Granules India Limited on Sunday announced that Granules Pharmaceuticals, Inc. (GPI) 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.
According to the company’s press statement, 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, it added.
This is Granules India’s fourth FDA audit since March with zero observations, it stated.
