Zydus Lifesciences secures USFDA tentative approval for Ibrutinib tablets, targeting the billion-dollar U.S. market for cancer treatment.

• Approval covers 140 mg, 280 mg, and 420 mg tablets; production to take place at Ahmedabad SEZ facility.
• Ibrutinib treats CLL/SLL with 17p deletion and Waldenstrom’s macroglobulinemia; U.S. sales total $2.15 billion annually.
• Zydus now holds 420 approvals, with 484 ANDAs filed since FY04, strengthening its U.S. generics portfolio.