Granules Pharma facility gets 5 USFDA observations

Hyderabad: Granules India Limited has announced that the United States Food and Drug Administration (USFDA) has concluded a GMP inspection with five observations at the facility of Granules Pharmaceuticals, Inc., a wholly-owned foreign subsidiary of the Company located in Chantilly, Virginia, USA.

The inspection was held from 11th December 2023 through 15th December 2023.

"USFDA has completed a GMP inspection of the facility of Granules Pharmaceuticals, Inc., a wholly-owned foreign subsidiary of the Company located in Chantilly, Virginia, USA from 11th December 2023 through 15th December 2023 with five observations," Granules informed in a recent BSE filing.

"Granules Pharmaceuticals, Inc. will respond to these observations within the stipulated time and does not anticipate any disruptions to its business," the Company added.

Read also: Granules India bags USFDA nod for Pantoprazole Sodium Delayed Release Tablets

Medical Dialogues team had earlier reported that Granules Pharmaceuticals, Inc. had successfully completed the USFDA Post-marketing Adverse Drug Experience (PADE) Inspection for all its entities in the United States, including Granules India Limited.

Read also: Granules Pharma successfully completes USFDA inspection with zero observations

Granules India Limited, incorporated in 1991 is a vertically integrated Indian pharmaceutical company headquartered in Hyderabad. The Company is among the few pharmaceutical companies in the world to be present in the manufacturing of entire value chain – from Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation Intermediates (PFIs) and Finished Dosages (FDs). Its 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, U.S. and U.K. The Company has 7 manufacturing facilities out of which 6 are located 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 India subsidiary bags USFDA nod for Sildenafil for Oral Suspension