Granules India’s wholly owned subsidiary--Granules Pharmaceuticals Inc (GPI) has received marketing approval from the U.S. Health Regulator (USFDA) for Dexmethylphenidate HCl extended-release (ER) 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. According to IQVIA Health, Dexmethylphenidate HCl ER Capsules had U.S. sales of approximately $556 million for the most recent twelve months ending in July 2020. Granules now have a total of 30 ANDA approvals from the US FDA (28 Final approvals and 2 tentative approvals).
Granules India is manufacturer and supplier of pharmaceutical products. Its products include active pharmaceutical ingredients (API) like tablets, caplets, rapid release, pharmaceutical, formulation intermediates (PFI) and Finished Dosages (FDs).
