Granules India gets USFDA nod for muscle contraction drugs

Granules India informed the bourses on Thursday that its wholly-owned subsidiary, Granules Pharmaceuticals Inc has received approval from the United States Food and Drug Administration (USFDA) for Butalbital, Acetaminophen and Caffeine Capsules USP, 50 mg/300 mg/40 mg.

The said drug is bioequivalent to the reference listed drug product (RLD), Butalbital, Acetaminophen and Caffeine Capsules USP, 50 mg/300 mg/40 mg, of Nexgen Pharma, which had US sales of approximately US$ 42 million MAT for the most recent twelve months ending in February 2020, according to IQVIA Health.

Butalbital, Acetaminophen and Caffeine Capsules are used for the relief of the symptom complex of tension (or muscle contraction) and headache. Granules now have a total of 25 ANDA approvals from USFDA (23 final approvals and two tentative approvals).

Granules India Limited is a mid-cap company, operating in the pharmaceutical sector. The company produces finished dosages (FDs), pharmaceutical formulation intermediates (FPIs) as well as active pharmaceutical ingredients (APIs).

At the time of market closing on Thursday, the stock was trading at Rs 169.30, down by 1.86 per cent. The 52-week high is recorded at Rs 188.85 and the 52-week low is Rs 84.25 on BSE.