US FDA completes inspection at Granules India's Bonthapally facility

The US FDA’s inspection of Granules India’s Bonthapally facility located at Hyderabad, Telangana, has been completed. The inspection was carried out from July 22 to July 26, 2019. Only one observation under 483, which is procedural in nature, was given by the US FDA.

The company is expected to 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 the US FDA for Metformin API from this facility.

In the month of May, the USFDA had approved the Abbreviated New Drug Application (ANDA) filed by Granules Pharmaceuticals, Inc., a wholly-owned foreign subsidiary of Granules India Limited, for Methylphenidate Hydrochloride extended-release capsules for 10 mg, 20 mg, 30 mg, 40 mg and 60 mg, bio-equivalent to the reference listed drug product (RLD), Ritalin LA extended release capsules, 10 mg, 20 mg, 30 mg, 40 mg, and 60 mg, of Novartis Pharmaceuticals Corporation.

On Friday, the stock of Granules India made intra-day high and low of Rs 86 and Rs 84.25, respectively, and closed at Rs 85.45.