Granules India shares in focus after USFDA concludes Hyderabad facility inspection with 11 observations

This was the first USFDA inspection of the facility since the Warning Letter of February 26, 2025, which followed an inspection in August - September 2024. None of the observations were related to data integrity or cross-contamination, while related to enhancements in investigations, change control, process and equipment qualification, visual-inspection controls and documentation practices, company said.

There is no impact on manufacturing or distribution of products from the site and will submit a comprehensive response to the USFDA within the stipulated 15 business days, company added. “The inspection progressed constructively, and the observations are of a nature that we believe can be fully addressed through our responses and corrective and preventive actions. Quality is the foundation of everything we do at Granules, and we will continue to engage transparently with the agency," said Krishna Prasad Chigurupati, Chairman and Managing Director.

Catch all the market action on our live blog The meeting of the board of directors of the company is scheduled to be held on Monday, November 2, 2026 to consider and approve the unaudited financial results for the second quarter and half-year ended on September 30, 2026. In the previous trading session, the share closed at Rs 839.55, up Rs 2.95, or 0.35 percent. The share touched a 52-week high of Rs 922.10 and a 52-week low of Rs 520.05 on 15 September, 2026 and 02 March, 2026, respectively.

Currently, the stock is trading 8.95 percent below its 52-week high and 61.44 percent above its 52-week low. The market capitalisation of the company stands at Rs 20,803.79 crore.