By: IPP Bureau
Last updated : September 09, 2024 8:03 am
The recent inspection covered both cGMP and PAI processes
Granules India Limited, announced the completion of the US Food and Drug Administration (USFDA) inspection from 26th August to 6th September, 2024 concluded with six observations at its Gagillapur facility in Hyderabad, Telangana.
The recent inspection covered both Current Good Manufacturing Practice (cGMP) and Pre-Approval Inspection (PAI) processes. Granules India is committed to addressing the observations promptly and will submit its response to the USFDA within the stipulated time frame. The Gagillapur facility continues to play a vital role in the company’s global operations, ensuring the supply of high-quality pharmaceutical products to markets worldwide.
The company has 10 manufacturing facilities out of which 8 are located in India and 2 are in the USA and has regulatory approvals from the US FDA, EDQM, EU GMP, COFEPRIS, WHO GMP, TGA, K FDA, DEA, MCC, and HALAL.