Siponimod API Suppliers & Bulk Manufacturers

Available Forms: API (drug substance)

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

Reference Brands: Mayzent

Category: Active Pharmaceutical Ingredient

Siponimod is an oral sphingosine-1-phosphate receptor modulator for multiple sclerosis, supplied as a fumaric acid co-crystal. It is sourced by formulators, CDMOs and R&D teams.

Product Description:

Siponimod is a selective sphingosine-1-phosphate (S1P) receptor modulator acting on the S1P1 and S1P5 subtypes. It keeps lymphocytes in the lymph nodes so fewer reach the brain and spinal cord. In the US it is approved for relapsing forms of multiple sclerosis in adults, including clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease, and in the EU for secondary progressive MS with active disease (reference brand: Mayzent).

Specification at a glance

Regulatory files and timing

The FDA list of Drug Master Files (third quarter 2026) shows 6 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 (Aug 2028 (compound patent)). European Union: No confirmed date.

Handling and quality points

The approved form is a 2:1 co-crystal with fumaric acid rather than a conventional salt, so suppliers should confirm the solid form by XRPD and show it stays stable through storage and milling. Siponimod acts at very low exposure, and many buyers treat it as a high-potency compound needing contained handling. Ask for a nitrosamine risk assessment and data on E/Z isomer control, because the oxime ether in the molecule can exist in two geometric forms.

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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.