Granules Pharmaceuticals Inc., receives ANDA Approval for Amphetamine Mixed Salts ER Capsules

Granules India Limited 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. 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 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.

Shares of Granules India Limited was last trading in BSE at Rs. 288.75 as compared to the previous close of Rs. 308.15. The total number of shares traded during the day was 114244 in over 2990 trades.

The stock hit an intraday high of Rs. 308.30 and intraday low of 287.85. The net turnover during the day was Rs. 33396974.00.

Source : Equity Bulls

Keywords

GranulesIndia INE101D01020 GranulesPharmaceuticalsInc ANDA USFDA Approval AmphetamineMixedSalts