upha MALAYSIA 16-Sep-15 Full
146 ALBENDAZOLE TABLETS 200MG ZENTEL TABLETS GlaxoSmithkiline Pharmaceuticlas (Pvt) Ltd
Glaxo Smithkiline Pakistan Ltd
PAKISTAN 05-Apr-17 Two Years
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28SCHEDULE - II (GROUP B) (Contd.)
147 ALBENDAZOLE TABLETS 400MG ALZEL 400 TABLETS ABC Pharma Services Pvt. Ltd
Zee Laboratories INDIA 02-Nov-17 Full
148 ALBENDAZOLE TABLETS 400MG OSIBEN TABLETS RS Biogenics (Pvt) ltd
Oasis Laboratories (Pvt) Ltd
INDIA 11-Oct-14 Full
149 ALBENDAZOLE TABLETS 400MG Al-DS TABLETS Tabrane Healthcare (Pvt) Ltd
Globe Pharmaceuticals Ltd
BANGLADESH 12-Apr-14 Full
150 ALBENDAZOLE TABLETS 400MG OSIBEN TABLETS Union Lanka Imports (Pvt ) Ltd
Oasis Laboratories (Pvt) Ltd
INDIA 11-Oct-14 Full
151 ALBENDAZOLE TABLETS 400MG ENDWORM TABLETS Pharma Associates Bafna Pharmaceuticals Ltd
INDIA 18-Jul-16 Full
152 ALBENDAZOLE TABLETS IP 400MG ALBEN CHEWABLE TABLETS
N/A Astron (Pvt) Ltd SRI LANKA 16-Aug-16 Full
153 ALBENDAZOLE TABLETS IP 400MG ANTHEL TABLETS Sunshine Healthcare lanka Ltd
Cadila pharmaceuticals Ltd
INDIA 15-Jul-14 Full
154 ALBENDAZOLE TABLETS USP 200MG
DAZOLE TABLETS George Steuart Health (Pvt) Ltd
Biolab Co Ltd THAILAND 13-Oct-16 Full
155 ALBENDAZOLE TABLETS USP 400MG
ALBEZOLE TABLETS Akbar Pharmaceuticals (Pvt) Ltd
Medopharm (PVT Ltd
INDIA 08-Mar-15 Full
156 ALBENDAZOLE TABLETS USP 400MG
ALKEN 400 TABLETS Alaris Lanka (Pvt) Ltd
Gepach International
INDIA 06-Nov-16 Full
157 ALBENDAZOLE TABLETS USP 400MG
LOKABEN TABLETS Slim Pharmaceuticals (Pvt) Ltd
J Duncan Healthcare (Pvt) Ltd
INDIA 28-Jan-15 Full
158 ALBENDAZOLE TABLETS USP 400MG
ABZ TABLETS Emar Pharma (Pvt) Ltd
Indoco Remedies India
INDIA 07-Jun-14 Full
159 ALBENDAZOLE TABLETS USP 400MG
UBENDAZOLE TABLETS Gamma Pharmaceuticals Pvt Ltd
Umedica Laboratories (Pvt) Ltd
INDIA 09-Aug-15 Full
160 ALBUMIN BOUND NANOPARTICLE PACLITAXEL INJECTION 100MG
PACLITAX NAB INJECTION Breathe Free Lanka (Pvt) Ltd
Cipla Ltd INDIA 27-Nov-17 Two Years
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A - 09.10.2019
29
SCHEDULE - II (GROUP B) (Contd.)
