The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product, Pradaxa capsules of Boehringer lngelheim pharmaceuticals, Inc. (Boehringer).

According to IQVIA, Dabigatran Etexilate capsules have an estimated market size of US$ 465 million for twelve months ending December 2021. Alembic has received a cumulative total of 162 ANDA approvals (139 final approvals and 23 tentative approvals) from USFDA, company added.

Dabigatran Etexilate capsules, are indicated for reduction of risk of stroke and systemic embolism in non-valvular atrial fibrillation in adult patients, treatment of deep venous thrombosis and pulmonary embolism in adult patients. It may not be indicated for certain other uses due to unexpired exclusivities for the RLD for such uses.

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 company reported a 39.7% fall in net profit to Rs 176.42 crore on a 3.2% fall in net sales to Rs 1,271.7 crore in Q3 FY22 over Q3 FY21.