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.
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2025 to August 01, 2025 at the facility of M/s. Granules Life Sciences Private Limited., a wholly
owned Indian subsidiary of the Company, located at Shamirpet Mandal, Hyderabad with 1 (One)
483 observation which is procedural in nature. The Company will respond to this observation
within the stipulated time,” Granules India stated in a BSE filing.
Dosages.
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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.
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