Granules India’s Bonthapally stated on Friday that its facility located at Hyderabad, Telangana completed the US FDA inspection from 22"ld July 2019 to 261h July 2019 with one(1) 483 observation which is procedural in nature. The company said that it will respond to this observation within the stipulated time period
This follows the other positive news in May wherein the company had received the FDA had approved the Abbreviated New Drug Application (ANDA) filed by its wholly-owned foreign subsidiary for Methylphenidate Hydrochloride extended-release capsules.
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.
The market has reacted positively to this news, with the stock price rising to gain a spot among the top five gainers on the BSE. The price rose to an intraday high of Rs 92, rising almost 8%. Its 20% UC for today is at Rs.102.50.