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Granules Pharmaceuticals gets ANDA approval for Amphetamine mixed salts ER Capsules

Granules India has received US Food & Drug Administration (US FDA) approval for Amphetamine Mixed Salts,5mg, 10mg, 15mg, 20mg, 25mg, and 30mg Extended-Release (ER) capsules.

Granules India has received US Food & Drug Administration (US FDA) approval for Amphetamine Mixed Salts,5mg, 10mg, 15mg, 20mg, 25mg, and 30mg Extended-Release (ER) capsules.

The company in a statement said, “Granules India Limited has announced 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.”

The company further said that 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.

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).”

 The pharma company said that 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 US FDA (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,” the company statement read.

 


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