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Nimesulide & Paracetamol Tablets

The document is an application for manufacturing a drug formulation of nimesulide and paracetamol tablets. It provides details such as the name and address of the manufacturing firm, the license number, composition of the drug including active ingredients nimesulide 100mg and paracetamol 325mg per tablet, proposed packaging in blisters of 10 tablets, and proposed label text including storage, dosage, warnings, and manufacturing details. The application seeks approval to manufacture the specified drug formulation for marketing.

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NamanJain
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506 views

Nimesulide & Paracetamol Tablets

The document is an application for manufacturing a drug formulation of nimesulide and paracetamol tablets. It provides details such as the name and address of the manufacturing firm, the license number, composition of the drug including active ingredients nimesulide 100mg and paracetamol 325mg per tablet, proposed packaging in blisters of 10 tablets, and proposed label text including storage, dosage, warnings, and manufacturing details. The application seeks approval to manufacture the specified drug formulation for marketing.

Uploaded by

NamanJain
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
You are on page 1/ 2

APPLICATION FOR MANUFACTURING OF DRUG FORMULATION

FORM:XXF
1. Name & Address of firm
PVT.LTD.

PANTHER HEALTH CARE

(An ISO9001:2008
&GMP Certified Co.)
Plot No.-318,Madhopur Road,
Saliyar
Dehradun Road, Roorkee247667(U.K)
2. Categories in which item applied
3. License No.
:
4. FOR PHARMACOPOEIAL DRUGS :
(a) Pharmacopoeial Name
:
(b) Pharmacopoeial reference(indicate :
The edition & page No. of
Pharmacopoeial )
(c)
Composition/Strength
:

:
Tablets
13/UA/2006 (25)
N.A
N.A
Each uncoated tablet contains:
Nimesulide

BP

Paracetamol

IP

Excipients

100mg
325mg
qs

Colour : Sunset yellow FCF

(d) Brand Name, if any

N.A

5. 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.A
Carton & 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.A
Added.if any
7. Detail of the excipients proposed to be : maize starch, mccp, dcp, pvpk -30, talcum,
added in the formulation
mag.sterate, aerosol, sunset yellow, etc.
Sunset yellow FCF
8. Nane of colour used. If any
:
9. Certificate that the proposed name
:
Does not infringe the Trade Mark
Act for the time being.In force
10. Size of packing in which the
Product is proposed to be marketed
:
Blister of 10 Tablets
11. In case of a new drug attach a
:
N.A
Photocopy of the letter received from
Drugs controller (India) granting
Permission 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.A
any 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:
Each uncoated tablet contains:
Nimesulide

BP

Paracetamol
Excipients
Colour : Sunset yellow

SCHEDULE H DRUG :
Warning: To be sold by retail on
the Prescription of a Registered
Medical Practitioner only

100mg
IP

325mg

qs
FCF

Dosage: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/2006
Batch No.:

PANTHER HEALTH CARE PVT.LTD.


(An ISO 9001:2008 &GMPCertified Co.)
Plot No.-318,MadhopurRoad,Saliyar
Dehradun Road,Roorkee-247667(U.K)

Mfg.Date

Exp.Date:
Maximum retail.
Price Rs.
Per Blister of 10 /15Tablets
Inclusive of all taxes.
SIGNATURE OF MANUFACTURING INCHARGE

(MFG. CHMIST) NAME & DESIGNATION

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