Granules India gets Zero 483's from USFDA for Unit V facility in AP

Medically Reviewed By : Dr. Kamal Kant Kohli

Published On 2024-04-13 06:38 GMT | Update On 2024-04-13 06:38 GMT

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.

This audit was a Pre Approval Inspection (PAI) and cGMP audit for Active Pharmaceutical Ingredients (APIs) and Formulations (FDs); oncology and non-oncology.

This facility manufactures APIs & formulations of oncology and non-oncology products.

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.

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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Granules India gets Zero 483's from USFDA for Unit V facility in AP

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