Granules India receives Form 483 with 1 observation from USFDA for Bonthapally API unit 1

Granules India receives Form 483 with 1 observation from USFDA for Bonthapally API unit 1

By: IPP Bureau

Last updated : June 23, 2025 9:52 am



Bonthapally facility is one of the world's largest single-site Paracetamol API manufacturing plants by volume


Granules India Ltd'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. The Company will respond to this observation within the stipulated time.

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.

Granules India USFDA

First Published : June 23, 2025 12:00 am