Zydus Lifesciences Ltd has received an establishment inspection report (EIR) from the United States Food and Drug Administration (USFDA) for its facility at Pharmez in Ahmedabad with nil observations.
The facility named ‘SEZ 2’ was inspected from July 3-7, the company said in filing to the stock exchanges on Tuesday, September 19. This was a Pre-Approval Inspection (PAI) and had concluded with nil observations, Zydus Lifesciences informed the bourses.
In July, the USFDA closed the inspection at Zydus Lifesciences' Pharmez unit in Ahmedabad with a voluntary action indicated (VAI) recommendation in the EIR. The US drug regulator conducted an inspection at the unit between March 20 and March 24, 2023.
Last week, Zydus Lifesciences received final approval from the USFDA for Norelgestromin and Ethinyl Estradiol Transdermal System, a contraceptive patch comprising a combination of hormone medication.
Last month, the pharmaceutical firm received final approval from the USFDA for Isotretinoin Tablets, which are used in the treatment of severe cystic acne. Also, it obtained final clearance from the USFDA to manufacture and market Indomethacin suppositories, which is used to treat arthritis.
The Ahmedabad headquartered pharma major manufactures and markets a broad range of active pharmaceutical ingredients (API) and formulations.
The Zydus group has research facilities across Gujarat, Maharashtra, Goa, Himachal Pradesh and Sikkim. It also has manufacturing and research units in the US and Brazil. The company operates outside India with licensing agreements with global multinationals.
Shares of Zydus Lifesciences were trading 0.64 percent lower at Rs 639.35 apiece on BSE at 9:26 AM on Wednesday.
(Edited by : Asmita Pant)
First Published: Sept 20, 2023 11:28 AM IST
