United States Food and Drug Administration (USFDA) has successfully completed post-marketing Adverse Drug Experience (PADE) inspection at Granules India’s wholly owned foreign subsidiary -- Granules Pharmaceuticals, Inc. (GPI). The inspection was conducted at Granules Pharmaceuticals Inc. (GPI) from July 31, 2023 to August 03, 2023. The inspection was closed with zero observations.
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 is manufacturer and supplier of pharmaceutical products. Its products include active pharmaceutical ingredients (API) like tablets, caplets, rapid release, pharmaceutical, formulation intermediates (PFI) and Finished Dosages (FDs).
