Granules India unit completes USFDA inspection at Hyderabad facility with 5 observations

Drug firm Granules India Ltd on Friday (December 19) said its wholly owned subsidiary, Granules Life Sciences Private Ltd, has completed a Good Manufacturing Practices and prior approval Inspection by the US Food and Drug Administration at its Hyderabad facility.

The inspection was conducted from December 15 to December 19, 2025, and concluded with five observations related to procedural requirements. The company said none of the observations are associated with data integrity or product safety.

Granules India stated that it is committed to addressing the observations promptly and will submit its response to the USFDA within the stipulated timeframe. Granules Life Sciences Private is engaged in the manufacturing of Pharmaceutical Formulation Intermediates and finished dosages.

Also Read: Granules India arm passes US FDA quality check for Hyderabad unit

Second Quarter Results

For the September quarter of FY25, Granules India's net profit rose 35% year-on-year to ₹131 crore, compared with ₹97.2 crore in the same period last year. Revenue grew 34.2% to ₹1,297 crore from ₹966.6 crore a year ago, while EBITDA increased 37% to ₹278 crore from ₹203.4 crore.

The company's EBITDA margin improved slightly to 21.4%, up from 21% in the year-ago quarter. The company's net debt stood at ₹1,024 crore and net debt to EBITDA at 0.98x.

Shares of Granules India Ltd ended at ₹583.30, up by ₹2.90, or 0.50%, on the BSE.