Granules India gets ANDA approval for Amphetamine mixed salts tablets

Granules now has a total of 47 ANDA approvals from the US Food & Drug Administration (US FDA) (45 final approvals and 2 tentative approvals).

Granules India announced that US FDA has approved the Abbreviated New Drug Application (ANDA) filed by Granules Pharmaceuticals, Inc. (GPI), a wholly owned foreign subsidiary, for Amphetamine mixed salts, USP 1.25mg, 1.875mg, 2.5mg, 3.125mg, 3.75mg, 5mg, 7.5mg immediate-release tablets.

It is bioequivalent to the reference listed drug product, Adderall of Teva Women's Health Inc. The product would be available for the US market shortly.

The current annual U.S. market for Amphetamine Mixed Salts immediate release tablets is approximately $335 million, according to MAT, Oct 2021 IQVIA/IMS Health.

Commenting on the approval Priyanka Chigurupati, executive director, GPI, said "We are pleased to receive the approval of the controlled substance product and will surely be a valuable addition to our growing product portfolio in the US market. We will be launching the product shortly."

Hyderabad-based Granules India is a vertically integrated fast growing Indian pharmaceutical company. It is present in the manufacturing of entire value chain - from Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation Intermediates (PFIs) and Finished Dosages (FDs).

On a consolidated basis, Granules India's net profit dropped 50.7% to Rs 80.68 crore on a 3.5% increase in net sales to Rs 888.33 crore in Q2 FY22 over Q2 FY21.

Shares of Granules India were down 0.76% to Rs 338.10 on BSE.

Powered by Capital Market - Live News