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Suppliers and packagers for DRAXIMAGE MDP-10
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DRAXIMAGE MDP-10
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Jubilant | DRAXIMAGE MDP-10 | 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 |
Suppliers for the Pharmaceutical Drug: DRAXIMAGE MDP-10
Introduction
DRAXIMAGE MDP-10 is a targeted medical imaging agent used primarily in diagnostic nuclear medicine. It is a technetium-99m (Tc-99m) labeled radiopharmaceutical, designed for imaging purposes. Its significance lies in its ability to improve the detection and assessment of certain types of cancer and other pathological conditions through precise imaging, significantly enhancing diagnostic accuracy. As with many radiopharmaceuticals, the supply chain for DRAXIMAGE MDP-10 involves various specialized suppliers—from manufacturing facilities producing the active pharmaceutical ingredient (API) and the radiolabeling kits to distributors facilitating clinical access. This article explores the key suppliers, manufacturing processes, and distribution channels critical to the availability of DRAXIMAGE MDP-10.
Manufacturers of DRAXIMAGE MDP-10
1. NDA Group and Structure of Supply
The core manufacturer associated with DRAXIMAGE MDP-10 is DraxImage Inc., a Canadian-based biopharmaceutical company specializing in radiopharmaceuticals for diagnostic imaging. DraxImage plays a pivotal role in the formulation and production of the MDP-10 kit, overseeing quality standards and regulatory compliance necessary for global distribution.
2. Production of Rhenium-188 Radiolabels and Related Components
Though DRAXIMAGE MDP-10 uses technetium-99m, the manufacturing process often involves the use of molybdenum-99 (Mo-99), which supplies the Tc-99m generator. Suppliers of these generators significantly impact the availability of radiopharmaceuticals:
- Mallinckrodt: Supplies Mo-99/technetium-99m generators globally, which are fundamental for radiolabeling kits, including MDP-10.
- Curium Pharma: A key provider of Mo-99 generators in Europe, ensuring stable, high-quality supplies for radiolabeling.
3. Kit Components and Radiopharmaceuticals Suppliers
The MDP-10 kit contains lyophilized components that bind technetium-99m for imaging purposes. These components are manufactured by specialized pharmaceutical companies:
- DraxImage Inc. itself produces the MDP-10 kits, which are supplied directly to hospitals and clinical centers.
- Lantheus Medical Imaging: A significant global supplier of radiopharmaceuticals, including imaging agents and kit components, with distribution networks spanning North America, Europe, and Asia.
- Bracco Diagnostics: Supplies radiolabeling kits comparable to MDP-10, although specific access to DRAXIMAGE products may vary regionally.
Distribution and Supply Chain
1. Distribution Networks
Distribution of DRAXIMAGE MDP-10 involves regional distributors licensed to handle radiopharmaceuticals due to their radioactive nature and regulatory restrictions. Notable distributors include:
- GE Healthcare: Engages in the distribution of contrast agents and radiopharmaceuticals in partnership with local providers.
- Medi-Pharm and Blue Earth Diagnostics: Key distribution partners providing radiopharmaceutical kits and imaging agents in North America and Europe.
2. Logistics and Handling
The supply chain requires strict adherence to radioactive material handling regulations. Logistics providers like BD Medical and specialized couriers (e.g., FedEx Express, DHL Global Forwarding) utilize temperature-controlled, secure transport to ensure the integrity of the radiopharmaceuticals during transit.
3. Regulatory Approvals and Certifications
Manufacturers and distributors must obtain approvals from mounting regulatory bodies, including:
- U.S. Food and Drug Administration (FDA)
- European Medicines Agency (EMA)
- Health Canada
These approvals facilitate the lawful distribution of DRAXIMAGE MDP-10 within respective jurisdictions, ensuring quality and safety.
Market Players and Competitive Landscape
1. Key Suppliers in the Radiopharmaceutical Market
Beyond DraxImage, several entities impact the supply dynamics:
- Lantheus Medical Imaging: As a global leader, Lantheus supplies Technetium generators, radiolabeling kits, and imaging agents.
