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 2025 to
27th June 2025.
“Granules Pharmaceuticals, Inc. addressed and resolved
the observation during the inspection,” the Company stated in a BSE filing.
Read also: Granules India Bonthapally API facility gets 1 USFDA observation
Granules products are being 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 10 manufacturing facilities out of which 8 are in India and 2 in the USA and has regulatory approvals from US FDA, EDQM, EU GMP, COFEPRIS, WHO GMP, TGA, K FDA, DEA, MCC, and HALAL.
Read also: Granules India successfully closes acquisition of Swiss based CDMO Senn Chemicals
