Granules India gains key FDA approval for Unit V facility, marking major compliance milestone
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 ... Read More
Granules India subsidiary completes FDA PADE inspection with zero observations
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 ... Read More
FDA greenlights Granules India’s Metoprolol Succinate ER tablets
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 ... Read More
Granules India reports FDA made six observations at Chantilly plant
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, ... Read More