USFDA inspection: Granules India Virginia arm gets EIR

Hyderabad: Granules India has announced that the United States Food and Drug Administration (US FDA) has issued an Establishment Inspection Report (EIR) to Granules Pharmaceuticals, Inc., a wholly-owned foreign subsidiary of the Company located in Chantilly, Virginia, USA, for the Pre-Approval Inspection (PAI) conducted by it in June 2025 for a first-to-file controlled substance Abbreviated New Drug Application (ANDA).

There was one observation during the inspection, and it has been resolved, Granules stated in a BSE filing.

Granules India Limited, incorporated in 1991 is a vertically integrated Indian pharmaceutical company headquartered in Hyderabad with best-in-class facilities. 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 (PFls), 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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