United States Food and Drug Administration (USFDA) has conducted an inspection at Zydus Lifesciences’ API site situated at Changodar, Ahmedabad. This PAI-cum-GMP USFDA inspection was conducted from December 14 to December 22, 2023. The inspection closed with 6 observations.
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.
Zydus Lifesciences (formerly known as Cadila Healthcare) is an India-based pharmaceutical company.
Company Name | CMP |
---|---|
Sun Pharma Inds. | 1464.85 |
Dr. Reddys Lab | 5955.65 |
Cipla | 1477.15 |
Zydus Lifesciences | 1050.35 |
Lupin | 1603.55 |
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