- Curium Pharma: Their Mo-99 supply chain is crucial for U.S. and European markets.
- NTP Radioisotopes: Provides alternative Mo-99 generators in select markets, diversifying supply sources.
- Iterative Innovation Companies: Several emerging firms are developing alternative radiopharmaceuticals aiming to replace or supplement MDP-10, potentially impacting long-term supply strategies.
2. Regional Variations
Supply chains vary by region due to differing regulatory environments and manufacturing capacity. North America primarily depends on Mallinckrodt and GE Healthcare, while Europe benefits from Curium Pharma and Lantheus. Emerging markets may source radiopharmaceuticals from local or regional manufacturers due to logistical or regulatory constraints.
Challenges and Future Outlook
1. Supply Chain Disruptions
Global dependency on Mo-99 generators makes the supply vulnerable to reactor maintenance, regulatory shifts, and geopolitical issues. The recent shutdowns of aging reactors underscore vulnerability, urging diversification strategies, including:
- Development of reactor-independent technetium production.
- Innovation in alternative radiolabeling methods.
2. Technological Advancements
Investments into cyclotron-based production or alternative imaging agents could reduce dependency on reactor-produced Mo-99, stabilizing supplies for kits like DRAXIMAGE MDP-10.
3. Regulatory and Market Shifts
Changing regulatory landscapes, especially in Europe and North America, aim to streamline approval processes and ensure safety, which could impact supply channels by either constraining or expanding access.
Key Takeaways
- Primary Manufacturers: DraxImage Inc. monopolizes the formulation and packaging of DRAXIMAGE MDP-10, relying on Mo-99 generators supplied mainly by Mallinckrodt and Curium Pharma.
- Distribution: Licensed regional distributors and logistic companies specializing in radioactive materials sustain the supply chain, adhering to rigorous regulatory standards.
- Challenges: The dependency on aging nuclear reactors and limited Mo-99 production capacity pose risks; diversification and innovation remain priorities.
- Market Dynamics: Competition among radiopharmaceutical providers influences pricing, availability, and innovation projects.
- Future Outlook: Advances in accelerator-based production and regulatory reforms could reshape supplier landscapes and improve global access.
FAQs
1. Who are the main suppliers of DRAXIMAGE MDP-10?
DraxImage Inc. manufactures the MDP-10 kits, while Mo-99 generators from companies like Mallinckrodt and Curium Pharma supply the radioactive component essential for the kit’s activation.
2. How does the supply chain for DRAXIMAGE MDP-10 work globally?
Regional distributors licensed to handle radioactive materials distribute the kits, with logistics providers ensuring safe, temperature-controlled transit. Regulatory approvals vary by country, shaping regional supply chains.
3. What are the vulnerabilities in the supply chain of DRAXIMAGE MDP-10?
Reliance on aging nuclear reactors and limited Mo-99 production capacity lead to supply shortages. Geopolitical issues and regulatory hurdles further exacerbate vulnerabilities.
4. Are there alternative suppliers or technologies emerging for imaging agents like MDP-10?
Yes. Developments include cyclotron-based technetium production, which seeks to reduce dependency on nuclear reactors, along with new imaging agents offering improved diagnostic capabilities.
5. What role do regulatory bodies play in the supply of DRAXIMAGE MDP-10?
Regulatory bodies like the FDA and EMA ensure quality, safety, and efficacy. They oversee manufacturing, licensing, and distribution, which directly influence the availability of the drug across regions.
References
[1] DraxImage Inc. “About Us,” DraxImage, 2023.
[2] Mallinckrodt Pharmaceuticals. “Molybdenum-99 Generators,” Mallinckrodt, 2023.
[3] Curium Pharma. “Technetium Supply Chain,” Curium Pharma, 2023.
[4] Lantheus Medical Imaging. “Radiopharmaceutical Portfolio,” Lantheus, 2023.
[5] European Medicines Agency. “Radiopharmaceutical Approvals,” EMA, 2023.
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