Business Standard

Granules India receives USFDA approval for Dexmethylphenidate HCI ER capsules

Image

Capital Market
Granules India announced its US subsidiary has received marketing approval from the U.S. Health Regulator (FDA) for Dexmethylphenidate HCI extended-release capsules for the treatment of attention-deficit hyperactivity disorder. Granules' capsule product is bioequivalent to the reference listed drug (RLD), Focalin XR.

The drug will be manufactured at the Granules manufacturing facility in Chantilly, Virginia.

Granules now have a total of 30 ANDA approvals from the US FDA (28 Final approvals and 2 tentative approvals).

Powered by Capital Market - Live News

Disclaimer: No Business Standard Journalist was involved in creation of this content

Don't miss the most important news and views of the day. Get them on our Telegram channel

First Published: Sep 11 2020 | 9:20 AM IST

Explore News