Zydus Lifesciences Ltd.

Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) for Diroximel Fumarate delayed-release capsules, 231 mg (USRLD: Vumerity 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, SEZ. Diroximel fumarate delayed-release capsules had annual sales of $999.4 million in the United States (IQVIA MAT September-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.

Zydus Lifesciences (formerly known as Cadila Healthcare), a company limited by shares, incorporated and domiciled in India, operates as an integrated pharmaceutical company with business encompassing the entire value chain in the research, development, production, marketing and distribution of pharmaceutical products.