Granules India gets Zero 483’s from USFDA for Unit V facility in AP
Telangana: Granules India has informed in a BSE filing that the Company’s Unit V facility located at Anakapally, Visakhapatnam, Andhra
Pradesh, India gets Zero 483’s from U.S. Food and Drug Administration (USFDA).
The inspection was held from 8th April 2024 to 12th April 2024.
a Pre Approval Inspection (PAI) and cGMP audit for Active Pharmaceutical Ingredients (APIs) and
Formulations (FDs); oncology and non-oncology.
Read also: USFDA classifies Granules Pharma facility as Voluntary Action Indicated
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 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 7 manufacturing facilities out of which 6 are located in India and 1 in USA and has regulatory approvals from US FDA, EDQM, EU GMP, COFEPRIS, WHO GMP, TGA, K FDA, DEA, MCC and HALAL.
Read also: Granules Pharma facility gets 5 USFDA observations
