Ahmedabad, January 15, 2026 – Zydus Lifesciences Limited (BSE: 532321 | NSE: Zyduslife) has received final approval to market Eltrombopag Tablets in multiple strengths, expanding its presence in the high-value specialty generics segment of the United States pharmaceutical market.
Approval Details and Product Scope
The approval covers Eltrombopag Tablets in four dosage strengths: 12.5 mg, 25 mg, 50 mg, and 75 mg. The drug is primarily used in the treatment of thrombocytopenia, a condition characterised by abnormally low platelet counts associated with specific blood disorders. Eltrombopag functions by stimulating bone marrow cells to enhance platelet production, thereby lowering the risk of bleeding-related complications.Manufacturing and Market Opportunity
The approved tablets will be manufactured at the company’s formulation manufacturing facility located in the Special Economic Zone at Ahmedabad. According to industry data, Eltrombopag tablets recorded annual sales of approximately USD 1.26 billion in the United States, highlighting the commercial significance of the approval for Zydus’ US portfolio.Strengthening the US Generics Portfolio
With this latest clearance, Zydus Lifesciences continues to reinforce its strong pipeline and execution capabilities in regulated markets. The group now has a cumulative total of 429 product approvals and has filed 505 abbreviated new drug applications since it began the filing process in FY2004, underlining its long-term focus on complex and specialty generics.Source:
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