Date : 11-12-2023

To,
Mr. Khaleeq Anwar,
Drug Controller / Inspector of Drugs,
Tehsil Pakpattan,
Office of the Chief Executive Officer (District Health Authority)
Pakpattan, Punjab - Pakistan

Subject: Substandard Susp. Hefticef 100mg (B#WS-510), 30mL Mfg. By M/S Wenovo Pharmaceuticals

Respected Sir,

Reference to your letter # 422/DC/DI/PPN Dated 07.12.23 received at our office on 11.12.23 regarding
subject Product. We will like to submit factual position that Sample of subject matter product was taken
from M/S Mehmood Medical Store, Opposite DHQ, Pakpattan on 28.09.23 by the Drug Inspector
Pakpattan for Analysis/test. However the Drug Inspector did not write any intimation letter to Wenovo
Pharmaceuticals in this regards and also didn’t dispatch sealed warrantor portion to us which was
mandatory legal requirement as per Drug Act 1976 Section 18 & 19, Section 32 (Sub-section 32) & The
Drug Regulatory Authority of Pakistan Act, 2012 Schedule V.

DTL Bahawalpur declared Hefticef 100mg Suspension (B#WS-510) as substandard, vide their test Report #
01-10097005260 dated 31.10.23. However we have retested the retained samples of the subject batch of
Hefticef Suspension and found the assay results 98.37% which are within USP Pharmacopeia limits.

Keeping the factual position of the case as explained above, it is requested to kindly provide sealed
warrantor portion of above mentioned Product to us being legal requirement of Drug Act 1976 Section
18 (32).

We will like to challenge the results of DTL Bahawalpur at Appellant Lab – NIH Islamabad. Please
dispatch the sealed warrantor portion to NIH Islamabad. We will bear all the expenses regarding
retesting at NIH Islamabad.
Thanks for your kind cooperation and consideration.

For Wenovo Pharmaceuticals

c.c.
1. The chairman
Provincial Quality Control Board.
Government of Punjab, P&SHC Department
The documents required by your good office are enclosed as under.
1. Names of CEO, QCM and PM
2. Testing Result of said Product in our Lab

`NAME OF TECHNICALL STAFF

No Name Designation

01 Mr. Muhammad Arshad Managing Director

02 Mr. Muhammad Imran Quality Control Manager

03 Mr. Saqib Yaqub Awan Production Manager