USFDA Flags Zydus Lifesciences' Gujarat Facility for Regulatory Issues

Zydus Lifesciences' injectables manufacturing facility in Jarod, near Vadodara, has been classified as 'Official Action Indicated' by the USFDA following an inspection. This implies regulatory concerns and potential withholding of pending product approvals. The company aims to resolve the issues swiftly.

Zydus Lifesciences Ltd faces regulatory hurdles as the USFDA classified its injectables manufacturing facility in Jarod, near Vadodara, Gujarat, as 'Official Action Indicated' (OAI) following an inspection from April 15 to April 23, 2024. This classification signals significant compliance issues.

The USFDA's OAI classification means pending product applications or supplements from this facility may be withheld until all compliance concerns are addressed. This presents a significant challenge for the company as it seeks to maintain its standing in the pharmaceutical market.

In a regulatory filing, Zydus Lifesciences stated its commitment to resolving these issues promptly in collaboration with the US regulatory agency. The company is focused on addressing the outstanding observations to regain operational approval.

(With inputs from agencies.)