Granules India arm clears USFDA audit
Hyderabad: Granules India Limited has announced that Granules Pharmaceuticals, Inc. (GPI), a wholly owned foreign subsidiary of the Company located in Chantilly, Virginia, USA had undergone a Pre-Approval Inspection (PAI) audit by the U.S. Food and Drug Administration (USFDA) from 21st June 2021 to 25th June 2021.
The audit is a pre-approval inspection for three of its applications filed from this facility. The FDA issued two minor observations during the audit.
"The observations were responded to within the stipulated time, and we are happy to inform that the FDA has closed the observations pertaining to this audit with an Establishment Inspection Report on the 20th of July 2021. This is the fifth USFDA audit for this facility" said Ms. Priyanka Chigurupati, Executive Director, GPI.
Granules manufactures varieties of drugs including Paracetamol, Ibuprofen, Metformin, and Guaifenesin, on a large scale for customers in the domestic as well as international markets.