Granules India receives USFDA approval for Dexmethylphenidate HCI ER capsules

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).

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