U.S. FDA gives nod for Granules copy of GlaxoSmithKline's Advil Dual Action tablets thehindu.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from thehindu.com Daily Mail and Mail on Sunday newspapers.
Granules India announced that Granules Consumer Health Inc. (GCH), a stepdown subsidiary of the company and a wholly owned subsidiary of Granules USA, Inc., has completed an audit by the U.S. Food and Drug Administration (US FDA) with zero 483s, the company said in an exchange filing.
The facility was inspected by the US FDA from 15th to 20th March 2023.
Granules India announced that Granules Consumer Health Inc., a stepdown subsidiary of the Company and a wholly owned subsidiary of Granules USA, Inc., has completed an audit by the U.S. Food and Drug Administration with zero 483s.
The US FDA has approved the ANDA filed by Granules Pharmaceuticals, Inc., for Amphetamine Mixed Salts, 5mg, 10mg, 15mg, 20mg, 25mg, and 30mg Extended-Release capsules.
Granules India announced on Tuesday that the US Food and Drug Administration (US FDA) has approved the abbreviated new drug application (ANDA) filed by its US subsidiary Granules Pharmaceuticals, Inc (GPI) for Amphetamine mixed salts used for treating attention disorder.