Granules India arm gets USFDA approval for ADHD drug

Granules India Limited on Tuesday said that its wholly-owned foreign subsidiary, Granules Pharmaceuticals has received approval from US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Amphetamine Mixed Salts capsules.

In the regulatory filing, “Granules India Limited announced today that 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 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, the pharma company said in the filing.

Commenting on the approval Ms. Priyanka Chigurupati, Executive Director, GPI, said “We are pleased to receive the approval of Amphetamine Mixed Salts ER Capsules within 10-months of ANDA filing, which is an Extended-Release dosage form of controlled substance (C-II).” 
Granules now have a total of 53 ANDA approvals from US FDA (51 Final approvals and 2 tentative approvals), the company said. 

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.

Mixed Salts of a Single-Entity Amphetamine ER Capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).