Zydus Lifesciences has secured tentative approval from the USFDA for Diroximel Fumarate Delayed-Release Capsules, 231 mg. These capsules are indicated for treating relapsing forms of multiple sclerosis (MS) in adults. The product, to be manufactured at Zydus Lifesciences Ltd, SEZ, had annual sales of USD 999.4 million in the United States as of September 2025.
USFDA Approval Received
Zydus Lifesciences has received tentative approval from the United States Food and Drug Administration (USFDA) for its Diroximel Fumarate delayed-release capsules, 231 mg.
Indication and Manufacturing
The Diroximel Fumarate delayed-release capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS) in adults. Production of these capsules will take place at Zydus Lifesciences Ltd, SEZ.
Market Opportunity
As of September 2025, annual sales for Diroximel fumarate delayed-release capsules reached USD 999.4 million in the United States, as per IQVIA data.
Approvals and Filings
As of the announcement date, Zydus Lifesciences has 426 approvals and has filed 487 ANDAs since FY 2003-04.
Source: BSE
