Zydus Lifesciences Limited received email dated September 3, 2024, from Listing Compliances Department (LISCO), National Stock Exchange of India Limited (NSE), regarding submission of additional details, intimation dated August 30, 2024 regarding receipt of warning letter from USFDA. Name of the authority: United States Food and Drug Administration (USFDA). Nature and details of the action: A Warning Letter from the USFDA identifies the concern(s), such as gaps in manufacturing practices or violations with respect to current good manufacturing practices (cGMP).
Zydus has received this letter for the injectable manufacturing facility situated at Jarod, near Vadodara, Gujarat. The letter provides an opportunity to the company to address USFDA's concerns, and it requests a response within a certain timeframe. The concerns noted by USFDA are already under remediation by the manufacturing site.
Necessary corrective and preventive measures are being taken. The warning letter summarizes certain violations with respect to current good manufacturing practice regulations.