Alembic Pharmaceuticals’ New Dabigatran Capsules Get USFDA Approval

Alembic Pharmaceuticals Limited (Alembic) has announced that it has secured final approval from the US Food & Drug Administration (USFDA) for its Dabigatran Etexilate Capsules, 110 mg, under an Abbreviated New Drug Application (ANDA). This new medication is a therapeutic equivalent to Boehringer Ingelheim's Pradaxa Capsules, 110 mg. The capsules are used to prevent deep vein thrombosis and pulmonary embolism after hip replacement surgery. With this approval, Alembic now holds a total of 211 ANDA approvals from the USFDA, including 183 final and 28 tentative approvals.

Alembic Pharmaceuticals Limited, a pioneer in the pharmaceutical industry since 1907, is a leading research and development firm based in India. As a publicly traded company, Alembic produces and sells generic drugs globally. With cutting-edge research and manufacturing facilities that meet the standards of major regulatory bodies, including the USFDA, Alembic stands out in the branded generics market in India. Supported by a dedicated marketing team of over 5,000 professionals, Alembic's brands are widely acknowledged and trusted by healthcare providers and patients alike.