USFDA inspection: Granules India Virginia arm gets EIR

Medically Reviewed By : Dr. Kamal Kant Kohli

Published On 2025-11-05 08:15 GMT | Update On 2025-11-05 08:15 GMT

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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Ruchika Sharma

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

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USFDA inspection: Granules India Virginia arm gets EIR

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