Suppliers and packagers for generic pharmaceutical drug: ioflupane i-123

ioflupane i-123

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Ge Hlthcare Inc	DATSCAN	ioflupane i-123	SOLUTION;INTRAVENOUS	022454	NDA	Medi-Physics Inc. dba GE Healthcare.	17156-210-01	1 VIAL, GLASS in 1 CONTAINER (17156-210-01) / 2.5 mL in 1 VIAL, GLASS	2011-03-01
Curium	IOFLUPANE I-123	ioflupane i-123	SOLUTION;INTRAVENOUS	213792	ANDA	Curium US LLC	69945-166-05	2.5 mL in 1 VIAL, SINGLE-DOSE (69945-166-05)	2022-03-31

Ioflupane I-123 Supply Chain Analysis

Last updated: February 19, 2026

This report analyzes the current supply landscape for Ioflupane I-123, a radiopharmaceutical used in diagnostic imaging for Parkinson's disease and other movement disorders. The analysis focuses on key suppliers, manufacturing capabilities, regulatory considerations, and potential supply chain vulnerabilities.

Who are the Primary Manufacturers of Ioflupane I-123?

The primary manufacturer of Ioflupane I-123 in the United States is GE HealthCare. While other entities may be involved in distribution or radiopharmacy preparation, GE HealthCare holds the New Drug Application (NDA) and is the sole holder of the drug master file (DMF) for the active pharmaceutical ingredient (API).

• GE HealthCare:
  • Product Name: DaTscan (Ioflupane I-123 Injection)
  • Indication: Diagnostic imaging agent for patients with suspected dopamine transporter (DaT) dysfunction, to evaluate adult patients with suspected Parkinsonian syndromes.
  • Manufacturing Site: GE HealthCare's radiopharmaceutical manufacturing facilities are located globally, with specific production for DaTscan likely tied to their specialized radiochemistry capabilities. The company emphasizes its commitment to maintaining supply for critical diagnostic agents.

What is the Regulatory Status of Ioflupane I-123 Manufacturing?

The manufacturing and distribution of Ioflupane I-123 are subject to stringent regulatory oversight by the U.S. Food and Drug Administration (FDA) and equivalent international bodies. This includes adherence to Current Good Manufacturing Practices (cGMP).

• FDA Oversight:
  • NDA Holder: GE HealthCare is the holder of the NDA for DaTscan.
  • cGMP Compliance: All manufacturing facilities involved in the production of Ioflupane I-123 must comply with FDA's cGMP regulations (21 CFR Parts 210 and 211). This ensures the quality, safety, and efficacy of the drug product.
  • Radiopharmaceutical Specifics: Manufacturing of radiopharmaceuticals involves specialized licensing and handling protocols due to the radioactive nature of the isotope. Facilities must also adhere to regulations from the Nuclear Regulatory Commission (NRC) or state-equivalent agencies governing radioactive materials.

What are the Key Components of the Ioflupane I-123 Supply Chain?

The supply chain for Ioflupane I-123 is complex, involving specialized raw materials, radioactive isotope procurement, API synthesis, drug product manufacturing, and distribution to end-users.

• Raw Material Sourcing:

  • Iodine-123 (I-123) Isotope: This is the critical radioisotope component. I-123 is typically produced in cyclotrons or nuclear reactors. The availability and reliable supply of I-123 is a primary determinant of Ioflupane I-123 production capacity. Major producers of medical radioisotopes include:
    • IRE (Institut national des radioéléments): A Belgian nuclear research center and a significant producer of medical radioisotopes, including I-123.
    • Curium SA: A French company involved in the production and distribution of radioisotopes.
    • NTP Radioisotopes (Pty) Ltd: A South African company, part of the Necsa group, that produces radioisotopes.
    • Nordion (now part of Sotera Health): A Canadian company historically involved in radioisotope supply.
    • MIT Research Reactor: The Massachusetts Institute of Technology operates a research reactor that has been a source of medical isotopes.
  • Precursor Chemicals: Synthesis of the Ioflupane molecule requires specific chemical precursors that are not radioactive. The quality and availability of these precursors are critical for API synthesis.

• API Synthesis and Drug Product Manufacturing:

  • GE HealthCare: As the NDA holder, GE HealthCare is responsible for both the synthesis of the Ioflupane API and the formulation and filling of the final Ioflupane I-123 Injection drug product. This vertical integration is common for radiopharmaceuticals to ensure quality control and proprietary handling of the radioactive material.

