Granules Pharma Completes US FDA Post-Marketing Adverse Drug Experience Inspection with Zero Observations

Granules India Limited, a vertically integrated and rapidly growing Indian pharmaceutical company, announced that Granules Pharmaceuticals, Inc. (GPI), a wholly owned foreign subsidiary of the company based in Chantilly, Virginia, USA, has successfully completed the United States Food and Drug Administration (FDA) Post-marketing Adverse Drug Experience (PADE) Inspection for all of its entities in the United States, including Granules India Limited.

The inspection ended with no observations. From July 31, 2023 to August 3, 2023, Granules Pharmaceuticals Inc. (GPI) was inspected. This inspection focused on Granules' PADE surveillance, receipts, evaluations, processing, and reporting system for globally marketed drug products. Granules India's fourth FDA audit since March has resulted in zero observations, demonstrating the company's unwavering commitment to ensuring the highest level of patient safety and product quality.

Granules India Limited, founded in 1991, is a vertically integrated, fast-growing Indian pharmaceutical company with best-in-class facilities and a commitment to operational excellence, quality, and customer service. 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.