Granules India arm gets USFDA gesture for ADHD treatment drug
- Post By : Kumar Jeetendra
- Source: PTI
- Date: 11 Sep,2020
New Delhi, Sep 11 (PTI) Medication 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.
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 recently 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 stated Dexmethylphenidate HCl extended release capsules had US sales of approximately USD 556 million for the latest 12 months ending in July 2020.
Shares of Granules India were trading 0.96 percent higher at Rs 364.55 apiece on BSE. PTI SVK ANS ANS