Zydus Lifesciences receives six USFDA observations about its API factory

26 Dec 2023 , 10:59 AM

Zydus Lifesciences reported on Friday that following an inspection of its active pharmaceutical ingredient (API) facilities in Ahmedabad, Gujarat, the US health authorities had issued six observations. The inspection was carried out by the US Food and Drug Administration (USFDA) between December 14 and December 22, 2023.

According to a regulatory filing from Zydus Lifesciences, the inspection concluded with six observations.

It also said that there were no observations pertaining to data integrity.

It also mentioned that there are no repeat observations from the prior inspection.

The drugmaker stated that the USFDA has approved four drug master files (DMFs) from the location.

It further stated that the company will closely collaborate with the USFDA to resolve the observations.

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