Bulk Pharmaceutical API Sources for FERUMOXIDES

Bulk Pharmaceutical API Sources for FERUMOXIDES

Vendor	Vendor Homepage	Vendor Sku	API Url
ABI Chem		AC1O5DID
MuseChem		M024325
Ambinter		Amb22053494
THE BioTek		bt-445514
BenchChem		B3416303
MolPort		MolPort-051-561-722

Bulk Active Pharmaceutical Ingredient (API) Sources for Ferumoxides

Last updated: July 28, 2025

Introduction

Ferumoxides, also known by its trade name Feridex IV, is an ultrasmall superparamagnetic iron oxide (USPIO) used predominantly as an MRI contrast agent for imaging purposes. Its unique magnetic properties enhance contrast in magnetic resonance imaging (MRI), particularly for liver lesions and lymph nodes. As a specialized API, ferumoxides' sourcing is critical for pharmaceutical companies, medical imaging providers, and research institutions. This report delineates key API sources, production dynamics, and strategic considerations for procurement.

Overview of Ferumoxides as an API

Ferumoxides comprises superparamagnetic iron oxide nanoparticles coated with dextran, facilitating biocompatibility and stability. Its manufacturing involves complex synthesis, encompassing nanoparticle fabrication, surface modification, and stringent quality control protocols aligned with pharmaceutical standards.

Importantly, ferumoxides' lifecycle as an API depends on controlled sources capable of adhering to Good Manufacturing Practices (GMP). Due to its niche application, the API supply chain is more concentrated relative to common pharmaceuticals but remains critical for ensuring availability and regulatory compliance.

Manufacturers and Key API Suppliers

1. Bayer AG (Germany)
Bayer historically produced Feridex IV, well-known for its high-quality ferumoxides API. Although the commercial production ceased around 2008 due to market shifts, Bayer remains a reference source for bulk API, especially for registered stocks and residual supplies. For ongoing research and specialty applications, Bayer's GMP-grade ferumoxides may still be accessible through specific licensing agreements or secondary markets.

2. Osrum Ltd. (Russia)
As a specialized nanomaterials manufacturer, Osrum supplies ferumoxides APIs primarily for research institutions and preclinical studies. Their products meet international standards, and they exemplify non-European sources capable of providing high-quality ferumoxides. They often cater to clients in Eastern Europe and Asia, expanding the global API sourcing landscape.

3. Nanotech Simulations and Suppliers from China and India
Emerging providers in China and India have ventured into the magnetic nanoparticle segment. Firms such as Nanjing Magnetic Materials Co. and Spectrum Chemical Manufacturing Corp. have developed GMP-compliant or research-grade ferumoxides APIs. These suppliers are attractive due to cost efficiencies and flexible supply options but require rigorous quality audits to ensure compliance with international standards.

4. Contract Manufacturing Organizations (CMOs)
Given the specialized nature of ferumoxides manufacturing, several CMOs globally offer custom synthesis and bulk API production tailored to client specifications. Companies like CROs in Europe and Asia with expertise in nanoparticle synthesis often serve as reliable sources, especially for preclinical and investigational applications.

Strategic Considerations for Sourcing Ferumoxides API

Regulatory Compliance
Suppliers must demonstrate adherence to GMP, with transparent documentation, batch release protocols, and stability data. The high regulatory burden associated with pharmaceutical APIs mandates rigorous vendor qualification processes.

Quality Assurance & Certification
For medical applications, API sourcing hinges on comprehensive Certificates of Analysis (CoA), endotoxin testing, and metal impurity profiling. Suppliers with ISO 13485, ISO 9001, and cGMP certifications are preferred.

Supply Chain Reliability
Given its niche market, ferumoxides API supply is vulnerable to manufacturing discontinuities. Therefore, establishing multi-supplier relationships or maintaining inventory buffers enhances security.

Cost and Pricing Dynamics
Price fluctuations reflect raw material costs, manufacturing complexity, and geopolitical factors. Emerging suppliers from Asia often offer competitive pricing but necessitate due diligence regarding quality and regulatory status.

Emerging Trends and Future Outlook

Shift Towards Alternative MRI Contrast Agents
While ferumoxides remains valuable, its market has tempered due to the advent of gadolinium-based agents, which are more widely available. Nonetheless, ferumoxides maintains relevance in specific clinical and research contexts, sustaining demand for reliable API sources.

Advancements in Nanoparticle Manufacturing
Innovations in nanoparticle synthesis are enabling more scalable, cost-effective production of ferumoxides-like agents. Research collaborations and technology transfer may diversify API sources further in the coming years.

Regulatory Evolution
Regulatory accelerations, particularly in regions like Asia and Europe, may streamline the approval process for ferumoxides APIs from new suppliers, potentially broadening the sourcing landscape.

Conclusion

The supply of ferumoxides API is characterized by a limited but strategically distributed ecosystem. Traditional sources, such as Bayer AG, provide high assurance but limited availability, prompting reliance on emerging suppliers and contract manufacturers. Companies seeking to procure ferumoxides must prioritize regulatory compliance, quality assurance, and supply stability to mitigate risks associated with such specialized APIs.

Key Takeaways

• Limited but Strategic Supplier Landscape: Established industry players like Bayer provide high-quality ferumoxides, but market shifts and discontinued production have prompted exploration of emerging suppliers in Russia, China, and India.
• Quality and Compliance Are Paramount: Due diligence on GMP certification, endotoxin levels, and impurity profiles is essential for medical-grade ferumoxides procurement.
• Supply Chain Resilience Is Crucial: Diversifying sources and maintaining safety stocks mitigate disruptions in this niche API market.
• Emerging Technologies May Expand Supply: Advances in nanoparticle manufacturing and regulatory facilitation could broaden API sourcing options in the future.
• Market Dynamics Are Shifting: The decreasing use of ferumoxides in favor of newer agents influences supplier availability and pricing.

FAQs

1. Are there alternative sources for ferumoxides API outside traditional manufacturers?
Yes. Contract manufacturing organizations and specialized nanomaterials suppliers can produce ferumoxides APIs, especially for research purposes. However, verification of quality and regulatory compliance is essential.

2. How does regulatory compliance affect ferumoxides API sourcing?
It ensures safety, efficacy, and quality. Suppliers must hold GMP certifications and provide comprehensive documentation, including Certificates of Analysis, endotoxin testing reports, and impurity profiles.

3. Can universities or research institutions buy ferumoxides API directly from manufacturers?
Potentially. Access depends on manufacturer policies, IP rights, and the intended use. Commercial distribution channels or research-specific suppliers often cater to institutional clients.

4. What are the main challenges in sourcing ferumoxides API?
Limited supplier numbers, regulatory hurdles, quality assurance requirements, and market discontinuations pose significant challenges to secure continuous supply.

5. Is ferumoxides API production scalable for large pharmaceutical demands?
Current market demand is relatively niche, limiting large-scale production. However, technological advances and increased research interest may enhance scalability options.

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References

[1] Bayer AG. Feridex IV Product Fact Sheet. (Archived, 2008).
[2] Osrum Ltd. Regulatory and Quality Data Sheets.
[3] Nanotech Simulations. "Nanoparticle Synthesis and Applications," Journal of Nano Materials.
[4] Global nanoparticle API market reports (2022).
[5] Regulatory standards for nanoparticle pharmaceuticals, International Journal of Pharmaceutical Regulation.