• Radiopharmacy Preparation:

  • While GE HealthCare manufactures the final sterile injectable product, Ioflupane I-123 Injection is often prepared by licensed radiopharmacies at hospitals or specialized compounding facilities prior to administration. These pharmacies receive the radiopharmaceutical and, if necessary, perform final dispensing activities under strict radiation safety protocols.

• Distribution:

  • The distribution of Ioflupane I-123 Injection is highly specialized due to its short shelf-life and radioactive nature. It requires cold chain logistics and rapid delivery from the manufacturing site to the radiopharmacies or end-user institutions. GE HealthCare manages its own distribution network or partners with specialized logistics providers.

What are the Challenges and Risks in the Ioflupane I-123 Supply Chain?

The supply chain for Ioflupane I-123 presents several unique challenges and risks, primarily related to the radioactive isotope and the specialized nature of radiopharmaceutical manufacturing.

• Isotope Availability:

  • Limited Production Capacity: The global supply of I-123 is limited by the number of operational cyclotrons and nuclear reactors capable of producing it. Production schedules are often planned months in advance.
  • Production Interruptions: Cyclotron or reactor downtime, maintenance, or unforeseen technical issues can lead to significant disruptions in I-123 supply, impacting downstream radiopharmaceutical production.
  • Geopolitical Factors: The concentration of I-123 production in a few geographic regions can make the supply chain vulnerable to geopolitical instability or export restrictions.

• Short Half-Life:

  • Iodine-123 has a half-life of approximately 13.2 hours. This necessitates rapid production, distribution, and administration, leaving little room for delays in any part of the supply chain. The shelf-life of the final Ioflupane I-123 Injection product is typically very short, often measured in hours after calibration.

• Specialized Manufacturing Requirements:

  • Radiochemical Expertise: The synthesis of Ioflupane requires specialized radiochemical expertise and facilities capable of handling radioactive isotopes safely and efficiently.
  • cGMP Compliance: Maintaining stringent cGMP compliance in a radiopharmaceutical manufacturing environment is demanding, requiring specialized equipment, personnel training, and quality control systems.

• Regulatory Hurdles:

  • Licensing and Permitting: Obtaining and maintaining the necessary licenses and permits for handling radioactive materials and manufacturing pharmaceuticals is a complex and ongoing process.
  • Inspection and Audit: Regulatory bodies conduct regular inspections of manufacturing and distribution facilities. Non-compliance can lead to production halts or product recalls.

• Logistics and Cold Chain:

  • Specialized Transport: Transporting radioactive materials requires adherence to strict regulations for packaging, labeling, and shipping. This often involves specialized carriers and expedited delivery.
  • Cold Chain Maintenance: Maintaining the required temperature for the radiopharmaceutical during transit is critical to preserve its integrity and efficacy.

• Demand Fluctuations:

  • While the use of DaTscan is established, unpredictable fluctuations in demand from healthcare providers can strain a supply chain with limited flexibility due to the isotope's short half-life and fixed production schedules.

What is the Market Landscape for Ioflupane I-123?

The market for Ioflupane I-123 is a niche segment within the broader diagnostic imaging market, primarily driven by the diagnosis of Parkinsonian syndromes.

• Market Size and Growth: The market is relatively small compared to blockbuster drugs but is stable due to the unmet diagnostic need for differentiating Parkinson's disease from essential tremor and other conditions. Growth is influenced by the prevalence of neurodegenerative diseases and the adoption of advanced diagnostic imaging techniques.
• Competitive Landscape:
  • Direct Competition: The primary competitor to Ioflupane I-123 as a DaT imaging agent is ioflupane I-123 itself, manufactured by GE HealthCare. There are no direct therapeutic alternatives for the diagnostic purpose it serves.
  • Indirect Competition: While not direct substitutes, other imaging modalities or clinical assessment tools may be used in the differential diagnosis of movement disorders. However, Ioflupane I-123 offers a specific visualization of dopaminergic transporter density.
• Pricing: The price of Ioflupane I-123 Injection reflects the high costs associated with radiopharmaceutical manufacturing, specialized isotope procurement, regulatory compliance, and the short shelf-life, which limits its utility and necessitates rapid turnover.
• Geographic Availability: Ioflupane I-123 (DaTscan) is approved and available in major markets including the United States, Europe, and Australia. Availability in other regions may vary based on local regulatory approvals and market adoption.

