Granules India Limited has announced a major achievement with the US Food & Drug Administration (US FDA) approving its Abbreviated New Drug Application (ANDA). The approval was granted to Granules Pharmaceuticals, Inc. (GPI), a wholly-owned foreign subsidiary of Granules India, for their product, Sildenafil for Oral Suspension, 10 mg/mL. This drug is bioequivalent and therapeutically […]
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 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 […]