161 ALBUMIN BOUND NANOPARTICLE PACLITAXEL INJECTION 100MG
PACLITAX NAB INJECTION Breathe Free Lanka (Pvt) Ltd
Cipla Ltd INDIA 27-Nov-17 Two Years
162 ALBUMIN HUMAN SOLUTION FOR INJECTION 20%
ALBURX 20% SOLUTION INFUSION
ABC Pharma Services Pvt. Ltd
CSL Behring GmbH
SWITZERLAND 19-Oct-18 Provisional
163 ALCOHOL BASED HAND RUB N/A TOPICAL SOLOTION
N/A Suraksa Pharma (Pvt) Ltd
SRI LANKA 15-May-18 Provisional
164 ALCOHOL BASED HAND RUB N/A TOPICAL SOLOTION
N/A Suraksa Pharma (Pvt) Ltd
SRI LANKA 15-May-18 Provisional
165 ALENDRONATE SODIUM 35MG TABLETS
OSTEOFOS TABLETS Breathe Free Lanka (Pvt) Ltd
Cipla Ltd INDIA 07-Sep-14 Full
166 ALENDRONATE SODIUM TABLETS USP 70MG
BONATE OW TABLETS PharmAce (Pvt) Ltd Wilshire Laboratories (Pvt) Ltd
PAKISTAN 09-May-18 Two Years
167 ALENDRONATE SODIUM TABLETS USP 70MG
DRATE 70 TABLETS Tropical Pharma (Pvt) Ltd
S J & G Fazul Ellahie (Pvt) Ltd
PAKISTAN 31-Jul-15 Full
168 ALENDRONATE SODIUM TABLETS USP 70MG
ALDREN 70 TABLETS Hemas Pharmaceuticals (Pvt) Ltd
Cadila Healthcare Ltd
INDIA 10-Aug-14 Full
169 ALENDRONATE SODIUM TABLETS USP 70MG
BONAFIDE TABLETS Slim Pharmaceuticals (Pvt) Ltd
Medisure Laboratories Pakistan (Pvt) Ltd
PAKISTAN 21-Sep-15 Full
170 ALENDRONATE SODIUM TABLETS USP 70MG
OSTEOFOS TABLETS Citihealth Imports (Pvt) Ltd
Cipla Ltd INDIA 18-Jun-14 Full
171 ALENDRONATE TABLETS 70MG RALENOST 70MG TABLETS Hemas Pharmaceuticals (Pvt) Ltd
Sun Pharmaceutical industries
INDIA 03-Apr-14 Full
172 ALENDRONIC ACID TABLETS 70MG BONGARD 70MG TABLETS CIC Holdings PLC PharmEvo (Pvt) Ltd
PAKISTAN 10-Sep-18 Two Years
173 ALENDRONIC ACID TABLETS USP 70MG
OSTEOMAX 70 TABLETS Tabrane Pharmaceuticals (Pvt) Ltd
Zim Laboratories Ltd
INDIA 27-Oct-15 Full
174 ALFACALCIDOL 0.25MCG ONE ALPHA CAPSULES Hemas Pharmaceuticals (Pvt) Ltd
Laboratories LEO S.A France for Leo Pharmaceutical ProductsLeo A/S DENMARK
DENMARK 12-Jun-14 Full
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30SCHEDULE - II (GROUP B) (Contd.)
175 ALFACALCIDOL 1MCG SOFT GELATIN CAP
ONE ALPHA SOFT GELETIN CAPSULES
Hemas Pharmaceuticals (Pvt) Ltd
LEO Pharma A S DENMARK 18-Nov-17 Full
176 ALFACALCIDOL CAPSULES 0.25MCG
CALCICURE SOFT GELETIN CAPSULES
Slim Pharmaceuticals (Pvt) Ltd
Olive Healthcare INDIA 09-Dec-15 Full
177 ALFACALCIDOL CAPSULES 0.25MCG
ALFACIP 0.25mcg CAPSULES Citihealth Imports (Pvt) Ltd
Cipla Ltd INDIA 25-Jun-14 Full
178 ALFACALCIDOL CAPSULES 0.5MCG ONE ALPHA CAPSULES Hemas Pharmaceuticals (Pvt) Ltd
Laboratories LEO S.A France for Leo Pharmaceutical ProductsLeo A/S DENMARK
DENMARK 02-Dec-14 Full
179 ALFACALCIDOL CAPSULES 1.0MCG ALPHADOL CAPSULES Hemas Pharmaceuticals (Pvt) Ltd
Panacea Biotec (Pvt) Ltd
INDIA 15-Aug-15 Full
180 ALFACALCIDOL CAPSULES BP 0.25MCG
TOPBONE CAPSULES Yaden International (Pvt) Ltd
Renown Pharmaceuticals Pvt Ltd
INDIA 12-Feb-18 Two Years
181 ALFACALCIDOL TABLETS 1MCG XBONE 1MCG TABLETS PharmAce (Pvt) Ltd Wilshire Laboratories (Pvt) Ltd
PAKISTAN 30-Jan-18 Full
182 ALGINIC ACID 200MG,MAGNESIUM HYDR.250MG,DRIED ALUMINIUM HYDR.250MG, MAGNISIUM TRIS 250MG,DIMETHICONE 125MG/15ML SUSPENSION
MEGACID SUSPENSION Sunshine Healthcare lanka Ltd
Sai Mirra Innopharm (Pvt) Ltd
INDIA 11-Sep-14 Full
183 ALLOPURINOL TABLETS BP 100MG ALLONOL TABLETS P Jayanetti & Sons Pvt Ltd
Kausikh Therapeutics (Pvt) Ltd
INDIA 05-Mar-14 Full
184 ALLOPURINOL TABLETS BP 100MG LOGOUT TABLETS Swedish Trading Co Ltd
Inga Laboraories (Pvt) Ltd
INDIA 12-Aug-14 Full
185 ALLOPURINOL TABLETS BP 100MG HILRIC TABLETS MAPS Pharma (Pvt) Ltd
Hiral Labs Ltd INDIA 02-May-18 Provisional
186 ALLOPURINOL TABLETS BP 100MG N/A TABLETS Indoscan (Pvt) Ltd Y S P Industries /SDN BHD
MALAYSIA 12-Nov-14 Full
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A - 09.10.2019
31
SCHEDULE - II (GROUP B) (Contd.)
