Aurobindo Pharma Limited, a global pharmaceutical company based in Hyderabad, India, has announced that its wholly owned subsidiary, Eugia Pharma Specialities Limited, has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Dasatinib Tablets in multiple strengths: 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg. The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Sprycel Tablets, produced by Bristol-Myers Squibb Company (BMS).

The approval is a significant milestone for Eugia Pharma, marking their 181st ANDA approval out of their facilities, which manufacture both oncology oral and sterile specialty products. The launch of Dasatinib Tablets is expected to take place in Q1FY26, with an estimated market size of US$ 1.8 billion for the 12 months ending February 2025, according to IQVIA MAT data.

Dasatinib Tablets are used to treat various types of leukemia, including Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase, CML in accelerated, myeloid, or lymphoid blast phases, and acute lymphoblastic leukemia (ALL) in adults who are resistant to or intolerant of prior therapy, including Imatinib.

This approval aligns with Aurobindo Pharma's strategy to expand its oncology portfolio and enhance its presence in the global pharmaceutical market. The company, which has a strong presence in over 150 countries, continues to focus on strengthening its R&D capabilities and manufacturing facilities, all of which are approved by leading regulatory agencies such as USFDA, UK MHRA, EDQM, PMDA Japan, and more.

The company’s comprehensive product portfolio spans several major therapeutic areas, including CNS, anti-retroviral, CVS, antibiotics, gastroenterology, anti-diabetics, and anti-allergic medications. As part of its long-term growth strategy, Aurobindo Pharma will continue to leverage its strong R&D capabilities and extensive global manufacturing network to enhance its presence in both generic and branded specialty pharmaceutical markets.

About Aurobindo Pharma Limited:

Aurobindo Pharma Limited is a leading global pharmaceutical company, engaged in the development, manufacturing, and commercialization of a wide range of generic pharmaceuticals, branded specialty pharmaceuticals, and active pharmaceutical ingredients (APIs). The company has over 30 manufacturing facilities across various regions, including the US, Europe, and India, and it serves more than 150 countries.

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