Ruxolitinib Phosphate API Suppliers & Bulk Manufacturers

Available Forms: API (drug substance)

Available Strengths: USP grade or in-house specification

Reference Brands: Jakafi, Jakavi

Category: Active Pharmaceutical Ingredient

Ruxolitinib phosphate is a JAK1/JAK2 inhibitor used in tablets for myelofibrosis, polycythaemia vera and graft-versus-host disease. It is sourced by formulators, CDMOs and R&D teams.

Product Description:

Ruxolitinib is a kinase inhibitor of Janus kinases JAK1 and JAK2, which carry signals for blood cell production and inflammation. In tablet form it is approved for intermediate or high-risk myelofibrosis, for polycythaemia vera in adults who have had an inadequate response to or cannot tolerate hydroxyurea, and for steroid-refractory acute graft-versus-host disease and chronic graft-versus-host disease after one or two lines of systemic therapy (reference brands: Jakafi, Jakavi).

Specification at a glance

Regulatory files and timing

The FDA list of Drug Master Files (third quarter 2026) shows 27 active Type II API DMFs for this molecule. There is a fair choice of sources, so compare documents and impurity profiles, not just price. 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 (late 2028). European Union: Patent expiry; entry not confirmed (mid 2028).

Handling and quality points

Ruxolitinib is a single (R)-enantiomer, so chiral purity is a core part of the specification. It is a potent kinase inhibitor and is commonly treated as a high-potency compound in manufacture, with containment and cleaning data expected. Ask for nitrosamine and mutagenic impurity assessments and confirm the phosphate salt stoichiometry and crystal form.

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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.