US Food and Drug Administration (USFDA) has completed inspection at Granules India’s Bonthapally facility located at Hyderabad in the state of Telangana. The inspection was conducted from July 22, 2019 to July 26, 2019. The inspection concluded with one 483 observation which is procedural in nature.
Bonthapally facility is one of the world’s largest single site Paracetamol API manufacturing plant by volume. Along with Paracetamol APIs, the company has established Metformin and Guaifenesin API manufacturing plants in the same facility. The company has already received approval from US FDA for Metformin API from this facility.
Granules India is manufacturer and supplier of pharmaceutical products. Its products include active pharmaceutical ingredients (API) like tablets, caplets, rapid release, pharmaceutical, formulation intermediates (PFI) and Finished Dosages (FDs).