Professional Documents
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10-07/2022-OTC (M-108)
Government of Pakistan
Ministry of National Health Services, Regulations & Coordination
Drug Regulatory Authority Of Pakistan
Health & OTC Products Division (Non-Drugs)
*****
The applications of following applicants were placed before the Enlistment Evaluation Committee (EEC)
in its 108th meeting held on 22nd June, 2022 and the same have been deferred being deficient of the information / documents
as specified in column (3) of the Table below which may be furnished within 20 days of uploading of this letter on official
website of DRAP along with soft data as per Annexed Format at the end of this letter/document. Replies received after
given time will not be entertained:-
S.No Brand name Decision
(1) (2) (3)
(For Export Purpose Only)
M/s Mint Pharmaceutical (Pvt.) Ltd,
10.2km Lahore Sheikhupure Road, Lahore (E. No. 00177)
1. Lozenol Lozenges Deferred for following reason:
The firm has applied two different formulation with the same brand name
therefore, the firm is required for clarification/ change of brand name and
omission of toxic substance from the formulation
(For Export Purpose Only)
M/s Sois Life Sciences,
A-84, S.I.T.E, Super Highway, Karachi (E. No. 0090)
2. Dr. J’s prostate complex capsule Deferred for further evaluation
(For Export Purpose Only)
M/s Paul Brooks Homeo Labs,
Plot No. A-69, S.I.T.E., Super Highway Phase-I, Karachi (E. No. 0088)
3. AGIOMOV GRANULES Deferred for clarification regarding dosage form.
4. QUENALOG ORAL GEL Deferred for clarification regarding dosage form.
5. NEUROCARE PAIN GEL Deferred for change of brand name.
6. SLIMTRIM CAPSULES Deferred for change of brand name.
7. TOTO CARE (Gripe Water) Deferred for change of brand name
(For Export Purpose Only)
M/s Hiranis Pharmaceutical,
E-145-149, North Western Industrial Zone, Port Qasim, Karachi (E. No. 00174)
8. Maximun Tablet Deferred for change of brand name
9. Vitalite B Tablet Deferred for change of brand name
10. Lipfer Sachet Deferred for change of brand name
(For Export Purpose Only)
M/s Hi-Nutrition,
9.5km, Sheikhupura Road, Lahore (E. No. 0077)
11. Neutroplex Tablet Deferred for change of brand name
(For Export Purpose Only)
M/s Stiflex Pharmaceuticals,
33-B, Industrial area, Bahtar Road, Wah Cantt (E. No. 0012)
12. Berrymax Plus Syrup Deferred for change of brand name
13. Chris Mom Sachet Deferred for the following reasons:
Change of brand name
Confirmation of food supplement section
14. Actisure Sachet Deferred for change of brand name
(For Export Purpose Only)
M/s Evergreen Pharmaceuticals,
58/RH Glaxo Town Industrial estate, 20km Ferozpur Road, Lahore (E. No. 0044)
15. Laxo-mag Powder Deferred for clarification regarding strength of elemental magnesium in
magnesium slat
16. Laximax Powder Deferred for clarification regarding formulation
M/s Route2Health (Pvt.) Limited,
229, Sundar Industrial Estate, Lahore (0022)
17. Route2Health’s Glucose Chewable Tablet 4g Deferred for clarification and justification of applied product as health
product
M/s Medicraft Pharmaceuticals (Pvt.) Ltd.,
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M/s Faiz Ismail & Sons, E-991/B, Nadirabad No.2, Bedian Road, Lahore, an agent of M/s Regilait SAS, 102 RD 906, Saint Martin
Belle Roche, CS, 20309, 71009, Macon, France (E. No. 01157)
878. France Lait 1 Powder Deferred for following reasons:
Needs clarification regarding the type of Vitamin K used in
formulation.
Long term and accelerated stabilidy studies data as per the
requirement of Zone IV A not provided.
Provided exact strength of Fluoride used in formulation.
879. France Lait 2 Powder Deferred for following reasons:
Needs clarification regarding the type of Vitamin K used in
formulation.
Long term and accelerated stabilidy studies data as per the
requirement of Zone IV A not provided.
Provided exact strength of Fluoride used in formulation.
880. France Lait LF Powder Deferred for following reasons:
Needs clarification regarding the type of Vitamin K used in
formulation.
Long term and accelerated stabilidy studies data as per the
requirement of Zone IV A not provided.
Provided exact strength of Fluoride, chromium and Molybdenum
used in formulation.
881. France Lait 3 Powder Deferred for following reasons:
Needs clarification regarding the type of Vitamin K used in
formulation.
Long term and accelerated stabilidy studies data as per the
requirement of Zone IV A not provided.
Provided exact strength of Fluoride used in formulation.
M/s Brand Station, 89 A2, Wapda Town Extension, Lahore, agent of M/s Inner Mongolia Huatian Pharmaceutical Co. Ltd.,
Development and Experiment Zone for Economical Transformation of Resource Dependent City, Chifeng, Inner Mongolia, China
(E. No. 01217)
882. Anti-Virus Oral Solution Deferred for following reasons:
Original free sale certificate issued by the regulatory body and
countersigned by the embassy of Pakistan is not provided.
Accelerated Stability Studies data of 3 batches according to the
requirement of Zone IV-A not provided.
Clarification is required regarding use and role of APN in
formulation .
Brand Name is not appropriate, needs to be changed.
883. Lysozyme Water Soluble Powder Deferred for following reasons:
Original free sale certificate issued by the regulatory body and
countersigned by the embassy of Pakistan is not provided.
Accelerated Stability Studies data of 3 batches according to the
requirement of Zone IV-A not provided.
(Ayyaz Ahmad)
Secretary, Enlistment Evaluation Committee
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ANNEXURE
The firm is directed to submit soft data in both MS Excel & MS Word on following formats in USB ONLY.
MS Excel Format
Sr. Company name Product Dosage Composition Common Recommended use Pack Date of R&I
No. Name Form name Size submission
1. (Company name, XYZ Tablet Each tablet XXX XXX 10’s DD.MM.YYYY
City) contains: 20’s
Without address Abc
(USP)...50mg
2.
MS Word Format
Company
Sr. No. Product Name and composition Common name Recommended use Pack Size
name
1. (Company XYZ Tablet XXX XXX 10’s
name, City) Each tablet contains: 20’s
Without Abc (USP)….50mg
address
2.
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