Zydus Lifesciences gets six observations from USFDA for API plant
There are four drug master files (DMFs) from the site under approval with the USFDA, the drugmaker said.
Zydus Lifesciences on Friday said the US health regulator has issued six observations after inspecting its active pharmaceutical ingredient (API) site in Ahmedabad, Gujarat.
The US Food and Drug Administration (USFDA) conducted the inspection from December 14 to December 22, 2023.
The inspection closed with six observations, Zydus Lifesciences said in a regulatory filing.
There were no data integrity related observations, it added.
Besides, there are no repeat observations from the previous inspection, it noted.
There are four drug master files (DMFs) from the site under approval with the USFDA, the drugmaker said.
The company will closely work with the USFDA to address the observations, it added.
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First Published: Dec 22 2023 | 6:59 PM IST