Zydus Lifesciences informed that it has received tentative approval from the United States Food and Drug Administration (USFDA) for Ibrutinib tablets 140 mg, 280 mg, and 420 mg.
Ibrutinib is a kinase inhibitor indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL) with a 17p deletion, and Waldenstr's macroglobulinemia (WM).
Ibrutinib tablets will be produced at Zydus Lifesciences Ltd (SEZ), Ahmedabad. The tablets had annual sales of $2,148.9 million in the United States (IQVIA MAT May 2025).
The group now holds 420 approvals and has filed a total of 484 ANDAs since the commencement of the filing process in FY 2003-04.
Zydus Lifesciences is a discovery-driven, global life sciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies.
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The companys consolidated net profit shed 0.96% to Rs 1,170.9 crore on a 17.21% rise in revenue from operations to Rs 6,290.2 crore in Q4 FY25 over Q4 FY24.
Shares of Zydus Lifesciences rose 0.78% to currently trade at Rs 969.15 on the BSE.
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