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Granules India arm gets 1 USFDA observation for Hyderabad facility

Hyderabad: Granules India has announced that the U.S. Food and Drug Administration (USFDA) has issued one observation for the facility of Granules Life Sciences Private Limited, a wholly owned Indian subsidiary of the Company, located at Shamirpet Mandal, Hyderabad.
A Pre-Approval Inspection (PAI) was held from July 28, 2025 to August 01, 2025.
Read also: Granules India Riaz Ahmed resigns as Senior Vice President & Head- Supply Chain Management
Read also: Granules India CEO Dr Kandiraju Venkata Sitaram Rao to step down
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.
Read also: Granules India enters high growing peptide segment, CDMO business by acquiring Senn Chemicals
Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751