Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Dabigatran Etexilate Capsules, 110 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Pradaxa Capsules, 110 mg of Boehringer Ingelheim Pharmaceuticals, Inc. (Boehringer).
Dabigatran Etexilate Capsules 110 mg are indicated for prophylaxis of deep vein thrombosis and pulmonary embolism following hip replacement surgery. The company has a cumulative total of 211 ANDA approvals (183 final approvals and 28 tentative approvals) from USFDA.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.