187 ALLYLESTRENOL TABLETS 5MG GESTON 5 TABLETS PharmAce (Pvt) Ltd Square Pharmaceuticals Ltd
BANGLADESH 02-Apr-15 Full
188 ALPHA LIPOIC ACID,COBALAMIN WITH MULTIVITAMIN CASULES
NEUROGEN TABLETS Prime Pharma Lanka (Pvt) Ltd
MMC Healthcare Ltd
INDIA 14-Oct-16 Full
189 ALPRAZOLAM TABLETS 0.5MG ZOLARAM 0.5 TABLETS Access International (Pvt) Ltd
Delobris Pharmaceuticals Ltd-AT 01.06.18 Yaden-LO42/17
CYPRUS 26-Jul-14 Full
190 ALPRAZOLAM TABLETS 0.5MG ZOLIUM 0.5 TABLETS Citihealth Imports (Pvt) Ltd
Incepta Pharmaceuticals Ltd
BANGLADESH 17-Oct-14 Full
191 ALPRAZOLAM TABLETS 0.5MG SEDALAM TABLETS Glenford Corporation (Pvt) Ltd
Aburaihan Pharmaceuticals Company
IRAN 16-Jul-15 Full
192 ALPRAZOLAM TABLETS USP 0.25MG
MANOREST TABLETS Euro Asian Pharma (Pvt) Ltd
Orchid Healthcare INDIA 14-Jul-18 Full
193 ALPRAZOLAM TABLETS USP 0.25MG
B-REST 0.25 TABLETS Browns & Company Plc
Akums Drugs & Pharmaceuticals Ltd
INDIA 14-Jun-17 Full
194 ALPRAZOLAM TABLETS USP 0.25MG
ALPAZ 0.25 TABLETS Pharma Associates The Madras Pharmaceuticals
INDIA 04-Jan-15 Full
195 ALPRAZOLAM TABLETS USP 0.25MG
ATREST 0.25 TABLETS George Steuart Health (Pvt) Ltd
Centaur Pharmaceutical (Pvt) Ltd
INDIA 11-Feb-15 Full
196 ALPRAZOLAM TABLETS USP 0.25MG
B-REST 0.25 TABLETS Lotus Pharmaceuticals (Pvt) Ltd
Akums Drugs & Pharmaceuticals Ltd
INDIA 14-Jun-17 Full
197 ALPRAZOLAM TABLETS USP 0.25MG
ALZOLAM TABLETS Emerchemie NB (Ceylon) Ltd
Sun Pharmaceutical industries
INDIA 14-Feb-18 Full
198 ALPRAZOLAM TABLETS USP 0.5MG TRANQUINALS 0.5
TABLETS Emerchemie NB (Ceylon) Ltd
Laboratories Bago S A
ARGENTINA 11-Oct-18 Provisional
199 ALPRAZOLAM TABLETS USP 0.5MG B-REST 0.5 TABLETS Browns & Company Plc
Akums Drugs & Pharmaceuticals Ltd
INDIA 18-Apr-17 Full
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32SCHEDULE - II (GROUP B) (Contd.)
