Zydus Lifesciences gets warning letter from USFDA; shares slip

As per the filing, the warning letter from the US drug regulator summarised the alleged violations by the pharmaceutical company with regards to the Current Good Manufacturing Practice (cGMP) regulation.

“The warning letter does not contain any data integrity-related violations,” the filing further noted.

After the disclosure was made, Zydus Lifesciences’ shares edged lower on the bourses. The scrip traded at ₹1,127.90 apiece on the NSE, down 0.37%.

Earlier, on July 18, the company had informed the exchanges that its Jaroda injectable manufacturing facility received an official action indicated (OAI) status from the USFDA.

The pharmaceutical’s Gujarat-based manufacturing unit was inspected by the USFDA from April 15 to April 23, 2024.

The drugmaker noted that the contents of the warning letter would be made public by the US drug regulator in due time. “The company will take all necessary steps to work with USFDA towards earliest remediation of the above facility,” it further said.