Zydus Lifesciences' Dasatinib Tablets Get USFDA Approval, To Manufacture At Ahmedabad Unit
The pharma major and its subsidiaries and affiliates received approval to manufacture the tablets in strengths 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg.
Zydus Lifesciences Ltd. on Wednesday announced receiving approval from the United States Food and Drug Administration for the Dasatinib tablets.
The pharmaceutical company, along with its subsidiaries and affiliates, has received final approval from the USFDA to manufacture Dasatinib tablets in strengths of 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg, according to its exchange filing.
The Dasatinib tablets—which are used for treating chronic myeloid leukaemia in newly diagnosed adults—will be manufactured at Zydus Lifesciences' unit in its special economic zone located in Ahmedabad.
The medication can also be used to treat adults with chronic, accelerated or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy, including imatinib.
Those with Philadelphia chromosome-positive acute lymphoblastic leukaemia with resistance or intolerance to prior therapy can also use it.
According to analytics platform IQVIA MAT, the annual sales of Dasatinib tablets stood at $1,807.7 million in the United States for the month of January 2025.
The group now has 415 approvals and has, as of Dec. 31, 2024, filed 483 ANDAs since the commencement of the filing process in FY 2003-04, the company added.
In the third quarter of FY2024-25, Zydus Lifesciences' consolidated net profit rose nearly 30% to Rs 1,024 crore.
The company had reported that income from its US formulations business has grown 31% to Rs 2,409.6 crore during the period.
Revenue in the quarter under review rose 17% to Rs 5,269 crore against Rs 4,505 crore in the similar period of last fiscal.
Shares of Zydus Lifesciences Ltd. closed 1.85% higher at Rs 887.95 apiece on the BSE, compared to a 1.01% advance in the benchmark Sensex.
