Granules India Limited announced that the US Food & Drug Administration (FDA) has approved the Abbreviated New Drug Application (ANDA) filed by Granules Pharmaceuticals, Inc (GPI)., a wholly-owned foreign subsidiary of the company, 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.
Commenting on the approval Priyanka Chigurupati, executive director, GPI, said
