Suppliers and packagers for ferumoxytol

ferumoxytol

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Sandoz	FERUMOXYTOL	ferumoxytol	SOLUTION;INTRAVENOUS	206604	ANDA	Sandoz Inc	0781-3154-01	1 VIAL, SINGLE-DOSE in 1 CARTON (0781-3154-01) / 17 mL in 1 VIAL, SINGLE-DOSE	2021-07-15
Sandoz	FERUMOXYTOL	ferumoxytol	SOLUTION;INTRAVENOUS	206604	ANDA	Sandoz Inc	0781-3154-95	10 VIAL, SINGLE-DOSE in 1 CARTON (0781-3154-95) / 17 mL in 1 VIAL, SINGLE-DOSE	2021-07-15

Suppliers for the Pharmaceutical Drug: FERUMOXYTOL

Last updated: July 27, 2025

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Introduction

Ferumoxytol is an intravenous iron formulation primarily used to treat iron deficiency anemia, especially in adult patients with chronic kidney disease (CKD). Marketed under the brand name Feraheme among others, ferumoxytol is produced by several pharmaceutical companies. Its unique nanomagnetic properties distinguish it from traditional iron therapies, enabling rapid infusion and high bioavailability. The competitive landscape for ferumoxytol supply involves a combination of established biopharmaceuticals, specialized contract manufacturing organizations (CMOs), and emerging biotech firms.

This article provides a comprehensive overview of the current suppliers of ferumoxytol, examining their manufacturing capacities, regulatory standing, and strategic positioning within the global iron therapy market.

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Manufacturers of Ferumoxytol

1. Takeda Pharmaceutical Company

Takeda is the original developer and sole marketer of ferumoxytol under the brand name Feraheme. Since acquiring the rights from AMAG Pharmaceuticals in 2019, Takeda has maintained exclusive global production and distribution rights. Takeda’s production facilities in the United States and Europe adhere to stringent FDA and EMA standards, ensuring high-quality manufacturing consistent with global regulatory requirements.

Despite being the primary supplier, Takeda’s manufacturing capacity has faced scrutiny over supply chain constraints, especially amid the COVID-19 pandemic, which affected many biopharmaceutical supply chains. The company’s strategic focus remains on optimizing manufacturing processes and expanding access to various markets.

2. Contract Manufacturing Organizations (CMOs)

Given the complex nature of nanomedicine production, several CMOs have entered the ferumoxytol supply chain for contract manufacturing, process development, or formulation scaling:

• Thermo Fisher Scientific: Known for its expansive bioprocessing capabilities, Thermo Fisher provides contract manufacturing services for nanoparticle-based drugs, including ferumoxytol. Their involvement typically revolves around formulation refinement and scale-up, supporting Takeda’s production needs.

• Samsung Biologics: Samsung’s biologics division offers contract manufacturing services that include nanotechnology-based drugs. While primarily focused on biologics, Samsung’s technological prowess extends into complex nanoparticle formulations like ferumoxytol, serving as an alternative supplier through contract manufacturing partnerships.

• WuXi AppTec: A global CMO specializing in drug development and manufacturing, WuXi provides process development, analytical testing, and scaled-up production for nanomedicines. Their role often involves manufacturing components or intermediates that support complete ferumoxytol production.

3. Potential New Entrants and Biosimilar Developers

Although ferumoxytol remains largely proprietary to Takeda, emerging biotech firms are exploring similar nanoparticle-based iron therapies or biosimilar formulations. These include:

• Nanoparticle Therapeutics, Inc.: Developing novel iron nanomedicines that could potentially compete or complement ferumoxytol formulations.

• Biosimilar Manufacturers: Although no biosimilars of ferumoxytol have received regulatory approval yet, several companies are conducting preclinical and clinical trials, signaling a possible increase in supply options in the future.

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Supply Chain and Market Dynamics

Manufacturing Capacity Constraints

The production of ferumoxytol’s nanostructure requires highly specialized facilities, adherence to Good Manufacturing Practices (GMP), and rigorous quality controls. Limited manufacturing capacity at Takeda has historically led to intermittent shortages, especially during spikes in demand owing to increasing adoption in CKD populations.

Regulatory Impact

Regulatory agencies such as the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) oversee manufacturing standards for ferumoxytol. Any process deviations or quality issues can significantly affect supply continuity, emphasizing the importance of compliance and strategic production scaling.

Market Share and Competition

Takeda, as the sole approved manufacturer, holds a dominant position in the global ferumoxytol market. However, its exclusivity creates a dependency risk for healthcare providers and distributors. The entry of contract manufacturing partnerships expands supply possibilities, but full market competition remains limited at this stage.

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Future Outlook and Strategic Considerations

The ferumoxytol supply landscape is poised for evolution. Key considerations include:

• Supply Chain Diversification: To mitigate shortages, Takeda may partner with additional CMOs or establish new manufacturing facilities, especially in regions with high CKD prevalence such as North America and Asia-Pacific.

• Emergence of Biosimilars and Alternatives: The development of biosimilar nanomedicines or alternative iron therapies (e.g., ferrous sulfate, iron sucrose) may impact ferumoxytol’s market share and supply-demand dynamics.

• Innovation in Nanoparticle Manufacturing: Advances in nanotech production methods could lower costs and increase capacity, enabling broader access and potentially attracting new suppliers.

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Key Takeaways

• Takeda Pharmaceutical remains the sole manufacturer of ferumoxytol globally, primarily through its Feraheme product.

• Contract manufacturing organizations like Thermo Fisher, Samsung Biologics, and WuXi AppTec play vital roles in supporting Takeda’s production and exploring capacity expansion.

• Manufacturing capacity limitations have historically caused intermittent supply shortages; strategic capacity expansion is crucial for stability.

• Regulatory standards govern production, with strict oversight from FDA and EMA, influencing global supply availability.

• Emergence of biosimilars and alternate nanomedicines could diversify supply sources in the future, increasing market competition.

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FAQs

1. What companies currently produce ferumoxytol?
Takeda Pharmaceutical is the sole approved manufacturer of ferumoxytol globally. Contract manufacturing organizations such as Thermo Fisher Scientific, WuXi AppTec, and Samsung Biologics support process development and manufacturing, but Takeda retains primary production rights.

2. Are there upcoming competitors or biosimilars for ferumoxytol?
While no biosimilars have yet received regulatory approval, several biotech firms are researching alternative nanomedicine iron therapies. Their commercial availability could influence future supply dynamics.

3. How does manufacturing capacity impact ferumoxytol availability?
Limited production capacity at Takeda and dependency on high-tech nanomedicine manufacturing processes can lead to supply shortages, especially during demand surges or process disruptions.

4. What regulatory factors influence ferumoxytol supply?
Strict compliance with FDA and EMA standards governs manufacturing. Regulatory scrutiny ensures quality but can also delay capacity expansion or introduce supply bottlenecks if issues arise.

5. Can alternative iron therapies replace ferumoxytol in clinical use?
Alternatives like iron sucrose or ferrous sulfate exist; however, ferumoxytol’s unique pharmacokinetics and rapid infusion features maintain its position for specific patient populations despite market competition.

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References

[1] Takeda Pharmaceutical Company. Feraheme (ferumoxytol) prescribing information.
[2] U.S. Food and Drug Administration. Drug shortages and supply chain updates.
[3] Market Intelligence Reports on Nanoparticle-Based Therapies.
[4] WuXi AppTec. Capabilities in nanomedicine manufacturing.
[5] ClinicalTrials.gov. Development pipeline of nanomedicine iron therapies.

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