Zydus Lifesciences has secured final approval from the USFDA for Diroximel Fumarate delayed-release capsules, 231 mg, indicated for treating relapsing forms of multiple sclerosis (MS) in adults. The drug, with a market size of USD 999.4 mn, will be manufactured at Zydus Lifesciences Ltd, SEZ. This approval brings Zydus’s total to 426 approvals with 487 ANDAs filed to date.
USFDA Approval Received
Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) for Diroximel Fumarate delayed-release capsules, 231 mg. This approval underscores the company’s commitment to providing affordable and accessible healthcare solutions.
Indication and Market Size
The Diroximel Fumarate delayed-release capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS) in adults. According to IQVIA data from September 2025, the annual sales for Diroximel Fumarate delayed-release capsules in the United States reached USD 999.4 mn.
Manufacturing and Regulatory Milestones
The Diroximel Fumarate delayed-release capsules will be manufactured at Zydus Lifesciences Ltd, SEZ. As of September 30, 2025, the Zydus group holds 426 approvals and has filed 487 ANDAs since the filing process began in FY 2003-04.
Source: BSE
