Zydus Lifesciences gets 2 USFDA observations for Ahmedabad site
Ahmedabad: Zydus Lifesciences has announced that the U.S. Food and Drug Administration (USFDA) has concluded a pre-approval inspection with two observations at the SEZ Oncology Injectable manufacturing site in SEZ1, Ahmedabad, in relation to the new isolator injectable line.
The inspection was conducted from 4th to 13th November, 2025. There were no data integrity related observations.
"The Company will closely work with the USFDA to address the observations expeditiously," Zydus stated in a BSE filing.
Zydus Lifesciences Ltd. is a global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. Over the last decade, Zydus has introduced several products in the market for treating unmet healthcare needs with vaccines, therapeutics, biologicals and New Chemical Entities.
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