Alembic gets USFDA nod for generic medication

Alembic Pharmaceuticals has received approval from the US Food and Drug Administration (USFDA) to market Dabigatran Etexilate Capsules (110 mg), a generic product for the prophylaxis of deep vein thrombosis and pulmonary embolism following hip replacement surgery. This product is therapeutically equivalent to Boehringer Ingelheim's Pradaxa Capsules. With this approval, Alembic now has a total of 211 ANDA approvals from the USFDA. Shares of Alembic Pharmaceuticals closed 3.17% lower at Rs 1,076 apiece on the BSE

Alembic Pharmaceuticals Secures USFDA Approval for Generic Dabigatran Etexilate Capsules; Image | Pixabay

Alembic Pharmaceuticals on Tuesday said it has received approval from the US health regulator to market a generic product indicated for prophylaxis of deep vein thrombosis. The company has received approval from the US Food and Drug Administration (USFDA) to market Dabigatran Etexilate Capsules (110 mg), the drug firm said in a regulatory filing.

Dabigatran Etexilate Capsules are indicated for prophylaxis of deep vein thrombosis and pulmonary embolism following hip replacement surgery. The approved product is therapeutically equivalent to Boehringer Ingelheim Pharmaceuticals Inc.'s Pradaxa Capsules (110 mg).

The company said it now has a cumulative total of 211 ANDA (abbreviated new drug application) approvals from the USFDA. Shares of the company on Tuesday closed 3.17 percent down at Rs 1,076 apiece on the BSE.

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