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Granules India receives final approval for ADHD treatment drug from USFDA

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

Press Trust of India  |  New Delhi 

medicine, pharma
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Drug firm Monday said its subsidiary has received approval from the US health regulator for Hydrochloride extended-release capsules, used for the treatment of (ADHD).

The approved product is bioequivalent to the reference listed (RLD), Ritalin LA extended-release capsules of

The (USFDA) has approved the abbreviated new drug application (ANDA) filed by Granules Pharmaceuticals, a wholly-owned of Granules India, for 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.

said, till date, had submitted 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 were trading 1.54 per cent higher at Rs 112.80 apiece on BSE.

First Published: Mon, May 27 2019. 10:35 IST