Suppliers and packagers for generic pharmaceutical drug: 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
Covis	FERABRIGHT	ferumoxytol	SOLUTION;INTRAVENOUS	219868	NDA	Azurity Pharmaceuticals, Inc.	24338-310-10	1 VIAL, SINGLE-DOSE in 1 CARTON (24338-310-10) / 10 mL in 1 VIAL, SINGLE-DOSE	2025-10-20
Covis	FERABRIGHT	ferumoxytol	SOLUTION;INTRAVENOUS	219868	NDA	Azurity Pharmaceuticals, Inc.	24338-510-17	1 VIAL, SINGLE-DOSE in 1 CARTON (24338-510-17) / 17 mL in 1 VIAL, SINGLE-DOSE	2025-10-20
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
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

FERUMOXYTOL DRUG SUPPLY CHAIN ANALYSIS

Last updated: February 19, 2026

Ferumoxytol, an intravenous iron replacement therapy, relies on a specialized supply chain for its production. The active pharmaceutical ingredient (API) and key excipients require specific manufacturing capabilities and regulatory compliance. This analysis identifies key suppliers involved in the ferumoxytol supply chain, focusing on their role, capabilities, and potential impact on drug availability.

WHO ARE THE PRIMARY SUPPLIERS FOR FERUMOXYTOL API?

The primary active pharmaceutical ingredient (API) for ferumoxytol is a superparamagnetic iron oxide nanoparticle. The synthesis of these nanoparticles is a complex chemical process requiring specialized expertise in nanoparticle engineering and quality control.

• Teva Pharmaceutical Industries Ltd. is the current manufacturer and marketer of ferumoxytol (known as Feraheme® in the U.S. and Rienso® in Europe and Australia) [1]. Teva is responsible for the integrated manufacturing process, which includes API synthesis and drug product formulation. While Teva manufactures the final drug product, the upstream production of the superparamagnetic iron oxide nanoparticles involves specific chemical synthesis steps. The exact internal or external manufacturing sites for the API are not publicly disclosed in detail, but Teva oversees the entire process under strict Good Manufacturing Practices (GMP) [1].

• Potential API Manufacturers (General Capability): Companies with expertise in colloid chemistry, nanoparticle synthesis, and pharmaceutical API manufacturing could potentially supply the superparamagnetic iron oxide nanoparticles. These capabilities typically reside within specialized chemical manufacturers or CDMOs (Contract Development and Manufacturing Organizations) with a strong track record in complex inorganic synthesis and particle characterization. Specific companies are not publicly identified as direct suppliers to Teva for ferumoxytol API.

WHAT ARE THE KEY EXCIPIENTS AND THEIR POTENTIAL SUPPLIERS?

Ferumoxytol's formulation includes several excipients that are crucial for its stability, solubility, and administration. These excipients must meet stringent pharmaceutical grade requirements.

• Water for Injection (WFI): This is a critical component for any injectable drug. Suppliers of pharmaceutical-grade WFI are numerous and widely regulated. Compliance with USP (United States Pharmacopeia) and EP (European Pharmacopoeia) standards is mandatory.

  • Key Characteristics: High purity, low endotoxin levels, sterility.
  • Potential Suppliers: Global pharmaceutical water system providers and large chemical manufacturers with dedicated pharmaceutical water production facilities. Examples include Fresenius Kabi (though often for finished drug products, they also have extensive water capabilities), and specialized water treatment companies that meet pharmaceutical industry standards. The specific WFI supplier for ferumoxytol is not disclosed.

• Sodium Hydroxide (NaOH): Used for pH adjustment during the manufacturing process.

  • Key Characteristics: Pharmaceutical grade, consistent purity.
  • Potential Suppliers: Major chemical manufacturers like BASF, Dow Chemical, and Sigma-Aldrich (part of Merck KGaA) supply pharmaceutical-grade sodium hydroxide. Sourcing for Teva would likely come from suppliers meeting specific quality agreements.

• Hydrochloric Acid (HCl): Also used for pH adjustment.

  • Key Characteristics: Pharmaceutical grade, consistent purity.
  • Potential Suppliers: Similar to sodium hydroxide, major chemical suppliers such as BASF, Dow Chemical, and Merck KGaA are capable of providing pharmaceutical-grade hydrochloric acid.

• Stabilizers/Buffering Agents (if applicable): While ferumoxytol's primary active is the iron oxide nanoparticle, formulations of such injectables often include agents to maintain pH and particle stability. The specific excipients beyond WFI and pH adjusters for ferumoxytol are not detailed in public domain literature readily available to third-party analysts, but would typically involve buffers like citrate or phosphate, or other stabilizing agents.

  • Key Characteristics: Pharmaceutical grade, high purity, compatibility with the API.
  • Potential Suppliers: Companies specializing in pharmaceutical excipients, including Evonik Industries, Ashland, DuPont (now IFF), and Roquette.

HOW IS THE FERUMOXYTOL DRUG PRODUCT MANUFACTURED?

The manufacturing of ferumoxytol involves the formulation of the API into the final injectable dosage form. This process requires sterile manufacturing environments and rigorous quality control.

• Teva Pharmaceutical Industries Ltd.: As the marketing authorization holder, Teva is responsible for the finished drug product manufacturing of Feraheme® and Rienso®. This includes the sterile filling, lyophilization (if applicable, though ferumoxytol is typically a liquid suspension), and packaging of the drug.

  • Manufacturing Sites: Teva operates multiple manufacturing facilities globally. The specific site(s) responsible for ferumoxytol production are proprietary and subject to regulatory oversight by the FDA, EMA, and other health authorities.
  • Capabilities: Sterile manufacturing, aseptic processing, quality control testing, and packaging of parenteral drugs.

