Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) for Diroximel Fumarate delayed-release capsules, 231 mg.

Diroximel fumarate delayed-release capsules, 231 mg, are indicated for the treatment of relapsing forms of multiple sclerosis (MS) in adults. Diroximel fumarate delayed-release capsules will be produced at Zydus Lifesciences Ltd, SEZ.

Diroximel fumarate delayed-release capsules had annual sales of USD 999.4 mn in the United States (IQVIA MAT Sept-2025).

The group now has 426 approvals and has so far filed 487 ANDAs since the commencement of the filing process in FY 2003-04 (as on 30-Sept-25).