Alembic Pharmaceuticals said that it has received final approval from the US Food & Drug Administration (US FDA) for its abbreviated new drug application (ANDA) Dabigatran Etexilate Capsules.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Pradaxa Capsules of Boehringer Ingelheim Pharmaceuticals, Inc. (Boehringer).
Dabigatran Etexilate Capsules are indicated for prophylaxis of deep vein thrombosis and pulmonary embolism following hip replacement surgery.
"Alembic has a cumulative total of 211 ANDA approvals (183 final approvals and 28 tentative approvals) from USFDA, the company said in a statement.
Alembic Pharmaceuticals is in the business of development, manufacturing, and marketing of Pharmaceuticals products i.e. Formulations and Active Pharmaceutical Ingredients.
The pharmaceutical companys consolidated net profit increased 11.69% to Rs 134.71 crore in Q1 FY25 as compared to Rs 120.60 crore posted in Q1 FY24. Revenue from operations grew 5.09% year on year (YoY) to Rs 1,561.73 crore in the quarter ended 30 June 2024.
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