• Contract Manufacturing Organizations (CMOs): While Teva appears to maintain significant in-house manufacturing control for ferumoxytol, pharmaceutical companies often utilize CMOs for specialized manufacturing steps or for overflow capacity. However, there is no public indication that Teva outsources the primary manufacturing of ferumoxytol to a CMO.

WHAT ARE THE REGULATORY AND QUALITY CONTROL CONSIDERATIONS FOR FERUMOXYTOL SUPPLY?

The supply chain for ferumoxytol is subject to extensive regulatory oversight to ensure patient safety and drug efficacy.

• Good Manufacturing Practices (GMP): All suppliers of raw materials, APIs, and finished drug products must adhere to current GMP regulations as mandated by regulatory agencies like the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and others. This includes stringent controls over facilities, equipment, personnel, and processes [2].

• API Characterization and Control: The superparamagnetic iron oxide nanoparticles require rigorous characterization to ensure consistent particle size, surface chemistry, iron content, and magnetic properties. Control of impurities, including residual solvents and heavy metals, is critical.

• Excipient Qualification: Each excipient must be sourced from qualified suppliers and meet pharmacopeial standards (e.g., USP, EP, JP). Certificates of Analysis (CoA) and vendor audits are standard practice.

• Sterility and Endotoxin Control: For injectable products like ferumoxytol, maintaining sterility throughout the manufacturing process and ensuring that endotoxin levels are below acceptable limits are paramount. This involves validated aseptic processing techniques and robust environmental monitoring.

• Supply Chain Security: Pharmaceutical companies are increasingly focused on supply chain security to prevent counterfeiting and ensure product integrity. This includes track-and-trace initiatives and robust inventory management.

WHAT ARE THE POTENTIAL RISKS AND MITIGATION STRATEGIES IN THE FERUMOXYTOL SUPPLY CHAIN?

Disruptions in the supply chain for ferumoxytol can lead to drug shortages, impacting patient access to treatment.

• Single-Source API Risk: If the superparamagnetic iron oxide nanoparticle API is manufactured by a limited number of entities, or primarily in-house by Teva, any disruption at that source poses a significant risk.

  • Mitigation: Teva may maintain multiple production lines or have robust business continuity plans. Exploring secondary suppliers for critical raw materials used in API synthesis could also be a strategy, though the specialized nature of the nanoparticle may limit options.

• Regulatory Compliance Issues: Failure of any supplier to maintain GMP compliance can lead to batch rejections or facility shutdowns, halting production.

  • Mitigation: Rigorous supplier qualification programs, regular audits, and strong quality agreements with suppliers. Diversifying the supplier base where feasible.

• Raw Material Availability: Fluctuations in the availability or price of precursor chemicals or essential excipients could impact production costs and lead times.

  • Mitigation: Long-term supply agreements, maintaining safety stock of critical raw materials, and exploring alternative, qualified suppliers for common excipients.

• Geopolitical or Environmental Disruptions: Natural disasters, political instability in sourcing regions, or global health crises can disrupt transportation and manufacturing operations.

  • Mitigation: Geographic diversification of manufacturing and sourcing where possible, maintaining adequate inventory buffers, and developing contingency plans for logistics.

KEY TAKEAWAYS

The supply chain for ferumoxytol is characterized by its reliance on specialized nanoparticle synthesis for the API, with Teva Pharmaceutical Industries Ltd. holding primary responsibility for both API production oversight and finished drug product manufacturing. Key excipients, such as water for injection, sodium hydroxide, and hydrochloric acid, are sourced from standard pharmaceutical-grade chemical suppliers. All entities within the supply chain must adhere to stringent GMP regulations to ensure product quality and patient safety. Potential risks include single-source API dependencies and regulatory compliance issues, which Teva mitigates through robust quality management and business continuity planning.

FAQS

1. Is ferumoxytol manufactured by multiple pharmaceutical companies? Ferumoxytol is primarily manufactured and marketed by Teva Pharmaceutical Industries Ltd. under brand names such as Feraheme® and Rienso®. While other companies may possess the technical capability for similar nanoparticle synthesis, they are not currently marketing ferumoxytol.

2. What is the primary challenge in sourcing ferumoxytol API? The primary challenge lies in the complex synthesis of superparamagnetic iron oxide nanoparticles. This requires specialized expertise and proprietary manufacturing processes, which may limit the number of qualified API manufacturers.

3. Are the suppliers of ferumoxytol's excipients readily available? Common pharmaceutical excipients like water for injection, sodium hydroxide, and hydrochloric acid are generally available from multiple qualified suppliers worldwide. The challenge lies in ensuring these suppliers meet Teva's specific quality agreements and regulatory requirements for pharmaceutical use.

4. Does Teva utilize contract manufacturers for ferumoxytol production? While Teva operates extensive manufacturing capabilities, public disclosures do not specify the use of contract manufacturing organizations for the primary production of ferumoxytol. Teva appears to maintain significant in-house control over its manufacturing processes.

5. What regulatory bodies oversee the ferumoxytol supply chain? The supply chain for ferumoxytol is overseen by major pharmaceutical regulatory bodies, including the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other national health authorities globally. These agencies enforce Good Manufacturing Practices (GMP) and review manufacturing processes and quality control data.

CITATIONS

[1] U.S. Food and Drug Administration. (n.d.). Feraheme® (ferumoxytol) Injection. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/200310s023lbl.pdf

[2] European Medicines Agency. (n.d.). Good manufacturing practice (GMP). Retrieved from https://www.ema.europa.eu/en/human-regulatory/manufacturing-quality/good-manufacturing-practice-gmp