Granules Pharma successfully completes USFDA inspection with zero observations

Hyderabad: Granules India Limited, announced that Granules Pharmaceuticals, Inc. (GPI), a wholly owned foreign subsidiary of the company, located in Chantilly, Virginia, USA has successfully completed the United States Food and Drug Administration (USFDA) Post-marketing Adverse Drug Experience (PADE) Inspection for all its entities in the United States, including Granules India Limited.

The inspection was closed with zero observations.

The inspection was conducted at Granules Pharmaceuticals Inc. (GPI) from July 31, 2023 to August 03, 2023.

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This inspection covered the Granules’ PADE surveillance, receipts, evaluations, processing and reporting system for the marketed drug products worldwide. This is Granules India’s fourth FDA audit since March with zero observations.

Medical Dialogues team had earlier reported that the USFDA had issued six observations after the inspection of the Chantilly facility of Granules India's US-based subsidiary.

Read also: Granules Pharma US facility gets 6 observations from USFDA

Granules India Limited, incorporated in 1991 is a vertically integrated Indian pharmaceutical company headquartered in Hyderabad. Amongst the few pharmaceutical companies in the world to be present across the manufacturing of the entire pharmaceutical value chain – from Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation Intermediates (PFIs) and Finished Dosages (FDs), Granules products are 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 8 manufacturing facilities out of which 6 are located in India and 2 are in USA and has regulatory approvals from US FDA, EDQM, EU GMP, COFEPRIS, WHO GMP, TGA, K FDA, DEA, MCC and HALAL.