Alembic Pharmaceuticals has received final approval from the US Food and 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 product is therapeutically equivalent to Sprycel Tablets of the same strengths, developed by Bristol-Myers Squibb Company (BMS).

Dasatinib tablets are indicated for the treatment of adult patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in the chronic phase, as well as in chronic, accelerated, or myeloid/lymphoid blast phase Ph+ CML resistant or intolerant to prior therapy, including imatinib. The medication is also approved for Ph+ acute lymphoblastic leukemia (ALL) with resistance or intolerance to prior therapy.

In addition, the drug is indicated for pediatric patients aged one year and older with Ph+ CML in the chronic phase.

According to IQVIA data, Dasatinib Tablets (20 mg–140 mg) had an estimated market size of USD 1,017 million for the 12 months ending September 2025.

Headquartered in India, Alembic Pharmaceuticals manufactures and markets a broad range of generic medicines globally. With this approval, the company’s cumulative USFDA tally now stands at 227 ANDA approvals, comprising 207 final and 20 tentative approvals.