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Zydus Lifesciences Receives USFDA Final Approval for Eltrombopag Tablets

Zydus Lifesciences Limited

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January 15, 2026, 07:46 AM

Zydus Lifesciences received USFDA final approval for Eltrombopag Tablets (12.5 mg, 25 mg, 50 mg, 75 mg). These tablets treat thrombocytopenia and will be produced in Ahmedabad. The original product had annual sales of USD 1262.5 million in the US. Zydus now has 429 approvals and 505 filed ANDAs.

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Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) for its Eltrombopag Tablets in strengths of 12.5 mg, 25 mg, 50 mg, and 75 mg. These tablets are generic versions of Promacta Tablets, which are used for treating thrombocytopenia (low platelet count) in certain blood disorders by stimulating platelet production.

The manufacturing of these tablets will take place at Zydus' formulation manufacturing facility located in the SEZ, Ahmedabad. The announcement also highlighted that Eltrombopag tablets had annual sales of USD 1262.5 million (₹10,50,00,00,000 crore) in the United States as of November 2025, according to IQVIA data.

With this approval, Zydus has now secured a total of 429 product approvals and has filed 505 Abbreviated New Drug Applications (ANDAs) since the commencement of its filing process in FY 2003-04, as of December 31, 2025.

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