Granules Pharmaceuticals successfully completes USFDA post marketing adverse drug experience inspection with zero observations

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

Granules India Limited, announced that Granules Pharmaceuticals (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.