Zydus Lifesciences has received tentative approval from the United States Food and Drug Administration (USFDA) for Diroximel Fumarate delayed-release capsules, 231 mg, a generic version of Vumerity delayed-release capsules of the same strength.

The drug is indicated for the treatment of relapsing forms of multiple sclerosis (MS) in adults. The product will be produced at Zydus Lifesciences Ltd, SEZ.  

According to IQVIA MAT data for September 2025, Diroximel fumarate delayed-release capsules had annual sales of USD 999.4 million in the United States.

With this, the group now has 426 approvals and has filed 487 ANDAs since it began its filing process in FY 2003–04.

Earlier this month, Zydus also received tentative approval from the USFDA for Olaparib Tablets, 100 mg and 150 mg —the generic version of Lynparza Tablets.  

Olaparib is indicated for the treatment of certain types of ovarian, breast, pancreatic and prostate cancers in patients who have specific genetic mutations (specifically in the BRCA gene or other homologous recombination repair [HRR] genes).

Recently, the company also secured approval from the National Medical Products Administration (NMPA), China, for Venlafaxine Extended-Release (ER) Capsules, 75 mg and 150 mg. The antidepressant, indicated for the treatment of Major Depressive Disorder (MDD), Generalised Anxiety Disorder (GAD), Social Anxiety Disorder (SAD) and Panic Disorder (PD), will be produced at Zydus’ manufacturing facility at Moraiya, Ahmedabad.

According to the company, Venlafaxine ER Capsules help restore the balance of serotonin and norepinephrine in the brain to improve mood and reduce anxiety.

This is the first approval that Zydus has received from NMPA in China.