Alembic Pharma gains on US FDA nod for Dronedarone Tablets

Alembic Pharmaceuticals added 1.29% to Rs 817 after the company said that it has received tentative approval from the US Food & Drug Administration (USFDA) for its ANDA for Dronedarone Tablets.

The tentatively approved abbreviated new drug application (ANDA) is therapeutically equivalent to the reference listed drug product (RLD) Multaq Tablets of Sanofi-Aventis U.S. LLC.

Dronedarone is indicated to reduce, the risk of hospitalization for atria) fibrillation in patients in sinus rhythm with a history of paroxysmal or persistent atrial fibrillation.

The tablets have an estimated market size of US$ 500 million for twelve months ending September 2021 according to IQVIA.

Alembic has settled the case with Sanofi-Aventis and will launch its generic as per the terms of settlement.

Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. It manufactures and markets generic pharmaceutical products all over the world.

On a consolidated basis, the drug maker's net profit dropped 49.22% to Rs 169.29 crore on 11.31% decline in sales to Rs 1,292.32 crore in Q2 FY22 over Q2 FY21.

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