Eugia Pharma receives USFDA Approval for Dasatinib Tablets

Aurobindo Pharma Limited is pleased to announce 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, 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). 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.

Dasatinib Tablets is indicated for the treatment of (i) newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (ii) adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib (iii) adults with Ph+ acute lymphoblastic leukemia (ALL) with resistance or intolerance to prior therapy.

Shares of Aurobindo Pharma Limited was last trading in BSE at Rs. 1247.80 as compared to the previous close of Rs. 1188.10. The total number of shares traded during the day was 84170 in over 4479 trades.

The stock hit an intraday high of Rs. 1252.00 and intraday low of 1182.50. The net turnover during the day was Rs. 102986754.00.

Source : Equity Bulls

Keywords

AurobindoPharma INE406A01037 EugiaPharmaSpecialities USFDA FinalApproval DasatinibTablets