DRAXIMAGE MDP-25: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Jubilant	DRAXIMAGE MDP-25	technetium tc-99m medronate	INJECTABLE;INJECTION	018035	NDA	Jubilant DraxImage Inc., dba Jubilant Radiopharma	65174-660-30	30 INJECTION, POWDER, FOR SOLUTION in 1 CARTON (65174-660-30)	2004-02-27
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 1, 2025

Introduction

Draximage MDP-25 is a radiopharmaceutical product used primarily in diagnostic imaging, particularly in myocardial perfusion imaging and other nuclear medicine procedures. As a specialized medical isotope kit, its procurement involves a complex supply chain that encompasses raw material providers, manufacturing facilities, distribution networks, and end-user healthcare providers. The efficacy of deploying DRAXIMAGE MDP-25 hinges on reliable sourcing, regulatory compliance, and logistical robustness.

This article provides a detailed analysis of the primary suppliers and supply chain considerations for DRAXIMAGE MDP-25, emphasizing the key stakeholders, manufacturing sources, and strategic considerations relevant to stakeholders in the nuclear medicine domain.

1. Overview of DRAXIMAGE MDP-25

DRAXIMAGE MDP-25 is marketed as a kit used to prepare Technetium-99m (Tc-99m) labeled macroaggregated albumin (MAA). The Troponin-based imaging agent is instrumental in pulmonary perfusion scans, facilitating the evaluation of pulmonary embolism and other thoracic pathologies. Its production depends heavily on the availability of the parent isotope, Mo-99, which decays into Tc-99m, forming the key radioactive component.

As a diagnostic tool, the supply chain for DRAXIMAGE MDP-25 intersects with the broader Mo-99/Tc-99m supply chain, which has historically experienced vulnerabilities due to reliance on aging nuclear reactors and geopolitical factors.

2. Core Suppliers and Manufacturing Sources

a. Kit Manufacturers

The primary suppliers of DRAXIMAGE MDP-25 are pharmaceutical companies specializing in radiopharmaceutical manufacturing. The company DraxImage Inc., a subsidiary of Nordion (a Sotera Health company), is the most prominent producer of this product. Their manufacturing process involves:

DraxImage Inc.: Engages in the formulation, quality control, and distribution of DRAXIMAGE MDP-25 kits globally. The company maintains manufacturing facilities compliant with Good Manufacturing Practices (GMP) to ensure safety and efficacy standards.
Other regional players: Some regional nuclear medicine suppliers may offer comparable or alternative kits, though DraxImage remains the primary source for DRAXIMAGE MDP-25 globally.

Source Validation: DraxImage's manufacturing facilities are accredited by regulatory agencies such as the U.S. Food and Drug Administration (FDA), Health Canada, and the European Medicines Agency (EMA). Their distribution network spans North America, Europe, Asia, and emerging markets.

b. Mo-99/ Tc-99m Generators

Since MDP-25 requires Technetium-99m, its production depends on the supply of Mo-99 generators. The key suppliers of Mo-99 generators include:

GE Healthcare: Supplies the MILLICYTOM range, including Mo-99 generators sourced from their irradiation and processing facilities.
Cardinal Health: Offers Mo-99 generators produced in collaboration with reactors, with a distribution network extending across North America and Europe.
Nordion / Nordion International: A significant supplier specializing in isotope-based products, including Mo-99 generators, leveraging their own irradiation facilities and partnerships.
Via Medica: Regional suppliers providing Mo-99 / Tc-99m generators primarily to European markets.

Note: The global Mo-99 supply chain faces challenges such as reactor outages, aging infrastructure, and geopolitical disruptions, affecting the consistent supply of Tc-99m kits like DRAXIMAGE MDP-25.

c. Raw Material and Ancillary Suppliers

The production of MDP-25 kits also relies on raw materials such as:

Bovine serum albumin / albumin-derived components: Sourced from reputable biological suppliers with stringent quality controls—companies like Biotang or Cytiva.
Sterile vials, filters, and packaging materials: Provided by pharmaceutical-grade component manufacturers, ensuring compatibility with GMP standards.
Chelating agents and stabilizers: Suppliers include specialized chemical firms such as Merck KGaA and Sigma-Aldrich.

