Granules India gets USFDA nod for Methylphenidate Hydrochloride ER capsules

The approved product, Methylphenidate Hydrochloride extended-release capsules, is bioequivalent to the reference listed drug product (RLD), Ritalin LA extended-release capsules of Novartis Pharmaceuticals Corporation.

New Delhi: 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.

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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.

The company is based in Hyderabad and manufactures tablets, Pharmaceutical Formulation Intermediates (PFIs) and active pharmaceutical ingredients (APIs) which are distributed in over 74+ countries.

Granules manufacture several off-patent drugs, including Paracetamol, Ibuprofen, Metformin and Guaifenesin, on a large scale for customers in the regulated and semi-regulated markets.

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