USFDA issues six observations for Granules India Gagillapur facility
Hyderabad: Granules India Limited, has announced that the US Food and Drug Administration (USFDA) has concluded inspection at the Company's Gagillapur facility in Hyderabad, Telangana with six observations.
The inspection was conducted from 26th August to 6th September 2024.
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 timeframe. 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 stated in a release.
Read also: Granules India bags USFDA okay for Glycopyrrolate Oral Solution
Granules India Limited, incorporated in 1991 is a vertically integrated Indian pharmaceutical company headquartered in Hyderabad. The Company is among the few pharmaceutical companies in the world to be present across the manufacturing of the entire pharmaceutical value chain – from Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation Intermediates (PFIs), and Finished Dosages (FDs), Granules products are distributed to over 300+ customers in regulated and semi-regulated markets with a global presence extending to over 80+ countries with offices across India, US and UK. 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.
Read also: Major depressive disorder drug: USFDA nod to Granules India Trazodone Hydrochloride Tablets
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