Zydus Lifesciences gets final nod from USFDA for 'Dasatinib' tablets. Details here

Zydus Lifesciences Ltd on Wednesday said it received final approval from the United States Food and Drug Administration (USFDA) to manufacture Dasatinib tablets in 20 mg, 50 mg, 70 mg, 80 mg, 100 mg and 140 mg strengths.

"Dasatinib is indicated for the treatment of newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukaemia (CML) in chronic phase. It is also used to treat adults with chronic, accelerated or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib and adults with Philadelphia chromosome-positive acute lymphoblastic leukaemia (Ph+ ALL) with resistance or intolerance to prior therapy," the pharma firm stated.

"Dasatinib tablets will be produced at Zydus Lifesciences Ltd (SEZ), Ahmedabad. Dasatinib tablets had annual sales of $1,807.7 million in the United States (IQVIA MAT January 2025)," it added.

As of December 31, 2024, the group said it has 415 approvals and filed 483 ANDAs so far since the commencement of the filing process in FY 2003-04.

On the stock-specific front, Zydus Life shares rose 1.85 per cent to settle at Rs 887.95. Despite the mentioned rise, the stock has slipped 8.80 per cent on a year-to-date (YTD) basis.

It saw high trading volume of BSE today as around 30,000 shares changed hands. The figure was higher than the two-week average volume of 27,000 shares. Turnover on the counter came at Rs 2.64 crore, commanding a market capitalisation (m-cap) of Rs 89,348.55 crore.

On technical setup, the counter traded higher than the 5-day and 10-day simple moving averages (SMAs) but lower than the 20-day, 30-, 50-, 100-, 150-day and 200-day SMAs. Its 14-day relative strength index (RSI) came at 41.08. A level below 30 is defined as oversold while a value above 70 is considered overbought.

The stock has a price-to-equity (P/E) ratio of 20.46 against a price-to-book (P/B) value of 4.99. Earnings per share (EPS) stood at 43.39 with a return on equity (RoE) of 24.40. Promoters held a 74.98 per cent stake in the company, BSE data showed.