Telangana: Granules India has announced that the U.S. Food and Drug Administration (FDA) has concluded an inspection with five observations at the Hyderabad facility of Granules Life Sciences, a wholly owned subsidiary of the Company.
The Good Manufacturing Practices (GMP) and Prior Approval Inspection was conducted from 15th to 19th December 2025.
The five observations were related to procedural requirements. None of these observations are associated with data integrity or product safety.
“Granules India is committed to addressing the observations promptly and will submit its response to the USFDA within the stipulated timeframe,” the company stated in a BSE filing.
Granules Life Sciences Private Limited is engaged in the manufacturing of PFI & Finished Dosages
Granules India Limited, incorporated in 1991 is a vertically integrated fast growing Indian pharmaceutical company headquartered at Hyderabad with best-in-class facilities and commitment to operational excellence, quality, and customer service. Granules is among the few pharmaceutical companies in the world to be present in the manufacturing of entire value chain – from Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation Intermediates (PFIs), and Finished Dosages (FDs).
Granules products are being distributed to over 300+ customers in regulated and semi-regulated markets with a global presence extending to over 80+ countries with offices across India, US, and UK. The Company has 10 manufacturing facilities out of which 8 are in India and 2 in the USA and has regulatory approvals from US FDA, EDQM, EU GMP, COFEPRIS, WHO GMP, TGA, K FDA, DEA, MCC, and HALAL.
