Archive · 13 Nov 2025
Zydus Lifesciences Secures USFDA Approval for Multiple Sclerosis Drug, Concludes Plant Inspection
Zydus Lifesciences, a medicine company, got good news from the US government's health agency, the USFDA.
First, they can now sell a new medicine in the U.S. that helps adults with a condition called multiple sclerosis, which affects the brain and nerves.
This new medicine is a cheaper version of an already existing one.
The company will make it in their factory in Ahmedabad, India.
Also, health inspectors from the USFDA recently visited Zydus' factory that makes cancer medicines.
The inspectors found a couple of things to improve, but they said the company's records were honest.
Zydus plans to fix these issues quickly.
These announcements come after Zydus shared that their business is doing really well, with more money coming in and profits growing.
Zydus Lifesciences received USFDA approval for its Diroximel Fumarate delayed-release capsules for treating multiple sclerosis.
The approved drug is a generic version of Vumerity and will be manufactured in Ahmedabad, India.
The US market sales for Diroximel Fumarate capsules were $999.4 million according to IQVIA MAT data (September 2025).
The USFDA also concluded an inspection of Zydus' oncology injectable manufacturing site, noting two observations.
Zydus reported strong Q2 FY26 financial results, with net profit up 39% and revenue up 17%.
- Who
- Zydus Lifesciences Ltd
- What
- Received final USFDA approval for Diroximel Fumarate delayed-release capsules and concluded an inspection of its oncology manufacturing site.
- When
- Approval announced recently; Plant inspection conducted November 4-13, 2025.
- Where
- USFDA approval for US market; Oncology plant located in Ahmedabad, India.
- Why
- To market a generic version of Vumerity for multiple sclerosis treatment and to comply with USFDA manufacturing standards.
- Drug Approved
- Diroximel Fumarate delayed-release capsules (231 mg), generic version of Vumerity
- Indication
- Treatment of relapsing forms of multiple sclerosis (MS) in adults
- US Market Sales (IQVIA MAT Sep 2025)
- $999.4 million
- Total USFDA Approvals
- 426
- Oncology Plant Inspection Dates
- November 4-13, 2025
- Oncology Plant Inspection Observations
- 2 (no data integrity issues)