Granules India subsidiary gets USFDA approval for ADHD treatment drug

The ANDA was filed by Granules Pharmaceuticals Inc. for Amphetamine Mixed Salts 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg, which are bioequivalent to Adderall XR extended-release capsules of Takeda Pharmaceuticals USA Inc.

Mixed Salts of Single-Entity Amphetamine ER Capsules are used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). ADHD is a neurodevelopmental condition, often noticed in childhood, in which children find difficulty in paying attention and controlling impulsive behaviours.

The company will manufacture this product at its facility in Chantilly, Virginia, US, and launch it shortly.

With the latest approval, Granules now has a total of 53 ANDA approvals from the USFDA (51 final approvals and 2 tentative approvals).

The annual US market for Amphetamine Mixed Salts ER capsule product is approximately $1.56 billion, according to IQVIA data for the 12-month period ending in November 2022.

Last week, the USFDA completed the pre-approval inspection at Granules India’s Gagillapur facility in Telangana. The inspection was conducted from January 9 to January 13. The Gagillapur facility manufactures finished dosages (FDs) and pharmaceutical formulation intermediates (PFIs).

Shares of Granules India ended 1.68 percent lower at Rs 306.90 on Tuesday.