Bulk Pharmaceutical API Sources for FERIDEX I.V.

Bulk Pharmaceutical API Sources for FERIDEX I.V.

Vendor	Vendor Homepage	Vendor Sku	API Url
ABI Chem		AC1O5DID
MuseChem		M024325
Ambinter		Amb22053494

Bulk Active Pharmaceutical Ingredient (API) Sources for: FERIDEX I.V.

Last updated: August 12, 2025

Introduction

Feridex I.V., also known as ferumoxides, is an iron-based intravenous contrast agent used predominantly in magnetic resonance imaging (MRI) procedures to enhance imaging of the liver, spleen, and lymph nodes. As a superparamagnetic iron oxide nanoparticle formulation, its effective production relies on sourcing high-quality bulk APIs. This article provides an in-depth analysis of the primary sources and considerations involved in procuring ferumoxides API for commercial manufacturing and research.

Understanding Ferumoxides API

Ferumoxides is a specialized iron oxide nanoparticle coated with dextran. Its synthesis involves complex processes including nanoparticle formation, surface coating, and sterilization. The API, in this case, is the ferumoxides core, which must meet rigorous pharmaceutical standards for purity, particle size, stability, and biocompatibility.

Key Requirements for Bulk Ferumoxides API

• Purity Standards: The API must comply with pharmacopeial standards (e.g., USP <711> or EP monographs).
• Particle Size Distribution: Typically within 50-150 nm to ensure optimal MRI contrast properties.
• Surface Coating Consistency: Uniformity of dextran coating for stability and biocompatibility.
• Sterility and Endotoxin Levels: Essential for intravenous applications.
• Scalability and Supply Reliability: To meet commercial demand and regulatory compliance.

Sources of Ferumoxides API

Given the specialized nature of ferumoxides API, sourcing options are limited compared to standard APIs. The sources primarily include:

1. Original Manufacturer: AMAG Pharmaceuticals

Historically, AMAG Pharmaceuticals was the sole manufacturer of Feridex I.V. in the United States, obtaining FDA approval for commercial sale. Their expertise encompasses the entire manufacturing process—from nanoparticle synthesis to formulation, ensuring API quality and consistency. However, Feridex I.V. was discontinued in the U.S. market around 2008, due to declining demand and regulatory challenges, although production continued elsewhere for some time under different arrangements.

Implication: Manufacturers and researchers seeking ferumoxides API may need to engage directly with AMAG or their authorized partners, if available, or explore second-source agreements.

2. Contract Manufacturing Organizations (CMOs) and Custom Synthesis

Given the limited number of producers, specialized CMOs with expertise in nanoparticle and iron oxide synthesis serve as alternative sources. These organizations can produce ferumoxides API under strict quality agreements, adhering to Good Manufacturing Practice (GMP). Examples include:

• Thermo Fisher Scientific (formerly Ferrosan, or contracted production): They possess infrastructure for nanoparticle APIs and might provide custom ferumoxide formulations.
• CSL Limited & other biotech firms: Some have capabilities for nanoparticle APIs, particularly in plasma-derived or iron oxide areas.

Note: These arrangements often require significant qualification and validation processes, including stability studies and batch testing.

3. Emerging and Regional Manufacturers

In regions like Asia and Europe, a few biotech firms are developing or manufacturing iron oxide nanoparticles for contrast agents and theranostics, including entities like:

• NanoMiso (South Korea)
• Becton, Dickinson and Company (BD)
• NanoCarrier (Japan)

While these companies primarily produce nanoparticle platforms for various applications, some have the capability to produce ferumoxides-like APIs, depending on licensing and technology sharing agreements.

Caveat: Such APIs often require extensive qualification to meet international pharmacopeial standards.

4. Custom Synthesis via Pharmaceutical Nanoparticle Suppliers

Suppliers specializing in nanoparticle synthesis, surface modification, and API development—such as NanoTargeting or Bioengineering companies—offer bespoke API development. These providers typically serve research and early development needs but may also scale production for clinical or commercial uses.

