Companies

Granules India arm gets USFDA nod for narcolepsy treatment drug

PTI New Delhi | Updated on November 27, 2018 Published on November 27, 2018

A file photo of Granules India Vizag unit.

Granules India’s subsidiary has received approval from the US health regulator for Methylphenidate Hydrochloride extended-release tablets used in the treatment of a sleep disorder called narcolepsy.

The US Food & Drug Administration (USFDA) has approved the abbreviated new drug application filed by Granules Pharmaceuticals, Inc, a subsidiary of Granules India Ltd, through its US agent First Time US Generics LLC, for Methylphenidate Hydrochloride extended-release tablets USP, 10 mg and 20 mg, Granules India said in a filing to the BSE today.

The approved product is the therapeutic equivalent of the reference listed drug Ritalin SR sustained-release tablets 20 mg of Novartis Pharmaceuticals Corporation. The company said Granules Pharmaceuticals Inc will market and distribute the product shortly.

Shares of Granules India were trading at Rs 90 apiece, down 0.61 per cent from previous close, on the BSE.

Published on November 27, 2018
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