“Please be informed that the Company’s API Unit-I facility located at Bonthapally Village, Sangareddy District, Hyderabad, Telangana, India has completed a US FDA inspection from June 16, 2025 to June 20, 2025 with 1 (one) 483 observation. The Company will respond to this observation within the stipulated time,” the pharma company said in a statement.
Granules’ Bonthapally site is one of the world’s largest single-location Paracetamol API manufacturing plants by volume. The site also houses facilities for manufacturing Metformin and Guaifenesin APIs.
Granules India reported subdued results for the fourth quarter ended March 30.
Granules’ revenue increased by 1.8% from the same quarter last year to ₹1,197.5 crore. The company had reported a topline of ₹1,175 crore in the base quarter.
Its Earnings Before Interest, Tax, Depreciation and Amortisation (EBITDA) declined by 1.4% year-on-year to ₹252 crore, while margins narrowed by nearly 70 basis points to 21.1% from 21.8% last year.
The company’s net profit increased by 18% from last year to ₹152 crore.
Shares of Granules India closed at ₹484.30, up 0.8% from Thursday’s close.
