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Zydus Lifesciences Receives 6 Observations from USFDA for API Site at Changodar

Zydus Lifesciences Receives 6 Observations from USFDA for API Site at Changodar

Zydus Lifesciences Ltd has announced that the USFDA conducted an inspection at the 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. 
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More news about: global pharma | Published by Manvi | December - 26 - 2023 | 629

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