Granules India’s Bonthapally facility completed US FDA inspection
Company’s Bonthapally facility located at Hyderabad, Telangana, India has completed the US FDA inspection from 22nd July 2019 to 26th July 2019 with one(1) 483 observation which is procedural in nature. The Company will respond to this observation within the stipulated time period.
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.