Hyderabad: Aurobindo Pharma Limited has announced that its wholly owned subsidiary, Eugia PharmaSpecialities Limited, has received final approval from the US Food & Drug Administration (USFDA) to
manufacture and market Dasatinib Tablets, 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg, which is
bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Sprycel Tablets, 20 mg,
50 mg, 70 mg, 80 mg, 100 mg, and 140 mg, of Bristol-Myers Squibb Company (BMS).Dasatinib Tablets is indicated for the treatment of newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase, adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib, adults with Ph+ acute lymphoblastic leukemia (ALL) with resistance or intolerance to prior therapy.The product is
expected to be launched in Q1FY26.
The approved product has an estimated market size of US$ 1.8 billion for the twelve months ending
February 2025, according to IQVIA MAT.
This is the 181st ANDA approval (including 9 tentative approvals received) out of Eugia Pharma
Specialities Group (EPSG) facilities, manufacturing both oncology oral and sterile specialty products.
Read also: Aurobindo Pharma gets USFDA final, tentative nod for different strengths of deep vein thrombosis drug RivaroxabanAurobindo Pharma Limited is an integrated global pharmaceutical company headquartered in
Hyderabad, India. The Company develops, manufactures, and commercializes a wide range of generic
pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients globally in
over 150 countries.
The company has 30+ manufacturing and packaging facilities that are approved by leading regulatory
agencies including USFDA, UK MHRA, EDQM, Japan PMDA, WHO, Health Canada, South Africa MCC,
Brazil ANVISA. The Company’s product portfolio is spread over seven major therapeutic/product
areas encompassing CNS, Anti-Retroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics and AntiAllergic.Read also: Aurobindo Pharma arm CuraTeQ Biologics completes successful Phase 1 Pharmacokinetics study of bone drug