Zydus Lifesciences gets warning letter from USFDA for Jarod facility
Ahmedabad: Zydus Lifesciences has informed in a BSE filing that the Company has received a Warning Letter from the US Food and Drug Administration (USFDA) relating to the Injectables manufacturing facility at Jarod near Vadodara.
The Warning Letter summarizes violations with respect to Current Good Manufacturing Practice (cGMP) regulations. It does not contain any data integrity related violations.
Earlier in July, the Company had received OAI status from the USFDA. The inspection which was conducted from April 15 to April 23, 2024.
Read also: Zydus Lifesciences gets USFDA OAI status for Jarod facility
"The contents of the Warning Letter shall be made public by the USFDA in due course," the Company stated.
"The Company will take all necessary steps to work with USFDA towards earliest remediation of the above facility," it added.
Zydus Lifesciences Ltd. is an innovative, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. Zydus has been actively discovering and developing New Chemical Entities (NCEs) novel biologicals, several biosimilars and vaccines as a part of its innovation pipeline. Over the last decade, Zydus has introduced several products in the market for treating unmet healthcare needs with vaccines, therapeutics, biologicals and biosimilars.
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