Granules gets US drug regulator's nod for Amphetamine capsules
Jan 24, 2023
Hyderabad (Telangana) [India], January 24 : Granules India announced on Tuesday that the US Food and Drug Administration (US FDA) has approved the abbreviated new drug application (ANDA) filed by its US subsidiary -- Granules Pharmaceuticals, Inc (GPI) -- for Amphetamine mixed salts used for treating attention disorder.
Amphetamine is bioequivalent to the reference listed drug product (RLD), Adderall XR extended-release capsules of Takeda Pharmaceuticals. This product will be manufactured at Granules manufacturing facility in Chantilly, Virginia, and is expected to be launched shortly, according to a company statement shared with stock exchanges.
An abbreviated new drug application (ANDA) is an application for a US generic drug approval for an existing licensed medication or approved drug.
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 a controlled substance (C-II)."
Mixed salts of single-entity Amphetamine ER Capsules are indicated for the treatment of attention deficit hyperactivity disorder (ADHD). The company added Granules now have a total of 53 ANDA approvals from US FDA with 51 final approvals and two tentative approvals.
The current annual US market for Amphetamine mixed salts ER capsule product is approximately USD 1.56 billion, according to MAT Nov 2022, IQVIA/IMS Health.
Granules India, incorporated in 1991 is a vertically integrated Indian pharmaceutical company headquartered at Hyderabad with modern facilities. The pharmaceutical company has manufacturing units of the entire value chain - from active pharmaceutical ingredients (APIs), pharmaceutical formulation intermediates (PFIs) and finished dosages (FDs).
The company has seven manufacturing facilities out of which six are located in India and one in the US.
