USFDA issues 6 observations for Zydus Lifesciences Ahmedabad facility
Ahmedabad: Zydus Lifesciences has announced that the U.S. Food and Drug Administration (USFDA) has closed the inspection with 6 observations at the Company's API site situated at Changodar, Ahmedabad.
This PAI-cum-GMP USFDA inspection was conducted from December 14 to December 22, 2023.
"There were no Data Integrity related observations. There are no repeat observations from the previous inspection. There are 4 DMFs of this site under approval with the USFDA. The Company will closely work with the USFDA to address the observations" the Company informed in a recent BSE filing.
Medical Dialogues team had earlier announced that the Company had received the Establishment Investigation Report (EIR) report from the USFDA for the injectables manufacturing facility at Zydus Biotech Park located at Changodar, Ahmedabad.
Read also: Zydus receives EIR for injectables manufacturing facility at Zydus Biotech Park, Ahmedabad
Formerly known as Cadila Healthcare Limited, Zydus Lifesciences Limited is an Indian multinational pharmaceutical company headquartered in Ahmedabad. The company is primarily engaged in the production of generic drugs. Cadila was founded in 1952 by Ramanbhai Patel.
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