Granules down 7% after USFDA issues warning letter or Gagillapur facility

Granules India shares slipped 7.07 per cent in Friday's trade on BSE, logging an intraday low at Rs 471.8 per share. The stock was under pressure after the United States food and drugs administration (US FDA)  issued a warning letter to Granules’ Gagillapur facility.

 

Around 9:45 AM, Granules India share price was down 7.07 per cent at Rs 471.8 per share on BSE. In comparison, the BSE Sensex was down 1.3 per cent at 73,638.91. The market capitalisation of the company stood at Rs 

11,440.85 crore. The 52-week high of the stock was at Rs 724.55 per share and the 52-week low was at Rs 382.05 per share.

 

 

"On February 26, 2025, the US FDA issued a Warning Letter to Granules’ Gagillapur facility based on its inspection conducted in August 2024," the filing read.

 

The warning letter highlights four key areas previously outlined in the FDA Form 483 observations. Granules has made significant progress addressing all of the FDA observations across these four areas, _ with most corrective actions completed and the remaining ones on track as scheduled.  

 

Even though the manufacturing and distribution of existing products from the Gagillapur facility continue unaffected, the warning letter may temporarily impact the FDA review of pending product submissions from this site until the issue is resolved, the company said through a filing. 

 

Further, the FDA has not indicated any further escalation. The company said that it will respond within the stipulated timeframe and seek a meeting with the FDA to demonstrate ongoing progress towards compliance. 

 

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. 

 

Granules India is a pharmaceutical company based in India, known for manufacturing active pharmaceutical ingredients (APIs), pharmaceutical formulations, and intermediates. The company is involved in the production of a wide range of generic drug products, including both over-the-counter (OTC) and prescription medicines. It caters to global markets, offering products in various therapeutic segments, including cardiovascular, central nervous system, and diabetes treatments, among others.

 

In the past one year, Granules India shares have gained 11 per cent against Sensex's rise of 3 per cent.