USFDA issues EIR for Granules India Gagillapur facility
Telangana: Indian pharmaceutical company, Graules India Limited, has announced that the US Food and Drug Administration (US FDA) has issued an Establishment Inspection Report (EIR) for the Gagillapur facility of the Company located in Hyderabad, Telangana, India.
This facility, that manufacturers finished dosages (FDs) and Pharmaceutical Formulation Intermediates (PFIs) was inspected by the US FDA as a part of a Pre-Approval Inspection (PAI) in January 2023 which resulted in 3(three) observations during the inspection.
Read also: USFDA issues 3 observations for Granules India Gagillapur facility
The Company responded to these observations within the stipulated period.
Read also: Granules India completes USFDA audit at Visakhapatnam facility with zero 483 observations
Granules India Limited, incorporated in 1991 is a vertically integrated Indian pharmaceutical company headquartered at Hyderabad. The company is among the few pharmaceutical companies in the world to be present in the manufacturing of entire value chain – from Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation Intermediates (PFIs) and Finished Dosages (FDs). Its products are being distributed to over 300+ customers in regulated and semi-regulated markets with a global presence extending to over 80+ countries with offices across India, U.S. and U.K. The Company has 8 manufacturing facilities out of which 6 are located in India and 2 are in USA and has regulatory approvals from US FDA, EDQM, EU GMP, COFEPRIS, WHO GMP, TGA, K FDA, DEA, MCC and HALAL.
