Granules India’s arm receives ANDA approval for Amphetamine Mixed Salts ER Capsules
24th Jan 2023

The 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 Amphetamine Mixed Salts, 5mg, 10mg, 15mg, 20mg, 25mg, and 30mg Extended-Release (ER) capsules. It is bioequivalent to the reference listed drug product (RLD), Adderall XR Extended-Release capsules of Takeda Pharmaceuticals USA Inc. This product will be manufactured at Granules manufacturing facility in Chantilly, Virginia and is expected to be launched shortly.

Mixed Salts of a Single-Entity Amphetamine ER Capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Granules now have a total of 53 ANDA approvals from US FDA (51 Final approvals and 2 tentative approvals). The current annual U.S. market for Amphetamine Mixed Salts ER capsule product is approximately $1.56 Billion, according to MAT Nov 2022, 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).