Alembic gets USFDA nod for generic medication, ET HealthWorld

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Alembic gets USFDA nod for generic medication, ET HealthWorld

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New Delhi: 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 ***** Administration (USFDA) to market Dabigatran Etexilate Capsules (110 mg), the ***** 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 ***** application) approvals from the USFDA.

Shares of the company on Tuesday closed 3.17 per cent down at Rs 1,076 apiece on the BSE.

• Published On Aug 14, 2024 at 06:31 AM IST

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