Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) to market Sacubitril and Valsartan Tablets, 24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 mg.

Sacubitril and Valsartan combination is used to treat chronic heart failure in adults to help reduce the risk of death and hospitalization. The drug will be manufactured at the group’s formulation manufacturing facility in Moraiya, Ahmedabad (India).

Sacubitril and Valsartan tablets had annual sales of USD 5,483 mn in the United States (IQVIAMAT May 2024).

The group now has 399 approvals and has so far filed over 460* ANDAs since the commencement of the filing process in FY 2003-04.