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

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.

Shares of Zydus Lifesciences Limited was last trading in BSE at Rs. 944.20 as compared to the previous close of Rs. 951.20. The total number of shares traded during the day was 8582 in over 740 trades.

The stock hit an intraday high of Rs. 959.45 and intraday low of 940.20. The net turnover during the day was Rs. 8120121.00.

(*As on 30-Sept-25)

Source : Equity Bulls

Keywords

ZydusLifesciences INE010B01027 Pharmaceuticals USFDA FinalApproval DiroximelFumarate DelayedReleaseCapsules