Zydus Lifesciences Limited — Updates, 05-03-2025: Press Release

Zydus Lifesciences Limited has received final USFDA approval to manufacture Dasatinib Tablets in multiple dosages (20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg). Dasatinib is crucial for treating specific types of leukemia, including Philadelphia chromosome-positive chronic myeloid leukemia and acute lymphoblastic leukemia in adults. The tablets will be produced in Ahmedabad, and this approval comes as Dasatinib had annual sales of approximately USD 1,807.7 million in the U.S. market as of January 2025. With this addition, Zydus now holds a total of 415 approvals, having filed 483 abbreviated new drug applications (ANDAs) since fiscal year 2003-04. This significant milestone could positively impact Zydus's revenue stream and market positioning in the oncology segment.