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
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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
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