Bulk Pharmaceutical API Sources for FERAHEME

Bulk Pharmaceutical API Sources for FERAHEME

Vendor	Vendor Homepage	Vendor Sku	API Url
MuseChem		M024325
Ambinter		Amb22053494
THE BioTek		bt-445514
BenchChem		B3416303
CymitQuimica		CQ_722492-56-0
Molport		MolPort-051-561-722

Bulk Active Pharmaceutical Ingredient (API) Sources for Feraheme

Last updated: July 27, 2025

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Introduction

Feraheme, the brand name for ferumoxytol, is a notable intravenous iron formulation used primarily to treat iron deficiency anemia, especially in chronic kidney disease patients. As a ferumoxytol-based nanoparticle, it differs from traditional iron supplements through its unique synthetic iron oxide core, encapsulated by a carbohydrate shell, enabling enhanced bioavailability and safety in specific patient populations. Understanding the sourcing of the API — ferumoxytol — is vital for pharmaceutical manufacturers, regulatory agencies, and supply chain stakeholders given its complex manufacturing processes and strict quality standards.

This article provides an in-depth review of bulk API sources for Feraheme, emphasizing manufacturing origins, key producers, raw material considerations, and regulatory landscapes influencing procurement and supply.

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Overview of Ferumoxytol API

Ferumoxytol APIs are intricate iron oxide nanoparticles stabilized with polyglucose sorbitol carboxymethyl ether. Their manufacturing involves sophisticated processes integrating nanotechnology, organic chemistry, and stringent quality controls, necessitating reliable upstream raw material sourcing and controlled production environments.

The fermentation-derived iron source, coupled with complex organic synthesis, underscores the need for specialized suppliers capable of consistent, scalable production aligning with Good Manufacturing Practices (GMP).

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Key API Manufacturers for Feraheme

1. United States – AMAG Pharmaceuticals

AMAG Pharmaceuticals originally developed and marketed Feraheme as a proprietary product. In 2017, AMAG entered a licensing agreement with the Chinese biopharmaceutical company Huadong Medicine for manufacturing and distribution rights in China, signaling a shift towards expanded manufacturing capabilities.

While AMAG is primarily responsible for the commercialization, it relies on third-party manufacturing facilities for API production, especially for ferumoxytol. The company's internal manufacturing facilities are subject to rigorous compliance with FDA regulations, ensuring that bulk APIs meet pharmacopeial standards.

2. China – Huadong Medicine

Huadong Medicine is a significant player in the production of ferumoxytol API. The company operates state-of-the-art GMP-certified facilities capable of synthesizing and purifying the complex ferumoxytol nanoparticle.

China's robust pharmaceutical manufacturing sector enhances Huadong’s capacity, driven by government support and increasing demand for iron therapies domestically. Their API production aligns with Chinese National Medical Products Administration (NMPA) standards, with an increasing push for compliance with international standards to facilitate export and global distribution.

3. India – Pharmaceutical Contract Manufacturers

While India is a major global hub for generic pharmaceuticals, as of now, there is limited information confirming India’s direct production of ferumoxytol API at commercial scale. However, Indian contract manufacturing organizations (CMOs) are increasingly investing in nanotechnology platforms and biopharmaceuticals, indicating potential future sources.

Potential Indian API producers are exploring nanoparticle synthesis and stabilization technologies conducive to ferumoxytol's complex structure, emphasizing the importance of establishing reliable, validated supply chains for future supply.

Emerging and Potential API Suppliers

4. European and Japanese Producers

Although not currently prominent in ferumoxytol API manufacturing, European biotech firms and Japanese nanotechnology specialists possess niche expertise in nanoparticle synthesis, offering potential future sources. Companies such as NanoPharm and Sumitomo Pharma could, with investment, serve as suppliers as nanomedicine manufacturing matures.

5. Academic and Public Sector Collaborations

Research institutions engaged in nanomedicine and iron oxide nanoparticle synthesis may contribute to next-generation ferumoxytol API development. These collaborations could inform process improvements, scalability, and sustainable sourcing, though commercial scale remains premature.

