Alembic Pharma gets USFDA final approval for Dasatinib tablets in multiple strengths

Alembic Pharmaceuticals announced that it has received final approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Dasatinib Tablets in strengths of 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg.

The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Sprycel Tablets, of Bristol-Myers Squibb Company (BMS). Dasatinib is indicated for adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase, chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib, and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. It is also approved for pediatric patients aged one year and above with Ph+ CML in chronic phase.

According to IQVIA, Dasatinib tablets have an estimated market size of US$ 1,017 million for the 12 months ending September 2025.

With this approval, Alembic has a cumulative total of 227 ANDA approvals from the USFDA, including 207 final approvals and 20 tentative approvals.

Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. It manufactures and markets generic pharmaceutical products all over the world. Its research and manufacturing facilities are approved by regulatory authorities of many developed countries, including the USFDA.

The companys consolidated net profit jumped 20.40% to Rs 184.71 crore in Q2 FY26, compared to Rs 153.41 crore posted in Q2 FY25. Revenue from operations grew 15.90% year on year (YoY) to Rs 1,910.15 crore in the quarter ended 30 September 2025.

Shares of Alembic Pharmaceuticals rose 0.16% to currently trade at Rs 917 on the BSE.

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