STOCKWATCH
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Pharmaceuticals
USFDA15 Jan 2026, 01:17 pm

Zydus receives final approval from USFDA for Eltrombopag Tablets, 12.5 mg, 25 mg, 50 mg, and 75 mg

AI Summary

Zydus Lifesciences Limited has received final approval from the USFDA for Eltrombopag Tablets, 12.5 mg, 25 mg, 50 mg, and 75 mg. The tablets are indicated for the treatment of thrombocytopenia in specific blood disorders and will be produced at the group’s formulation manufacturing facility at SEZ, Ahmedabad. The group now has 429 approvals and has so far filed 505 ANDAs since the commencement of the filing process in FY 2003-04. Eltrombopag tablets had annual sales of USD 1262.5 mn in the United States (IQVIA MAT Nov-2025).

Key Highlights

  • Zydus receives final approval from USFDA for Eltrombopag Tablets, 12.5 mg, 25 mg, 50 mg, and 75 mg
  • Eltrombopag tablets are indicated for the treatment of thrombocytopenia in specific blood disorders
  • Eltrombopag tablets will be produced at the group’s formulation manufacturing facility at SEZ, Ahmedabad
  • Zydus now has 429 approvals from USFDA
  • Eltrombopag tablets had annual sales of USD 1262.5 mn in the United States (IQVIA MAT Nov-2025)
ZYDUSLIFE
Pharmaceuticals
Zydus Lifesciences Ltd

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