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USFDA approves Alembic Pharma Dabigatran Etexilate Capsules

Ruchika SharmaWritten by Ruchika Sharma   |  
USFDA approves Alembic Pharma Dabigatran Etexilate Capsules

Mumbai: Drugmaker, Alembic Pharmaceuticals Limited, today announced that the company has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Dabigatran Etexilate Capsules, 150 mg. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product...

Mumbai: Drugmaker, Alembic Pharmaceuticals Limited, today announced that the company has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Dabigatran Etexilate Capsules, 150 mg.

The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) PRADAXA Dabigatran Etexilate Mesylate Capsules, Eq to 150 mg base, Boehringer Ingelheim.

Dabigatran Etexilate Capsules are indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation, and for the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have been treated with a parenteral anticoagulant for 5 to 10 days. It is also indicated to reduce the risk of recurrence of DVT and PE in patients who have been previously treated.
Dabigatran Etexilate Capsules, 150 mg have an estimated market size of US$ 410 million for twelve months ending Sep. 2021 according to IQVIA.
Alembic has received year to date (YTD) 14 approvals (11 final approvals and 3 tentative approvals) and a cumulative total of 153 ANDA approvals (134 final approvals and 19 tentative approvals) from USFDA.

Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company headquartered in Gujarat.

Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world.

alembic pharma alembic pharma news deep venous thrombosis dabigatran etexilate capsules usfda pradaxa dabigatran etexilate mesylate capsules boehringer ingelheim pulmonary embolism 
Ruchika Sharma
Ruchika Sharma

    B.Com, M.Com

    Ruchika joined Medical Dialogue as an Desk Editor for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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