Ferric Derisomaltose API Suppliers & Bulk Manufacturers

Available Forms: API (drug substance)

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

Reference Brands: Monoferric, Monofer

Category: Active Pharmaceutical Ingredient

Ferric derisomaltose is an iron(III)-carbohydrate complex used in intravenous iron products. It is sourced by injectable manufacturers, CDMOs and R&D teams working on parenteral iron.

Product Description:

Ferric derisomaltose is a colloidal complex of iron(III) and a short-chain isomaltooligosaccharide that releases iron gradually to the body's own iron-transport and storage proteins. In the US it is approved for iron deficiency anaemia in adults who cannot tolerate oral iron or have not responded well to it, and in adults with non-dialysis-dependent chronic kidney disease (reference brand: Monoferric). In the EU, Australia and other markets it is indicated for iron deficiency when oral iron is ineffective or cannot be used, or when iron has to be delivered quickly (reference brand: Monofer).

Specification at a glance

Regulatory files and timing

The FDA list of Drug Master Files (third quarter 2026) shows 1 active Type II API DMF 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 2029 (compound patent)). European Union: No confirmed date.

Handling and quality points

Ferric derisomaltose is a non-biological complex drug, so its quality depends heavily on the manufacturing process and cannot be fully described by a single assay. Buyers should look closely at the characterisation package: total iron, labile or free iron, carbohydrate content and the molecular weight distribution of the complex, with evidence that these stay consistent from batch to batch. Because the substance goes into intravenous products, tight limits on endotoxin, bioburden and elemental impurities are expected.

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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.