Drug firm Granules India Friday said its subsidiary has received marketing approval from the US health regulator for Dexmethylphenidate HCl extended-release capsules, used for the treatment of attention-deficit hyperactivity disorder (ADHD). The approved product is bioequivalent to the reference listed drug Focalin XR of Novartis AG.
Mumbai:
In a BSE filing, Granules said its US subsidiary has received marketing approval from the US Food and Drug Administration (USFDA) for Dexmethylphenidate HCl extended-release capsules. The company said the newly approved drug will be manufactured at the Granules' manufacturing facility in Chantilly, Virginia. Granules now have a total of 30 abbreviated new drug application (ANDA) approvals from the USFDA (28 final and 2 tentative). Quoting IQVIA Health data, Granules said Dexmethylphenidate HCl extended release capsules had US sales of approximately USD 556 million for the most recent 12 months ending in July 2020.
Shares of Granules India were trading 0.96 per cent higher at Rs 364.55 apiece on BSE.