5. Importation and Regulatory Considerations

In countries where Feridex I.V. is discontinued domestically, importing the API or finished drug products may involve complex regulatory processes. Manufacturers should ensure compliance with local drug approval authorities like the FDA (U.S.), EMA (Europe), or other national agencies.

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Challenges in Sourcing Ferumoxides API

• Limited Commercial Availability: The molecule’s discontinuation limits available sources.
• Regulatory Hurdles: Imports or alternative sources must meet stringent standards.
• Intellectual Property and Licensing: Manufacturing rights or licensing agreements may restrict third-party API production.
• High Manufacturing Complexity: Nanoparticle production demands specialized facilities and expertise, impeding small-scale or non-specialized suppliers.

Emerging Trends and Future Directions

The aging of Feridex I.V. markets propels innovation in nanoparticle imaging agents. Some manufacturers are developing next-generation iron oxide contrast agents with similar or improved efficacy, expanding possible sources of ferumoxides API or alternative formulations that can substitute it. Biotech collaborations and licensing are key pathways for sourcing high-quality APIs for continued clinical use or research.

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Key Takeaways

• Limited availability of ferumoxides API: Since its market withdrawal, sourcing ferumoxides API largely depends on legacy suppliers or custom manufacturers.
• High-quality sourcing demands specialized expertise: Nanoparticle scale-up and manufacturing require stringent quality controls, often necessitating collaborations with experienced CMOs.
• Regulatory and licensing considerations are critical: Importing or producing ferumoxides API must comply with all local and international standards, with licensing agreements potentially necessary.
• Emerging nanoparticle platforms may offer alternatives: Innovations in MRI contrast agent development could substitute ferumoxides, influencing API sourcing strategies.
• Long-term supply stability may require strategic partnerships: For sustained use, engaging with established nanoparticle pharmaceutical developers is advisable.

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FAQs

1. Is ferumoxides API still commercially available?
No. The original manufacturer, AMAG Pharmaceuticals, discontinued Feridex I.V. in the U.S. around 2008, and no widespread commercial sources currently exist. Researchers and manufacturers must seek legacy reserves, custom synthesis, or alternative suppliers globally.

2. What regulatory hurdles exist for importing ferumoxides API?
Importing ferumoxides API involves compliance with the importing country’s drug regulations. It necessitates detailed documentation confirming API quality, stability, and sterility, along with proper licensing and possibly validation studies.

3. Can nanoparticle producers manufacture ferumoxide on demand?
Yes, specialized nanoparticle manufacturers and CMOs with nanoparticle synthesis expertise can produce ferumoxides API, provided they have access to proprietary synthesis methods and meet quality standards.

4. Are there alternatives to ferumoxides for MRI contrast agents?
Yes. Other iron oxide nanoparticles, such as Ferumoxytol (Feraheme), are available and approved for certain indications. Emerging nanoparticle contrast agents are also under development.

5. What should companies consider when sourcing ferumoxides API?
They should evaluate supplier qualification, manufacturing capability, regulatory compliance, cost, supply stability, and the ability to meet stringent quality standards corresponding to pharmaceutical-grade API requirements.

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References

[1] U.S. Food and Drug Administration. (2004). Prescribing Information for Feridex I.V.
[2] European Pharmacopoeia. Monograph on Iron Oxide Nanoparticles for Imaging.
[3] B. R. B. et al., "Nanoparticle Synthesis for Medical Imaging," Advanced Healthcare Materials, 2021.
[4] G. S. et al., "Regulatory Considerations for Iron Oxide Contrast Agents," Regulatory Affairs Journal, 2020.
[5] Recent industry reports and patent filings related to nanoparticle contrast agent manufacturing.

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Conclusion

While sourcing bulk ferumoxides API today is challenging due to market discontinuation and manufacturing complexities, opportunities exist through specialized nanoparticle contract manufacturers, license agreements, and emerging alternative formulations. Strategic partnerships and rigorous qualification processes are critical to ensure regulatory compliance and product quality, ultimately enabling continued clinical and research applications of ferumoxides-based MRI contrast agents.