Granules India share price falls nearly 8% as US FDA issues warning letter to Gagillapur facility

Granules India share price: Shares of pharmaceuticals major Granules India declined nearly 8% on Friday after the United States Food and Drug Administration (US FDA) issued a warning letter to the company's Gagillapur facility.

Intraday, the stock fell as much as 7.65% to ₹468.15 per share on the National Stock Exchange (NSE). At 11:02 am, it was down 6.83% to ₹472.30 apiece.

On Wednesday, the US FDA issued a warning letter to the pharma company's Gagillapur Facility.

The manufacturing and distribution of existing products at the plant continue unaffected. "However, the warning Letter may temporarily impact the FDA review of pending product submissions from this site until the issue is resolved," the company said in an exchange filing.

The facility has been classified as "Official Action Indicated", and the US regulator has not indicated any further escalation.

"Following the FDA audit and six Form 483 observations, Granules has implemented a proactive and comprehensive remediation plan to strengthen compliance and reinforce product quality and safety at the Gagillapur site. As part of this initiative, we voluntarily paused manufacturing and dispatches in September to conduct a thorough risk assessment, ensuring no product contamination or patient safety concerns. Operations resumed following this assurance," the company said.

Granules India said it would respond within the stipulated timeframe and meet with the FDA to demonstrate ongoing progress towards compliance.

The warning highlighted four key areas previously mentioned in the FDA Form 483 observations. The company said it had made significant progress in addressing observations.

The pharma giant is regularly updating the FDA on progress and remediation measures.

"A key focus of these efforts remains risk mitigation, ensuring that there is no adverse impact on the safety or quality of products manufactured and distributed from the Gagillapur facility," it added.