USFDA concludes inspection at Granules India’s API facility in Hyderabad

21 Jun 2025 Evaluate

U.S. Food & Drug Administration (USFDA) has concluded inspection at Granules India’s API Unit-I facility located at Bonthapally Village, Hyderabad, Telangana. The inspection was conducted from June 16, 2025 to June 20, 2025 and conluded with 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 is manufacturer and supplier of pharmaceutical products. Its products include active pharmaceutical ingredients like tablets, caplets, rapid release, pharmaceutical, formulation intermediates (PFI) and Finished Dosages.

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