Alembic Pharma gets USFDA nod for stroke and blood clots drug

The drug major said that it has received a final approval from the US drug regulator for Dabigatran Etexilate Capsules in strengths of 75 mg and 150 mg, and a tentative approval for the 110 mg variant.

The approved abbreviated new drug application (ANDA) is therapeutically equivalent to the reference listed drug product (RLD), Pradaxa Capsules, 75 mg, 110 mg, and 150 mg of Boehringer Ingelheim Pharmaceuticals, Inc. (Boehringer).

Dabigatran Etexilate capsules are indicated for reduction of risk of stroke and systemic embolism in non-valvular atrial fibrillation in adult patients; treatment and reduction in the risk of recurrence of deep venous thrombosis and pulmonary embolism in adult patients.

 

According to IQVIA, Dabigatran Etexilate capsules, 75 mg and 150 mg have an estimated market size of $179 million, while the 110 mg variant's market size was $5 million for the twelve months ending March 2024.

Alembic has a cumulative total of 205 ANDA approvals (178 final approvals and 27 tentative approvals) from US Food & Drug Administration (USFDA).

Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. The company manufactures and markets generic pharmaceutical products all over the world.

The company reported 16.78% increase in consolidated net profit to Rs 178.21 crore on 7.85% rise in revenue from operations to Rs 1,516.98 in Q4 FY24 over Q4 FY23.

The scrip declined 2.21% to currently trade at Rs 870.40 on the BSE.

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