US Food & Drug Administration (US FDA) has approved the Abbreviated New Drug Application (ANDA) filed by Granules Pharmaceuticals, Inc. (GPI), a wholly owned foreign subsidiary of Granules India for Dofetilide Capsules, 125 meg, 250 meg, and 500 meg. It is bioequivalent to the reference listed drug product (RLD), Tikosyn Capsules, 125 meg, 250 meg, and 500 meg, of Pfizer Inc. This product would be manufactured at the GPI facility located in Chantilly, Virginia, USA and is expected to be launch soon.
Granules now has a total of 45 ANDA approvals from US FDA (43 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).
