Suppliers and packagers for FERAHEME

FERAHEME

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Covis	FERAHEME	ferumoxytol	SOLUTION;INTRAVENOUS	022180	NDA	AMAG Pharmaceuticals, Inc.	59338-775-01	1 VIAL, SINGLE-USE in 1 CARTON (59338-775-01) / 17 mL in 1 VIAL, SINGLE-USE	2009-07-13
Covis	FERAHEME	ferumoxytol	SOLUTION;INTRAVENOUS	022180	NDA	AMAG Pharmaceuticals, Inc.	59338-775-10	10 VIAL, SINGLE-USE in 1 CARTON (59338-775-10) / 17 mL in 1 VIAL, SINGLE-USE	2009-07-13

Last updated: July 27, 2025

ppliers for the Pharmaceutical Drug: Feraheme

Introduction
Feraheme (ferumoxytol) is an intravenously administered iron replacement product primarily used to treat iron deficiency anemia, especially in patients with chronic kidney disease (CKD). As a biologic and complex nanoparticle formulation, Feraheme’s supply chain involves specialized manufacturers and suppliers across multiple segments, including raw material providers, manufacturing entities, and distribution channels. This article offers a comprehensive review of its key suppliers, exploring their roles, market dynamics, and implications for stakeholders.

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Manufacturers of Feraheme

1. Takeda Pharmaceuticals
Takeda Pharmaceutical Company Limited is the primary manufacturer and patent-holder of Feraheme. They completed the acquisition of the drug from the original developer, AMAG Pharmaceuticals, in 2017. Takeda is responsible for the formulation, clinical development, manufacturing, and distribution of Feraheme globally.

Manufacturing Operations:
Takeda’s manufacturing facilities are strategically located to ensure supply chain resilience and compliance with Good Manufacturing Practices (GMP). The company's facilities in the United States and Europe produce the nanoparticle formulation, including the ferumoxytol core and the dextran coating.

Implication:
Takeda’s control over the manufacturing process makes it the primary supplier, and any disruptions or capacity constraints at Takeda’s facilities directly impact Feraheme’s global supply.

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2. Raw Material Suppliers for Ferumoxytol Components

a. Iron Source Providers
The core of Feraheme is ferumoxytol nanoparticles, derived from ferric iron sources. Specialty chemical suppliers provide high-purity ferric salts (e.g., ferric chloride or ferric sulfate), essential for nanoparticle synthesis.

• Major Suppliers:
  • Sigma-Aldrich (now part of Merck): Supplies high-grade ferric salts used in nanoparticle synthesis.
  • Fisher Scientific: Another key distributor of raw ferric compounds.
  • Local or regional chemical suppliers: For specialized or bulk raw material needs.

b. Dextran and Coating Materials
The nanoparticle core is encapsulated within a dextran coating to improve stability and biocompatibility. Large-scale production of dextran involves microbial fermentation and purification processes carried out by specialized biopharmaceutical excipient providers.

• Leading Providers:
  • Cargill, Roquette, and Genzyme (a Sanofi division): Known producers of pharmaceutical-grade polysaccharides, including dextran.
  • Others: Companies with capabilities in manufacturing and supplying high-quality polysaccharides for injectable applications.

Implication:
Dependence on high-purity raw material suppliers introduces vulnerabilities, notably if shortages of ferric salts or dextran occur or if quality standards fluctuate.

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3. Contract Manufacturing Organizations (CMOs)

While Takeda handles Feraheme’s primary production, additional manufacturing steps, including final formulation, packaging, and quality testing, often involve CMOs.

• Key Players in CMO Services:
  • Patheon (Thermo Fisher Scientific): Offers biologic manufacturing services that can include nanoparticle-formulated drugs.
  • Fujifilm Diosynth Biotechnologies: Known for complex biologic production, including nanoparticle-based therapeutics.
  • Cytovance Biologics: Provides contract manufacturing for nanoparticle drugs, ensuring capacity to meet global demand.

Implication:
Reliance on CMOs requires effective oversight to ensure supply continuity, quality compliance, and timely delivery.

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Distribution and Supply Chain Partners

1. Distributors and Logistics Companies
Feraheme’s distribution involves specialized logistics providers experienced in cold chain management, given its delicate nanoparticle formulation.

