Hyderabad, Sep 11 (IANS) Granules, a leading APIs and formulations corporation, on Friday announced that its US subsidiary has received marketing approval from the USFDA for Dexmethylphenidate HCl extended-release capsules for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD).
Granules' capsule product is bioequivalent to the reference listed drug (RLD), Focalin XR, which is a trademark of Novartis AG.
Priyanka Chigurupati, Executive Director of Granules Pharmaceuticals Inc.Asaid this approval has been received within 13 months of filing. "This reiterates our strength in the development of complex generics. The approval of Dexmethylphenidate XR, a complex, extended-release C-II product, is a good addition to our portfolio. We will be launching the product in the US market soon."
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.
According to IQVIA Health, Dexmethylphenidate HCl ER Capsules had US sales of approximately $556 million for the most recent 12 months ending in July 2020.
Granules is a vertically integrated pharmaceutical company, headquartered in Hyderabad. A world leading manufacturer of Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation Intermediates (PFIs) and Finished Dosages (FDs), Granules markets its products worldwide, in both regulated and semi-regulated markets.
With eight manufacturing plants, including the world's largest PFI facility, its presence spans across 75 countries worldwide.