200 ALPRAZOLAM TABLETS USP 0.5MG ALZOLAM TABLETS Emerchemie NB (Ceylon) Ltd
Sun Pharmaceutical industries
INDIA 14-Feb-18 Full
201 ALPRAZOLAM TABLETS USP 0.5MG ATREST 0.5 TABLETS George Steuart Health (Pvt) Ltd
Centaur Pharmaceutical (Pvt) Ltd
INDIA 20-Jun-16 Full
202 ALPRAZOLAM TABLETS USP 0.5MG B-REST 0.5 TABLETS Lotus Pharmaceuticals (Pvt) Ltd
Akums Drugs & Pharmaceuticals Ltd
INDIA 18-Apr-17 Full
203 ALPRAZOLAM TABLETS USP 0.5MG MANOREST TABLETS Euro Asian Pharma (Pvt) Ltd
Orchid Healthcare INDIA 21-Jul-17 Full
204 ALPROSTADIL INJECTION IP 500MCG
BIOGIANDIN INJECTION Klintas (Pvt) Ltd United Biotech (Pvt) Ltd
INDIA 16-Nov-18 Two Years
205 ALPROSTADIL INJECTION USP 0.5MG/ML
N/A INJECTION The Esses Pharmacy (Pvt) Ltd
SG Pharma (Pvt) Ltd
INDIA 07-Jul-14 Full
206 ALPROSTADIL INJECTION USP 0.5MG/ML
ALPOSTIN INJECTION Pharma Associates Samarth Life Sciences (Pvt) Ltd
INDIA 13-Jun-17 Two Years
207 ALTEPLASE (RECOMBINANT HUMAN TISSUE TYPE PLASMINOGEN ACTIVATOR INJECTION 20MG
ACTILYSE INJECTION Hemas Pharmaceuticals (Pvt) Ltd
Boehringer Ingelheim Pharma gmBH & Co.Kg
GERMANY 15-Dec-15 Full
208 ALUMINA , MAGNESIA & SIMETHICONE ORAL SUSPENSION (EACH 5ML CONTAINS,Dried ALUM.HYD BP 400MG,SIMETHICONE SUP 500MG) DOUBLE STRENGTH
ANTAGIT DS ORAL SUSPENSION
Ceyoka (Pvt) Ltd Leben Laboratories (Pvt) Ltd
INDIA 28-May-15 Full
209 ALUMINA , MAGNESIA & SIMETHICONE ORAL SUSPENSION WITH OXETACAINE
GASTRICAINE ORAL SUSPENSION
N/A Gamma Pharmaceuticals (Pvt) Ltd
SRI LANKA 16-Jul-18 Provisional
210 ALUMINIUM +MAGNESIUM & SIMETHICONE ORAL SUSPENSION
GASTRIL-MINT ORAL SUSPENSION
N/A Interpharm (Pvt) Ltd -Sri Lanka
SRI LANKA 06-Jun-18 Two Years
211 ALUMINIUM +MAGNESIUM & SIMETHICONE ORAL SUSPENSION
ANTAGIT DS ORAL SUSPENSION
Ceyoka (Pvt) Ltd Leben Laboratories (Pvt) Ltd
INDIA 28-May-15 Full
212 ALUMINIUM 300MG+MAGNESIUM 250MG & SIMETHICONE 40MG ORAL SUSPENSION USP
DIOVOL FORTE SUSPENSION Emar Pharma (Pvt) Ltd
Wallace Pharmaceuticals Ltd
INDIA 25-May-15 Full
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33
SCHEDULE - II (GROUP B) (Contd.)
213 ALUMINIUM HYD 300+MAGNESIUM HYD 150MG & SIMETHICONE BP 125MG+OXETACAINE BP 5MG/5ML
ANACID FORTE GEL
ORAL SUSPENSION
Harcourts (Pvt) Ltd Parmax Labo. Ltd
INDIA 12-Feb-14 Full
214 ALUMINIUM HYD.306MG+MAGNESIUM HYD. 110MG+SIMETHICONE 30MG USP ORAL SUSPENSION
BELEID XTRA ORAL SUSPENSION
George Steuart Health (Pvt) Ltd
Biolab Co Ltd THAILAND 06-Jul-18 Two Years
215 ALUMINIUM HYDROXIDE +MANGESIUM HYDROXIDE +SIMETHICONE USP ORAL SUSPENSION
PEPTICA GEL ORAL SUSPENSION
Mansel (Ceylon) (Pvt) Ltd
Geno Pharmaceuticals Pvt Ltd
INDIA 14-Feb-17 Full
216 ALUMINIUM HYDROXIDE BP 120MG + MAGNESIUM TRISILICATE BP 250MG CHEWABLE COMPOUND TABLETS
N/A TABLETS Pharma Associates Bafna Pharmaceuticals Ltd
INDIA 01-Mar-15 Full
217 ALUMINIUM HYDROXIDE DRIED 300MG+MANGESIUM SILICATE HYDR 50MG+SIMETHICONE 25MG (ORANGE)
DIGENE TABLETS Sunshine Healthcare lanka Ltd
Abbott India Ltd INDIA 31-Oct-15 Full
218 ALUMINUM 250MG,MAGNESIA 250MG AND SIMETHICONE BP 50 ORAL SUSPENSION USP
COOLGEL ORAL SUSPENSION
