Last updated: May 25, 2026
Ferric derisomaltose is supplied globally through brand and generic channels, with manufacturing typically concentrated in a small set of producers. The product is commonly marketed as Monofer (Vifor Fresenius) in Europe and as Injectafer (American Regent) in the US, with supply supported by contract manufacturing and secondary packaging for different markets.
Who manufactures ferric derisomaltose injections (Monofer, Injectafer) and what are the key suppliers?
Primary branded supply
- Monofer (ferric derisomaltose): historically supplied by Vifor (Vifor Fresenius Medical Care Renal Pharma Ltd./Vifor Pharma) in major European markets.
- Injectafer (ferric derisomaltose): historically supplied in the US via American Regent (brand owner/US marketing channel), with manufacturing and distribution structured around US commercial supply chains.
Common industrial reality
Ferric derisomaltose is manufactured as a sterile injectable colloidal iron-carbohydrate complex. In practice, supply is maintained via:
- bulk drug substance and sterile drug product manufacturing (often on dedicated parenteral lines)
- batch release and stability programs under GMP
- market-specific secondary packaging and labeling
What companies supply ferric derisomaltose drug product for sterile injection markets?
The supply chain is typically anchored by:
- Brand owners/primary marketing authorization holders (commercial responsibility and regulatory dossier ownership for many jurisdictions).
- GMP manufacturers producing sterile injectable drug product (finished dose, container, and configuration).
- Secondary packagers/logistics providers handling region-specific presentation formats.
Which suppliers support US commercial supply of ferric derisomaltose (Injectafer)
US brand presence
- Injectafer is the US-facing ferric derisomaltose brand name, distributed through the American commercial channel.
- US supply depends on maintaining sterile manufacturing slots and consistent iron complex characteristics that meet stability and release specifications.
How do US supplier roles split between marketing and manufacturing?
- Marketing authorization and commercialization are handled by the US brand channel (American Regent historically).
- Manufacturing is handled by GMP facilities under contract or corporate production, with product configuration tied to the injectable presentation sold in the US.
Which suppliers support European supply of ferric derisomaltose (Monofer)
EU brand presence
- Monofer is the core European ferric derisomaltose presentation, associated with Vifor.
What does “supplier” mean in EU distribution for Monofer?
For EU market mapping, supplier identification typically splits into:
- the marketing authorization holder in each country (who controls labeling, regulatory updates, and distribution strategy)
- the sterile manufacturing site(s) listed in dossiers
- local distribution partners for wholesale and tendering workflows
Where do generic or “similar” ferric derisomaltose products fit in supplier mapping
In iron deficiency anemia parenteral markets, products can appear as:
- true generics/biosimilar-type analogs only if regulatory pathways and interchangeability support the exact complex and manufacturing comparability
- alternative ferric-carbohydrate complexes (not the same INN), which can substitute therapeutically but do not change ferric derisomaltose supplier dependence
For ferric derisomaltose specifically, supply mapping is most cleanly done through:
- authorized product listings (national and cross-border)
- regulatory product dossiers
- tender award records that name the commercial supplier delivering the tendered finished product
How to build an actionable ferric derisomaltose supplier list for procurement, tendering, or diligence
A procurement-grade supplier map should include, for each jurisdiction:
- Regulatory product owner / marketing authorization holder
- Finished product supplier delivering to the local market
- GMP manufacturing site (primary and any backup sites)
- Distributor/wholesaler for the tender channel
- Pack presentation (dose concentration, container type, kit format if applicable)
- Supply continuity indicators (historical shortages, allocation notices, batch delays)
What documentation to use to confirm ferric derisomaltose supplier identity
- National product registry entries for the specific brand name and INN presentation
- EU labeling and SmPC package details naming the MAH and manufacturing locations
- FDA prescribing information and product labeling for the US market
- tender documents listing commercial suppliers and delivered presentation
Key Takeaways
- Ferric derisomaltose supply is anchored by branded channels: Monofer (associated with Vifor) and Injectafer (US channel historically through American Regent).
- “Supplier” in this asset is best mapped by splitting MAH/commercial owner, GMP manufacturing site(s), and local distributor/wholesaler.
- For procurement and diligence, confirm suppliers using local regulator registries, labeling manufacturing site statements, and tender documentation that names the actual delivered finished product provider.
FAQs
1) Who is the marketing authorization holder for ferric derisomaltose in key European countries?
The MAH is tied to the Monofer brand channel (Vifor-linked in most markets), but country-by-country listings should be used for the exact legal entity.
2) Is ferric derisomaltose the same as other IV iron formulations like ferric carboxymaltose or iron sucrose?
No. Ferric derisomaltose is a specific iron-carbohydrate complex with distinct dosing and product characteristics.
3) Who supplies Injectafer in the US?
Injectafer is supplied through the US brand channel associated with American Regent, with manufacturing performed at GMP sites supplying the sterile injectable.
4) What manufacturing sites produce ferric derisomaltose injection?
Manufacturing is defined in the regulatory labeling/dossiers. For supplier due diligence, use the “manufactured by” and site addresses shown on product labeling.
5) How do I identify alternate suppliers if there are IV iron shortages?
Use national tender awards, distributor allocation announcements, and regulator shortage communications tied to the specific brand/INN and presentation.
References (APA)
- FDA. (n.d.). Injectafer (ferric derisomaltose) prescribing information. U.S. Food and Drug Administration.
- EMA. (n.d.). Monofer (ferric derisomaltose) product information (EPAR/SmPC). European Medicines Agency.
- European Medicines Agency. (n.d.). Monofer EPAR. European Medicines Agency.
- National drug registries (country-specific). (n.d.). Ferric derisomaltose medicinal product listings and labeling (SmPC).
