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(24 Jul 2025, 13:16)

Zydus Lifesciences gets USFDA Nod for Ibrutinib tablets

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 Waldenström'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.

The company’s 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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