USFDA completes inspection at Zydus Lifesciences’ arm’s unit with 2 observation

30 Sep 2022 Evaluate

United States Food and Drug Administration (USFDA) has conducted an inspection at the manufacturing facility located at SEZ, Ahmedabad of Zydus Lifesciences’ wholly owned subsidiary -- Zydus Animal Health and Investments from September 23 to 29, 2022. The inspection was a Pre-Approval Inspection (PAI) and ended with two observations. None of these observations were related to data integrity. The company will address the observations within a stipulated timeline working with the regulators. This is a new dedicated manufacturing facility for the animal health business which will cater to US and other regulated markets.

Zydus Lifesciences (formerly known as Cadila Healthcare) is an India-based pharmaceutical company.

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