APPLICATION FOR MANUFACTURING OF DRUG FORMULATIONFORM:XXF1. Name
& Address of firm:PANTHER HEALTH CARE PVT.LTD. (An ISO9001:2008
&GMP Certified Co.) Plot No.-318,Madhopur Road, SaliyarDehradun
Road, Roorkee-247667(U.K)2. Categories in which item
applied:Tablets3. License No.: 13/UA/2006 (25)4. FOR PHARMACOPOEIAL
DRUGS:(a) Pharmacopoeial Name:N.A(b) Pharmacopoeial
reference(indicate:N.AThe edition & page No. of Pharmacopoeial
)(c) Composition/Strength:Each uncoated tablet
contains:NimesulideBP 100mg ParacetamolIP 325mg Excipients qs
Colour : Sunset yellow FCF (d) Brand Name, if any:N.A5. FOR PATENT
AND PROPRIETORY DRUGS:(a) Brand Name of Drugs:N.A(b) Complete
Formula:N.A(c) Suggested Dosages:As directed by Physician. (d) Main
Therapeutic claim Proposed to made on the lable:N.ACarton &
Packing insert.( e) In case of combination drug give detail:N.A Of
rational,efficacy, safety of each ingredient.6. Name and percentage
of preservative :N.AAdded.if any7. Detail of the excipients
proposed to be: maize starch, mccp, dcp, pvpk -30, talcum, added in
the formulation mag.sterate, aerosol, sunset yellow, etc.8. Nane of
colour used. If any:Sunset yellow FCF9. Certificate that the
proposed name:Does not infringe the Trade Mark Act for the time
being.In force10. Size of packing in which the Product is proposed
to be marketed:Blister of 10 Tablets11. In case of a new drug
attach a:N.APhotocopy of the letter received fromDrugs controller
(India) grantingPermission for its manufacture 12.Detailsmethod of
analysis of active:Method of analysis by I.H.S Ingredients and its
reference 13.If tested from approved testing:Consent leter already
submitted. Laboratory attach their consent letterfor carrying out
complete analysis. 14.Stabilitydata.In case of thermo labile
Ingredient for the proposed life period:N.A 15.Whether any special
Machinewhether:N.Aany special Machinery or Condition are required
for the manufacture of this product and the Same have been arranged
10X15 ,10x2x10,25x2x10 Tablets TEXT OF THE PROPOSED LABEL:Rx
Storage: Store in cool dry and dark place Protect from
light.Nimesulide & ParacetamolTablets Keep out of reach of
children.Composition:SCHEDULE H DRUG :Warning: To be sold by retail
on the Prescription of a Registered Medical Practitioner only
Each uncoated tablet contains:Nimesulide BP 100mgParacetamol IP
325mgExcipients qsColour : Sunset yellow FCFDosage:As directed by
Physician.
Caution : Overdose of Paracetamol may be Injurious to liver May
be Injurious to liver. 1. Box Warning
2.Co.-Administration(Caution)
Manufactured by: Mfg.Lic.No.:13/UA/2006Batch No.:PANTHER HEALTH
CARE PVT.LTD.(An ISO 9001:2008 &GMPCertified Co.)Mfg.DatePlot
No.-318,MadhopurRoad,SaliyarDehradun
Road,Roorkee-247667(U.K)Exp.Date:Maximum retail.Price Rs.Per
Blister of 10 /15TabletsInclusive of all taxes.
SIGNATURE OF MANUFACTURING INCHARGE
(MFG. CHMIST) NAME & DESIGNATION