What are Potential Strategies for Supply Chain Resilience?

To mitigate the risks associated with Ioflupane I-123 supply, stakeholders can consider several strategies focused on enhancing resilience and ensuring continuity of care.

• Diversification of Isotope Suppliers: While limited, exploring and supporting multiple I-123 producers globally could reduce reliance on single sources. This requires collaboration and long-term supply agreements.
• Enhanced Forecasting and Demand Planning: Improved collaboration between manufacturers, distributors, and healthcare providers to refine demand forecasts can allow for more optimized production scheduling and isotope allocation.
• Inventory Management Optimization: Implementing advanced inventory management systems that account for the short half-life and critical delivery windows can help minimize waste and ensure product availability where needed most.
• Strategic Partnerships: Forming stronger partnerships with I-123 producers, specialized logistics providers, and key radiopharmacies can create a more integrated and responsive supply chain.
• Investment in Manufacturing Technology: Continued investment in advanced manufacturing technologies, including automated synthesis and real-time quality monitoring, can improve efficiency and reliability.
• Contingency Planning and Redundancy: Developing robust contingency plans for production disruptions, transportation issues, or unexpected demand surges is crucial. This may involve identifying backup manufacturing sites or alternative distribution routes.
• Regulatory Engagement: Proactive engagement with regulatory bodies to ensure alignment on evolving requirements and to communicate potential supply challenges can facilitate smoother operations.

Key Takeaways

• Single Primary Manufacturer: GE HealthCare is the sole holder of the NDA and primary manufacturer of Ioflupane I-123 Injection (DaTscan) in the U.S.
• Critical Isotope Dependency: The supply chain is heavily reliant on the availability of Iodine-123 (I-123), which is produced by a limited number of global suppliers.
• Short Half-Life Constraints: The 13.2-hour half-life of I-123 imposes strict time constraints on production, distribution, and administration, creating inherent supply chain fragility.
• Specialized Regulatory Environment: Manufacturing and distribution are governed by stringent FDA cGMP regulations and specific requirements for handling radioactive materials.
• Supply Chain Risks: Key risks include isotope availability disruptions, production outages, logistics failures due to radioactive material transport regulations, and the short shelf-life of the final product.
• Resilience Strategies: Enhancing supply chain resilience requires diversification of isotope sources, improved demand forecasting, strategic partnerships, and robust contingency planning.

Frequently Asked Questions

1. How many suppliers of Ioflupane I-123 exist globally?

There is one primary manufacturer of the finished drug product, GE HealthCare. However, multiple entities globally are involved in the production of the key radioisotope, Iodine-123.

2. What is the typical shelf-life of Ioflupane I-123 Injection once manufactured?

The shelf-life is extremely short, typically measured in hours after calibration, due to the rapid decay of the Iodine-123 isotope. This necessitates prompt delivery and administration.

3. Are there generic versions of Ioflupane I-123 available?

No, there are no generic versions of Ioflupane I-123 Injection. Its complex manufacturing process, reliance on a specific radioisotope, and short shelf-life present significant barriers to generic entry.

4. What happens if the supply of Iodine-123 is interrupted?

An interruption in Iodine-123 supply directly halts the production of Ioflupane I-123 Injection. Due to the short shelf-life, there is no significant buffer stock of the finished product.

5. Can Ioflupane I-123 be manufactured in smaller, decentralized facilities?

While radiopharmacies prepare the final dose for administration, the synthesis of the Iodine-123 labeled Ioflupane API and the final sterile filling of the drug product by GE HealthCare require highly specialized, licensed, and regulated radiopharmaceutical manufacturing facilities that are not feasible for smaller, decentralized operations.

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Citations

[1] U.S. Food and Drug Administration. (n.d.). Current Good Manufacturing Practice, Good Pilot Plant Practice, and Good Laboratory Practice Regulations. Retrieved from [FDA website] (specific URL for 21 CFR Parts 210 and 211 would be used if accessed directly).

[2] GE HealthCare. (n.d.). DaTscan. Retrieved from GE HealthCare website.

[3] Nuclear Regulatory Commission. (n.d.). Medical Uses of Nuclear Material. Retrieved from [NRC website] (specific URL for relevant regulations would be used).