Kolkata: Alembic Pharmaceuticals Limited (Alembic) today announced that it 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. Refer label for a detailed indication.
Alembic has a cumulative total of 211 ANDA approvals (183 final approvals and 28 tentative approvals) from USFDA.
About Alembic Pharmaceuticals Limited
Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company, has been at the forefront of healthcare since 1907. Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world. Alembic’s state of the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA. Alembic is one of the leaders in branded generics in India. Alembic’s brands, marketed through a marketing team of over 5000 are well recognized by doctors and patients.
Information about Alembic can be found at https://www.alembicpharmaceuticals.com/
