Zydus Lifesciences Hit with USFDA Warning for Gujarat Facility

Zydus Lifesciences Ltd has received a warning letter from the USFDA for its injectables manufacturing facility in Jarod, Gujarat. The letter cites violations of Current Good Manufacturing Practice (cGMP) regulations but no data integrity issues. The company aims to work with the USFDA for a quick resolution.

Zydus Lifesciences Ltd announced on Friday that its injectables manufacturing facility located in Jarod, near Vadodara, Gujarat, has received a warning letter from the US Food and Drug Administration (USFDA) due to regulatory violations.

The company clarified that the warning letter, although critical of its compliance with Current Good Manufacturing Practice (cGMP) regulations, does not contain any allegations related to data integrity issues.

Zydus Lifesciences is committed to addressing the concerns raised by the USFDA and will take all necessary steps to resolve the issues at the earliest. The USFDA will publicly disclose the details of the warning letter soon.

(With inputs from agencies.)