Midostaurin API Suppliers & Bulk Manufacturers

Available Forms: API (drug substance)

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

Reference Brands: Rydapt

Category: Active Pharmaceutical Ingredient

Midostaurin is a multi-target kinase inhibitor used in capsules for certain blood cancers. It is sourced by formulation manufacturers, CDMOs and research teams for generic development.

Product Description:

Midostaurin is a semi-synthetic derivative of staurosporine that inhibits several kinases, including FLT3 and KIT, which drive the growth of some leukaemia cells and mast cells. It is approved for adults with newly diagnosed FLT3 mutation-positive acute myeloid leukaemia, together with standard induction and consolidation chemotherapy, and for aggressive systemic mastocytosis, systemic mastocytosis with an associated haematological neoplasm and mast cell leukaemia (reference brand: Rydapt).

Specification at a glance

Regulatory files and timing

The FDA list of Drug Master Files (third quarter 2026) shows 9 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 (Oct 2028 (use patent)). European Union: No confirmed date.

Handling and quality points

Because the starting material staurosporine comes from fermentation, ask how the supplier controls related indolocarbazole alkaloids carried through from that step, as well as residual solvents and elemental impurities. Midostaurin is a potent anticancer kinase inhibitor and is normally handled under containment with defined occupational exposure limits. The reference product is a soft capsule, so solubility in the fill vehicle and particle size are worth confirming early with the supplier.

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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.