Granules Pharma bags USFDA nod for ADHD drug Amphetamine Mixed Salts ER

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

Published On 2023-01-24 06:32 GMT | Update On 2023-01-24 06:32 GMT

Hyderabad: Granules India Limited announced today that the US Food & Drug Administration (USFDA) 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 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).”

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

Granules now have a total of 53 ANDA approvals from USFDA (51 Final approvals and 2 tentative approvals). 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 India Limited, incorporated in 1991 is a vertically integrated Indian pharmaceutical company headquartered in Hyderabad. The company's products are being distributed in regulated and semi-regulated markets with a global presence extending to over 80+ countries with offices across India, U.S., and U.K. The Company has 7 manufacturing facilities out of which 6 are located in India and 1 in USA and has regulatory approvals from US FDA, EDQM, EU GMP, COFEPRIS, WHO GMP, TGA, K FDA, DEA, MCC, and HALAL.

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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Granules Pharma bags USFDA nod for ADHD drug Amphetamine Mixed Salts ER

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

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