Aurobindo Pharma's Unit gets USFDA Approval for Cancer Drug

India Pharma Outlook Team | Thursday, 24 April 2025

Aurobindo Pharma announced that it’s fully owned subsidiary Eugia Pharma Specialities Ltd has received the USFDA approval for manufacturing and marketing its generic equivalent of Dasatinib tablets for the treatment of specific cancers of bone marrow and blood.

These tablets are therapeutically and bioequivalent to Sprycel Tablets manufactured by Bristol-Myers Squibb. Eugia Pharma is expected to make the product available in the first quarter of FY2026. The approved product has an estimated market size of $1.8 billion for the 12 months ended February 2025 as per IQVIA MAT data.

Dasatinib Tablets are indicated in adults with new diagnosis of Philadelphia chromosome-positive (Ph+) chronic myeloid leukaemia in the chronic phase. Dasatinib Tablets are also administered when patients with Ph+ chronic myeloid leukaemia—in chronic, accelerated, or blast phases—develop resistance or intolerance to other treatments, including imatinib. Dasatinib Tablets are indicated in adults with Ph+ acute lymphoblastic leukaemia with resistance or intolerance to prior treatment.

In the stock market, Aurobindo Pharma's shares gained 2.65% to ?1,219.60. Though there has been a gain, the stock has declined by 9.75% since the beginning of 2025.

As per BSE figures, Aurobindo Pharma's price-to-earnings (P/E) is 36.91 and price-to-book (P/B) is 3.60. Its earnings per share (EPS) is ?33.01, and return on equity (RoE) is 9.75%. According to Trendlyne, the one-year beta of the stock is 0.8, which is relatively low volatility.

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