Granules India arm receives USFDA approval for ADHD drug

Granules India 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.

Mixed Salts of a Single-Entity Amphetamine extended-release (ER) capsules are indicated for the treatment of attention deficit hyperactivity disorder (ADHD). 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 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 now have a total of 53 ANDA approvals from USFDA (51 Final approvals and 2 tentative approvals).

Priyanka Chigurupati, executive director, Granules Pharmaceuticals, 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 India is primarily involved in the manufacturing and selling of active pharmaceutical ingredients (APIs), pharmaceutical formulation intermediates (PFIs) and finished dosages (FDs).

The company's consolidated net profit soared 79.8% to Rs 145.10 crore on 29.5% jump in net sales to Rs 1,150.73 crore in Q2 FY23 over Q2 FY22.

The scrip rose 0.38% to Rs 313.30 on the BSE.

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