USFDA issues 1 observation for Granules Pharma USA facility
Hyderabad: Granules India has announced that the U.S. Food and Drug Administration (US FDA) has issued one 483 observation after a Pre-Approval Inspection (PAI) for a first to file controlled substance ANDA at the facility of Granules Pharmaceuticals, Inc., a wholly-owned foreign subsidiary of the Company located in Chantilly, Virginia, USA. The facility was inspected from 23rd June […]