Granules India Bonthapally API facility gets 1 USFDA observation

Written By :  Ruchika Sharma
Medically Reviewed By :  Dr. Kamal Kant Kohli
Published On 2025-06-20 12:44 GMT   |   Update On 2025-06-20 12:44 GMT

Hyderabad: Granules India has announced that the Company's Bonthapally API Unit-I facility has concluded a U.S. Food and Drugs Administration (US FDA) inspection with one 483 observation.

The facility was inspected from June 16, 2025 to June 20, 2025.
"Please be informed that the Company’s API Unit-I facility located at Bonthapally Village, Sangareddy District, Hyderabad, Telangana, India has completed a US FDA inspection from June 16, 2025 to June 20, 2025 with 1 (one) 483 observation," Granules stated in a filing on BSE.
"The Company will respond to this observation within the stipulated time," it added.
Bonthapally facility is one of the world’s largest single-site Paracetamol API manufacturing plants by volume.
Along with Paracetamol APIs, the Company has established Metformin and Guaifenesin API manufacturing plants in the same facility.

Read also: Granules India Riaz Ahmed resigns as Senior Vice President & Head- Supply Chain Management

Granules India Limited, incorporated in 1991 is a vertically integrated fast growing Indian pharmaceutical company headquartered at Hyderabad with best-in-class facilities and commitment to operational excellence, quality, and customer service. Granules 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). 

Read also: Granules India enters high growing peptide segment, CDMO business by acquiring Senn Chemicals

Granules 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, US, and UK. The Company has 10 manufacturing facilities out of which 8 are in India and 2 in the USA and has regulatory approvals from US FDA, EDQM, EU GMP, COFEPRIS, WHO GMP, TGA, K FDA, DEA, MCC, and HALAL.

Read also: Granules India: Sethu Madhavan Sankaran resigns as Senior Vice President, Head- API Manufacturing, Operations



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