Granules India's step-down subsidiary completes USFDA audit with zero observations
Hyderabad: Granules India has 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 (US FDA) with zero 483s.
The facility was inspected by the US FDA from 15th to 20th March 2023.
“The audit is a pre-approval inspection for three products filed from the facility. The packaging site strengthens our proposition to control the value chain and provides us with the agility needed in a very dynamic OTC space,” said Priyanka Chigurupati, Executive- Director, Granules USA, Inc. & Granules Pharmaceuticals, Inc.
Read also: Granules India bags USFDA okay for hypertension drug Losartan Potassium
Granules India Limited, incorporated in 1991 is a vertically integrated Indian pharmaceutical company headquartered in Hyderabad. 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 7 manufacturing facilities out of which 6 are in India and 1 in USA and has regulatory approvals from US FDA, EDQM, EU GMP, COFEPRIS, WHO GMP, TGA, K FDA, DEA, MCC and HALAL.
Read also: Granules Pharma bags USFDA nod for ADHD drug Amphetamine Mixed Salts ER
