Zydus receives final approval from USFDA for Eltrombopag Tablets

Eltrombopag tablets will be produced at the group’s formulation manufacturing facility at SEZ, Ahmedabad

Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) for Eltrombopag Tablets, 12.5 mg, 25 mg, 50 mg, and 75 mg (USRLD: Promacta Tablets, 12.5 mg, 25 mg, 50 mg, and 75 mg).

Eltrombopag tablets are indicated for the treatment of thrombocytopenia (low platelet count) in specific blood disorders. Eltrombopag works by stimulating bone marrow cells to produce more platelets, thereby reducing the risk of bleeding.

Eltrombopag tablets will be produced at the group’s formulation manufacturing facility at SEZ, Ahmedabad.

Eltrombopag tablets had annual sales of USD 1262.5 mn in the United States (IQVIA MAT Nov-2025).

The group now has 429 approvals and has so far filed 505 ANDAs (as on Dec 31, 2025) since the commencement of the filing process in FY 2003-04.