• Major Distributors:
  • McKesson
  • Janssen (for specific regional distributions)
  • AmerisourceBergen
  • Cardinal Health

Supply Chain Dynamics:
These firms ensure regulatory compliance, temperature-sensitive handling, and timely delivery across healthcare institutions, hospitals, and clinics.

2. Regional Supply Variability
Feraheme’s global distribution relies on region-specific approvals, import regulations, and healthcare infrastructure. As a result, regional suppliers and distributors play crucial roles, and variations can lead to supply gaps or delays.

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Market and Supplier Dynamics

1. Patent and Regulatory Exclusivity
Takeda’s patent rights and regulatory exclusivity influence the supply landscape by limiting the entry of biosimilar or alternative nanoparticle-based iron therapies. This exclusivity can impact pricing, competition, and the agility of the supply chain.

2. Supply Chain Risks
Key vulnerabilities include manufacturing disruptions, raw material shortages, quality control issues, and geopolitical factors. The recent global supply chain strains, exemplified during the COVID-19 pandemic, underscore the importance of diversified sourcing strategies.

3. Competition and Alternative Suppliers
While Takeda remains the sole supplier, market entrants are exploring biosimilar candidates and alternative nanoparticle formulations. Their development could reshape the supplier landscape in the coming years.

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Future Outlook and Strategic Considerations

• Vertical Integration Trends: Takeda’s ongoing investments in manufacturing capacity and raw material sourcing could enhance supply security.
• Diversification of Raw Material Sources: To mitigate risks, stakeholders advocate for sourcing redundancy and establishing multiple supply agreements with raw material providers.
• Regulatory Approvals and Market Expansion: Expanding approvals, especially in emerging markets, could diversify supply chains but also introduce new suppliers and logistical complexities.
• Supply Chain Resilience: Strengthening cold chain logistics, engaging secondary manufacturing facilities, and fostering long-term relationships with raw material suppliers are crucial strategies.

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Key Takeaways

• Takeda Pharmaceuticals holds the exclusive manufacturing rights for Feraheme, making it the central figure in the supply chain.
• Raw materials, including high-purity ferric salts and dextran, are supplied by specialized chemical and biopolymer producers, with any disruption potentially affecting availability.
• Contract manufacturing organizations support final formulation, packaging, and quality assurance, adding flexibility but also complexity to the supply chain.
• Distribution depends on experienced logistics firms skilled in temperature-sensitive biologic delivery, with regional distribution channels influencing overall supply stability.
• Supply chain resilience must address raw material sourcing, manufacturing capacity, regulatory landscape, and logistical risks, especially amid global disruptions.

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FAQs

1. Who is the primary manufacturer of Feraheme?
Takeda Pharmaceuticals is the sole manufacturer and patent holder of Feraheme, overseeing its production, distribution, and development processes globally.

2. What raw materials are crucial in Feraheme production?
High-purity ferric salts for nanoparticle synthesis and pharmaceutical-grade dextran for coating are essential raw materials supplied by chemical and biopolymer manufacturers.

3. Are there alternative suppliers for Feraheme?
Currently, Takeda maintains exclusivity; however, biosimilar and generic competitors are under development, which could introduce alternative supply options in the future.

4. How is Feraheme distributed globally?
Distribution involves regional partners and logistics firms specialized in cold chain transportation, ensuring secure and compliant delivery to healthcare providers worldwide.

5. What are risks associated with Feraheme’s supply chain?
Risks include raw material shortages, manufacturing disruptions, regulatory delays, and logistical challenges, all of which can impact drug availability and pricing.

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References

[1] Takeda Pharmaceutical Company Limited. Feraheme (ferumoxytol) Prescribing Information. 2022.
[2] AMAG Pharmaceuticals. "Feraheme: Product Overview." 2017.
[3] Wikipedia Contributors. "Ferumoxytol." Wikipedia, The Free Encyclopedia.
[4] Cargill, Roquette. "Pharmaceutical-grade polysaccharides." 2022.
[5] Contract Pharma. "Emerging Trends in Nanoparticle Manufacturing." 2021.