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Raw Material and Supply Chain Considerations

1. Iron Sources

The primary raw material for ferumoxytol is high-purity ferrous and ferric salts, typically sourced from global suppliers of specialty chemicals. Reliable supply chains for ferrous sulfate or ferric chloride are critical, with suppliers such as BASF and Kemira providing compliant raw materials.

Ensuring impurity-free iron salts is essential given the nanoparticle synthesis sensitivity, affecting product safety and efficacy.

2. Carbohydrate Stabilizers and Coatings

The carbohydrate shell involves sorbitol, dextran derivatives, or other polysaccharide stabilizers. These excipients must meet pharmacopeial standards to prevent compatibility issues, with suppliers like CP Kelco and FMC Biopolymer providing GMP-grade polysaccharides.

Regulatory Landscape and Impact on API Sourcing

Regulatory oversight by the FDA, EMA, and NMPA emphasizes control over manufacturing processes for nanoparticle-based APIs. API suppliers must demonstrate compliance through rigorous GMP audits, stability data, and characterization reports (e.g., electron microscopy, particle size distribution).

The transfer of manufacturing rights across jurisdictions impacts sourcing strategies, with companies increasingly favoring established GMP-certified suppliers or those with validated manufacturing processes.

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Conclusion

The primary API source for Feraheme, ferumoxytol, centers on high-specialization manufacturers equipped with nanotechnology synthesis capabilities. Currently, Huadong Medicine and AMAG Pharmaceuticals dominate supply, with other regional players poised to emerge as nanomedicine manufacturing markets mature.

Securing a reliable API source involves assessing GMP compliance, process scalability, raw material quality, and regulatory adherence. The global landscape suggests a growing ecosystem of nanoparticle producers, with China and North America leading innovation and manufacturing.

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Key Takeaways

• Major API Sources: Huadong Medicine (China) and AMAG Pharmaceuticals (U.S.) are the leading ferumoxytol API producers.
• Regulatory Standards: Compliance with GMP and international regulations remains pivotal; manufacturers must demonstrate rigorous quality controls.
• Raw Material Integrity: High-purity iron salts and polysaccharides are essential for API quality, with sourcing from reputable specialty chemical suppliers.
• Emerging Suppliers: Future growth may involve Indian CMOs and European biotech firms investing in nanotechnologies.
• Supply Chain Strategy: Diversification and rigorous qualification of API sources mitigate risks associated with geopolitical, regulatory, or manufacturing disruptions.

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FAQs

1. Are there any alternative sources for ferumoxytol API outside China and the US?
Currently, the primary commercial sources are centered in China and the United States. Emerging regional players and collaborations could expand this landscape, but no large-scale alternative suppliers have yet achieved Tier 1 status.

2. What regulatory challenges affect sourcing for ferumoxytol API?
Regulatory challenges include demonstrating GMP compliance, nanoparticle characterization, batch-to-batch consistency, and stability data, especially as nanomedicine APIs undergo rigorous review due to their complex structures.

3. Can bulk ferumoxytol API be produced biotechnologically?
Ferumoxytol production involves synthetic nanoparticle manufacturing rather than biological fermentation. However, biotechnological advances in nanoparticle synthesis could impact future APIs, although currently, chemical synthesis dominates.

4. How does import/export regulation influence API sourcing for Feraheme?
Regulations such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and China's NMPA necessitate compliance with local GMP standards. Manufacturers often need to validate cross-border supply chains and navigate import controls, tariffs, and licensing.

5. What are the risks associated with API sourcing for nanomedicines like Feraheme?
Risks include supply chain disruptions, regulatory compliance variability, raw material purity, and technological complexity. These factors emphasize the importance of establishing qualified, validated suppliers and contingency plans.

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References

[1] U.S. Food and Drug Administration. (2017). Feraheme (ferumoxytol) Prescribing Information.
[2] Huadong Medicine. (2022). GMP Certification and Manufacturing Capabilities.
[3] Nanotechnology in Medicine: Overview of Nanoparticle Synthesis. Journal of Nanomedicine, 2021.
[4] GMP Guidelines for Nanotechnology-Based Pharmaceuticals. EMA, 2022.
[5] Global Pharmaceutical Raw Material Suppliers Directory. (2022).