Ferric Carboxymaltose API Suppliers & Bulk Manufacturers

Available Forms: API (drug substance)

Available Strengths: USP grade or in-house specification

Reference Brands: Injectafer, Ferinject

Category: Active Pharmaceutical Ingredient

Ferric carboxymaltose is an iron-carbohydrate complex given intravenously for iron deficiency. Injectable formulation makers and CDMOs source this complex drug substance.

Product Description:

Ferric carboxymaltose is a colloidal complex of a polynuclear iron(III) hydroxide core with a carboxymaltose carbohydrate ligand, which releases iron gradually for uptake into the body's iron stores. It is approved for iron deficiency anaemia when oral iron is not tolerated or has not worked, for iron deficiency anaemia in non-dialysis chronic kidney disease, and for iron deficiency in adults with NYHA class II/III heart failure to improve exercise capacity (reference brand: Injectafer, Ferinject).

Specification at a glance

Regulatory files and timing

The FDA list of Drug Master Files (third quarter 2026) shows 16 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: Generics/biosimilars on the market (Jul 2026). European Union: No confirmed date.

Handling and quality points

Ferric carboxymaltose is a complex drug rather than a single molecule, so sameness rests on physicochemical characterisation: molecular weight distribution, iron core size and structure, labile iron, and carbohydrate content. EMA and FDA set out specific expectations for iron-carbohydrate products, and buyers should ask how the supplier's material compares with the reference product on these points. Endotoxin, bioburden and elemental impurity data are needed because the product is given intravenously.

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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.