Zydus Lifesciences gets USFDA’s tentative approval for Ibrutinib tablets

24 Jul 2025 Evaluate

Zydus Lifesciences has received tentative approval from the United States Food and Drug Administration (USFDA) for Ibrutinib tablets 140 mg, 280 mg, and 420 mg (USRLD: Imbruvica tablets, 140 mg, 280 mg and 420 mg). Ibrutinib is a kinase inhibitor indicated for the treatment of adult patients with Chronic lymphocytic leukaemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion, and Waldenstrom's macroglobulinemia (WM). 

Ibrutinib tablets will be produced at Zydus Lifesciences (SEZ), Ahmedabad. Ibrutinib tablets had annual sales of $2148.9 million in the United States (IQVIA MAT May 2025). The group now has 420 approvals and has so far filed around 484 ANDAs since the commencement of the filing process in FY 2003-04.

Zydus Lifesciences (formerly known as Cadila Healthcare), a company limited by shares, incorporated and domiciled in India, operates as an integrated pharmaceutical company with business encompassing the entire value chain in the research, development, production, marketing and distribution of pharmaceutical products.

Zydus Lifesciences Share Price

911.50 -5.95 (-0.65%)
26-Dec-2025 16:59 View Price Chart
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Company Name CMP
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