Granules Pharmaceuticals, Inc., a US subsidiary of Granules India Limited, underwent a USFDA Post-Marketing Adverse Drug Experience (PADE) Inspection for all its US entities, including Granules India Limited. The FDA closed the inspection with zero observations, demonstrating a commitment to patient safety and product quality.

GPI underwent the USFDA's PADE inspection from July 31 to August 3, 2023, which encompassed Granules' PADE surveillance, receipts, evaluations, processing, and reporting system for marketed drug products globally.

This audit represents Granules India's fourth FDA assessment since March, concluding without any observations. This underscores the company's resolute dedication to upholding the utmost standards of patient safety and product quality.