Zydus receives final approval from USFDA for Diroximel Fumarate Delayed-Release Capsules, 231 mg

Zydus receives final approval from USFDA for Diroximel Fumarate Delayed-Release Capsules, 231 mg Ahmedabad, India, 13 November, 2025 Zydus Lifesciences Limited (including its subsidiaries/ affiliates, hereafter referred to as “Zydus”) 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 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)

The release as fetched from its publisher. zyduslife.com ↗