Salveo Pharma (Pvt) Ltd
Mc W Healthcare (P) Ltd
INDIA 07-Mar-18 Two Years
219 ALUMINUM HDR. BP 250MG +MAGNESIUM HYD. BP 250MG & SIMETHICONE BP 50MG/5ML
COOLGEL ORAL SUSPENSION
Salveo Pharma (Pvt) Ltd
Mc W Healthcare (P) Ltd
INDIA 07-Mar-18 Two Years
220 ALUMINUM HYDROXIDE Dried +MAGNESIUM HYDROXIDE + SIMETHICONE SUSPENSION
ENICID SYRUP SUSPENSION PharmAce (Pvt) Ltd Enicar Pharmaceuticals Pvt Ltd
INDIA 04-May-18 Two Years
221 ALUMINUM HYDROXIDE USP 153MG+MAGNESIUM HYDROXIDE USP 200MG & SIMETHICONE USP 20MG
BELCID CHEWABLE TABLETS
George Steuart Health (Pvt) Ltd
Biolab Co Ltd THAILAND 06-Apr-18 Full
222 AMANTADINE CAPSULES BP 100MG
COMANTREL 100 CAPSULES PharmAce (Pvt) Ltd Consern Pharma Pvt Ltd
INDIA 22-Mar-18 Two Years
223 AMBROXOL HCL 15MG+TURBUTALINE SULPH 1.5MG +GUAPHENESIN 50MG/5ML SYRUP
ELTUSS-A SYRUP Siba Healthcare (Pvt) Ltd
Stallion Laboratories Pvt Ltd
INDIA 26-Jun-15 Full
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34SCHEDULE - II (GROUP B) (Contd.)
224 AMBROXOL HCL BP 15MG+TURBUTALINE SULPH BP 1.25MG +GUAPHENESIN 50MG/5ML SYRUP
NORVENT SYRUP Pharma Associates Indchemie Health Specialities (Pvt) Ltd
INDIA 05-Feb-15 Full
225 AMBROXOL HYDROCHLORIDE 15MG & SALBUTAMOL SULPHATE 1MG SYRUP 5ML
DAWACOF SYRUP T & J Pharma Imports (Pvt) Ltd
Lincolin Pharmaceuticals
INDIA 15-Feb-17 Full
226 AMBROXOL HYDROCHLORIDE BP SYRUP 30MG/5ML
AMBROLITE SYRUP CIC Holdings PLC TILL Heathcare Pvt Ltd
INDIA 20-Sep-18 Two Years
227 AMBROXOL HYDROCHLORIDE SYRUP 15MG/5ML
AMBOTEN SYRUP Sunshine Healthcare lanka Ltd
Eskayef Bangladesh Ltd
BANGLADESH 09-Jul-14 Full
228 AMBROXOL HYDROHLORIDE BP SYRUP 30MG/5ML
MUCOROL SYRUP Alaris Lanka (Pvt) Ltd
Universal Pharmaceuticals Ltd
INDIA 05-Jun-17 Two Years
229 AMBROXOL HYDROHLORIDE SYRUP 15MG/5ML
AMBOTEN SYRUP Sunshine Healthcare lanka Ltd
Eskayef Bangaladesh Ltd
BANGLADESH 09-Jul-14 Full
230 AMBROXOL HYDROHLORIDE SYRUP 15MG/5ML
AMBROCARE SYRUP Breathe Free Lanka (Pvt) Ltd
Cipla Ltd INDIA 31-Jul-15 Full
231 AMIKACIN SULPHATE INJECTION BP 250MG/2ML
N/A INJECTION Yaden International (Pvt) Ltd
Vital Healthcare (Pvt) Ltd
INDIA 11-Sep-14 Full
232 AMIKACIN SULPHATE INJECTION BP 500MG/2ML
N/A INJECTION Yaden International (Pvt) Ltd
Mercury Laboratories Ltd
INDIA 28-Dec-18 Two Years
233 AMIKACIN SULPHATE INJECTION USP 100MG/2ML
AMPRO 100 INJECTION Access International (Pvt) Ltd
Protech Biosystems (Pvt) Ltd
INDIA 26-Jun-15 Full
234 AMIKACIN SULPHATE INJECTION USP 250MG/2ML
AMIBAC 250 INJECTION PharmAce (Pvt) Ltd Kavbir Pharmaceutical Pvt Ltd
INDIA 30-Jul-15 Full
235 AMIKACIN SULPHATE INJECTION USP 500MG/2ML
N/A INJECTION P T C Medical (Pvt) Ltd
Scott Edil Pharmacia Ltd
INDIA 19-Jun-16 Full
236 AMIKACIN SULPHATE INJECTION USP 500MG/2ML
N/A INJECTION Yaden International (Pvt) Ltd
Vital Healthcare (Pvt) Ltd
INDIA 19-Jun-17 Full
237 AMILORIDE HYDROCHLORIDE USP 5MG+HYDROCHLOROTHIAZIDE USP 50MG
MODURETIC TABLETS Mansel (Ceylon) (Pvt) Ltd
OBS Pakistan (Pvt) Ltd
PAKISTAN 05-Apr-17 Full
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35
SCHEDULE - II (GROUP B) (Contd.)
