Granules India’s wholly owned foreign subsidiary -- Granules Pharmaceuticals, Inc. (GPI), has received the Abbreviated New Drug Application (ANDA) approval for Amphetamine Mixed Salts, USP 1.25mg, 1.875mg, 2.5mg, 3.125mg, 3.75mg, 5mg, 7.5mg Immediate-Release Tablets. It is bioequivalent to the reference listed drug product (RLD), Adderall of Teva Women’s Health Inc. The product would be available for the US market shortly.
Granules now have a total of 47 ANDA approvals from the US FDA (45 Final approvals and 2 tentative approvals). The current annual U.S. market for Amphetamine Mixed Salts, USP 1.25mg, 1.875mg, 2.5mg, 3.125mg, 3.75mg, 5mg, 7.5mg Immediate Release Tablets strengths is approximately $ 335 Million, according to MAT, Oct 2021 IQVIA/IMS Health.
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).
