Alembic Pharmaceuticals Limited 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 six strengths — 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg.
The approved product is therapeutically equivalent to Sprycel Tablets, the reference listed drug of Bristol-Myers Squibb Company (BMS). Dasatinib is indicated for the treatment of Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL) in adults, including those with resistance or intolerance to prior therapy such as imatinib. It is also approved for use in pediatric patients aged one year and older with Ph+ CML in the chronic phase.
According to IQVIA data, the market size for Dasatinib Tablets in the United States was approximately USD 1,017 million for the twelve months ending September 2025.
With this latest approval, Alembic has now secured a cumulative total of 227 ANDA approvals from the USFDA — comprising 207 final approvals and 20 tentative approvals.
Alembic Pharmaceuticals, a vertically integrated research-driven company established in 1907, continues to be among India’s leading manufacturers and marketers of generic pharmaceuticals worldwide.
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