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Granules Pharma facility gets 5 USFDA observations
![Granules Pharma facility gets 5 USFDA observations Granules Pharma facility gets 5 USFDA observations](https://medicaldialogues.in/h-upload/2020/04/16/750x450_127325-125386-usfda-inspection-1.webp)
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
Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751