Aurobindo Pharma arm Eugia gets USFDA nod for Dasatinib tablets, eyes $1.8 billion market

Aurobindo Pharma Ltd's wholly-owned subsidiary Eugia Pharma Specialities Ltd on Wednesday said it received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Dasatinib Tablets in 20 mg, 50 mg, 70 mg, 80 mg, 100 mg and 140 mg strengths.

These products are bioequivalent and therapeutically equivalent to Sprycel Tablets by Bristol-Myers Squibb and are expected to be launched in the first quarter of fiscal year 2026, the company stated in a BSE filing.

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 approval marks the 181st Abbreviated New Drug Application (ANDA) approval for Eugia Pharma Specialities Group, which includes nine tentative approvals.

Dasatinib Tablets are used for treating newly diagnosed adults with Philadelphia chromosome-positive chronic myeloid leukaemia in the chronic phase. They are also used in adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ chronic myeloid leukaemia with resistance or intolerance to prior therapies, including imatinib.

Additionally, Dasatinib Tablets are indicated for adults with Philadelphia chromosome-positive acute lymphoblastic leukaemia, facing resistance or intolerance to prior therapies.

Stock-wise, Aurobindo Pharma was up 2.65 per cent at Rs 1,219.60. At this price, it has slipped 9.75 per cent in the calendar year 2025 so far. 

Technically, the scrip traded higher than the 5-day, 10-, 20-, 30-, 50-day and 100-day simple moving averages (SMAs) but lower than the 150-day and 200-day SMAs. Its 14-day relative strength index (RSI) came at 61.77. A level below 30 is defined as oversold while a value above 70 is considered overbought.

As per BSE, the stock has a price-to-equity (P/E) ratio of 36.91 against a price-to-book (P/B) value of 3.60. Earnings per share (EPS) stood at 33.01 with a return on equity (RoE) of 9.75. As per Trendlyne, Auropharma has a one-year beta of 0.8, indicating low volatility on the counter.

As of March 2025, promoters held a 51.82 per cent stake in the pharma firm.