Hyderabad-based Granules India Limited has achieved a significant regulatory milestone, securing an Establishment Inspection Report (EIR) with a “No Action Indicated” (NAI) status from the U.S. Food and Drug Administration (FDA) for its Unit V facility in Jawaharlal Nehru Pharma City, Andhra Pradesh. The pharmaceutical firm received the EIR following a comprehensive inspection held in […]
Granules Pharmaceuticals, Inc. (GPI), a wholly owned foreign subsidiary of Granules India Limited, situated in Chantilly, Virginia, USA, has successfully concluded the United States Food and Drug Administration (USFDA) Post-marketing Adverse Drug Experience (PADE) Inspection. The inspection occurred at GPI from July 31 to August 3, 2023, with zero observations recorded. Detailed Look at the […]
Granules India Limited announced its receipt of US Food and Drug Administration (FDA) approval for its Abbreviated New Drug Application (ANDA) of Metoprolol Succinate Extended-Release Tablets USP, 25 mg, 50 mg, 100 mg, and 200 mg. The approval positions Granules India more strongly within the approximately $321 million US market for this particular medication. The […]
Granules India Limited said that the US Food and Drug Administration (FDA) has carried out an inspection of its pharmaceutical manufacturing facility in Chantilly, Virginia, and has made six observations. The Indian pharma manufacturing company operates the site through its fully-owned subsidiary — Granules Pharmaceuticals. The FDA inspection took place on 22 July, said Granules […]