Zydus Lifesciences Limited — Updates, 24-07-2025: Press Release

Zydus Lifesciences secured tentative USFDA approval for Ibrutinib tablets (140 mg, 280 mg, 420 mg), targeting Chronic lymphocytic leukemia and Waldenstrom's macroglobulinemia. This is a significant development, as Ibrutinib recorded annual US sales of USD 2148.9 million (approx. ₹17,945 Cr). This approval expands Zydus's oncology portfolio and market potential. Production will be at their Ahmedabad SEZ facility. The company now holds 420 approvals, signaling strong progress and a substantial revenue opportunity.