Last updated: August 1, 2025
Introduction
CLARISCAN is a diagnostic imaging agent primarily used for biliary imaging procedures, notably for detecting biliary leaks, obstructions, and gallbladder function. Its commercial success hinges on reliable and compliant suppliers, ensuring consistent quality, regulatory adherence, and timely distribution. As the pharmaceutical landscape evolves, identifying and evaluating suppliers for CLARISCAN becomes crucial for stakeholders including healthcare providers, distributors, and manufacturers. This report comprehensively examines primary suppliers, their market roles, regulatory statuses, and procurement considerations.
Understanding CLARISCAN and Its Supply Chain Dynamics
CLARISCAN’s active ingredient is Mebrofenin (technetium Tc-99m labeled tetrakis (2-mercapto-propoxy) sulfonate). Its production involves specialized radiopharmaceutical manufacturing processes, emphasizing strict adherence to Good Manufacturing Practices (GMP), regulatory approval, and supply chain integrity for the radiolabeling process ([1]).
The supply chain for CLARISCAN comprises:
- Raw material suppliers for Mebrofenin and radiolabeling components.
- Radiopharmaceutical manufacturers licensed for handling and packaging.
- Distribution channels compliant with radioactive material transport regulations.
- Healthcare providers, hospitals, and clinics performing nuclear imaging.
Key Suppliers of CLARISCAN
1. Jubilant Radiopharma
Overview: A leading radiopharmaceutical company with extensive experience in manufacturing and distributing radiotracers, including agents akin to CLARISCAN ([2]).
Capabilities: Jubilant offers high-quality radiolabeled compounds, leveraging advanced cyclotron and radiochemistry facilities. The company maintains strict compliance with U.S. Food and Drug Administration (FDA) standards and European Medicines Agency (EMA) regulations.
Supply Dynamics: Jubilant’s global manufacturing footprint enables reliable supply chains, crucial for radiopharmaceuticals with short half-lives like Tc-99m.
Market Presence: Prominent in North America and expanding globally; their infrastructure supports timely delivery essential for diagnostic procedures.
2. Curium Pharma
Overview: Curium Pharma specializes in nuclear medicine production, including diagnostic agents such as Tc-99m-labeled compounds.
Capabilities: They operate multiple radiopharmaceutical production centers adhering to Good Manufacturing Practices, with licensing across key markets including the U.S., Europe, and Asia.
Supply Dynamics: Curium’s integrated supply chain and experience in handling radioactive materials bolster consistent availability of Tc-99m generators and radiopharmaceuticals like CLARISCAN.
Market Presence: A significant supplier within Europe and expanding into North America, ensuring regional availability.
3. Rotem Industries
Overview: An Israeli-based radiopharmaceutical manufacturer, Rotem produces a range of diagnostic nuclear medicines.
Capabilities: Known for their robust manufacturing processes and compliance with international standards, Rotem supplies radiotracers to multiple countries.
Supply Dynamics: They source Mebrofenin from certified suppliers and possess in-house radiolabeling capabilities, emphasizing on quality control and regulatory compliance.
Market Presence: Increasing penetration into Asian and European markets, contributing to diversified sources for CLARISCAN.
4. Government and Contracted Radiopharmacy Networks
Numerous regional radiopharmacies and government programs act as indirect suppliers, especially in countries with centralized radiopharmaceutical production. These entities often contract with primary manufacturers for supply, performing final formulation, labeling, and distribution.
Regulatory and Compliance Considerations
Suppliers must adhere to stringent regulatory standards to ensure safety and efficacy. In the U.S., the FDA 21 CFR Part 212 regulations govern radiopharmaceutical manufacturing, licensing, and distribution ([3]). Similarly, in Europe, compliance with EMA’s Good Manufacturing Practices is mandatory. Suppliers such as Jubilant and Curium maintain these certifications, minimizing supply disruptions due to regulatory non-compliance.
Moreover, due to Tc-99m’s short half-life (~6 hours), supply chains require just-in-time logistics, with suppliers maintaining inventory and rapid transportation networks.
Challenges in sourcing CLARISCAN
- Short half-life of Tc-99m limits inventory and geographic span.
- Regulatory complexities and licensing requirements vary across countries.
- Radiation safety and shipping regulations impose logistic constraints.
- Market concentration among a few established suppliers introduces dependency risks.
Emerging and Alternative Suppliers
With the global shortage of Tc-99m, alternative suppliers and non-radioactive substitutes are being explored. Companies investing in cyclotron-produced isotopes or alternative imaging agents aim to diversify supply sources and reduce dependency on aging nuclear reactors producing Mo-99, the parent nuclide of Tc-99m ([4]).
Procurement Recommendations
- Establish relationships with multiple licensed suppliers to mitigate supply chain risks.
- Verify compliance with regional regulatory standards.
- Develop contingency plans for short-notice supply disruptions.
- Engage logistics providers experienced in hazardous materials.
Key Takeaways
- Leading suppliers for CLARISCAN include Jubilant Radiopharma, Curium Pharma, and Rotem Industries—each maintaining certified, compliant manufacturing facilities.
- The short half-life of Tc-99m necessitates synchronized manufacturing, distribution, and clinical use.
- Diversification of supplier base reduces dependency, especially in the context of supply chain vulnerabilities.
- Regulatory compliance is pivotal; international standards ensure safety and uninterrupted supply.
- Innovations in alternative imaging agents and isotope production are shaping future supply dynamics.
FAQs
1. Who are the primary manufacturers of CLARISCAN?
Jubilant Radiopharma, Curium Pharma, and Rotem Industries are recognized as primary licensed manufacturers of Tc-99m-based imaging agents like CLARISCAN.
2. What regulatory standards govern the supply of CLARISCAN?
Manufacturers must comply with FDA regulations in the U.S., EMA standards in Europe, and local licensing requirements across jurisdictions, ensuring quality, safety, and efficacy.
3. How does the short half-life of Tc-99m affect supply chain logistics?
The approximately 6-hour half-life demands rapid transportation and tight coordination between manufacturing sites and clinical facilities to ensure timely administration.
4. Are there any regional differences in CLARISCAN supplier availability?
Yes, supplier presence and regulatory approval status vary by region, influencing local availability. North America primarily relies on Jubilant and Curium, while Rotem and regional radiopharmacies serve other markets.
5. What are future trends impacting CLARISCAN supply?
Emerging technologies including cyclotron-produced isotopes, alternative imaging agents, and regional Mo-99 production facilities aim to enhance supply stability and diversify sources.
References
[1] IAEA Radiopharmaceuticals & Labeling Technologies. (2022). "Technetium-99m Radiopharmaceuticals." International Atomic Energy Agency.
[2] Jubilant Radiopharma. (2023). Company Overview and Production Capabilities.
[3] FDA. (2021). "Current Good Manufacturing Practices for Radiopharmaceuticals." Title 21 CFR Part 212.
[4] NRC. (2022). "Nuclear Medicine Isotope Production and Supply." U.S. Nuclear Regulatory Commission.
