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. 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 - a testament to Granules India's unwavering commitment to ensuring the highest level of patient safety and product quality.
Granules India Limited, incorporated in 1991 is a vertically integrated fast growing Indian pharmaceutical company headquartered in Hyderabad with best-in-class facilities and a commitment to operational excellence, quality, and customer service. The Company has 8 manufacturing facilities out of which 6 are located in India and 2 are in the USA and has regulatory approvals from US FDA, EDQM, EU GMP, COFEPRIS, WHO GMP, TGA, K FDA, DEA, MCC and HALAL.
The shares of Granules on Friday morning at 10:07 am IST were trading at Rs 322, up by 1.19 per cent.