USFDA issues 2 observations for Zydus Lifesciences arm Ahmedabad facility
Ahmedabad: Pharma major, Zydus Lifesciences, has recently announced that the US Food and Drug Administration (USFDA) has concluded a Pre-Approval Inspection (PAI) with two observations at the SEZ, Ahmedabad facility of Zydus Animal Health and Investments Limited, a wholly owned subsidiary of Zydus Lifesciences Limited). This is a new manufacturing facility for the animal health business, which will cater to the US and other regulated markets.
The inspection was held from 23rd to 29th September 2022.
None of these observations were related to data integrity.
"The company will address the observations within a stipulated timeline working with the regulators," Zydus Lifesciences stated in a recent BSE filing.
Zydus group is headquartered in Ahmedabad, India, and ranks 4th in the Indian pharmaceutical industry. The group has manufacturing sites and research facilities spread across five states of Gujarat, Maharashtra, Goa, Himachal Pradesh, and Sikkim in India and in the US and Brazil.
Zydus' global business has a strong presence in the regulated markets of the US, Europe (France and Spain), and the high-profile markets of Latin America and South Africa. It is also present in a big way in 25 other emerging markets worldwide.
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