Carfilzomib API Suppliers & Bulk Manufacturers

Available Forms: API (drug substance)

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

Reference Brands: Kyprolis

Category: Active Pharmaceutical Ingredient

Carfilzomib is an epoxyketone tetrapeptide proteasome inhibitor used in injectables for multiple myeloma. It is sourced by oncology injectable formulators, CDMOs and research teams.

Product Description:

Carfilzomib is a tetrapeptide epoxyketone that binds irreversibly to the proteasome, the cell's protein-recycling machinery; myeloma cells are particularly sensitive to the resulting build-up of unwanted proteins. It is approved for adults with relapsed or refractory multiple myeloma, alone or in combination with dexamethasone, lenalidomide, daratumumab or isatuximab, as set out in the label (reference brand: Kyprolis).

Specification at a glance

Regulatory files and timing

The FDA list of Drug Master Files (third quarter 2026) shows 19 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 (Jan 2027). European Union: No confirmed date.

Handling and quality points

Carfilzomib is a cytotoxic, high-potency compound and should come from a contained facility with validated cleaning. The epoxyketone and the several stereocentres are the main quality focus: ask how stereoisomers, epoxide ring-opened degradants and other peptide-related impurities are controlled. The reference product is stored at 2 to 8 °C and protected from light, so check the supplier's drug substance stability data for temperature and light sensitivity before agreeing shipping conditions.

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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.