Ozanimod Hydrochloride API Suppliers & Bulk Manufacturers

Available Forms: API (drug substance)

Available Strengths: Supplied to an in-house or pharmacopoeial specification

Reference Brands: Zeposia

Category: Active Pharmaceutical Ingredient

Ozanimod hydrochloride is an oral S1P receptor modulator used in multiple sclerosis and ulcerative colitis. It is sourced by formulation manufacturers, CDMOs and R&D teams.

Product Description:

Ozanimod is a sphingosine-1-phosphate receptor modulator that binds the S1P1 and S1P5 subtypes and keeps lymphocytes in the lymph nodes, reducing the number that reach sites of inflammation. It is approved for adults with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease, and for adults with moderately to severely active ulcerative colitis (reference brand: Zeposia).

Specification at a glance

Regulatory files and timing

The FDA list of Drug Master Files (third quarter 2026) shows 4 active Type II API DMFs for this molecule. Few filings usually means few qualified sources, so early contact with suppliers pays off. For Europe, ask whether the supplier holds a CEP or an EU ASMF and, for imports into the EU, a written confirmation.

Generic or biosimilar entry. United States: Patent expiry; entry not confirmed (2033). European Union: Protected beyond 2033 (2034).

Handling and quality points

Ozanimod contains a secondary amine, which puts nitrosamine drug substance-related impurities (NDSRIs) near the top of any supplier review: ask for the risk assessment, test data and the controls on nitrite in reagents and solvents. It is a single (S)-enantiomer, so chiral purity must be specified. It is active at low exposure and is often handled as a high-potency compound under containment.

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Brand names are trademarks of their respective owners and identify the reference medicine only. Information is general and was checked in October 2026; confirm specifications and filings with the supplier before purchase.