Zydus Lifesciences gets 2 USFDA observations for Ahmedabad site
Written By : Ruchika Sharma
Published On 2025-11-14 06:06 GMT | Update On 2025-11-14 06:06 GMT
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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.
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