Zydus Lifesciences Limited has received tentative approval from the United States Food and Drug Administration (USFDA) for its Diroximel Fumarate delayed-release capsules, 231 mg. The approved product is the generic version of Vumerity delayed-release capsules, 231 mg, used in the treatment of relapsing forms of multiple sclerosis (MS) in adults.
According to the company, the capsules will be manufactured at the Zydus Lifesciences SEZ facility. The therapy addresses a key segment within the MS treatment landscape, where demand for effective and tolerable formulations continues to grow.
Market data from IQVIA MAT September 2025 shows that Diroximel Fumarate capsules recorded annual sales of USD 999.4 million in the United States, highlighting the size and relevance of this category in the generics market.
With this tentative approval, Zydus now holds 426 regulatory approvals, supported by a total of 487 ANDA filings since initiating its submission process in FY 2003–04. The latest milestone reinforces the company’s continued effort to expand its portfolio across key regulated markets.
