Suppliers and packagers for DATSCAN

DATSCAN

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

Suppliers for the Pharmaceutical Drug: Datscan

Last updated: August 2, 2025

Introduction

Datscan (also spelled DaTscan) is a radiopharmaceutical diagnostic agent primarily used in neuroimaging to assist in the evaluation of Parkinsonian syndromes. Its primary function is to visualize dopamine transporter (DAT) levels in the brain, aiding in differentiating Parkinson's disease from other movement disorders such as essential tremor or drug-induced Parkinsonism.

Developed by GE Healthcare, Datscan's reliance on radioactive tracers and specialized imaging technology makes its supply chain complex, entailing multiple components: the radiopharmaceutical, the radioisotope, imaging hardware, and the service and distribution network. This article examines current suppliers of Datscan, focusing on the manufacturing, distribution, and global availability to inform business and clinical decision-making.

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Manufacturers of Datscan

GE Healthcare

GE Healthcare holds the patent, manufacturing rights, and regulatory approvals for Datscan globally. The company is the principal supplier, overseeing production and distribution in multiple regions. Their manufacturing process involves the synthesis of the radioactive ligand, iodine-123 ioflupane, bound to a molecule that targets dopamine transporters.

GE Healthcare’s integrated manufacturing facilities, primarily based in the United States and Europe, produce the radiopharmaceutical under stringent quality control standards compliant with FDA, EMA, and other regulatory bodies. The company also manages a global distribution network, ensuring the availability of Datscan for clinical use in hospitals and imaging centers.

Radiopharmaceutical Production Partnerships

While GE Healthcare is the primary manufacturer, certain regional suppliers and radiopharmacy networks obtain the iodine-123 radioisotope necessary for Datscan synthesis through local or regional radioisotope production facilities. These partnerships ensure supply continuity, especially where geopolitical or logistical issues affect nuclear medicine supply chains.

Supply Challenges and Regional Variability

Due to the radioactive nature of iodine-123, its production depends on nuclear reactors, with a limited number of facilities worldwide, such as those operated by companies like Nordion (Canada), IRE (Italy), and others. The limited reactor capacity can lead to shortages or delays in supply, impacting Datscan production timelines.

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Radioisotope Suppliers

The critical component for Datscan is iodine-123 (I-123), a radioisotope with a half-life of approximately 13 hours, necessitating prompt delivery and utilization.

Iodine-123 Production

• Nordion (Canada): Historically a leading supplier of I-123, Nordion (a health and biosciences company now part of ST Gene therapy group) provided I-123 for Datscan manufacturing. They source I-123 through reactors specializing in low-energy gamma emitters.

• IRe (Italy): Operates cyclotrons and reactors producing I-123, supplying the European market.

• Other Regional Suppliers: Countries such as India, South Africa, and Japan have emerging capabilities to produce iodine-123, which could influence regional supply dynamics.

Supply Limitations

Limited reactor availability and the short half-life of I-123 constrain bulk or stockpile accumulation, imposing logistical challenges that necessitate just-in-time manufacturing and distribution. Regulatory standards for radioisotope transportation further restrict supply routes, impacting global availability.

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Distribution and Supply Chain

Global Distribution Networks

GE Healthcare manages a worldwide distribution, utilizing specialized logistics providers capable of handling radioactive materials. The distribution network ensures that Datscan is available in developed markets like North America, Europe, and parts of Asia, where neuroimaging services are prevalent.

Regional Distribution Constraints

Regions with limited nuclear medicine infrastructure or regulatory hurdles may face difficulties in obtaining Datscan. In such cases, local radiopharmacies and imaging centers depend on imports or regional manufacturing partnerships.

Alternative Diagnostic Agents

Where Datscan availability is restricted, clinicians may consider alternative imaging modalities, such as PET tracers or other SPECT agents, albeit with differences in diagnostic accuracy.

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Regulatory and Market Dynamics

The regulatory environment influences supplier viability and market access:

• FDA and EMA Registration: GE Healthcare’s Datscan holds specific approvals, with regional variations impacting manufacturing and distribution rights.

• Market Demand: Rising awareness of Parkinson's disease diagnostics increases demand, influencing supply chain investments and capacities.

• Supply Disruptions: External factors such as geopolitical issues, nuclear fuel cycle concerns, and pandemic-related logistics disruptions can ripple through the supply chain, causing shortages.

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Future Outlook

Developments in alternative tracer technology and nuclear medicine might diversify supply sources in the coming years. Regional production initiatives for iodine-123 could alleviate dependency on a handful of global producers, stabilizing the supply chain and reducing costs.

In conclusion, GE Healthcare remains the primary supplier for Datscan, with a tightly controlled supply chain involving regional radioisotope producers, regulated logistics, and clinical distribution networks. The complexity of nuclear medicine manufacturing means that supply stability hinges on reactor capacity, regulatory compliance, and geopolitical factors.

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Key Takeaways

• GE Healthcare is the sole global manufacturer of Datscan, overseeing production and distribution.

• Iodine-123 (I-123) production by regional radioisotope suppliers (e.g., Nordion, IRE) is critical for Datscan supply; reactor limitations can cause shortages.

• Supply challenges include short half-life, logistical constraints, and regulatory hurdles, which require seamless coordination in the nuclear medicine supply chain.

• Regional manufacturing initiatives for I-123 could improve supply stability and reduce costs.

• Clinicians and healthcare providers should factor in regional availability and potential logistical delays when planning diagnostic procedures involving Datscan.

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FAQs

1. Is Datscan available from multiple manufacturers globally?
No. GE Healthcare is the exclusive manufacturer of Datscan globally, although regional radioisotope suppliers provide the iodine-123 necessary for its synthesis. No other commercial entities currently hold authorized production rights at a global scale.

2. What are the primary challenges in sourcing Datscan?
The key challenges include limited iodine-123 production capacity, short isotope half-life, transportation logistics, and regulatory restrictions, which can result in supply shortages or delays, particularly in regions with limited nuclear medicine infrastructure.

3. Are there alternatives to Datscan for Parkinsonian diagnosis?
Yes, PET tracers like 18F-fluorodopa offer alternative imaging options, but they are more costly and less widely available. MRI-based techniques are also explored but lack the specificity of dopamine transporter imaging.

4. How might supply chain disruptions impact clinical practice?
Disruptions can delay diagnosis, lead to treatment postponements, or necessitate the use of less specific diagnostic methods, potentially impacting patient outcomes.

5. What developments could improve the supply of Datscan in the future?
Emerging regional iodine-123 production facilities, advances in nuclear reactor technology, and alternative tracer development can enhance supply stability, reduce costs, and expand access.

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References

1. GE Healthcare. (2022). DaTscan (Ioflupane I123) Prescribing Information.
2. European Medicines Agency (EMA). (2014). Summary of Product Characteristics: DaTscan.
3. Nordion. (2022). Radioisotope Supply Chain Report.
4. International Atomic Energy Agency (IAEA). (2020). Radioisotope Production and Supply.
5. Bloomberg Industry Analysis. (2023). Global Nuclear Medicine Supply Chain Assessment.