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Granules gets USFDA nod for ADHD drug
Highlights
Drug firm Granules India on Monday said its subsidiary has received approval from the US health regulator for Methylphenidate Hydrochloride
Hyderabad: Drug firm Granules India on 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.
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