Ferumoxytol API Suppliers & Bulk Manufacturers

Available Forms: API (drug substance)

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

Reference Brands: Feraheme, Rienso

Category: Active Pharmaceutical Ingredient

Ferumoxytol is a colloidal iron oxide with a carbohydrate coating, used in intravenous iron for iron deficiency anaemia. It is sourced by complex injectable developers and CDMOs.

Product Description:

Ferumoxytol is a superparamagnetic iron oxide (non-stoichiometric magnetite) nanoparticle coated with polyglucose sorbitol carboxymethylether; after infusion the particles are taken up by macrophages, which release the iron for the body's stores and for making haemoglobin. It is approved for iron deficiency anaemia in adults who cannot tolerate or have not responded adequately to oral iron, or who have chronic kidney disease (reference brand: Feraheme).

Specification at a glance

Regulatory files and timing

The FDA list of Drug Master Files (third quarter 2026) shows 3 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: Generics/biosimilars on the market (Jan 2021). European Union: No confirmed date.

Handling and quality points

Ferumoxytol is a complex non-biological product, so equivalence rests on detailed physicochemical characterisation: iron core size and crystal structure, coating composition and molecular weight, overall particle size distribution, free and labile iron, and magnetic properties. Expect a credible supplier to share comparative data against several lots of the reference product. Sterility, endotoxin control and the physical stability of the colloid (no aggregation or settling) also need checking, with transport conditions matched to the supplier's stability data.

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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.