Drug firm Zydus Lifesciences Ltd on Friday (December 22) said its active pharmaceutical ingredient (API) site located at Changodar, Ahmedabad, underwent an inspection by the United States Food and Drug Administration (USFDA) from December 14 to December 22, 2023.
The inspection, which encompassed Pre-Approval Inspection (PAI) and Good Manufacturing Practices (GMP), concluded with the issuance of six observations, according to a stock exchange filing.
"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," the drugmaker said.
Zydus Lifesciences said it is working closely with the USFDA to promptly address the observations and ensure adherence to regulatory standards. The API site in Changodar, Ahmedabad, currently has 4 Drug Master Files (DMFs) under approval with the USFDA, the company added.
Shares of Zydus Lifesciences Ltd ended at ₹679.70, up by ₹8.80, or 1.31%, on the BSE.
