Zydus Lifesciences Gets USFDA Approval for Generic Dasatinib Tablets

Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Dasatinib Tablets in multiple strengths: 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg. This is a generic version of Sprycel Tablets, which is used for treating Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL).

Dasatinib Market in the US

According to IQVIA MAT January 2025 data, Dasatinib tablets had annual sales of $1.81 billion in the United States. The approval allows Zydus to enter this segment with its generic version, adding to its portfolio of 415 USFDA approvals. Since FY 2003-04, the company has filed 483 Abbreviated New Drug Applications (ANDAs).

Manufacturing and Distribution

The Dasatinib tablets will be manufactured at Zydus Lifesciences’ facility in Ahmedabad. The plant has been producing various pharmaceutical products for global markets and is part of the company’s USFDA-approved manufacturing network.

Financial Performance

In the third quarter of FY25, Zydus reported a 29.62% increase in net profit, reaching ₹1,023.5 crore, compared to ₹789.6 crore in the same quarter of the previous year. Revenue from operations grew by 16.96% YoY, standing at ₹5,269.1 crore. The company attributed this growth to strong sales in India and the US.

As of March 6, 11:23 AM, Zydus Lifesciences Ltd is trading at ₹905.80, up ₹18.35 (2.07%) for the day. However, the stock has declined 10.16% over the past month and 5.83% over the past year.

Additional Product Launch in India

Zydus has also introduced ANVIMO (Letermovir) in India, a drug aimed at preventing Cytomegalovirus (CMV) infections in transplant patients. The company claims it has reduced the cost of CMV treatment by 91%, making it more accessible.

Conclusion

Bringing it all together, the approval of generic Dasatinib adds another product to Zydus’ US portfolio, increasing its presence in the oncology segment.

Disclaimer: This blog has been written exclusively for educational purposes. The securities mentioned are only examples and not recommendations. This does not constitute a personal recommendation/investment advice. It does not aim to influence any individual or entity to make investment decisions. Recipients should conduct their own research and assessments to form an independent opinion about investment decisions. 

Investments in the securities market are subject to market risks, read all the related documents carefully before investing.