Granules Life Sciences gets USFDA approval for Hyderabad Facility
Written By : Ruchika Sharma
Published On 2025-11-11 07:05 GMT | Update On 2025-11-11 07:05 GMT
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Hyderabad: Granules India Limited has announced that its wholly owned subsidiary, Granules Life Sciences Private Limited (GLS), located in Hyderabad, has received U.S. Food and Drug Administration (FDA) approval for a product that was the subject of a Pre- Approval Inspection (PAI) conducted between July 28 and August 1, 2025.
There was one observation during that inspection, and the GLS had submitted its response within the stipulated time.
Granules India Limited, incorporated in 1991 is a vertically integrated Indian pharmaceutical company headquartered in Hyderabad. Amongst the few pharmaceutical companies in the world to be present across the manufacturing of the entire pharmaceutical value chain – from Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation Intermediates (PFIs), and Finished Dosages (FDs), Granules products are 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 located in India and 2 are in the USA and has regulatory approvals from the US FDA, EDQM, EU GMP, COFEPRIS, WHO GMP, TGA, K FDA, DEA, MCC, and HALAL.
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