3. Supply Chain Dynamics and Challenges

a. Dependence on Mo-99 Supply

DRAXIMAGE MDP-25's primary supply constraint traces back to the availability of Mo-99. The decay properties and limited reactor infrastructure mean that fluctuations and outages significantly impact the production and distribution of Tc-99m-based kits. Some key points:

Aging Reactors: Older reactors such as NRU (Canada), HFR (Netherlands), and BR-2 (Belgium) are primary sources of Mo-99. Scheduled outages and decommissioning have periodically curtailed supply.
Limited Production Facilities: Only a handful of reactors worldwide produce Mo-99, and geopolitical issues can disrupt supply chains.
Transportation Constraints: Handling radioactive materials involves international regulations and safety protocols, sometimes delaying distribution, especially to remote or underserved regions.

b. Market Concentration and Competition

The radiopharmaceutical supply market is concentrated, with DraxImage and a handful of other companies holding dominant positions. The limited number of suppliers necessitates strategic procurement planning and thorough supply chain management.

c. Regulatory Compliance

Manufacturers and suppliers must adhere to strict Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and licensing requirements from agencies like FDA, EMA, and national authorities—imposing high standards but limiting flexibility.

4. Strategic Considerations

Diversification of Suppliers: To mitigate supply disruptions, healthcare providers should diversify procurement sources, including regional suppliers and alternative kits from alternative manufacturers.
Collaborations and Long-term Supply Agreements: Establishing long-term agreements with primary manufacturers ensures priority access during shortages.
Supply Chain Transparency: Tracking shipments and inventory levels in real-time enhances responsiveness to supply chain disruptions.
Investment in Alternative Technologies: Exploring cyclotron-produced Tc-99m or alternative imaging agents can mitigate reliance on aging reactors.

5. Current Global Initiatives and Future Outlook

Recognizing vulnerabilities in the Mo-99 supply chain, international efforts prioritize:

Multiplying Production Facilities: New reactors and accelerator-based production platforms—such as the Australian National Medical Cyclotron—aim to increase supply and regionalize production.
Reactor Modernization and Recommissioning: Reactors like the NRU and HFR are undergoing upgrades to extend operational life.
Policy and Funding Support: Governments in North America, Europe, and Asia invest in establishing resilient supply chains for critical isotopes and radiopharmaceuticals.
Emerging Alternatives: Development of technetium-free imaging agents or solid-state cyclotron-produced isotopes is ongoing, potentially transforming future supply dynamics.

Key Takeaways

Primary suppliers of DRAXIMAGE MDP-25 are DraxImage Inc. and regional radiopharmaceutical companies, with the critical dependency on the Mo-99/Tc-99m supply chain.
The Mo-99 supply chain faces vulnerabilities due to reactor aging, geopolitical risks, and logistical constraints, impacting DRAXIMAGE MDP-25 availability.
Raw materials and ancillary components are sourced from specialized GMP-compliant suppliers, ensuring quality and regulatory adherence.
Mitigation strategies include diversified supplier networks, long-term contracts, and exploring alternative production methods.
Global initiatives aim to modernize and decentralize isotope production, promising improved reliability for radiopharmaceuticals like DRAXIMAGE MDP-25.

FAQs

What is the main supplier of DRAXIMAGE MDP-25?
DraxImage Inc. is the primary manufacturer and supplier of DRAXIMAGE MDP-25 globally.
How does Mo-99 availability affect DRAXIMAGE MDP-25 supply?
Since DRAXIMAGE MDP-25 relies on Tc-99m derived from Mo-99, any disruption in Mo-99 production directly impacts the kit’s availability.
Are there regional differences in suppliers for DRAXIMAGE MDP-25?
Yes. While DraxImage supplies globally, regional distributors and hospitals often source from local radiopharmacies and regional Mo-99 generator suppliers.
What efforts are underway to improve the reliability of Mo-99 supply?
International collaborations focus on establishing new production facilities, refurbishing reactors, and developing accelerator-based isotope production options.
Can alternative imaging agents replace DRAXIMAGE MDP-25?
Alternatives exist, such as PET tracers and other nuclear imaging agents, but DRAXIMAGE MDP-25 remains a standard in many diagnostic settings due to existing infrastructure and clinical familiarity.

References

U.S. Food and Drug Administration. DraxImage MDP-25 Product Information.
IAEA. Medicine and Radiation Safety.
Nordion. Mo-99 Supply Chain and Strategic Initiatives.
World Nuclear Association. Supply of Mo-99 for Nuclear Medicine.
DraxImage Inc. Corporate Website.

By understanding the underpinning supplier landscape and supply chain intricacies for DRAXIMAGE MDP-25, stakeholders can better navigate risks and optimize procurement strategies in the evolving nuclear medicine marketplace.

Suppliers and packagers for DRAXIMAGE MDP-25

DRAXIMAGE MDP-25

Suppliers for the Pharmaceutical Drug: DRAXIMAGE MDP-25