238 AMINO ACID 5% AND SORBITIOL 5% W/V INJECTION
NIRMIN 5 INJECTION Sunshine Healthcare lanka Ltd
Aculife Healthcare (Pvt) Ltd
INDIA 18-Oct-18 Two Years
239 AMINO ACID ELECTROLYTES 10% W/V
NIRMIN PLUS INJECTION Sunshine Healthcare lanka Ltd
Aculife Healthcare (Pvt) Ltd
INDIA 23-Sep-16 Full
240 AMINO ACID INJECTION 7% W/V CELEMIN NEPHRO
INJECTION Akbar Pharmaceuticals (Pvt) Ltd
Otsuka Pharmaceuticals (Pvt) Ltd
INDIA 24-Feb-15 Full
241 AMINO ACID SOLUTION FOR INJ 10%
AMINOVEN 10% INJECTION Hemas Pharmaceuticals (Pvt) Ltd
Fresenius Kabi Austria Gmbh Austria Fresenius kabi Ab Sweden
AUSTRIA 31-Jul-17 Two Years
242 AMINO ACID SOLUTION FOR INJ 70g/L
NEPHROSTERIL INJECTION Markss HLC (Pvt) Ltd
Fresenius Kabi Austria Gmbh Austria Fresenius kabi Ab Sweden
AUSTRALIA 21-Jan-14 Full
243 AMINO ACID SOLUTION FOR INTRAVENOUS NUTRITION 65.3G/L
VAMINOLACT INJECTION Hemas Pharmaceuticals (Pvt) Ltd
Fresenius Kabi A.B
AUSTRIA 27-Jul-15 Full
244 AMINOPHYLLIN 32MG+DIPHENYDRAMINE 8MG+AMMONIUM CHLORID 30MG, MENTHOL 0.98MG/5ML
AMINOLLIN SYRUP Ceyoka (Pvt) Ltd ISIS Pharmaceuticals & Chemical Works
PAKISTAN 24-Feb-16 Full
245 AMINOPHYLLIN PHEUR. 32+DIPHEHYDRAMINE 8MG+AMMONIUM CHLORIDE 30MG/5ML
EXALYN SYRUP SYRUP Hemas Pharmaceuticals (Pvt) Ltd
Brookes Pharma (Pvt) Ltd
PAKISTAN 27-Feb-15 Full
246 AMINOPHYLLINE INJECTION BP 25MG/ML
VITAPHYLLINE INJECTION Yaden International (Pvt) Ltd
Vital Healthcare (Pvt) Ltd
INDIA 26-Apr-15 Full
247 AMINOPHYLLINE INJECTION BP 25MG/ML
N/A INJECTION The Esses Pharmacy (Pvt) Ltd
SG Pharma (Pvt) Ltd
INDIA 10-Apr-16 Full
248 AMIODARONE 150MG/3ML SOLUTION FOR INJECTION
N/A INJECTION Akbar Pharmaceuticals (Pvt) Ltd
Hikma pharmaceuticals
PORTUGAL 20-Jan-14 Full
249 AMIODARONE CONCENTRAT STERILE INJECTION 50MG/ML
CORDASOL INJECTION The Esses Pharmacy (Pvt) Ltd
SG Pharma (Pvt) Ltd
INDIA 11-Feb-14 Full
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