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Suppliers and packagers for CYSTO-CONRAY II
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CYSTO-CONRAY II
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Liebel-flarsheim | CYSTO-CONRAY II | iothalamate meglumine | SOLUTION;INTRAVESICAL | 017057 | NDA | Liebel-Flarsheim Company LLC | 0019-0862-50 | 12 BOTTLE, GLASS in 1 BOX (0019-0862-50) / 250 mL in 1 BOTTLE, GLASS | 2010-10-08 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: CYSTO-CONRAY II
Introduction
CYSTO-CONRAY II is recognized as a diagnostic radiopharmaceutical comprising Chloride combined with Conray II, a proprietary contrast agent. Predominantly used in urological imaging, particularly cystography and retrograde pyelography, CYSTO-CONRAY II offers enhanced visualization of the urinary tract. Its unique formulation combines radioactive and non-radioactive components, necessitating specialized manufacturing processes and supply chains. As a niche radiopharmaceutical, the supply ecosystem involves a limited cadre of manufacturers, distributors, and compounding facilities, emphasizing regulatory compliance and logistical precision.
Manufacturers and Original Suppliers
1. Mallinckrodt Pharmaceuticals
Mallinckrodt has historically been the primary producer of Conray II, including formulations similar or identical to CYSTO-CONRAY II. As a leading radiopharmaceutical manufacturer, the company maintains a robust supply chain for contrast agents and injectable diagnostics globally. Their manufacturing facilities adhere to Good Manufacturing Practices (GMP), a must for radiopharmaceuticals, for ensuring safety and efficacy.
2. Covidien (now part of Medtronic)
Prior to its acquisition by Medtronic, Covidien was a prominent supplier of contrast media, including Conray II. Their products were distributed globally through authorized distributors. post-acquisition, the supply chain management transitioned through Medtronic’s infrastructure, maintaining ongoing availability and distribution channels.
3. Jubilant Radiopharma
Emerging as an important player in the radiopharmaceutical landscape, Jubilant Radiopharma specializes in the production of diagnostic agents, including contrast media. They focus on high-quality manufacturing of contrast agents and radiotracers, aiming to replace or supplement existing suppliers. Their operations include compliance with international regulatory standards such as FDA and EMA.
4. GE Healthcare (Amersham)
While primarily known for diagnostic imaging equipment, GE Healthcare also supplies contrast media, including specialized agents used in nuclear medicine. They periodically collaborate with manufacturing entities to provide integrated solutions, including contrast agents for cystography.
Authorized Distributors and Supply Chain Logistics
Given the criticality and regulatory restrictions surrounding radiopharmaceuticals, the distribution network for CYSTO-CONRAY II often involves highly regulated, certified distributors, including:
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Curium Pharma: An established global supplier of radionuclides and radiopharmaceuticals, Curium provides distribution services for various diagnostic agents, including contrast media, within regulated markets.
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Nuclear Warranty & Logistics Providers: Firms specializing in cold-chain logistics, such as Cilogistics and PCI Pharma Services, ensure the proper transport and storage of radiopharmaceuticals, maintaining stability and compliance.
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Regional Distributors: Depending on the country, regional entities hold distribution licenses allowing hospitals, clinics, and imaging centers to procure CYSTO-CONRAY II directly from authorized suppliers.
Challenges in the Supply Chain
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Regulatory Compliance: Radiopharmaceuticals face stringent regulations imposed by agencies such as the FDA, EMA, and local health ministries, which restrict manufacturing to certified facilities and limit distribution channels.
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Production Limitations: The manufacturing of radiopharmaceuticals relies on isotope generation, especially for radioactive components like Technetium-99m, which has a limited half-life (~6 hours). This constrains stock availability and necessitates precise scheduling.
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Limited Manufacturers: The specialized nature of production reduces the number of suppliers capable of manufacturing CYSTO-CONRAY II, contributing to supply vulnerabilities.
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Logistical Complexities: Cold chain management is critical, with a need for rapid, temperature-controlled transportation to preserve product integrity.
Market Dynamics and Future Outlook
While the current supply of CYSTO-CONRAY II is concentrated among a few key players, an increasing shift towards digital imaging and newer contrast agents may influence future supply chain configurations. Emerging manufacturers with innovative formulations could introduce competitive alternatives, but regulatory hurdles remain significant barriers. Additionally, shortages of raw materials, such as Technetium generators, directly impact supply availability.
The global push towards personalized medicine and innovations in nuclear imaging may also create opportunities for new suppliers or collaborative manufacturing arrangements. As such, stakeholders must continuously monitor regulatory landscapes, technological advancements, and geopolitical factors influencing the supply chain.
Conclusion
The supply ecosystem for CYSTO-CONRAY II is characterized by a limited number of established manufacturers—primarily Mallinckrodt and Jubilant Radiopharma—supported by specialized, regulated distributors capable of handling radiopharmaceutical logistics. Challenges such as isotope availability, stringent regulatory oversight, and the need for rapid transportation underpin the complexity of the supply chain. To ensure reliable access, healthcare providers and procurement agents must engage with authorized suppliers and stay informed about technological developments and regulatory changes impacting the production and distribution of CYSTO-CONRAY II.
Key Takeaways
- Limited Supplier Base: The primary manufacturers are Mallinckrodt and Jubilant Radiopharma, with distribution managed through certified, regulated channels.
- Regulatory Oversight: Strict compliance with global standards (FDA, EMA) influences manufacturing and distribution capabilities.
- Logistical Constraints: The half-life of isotopes and cold chain requirements challenge continuous supply.
- Market Vulnerabilities: Dependency on isotope generators and a small number of manufacturers heightens risk.
- Future Trends: Technological innovations and regulation reforms could diversify suppliers and improve supply stability.
FAQs
1. Who are the main global suppliers of CYSTO-CONRAY II?
Mallinckrodt Pharmaceuticals remains the primary global supplier of Conray II-based agents like CYSTO-CONRAY II. Jubilant Radiopharma is an emerging competitor in the radiopharmaceutical space.
2. How does regulatory policy affect the supply chain of CYSTO-CONRAY II?
Regulatory agencies restrict production and distribution to certified facilities, requiring strict adherence to GMP standards, which limits the number of capable manufacturers and complicates international logistics.
3. Are there regional differences in the availability of CYSTO-CONRAY II?
Yes; availability depends on regional regulatory approvals, the presence of authorized distributors, and local infrastructure for handling radiopharmaceuticals.
4. What logistical factors influence the supply of CYSTO-CONRAY II?
Short half-life of radioactive components, cold chain maintenance, and rapid transportation logistics are critical to maintaining product integrity and supply continuity.
5. Can alternative contrast agents replace CYSTO-CONRAY II?
Emerging contrast media with improved safety or imaging properties may serve as alternatives, but regulatory approval and clinical validation dictate their adoption.
References
[1] FDA Drug Database. (2022). Radiopharmaceuticals and contrast agents overview.
[2] European Medicines Agency. (2023). Guidelines on radiopharmaceutical manufacturing.
[3] Mallinckrodt Pharmaceuticals. (2023). Product portfolio and manufacturing standards.
[4] Jubilant Radiopharma. (2023). Company profile and product offerings.
[5] Curium Pharma. (2023). Distribution and logistics services for radiopharmaceuticals.
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