Aurobindo Pharma rallies after arm receives USFDA nod for Dasatinib tablets

Aurobindo Pharma rose 1.81% to Rs 1,209.60 after its wholly owned subsidiary, Eugia Pharma Specialities, received final approval from the U.S. Food and Drug Administration (USFDA) to manufacture and market Dasatinib Tablets.

The drug is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Sprycel Tablets by Bristol-Myers Squibb Company (BMS).

Dasatinib is approved for treating Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in adults and children, including newly diagnosed cases. It is also indicated for Ph+ CML with resistance or intolerance to prior therapies like imatinib and for Ph+ acute lymphoblastic leukemia (ALL) with treatment resistance or intolerance.

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 marks the 181st ANDA approval (including 9 tentative approvals) from Eugia Pharma Specialties Group (EPSG) facilities, which manufacture both oncology oral and sterile specialty products.

Aurobindo Pharma 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 companys consolidated net profit fell 9.7% to Rs 845.81 crore in Q3 FY25 as compared with Rs 936.26 crore in Q3 FY24. Net sales increased 8.6% YoY to Rs 7,893.15 crore during the quarter ended 31st December 2024.

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