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

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

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

  • By IPP Bureau | June 23, 2025

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.

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