Granules subsidiary gets USFDA nod for ADHD related capsules

Drug firm Granules India Monday said its subsidiary has received approval from the US health regulator for Methylphenidate Hydrochloride extended-release capsules, used for the treatment of attention deficit hyperactivity disorder (ADHD). The approved product is bioequivalent to the reference listed drug product (RLD), Ritalin LA extended-release capsules of Novartis Pharmaceuticals Corporation.

The US Food and Drug Administration (USFDA) has approved the abbreviated new drug application (ANDA) filed by Granules Pharmaceuticals, a wholly-owned foreign subsidiary of Granules India, for Methylphenidate Hydrochloride extended-release capsules in the strengths of 10 mg, 20 mg, 30 mg, 40 mg and 60 mg, Granules said in a BSE filing. Granules India said, till date, Granules Pharmaceuticals had submitted a total 19 ANDAs and the current approval is the third ANDA approval for the entity. Go-ahead for the balance 16 ANDAs are awaited. Shares of Granules India were trading 1.54 per cent higher at Rs 112.80 apiece on BSE.