Pharm'Up 
Zydus Lifesciences Limited has announced a significant regulatory milestone, having received final approval from the United States Food and Drug Administration (USFDA) for its Diroximel Fumarate delayed-release capsules, 231 mg.
This product is the generic equivalent of Vumerity Delayed-Release Capsules, 231 mg (the U.S. Reference Listed Drug – USRLD) and is indicated for the treatment of relapsing forms of multiple sclerosis (MS) in adults.
Key Details and Market Potential
- Indication: Treatment of relapsing forms of multiple sclerosis (MS) in adults.
- Manufacturing Site: The capsules will be manufactured at Zydus Lifesciences Ltd’s SEZ facility.
- Market Size: The drug had estimated annual sales of USD 999.4 million in the United States as of September 2025 (IQVIA MAT data).
R&D and Regulatory Strength
This approval further strengthens Zydus’s position in the regulated U.S. market.
- Total Approvals: The Zydus group now holds a total of 426 approvals from the USFDA.
- ANDA Filings: As of September 30, 2025, the company has filed 487 Abbreviated New Drug Applications (ANDAs) since it began the filing process in FY 2003-04.
This approval for a high-value, niche therapy is expected to contribute positively to Zydus’s revenue stream in the U.S. market.
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