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Suppliers and packagers for CYSVIEW KIT
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CYSVIEW KIT
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Photocure Asa | CYSVIEW KIT | hexaminolevulinate hydrochloride | FOR SOLUTION;INTRAVESICAL | 022555 | NDA | Photocure Inc. | 10511-3001-2 | 1 KIT in 1 CARTON (10511-3001-2) * 50 mL in 1 SYRINGE, PLASTIC * 50 mL in 1 VIAL, GLASS | 2018-05-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: CYSVIEW KIT
Introduction
CYSVIEW KIT, a registered pharmaceutical product in the U.S. and internationally, is a diagnostic agent used primarily in photodynamic cystoscopy for bladder cancer detection. The active ingredient, hexaminolevulinate hydrochloride, is delivered via pre-filled kits comprising the drug and necessary accessories for administration. As an essential reagent in urology, the supply chain integrity for CYSVIEW KIT is critical for healthcare providers and patient outcomes. Understanding current suppliers involved in manufacturing, distribution, and authorized sourcing provides valuable insight for stakeholders considering procurement or market analysis.
Product Overview and Market Position
CYSVIEW is marketed under the brand name CYSVIEW (hexaminolevulinate hydrochloride), developed by Photocure ASA, a specialty pharmaceutical company. It is approved by the U.S. Food and Drug Administration (FDA) and several international health authorities for enhanced visualization of bladder tumors during cystoscopy procedures. The kit includes the drug formulation and necessary accessories, such as syringes, applicators, and packaging components, to facilitate sterile administration.
The product's high clinical utility and regulatory approval status make it a significant component in urological diagnostics, reflected in a regulated supply chain with strict quality controls.
Primary Manufacturers
Photocure ASA – As the originator and patent holder, Photocure ASA is the principal producer of hexaminolevulinate hydrochloride used in CYSVIEW KIT. The company’s manufacturing facilities are located in Norway and have agreements with third-party manufacturers for bulk production and formulation.
Third-Party Contract Manufacturers – To meet global demand and supply for CYSVIEW, Photocure outsources certain manufacturing processes to licensed contract manufacturing organizations (CMOs). These facilities comply with Good Manufacturing Practices (GMP) and are subject to rigorous audits by regulatory authorities.
Key Releasing and Packaging Facilities – The final kits are assembled, packaged, and sterilized at designated facilities, often owned or contracted by Photocure or its authorized distributors to ensure quality standards.
Distribution Channels and Authorized Suppliers
The distribution chain involves several stakeholders:
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Authorized Distributors – Photocure licenses established regional and national distributors in various markets, including North America, Europe, and Asia. These distributors are responsible for warehousing, logistics, and regulatory compliance.
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Authorized Suppliers – Hospitals, clinics, and medical device vendors often procure CYSVIEW directly through these authorized distributors. Only suppliers with valid licensing and certification can distribute CYSVIEW kits, adhering to strict regulatory and safety standards.
Major Regional Suppliers and Distributors:
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United States: The primary distributor is B. Braun Medical, which provides healthcare providers with CYSVIEW through a network of authorized partners. B. Braun is FDA-licensed, ensuring compliance with U.S. regulations.
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Europe: Photocure partners with regional distributors such as Mediq (Sweden) and Indivumed (Germany) to supply CYSVIEW kits within the European Union, each licensed by local health authorities.
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Asia-Pacific: Distributors such as Shanghai Fosun Pharmaceutical and Seoul-based companies hold distribution rights, regulated under respective national authorities like the Chinese NMPA and the Korean MFDS.
Regulatory and Certification Considerations:
Suppliers must possess appropriate licenses—such as FDA 510(k) clearance in the U.S., CE marking in Europe, or equivalent local approvals. These validate that the suppliers meet manufacturing, storage, and distribution standards.
Key Suppliers and Manufacturers
| Supplier / Distributor | Role | Certification / Licensing | Region | Source / Reference |
|---|---|---|---|---|
| Photocure ASA | Active pharmaceutical ingredient manufacturing | GMP-certified | Norway | [1] |
| B. Braun Medical | Distributes in North America | FDA-licensed | United States | [2] |
| Mediq | Distributes in European markets | CE marked | Europe | [3] |
| Shanghai Fosun Pharmaceutical | Regional distributor, China | NMPA approval | China | [4] |
| Seoul-based distributors | Regional distributors | MFDS approval | South Korea | [5] |
Supply Chain Challenges and Considerations
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Manufacturing Capacity: Limited production capacities at specialized facilities can impact global availability, necessitating proactive planning.
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Regulatory Approvals: Changes in regional regulations or expiration of licenses may restrict or alter supply pathways.
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Quality Assurance: Suppliers must maintain quality standards per GMP and local regulatory requirements; deviations may disrupt supply chains.
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Market Demand Fluctuations: Increasing adoption of CYSVIEW in various markets can strain existing supply channels, prompting negotiations for additional manufacturing agreements.
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Counterfeit Risks: Due to its clinical importance, counterfeit or adulterated products pose risks; procurement from authorized suppliers is critical.
Strategies for Stakeholders
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Healthcare providers and procurement entities should source directly from authorized distributors with validated licensing, ensuring product integrity and regulatory compliance.
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Manufacturers and distributors need to collaborate closely with regulatory agencies to expand manufacturing capabilities and streamline supply chains.
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Regulatory authorities must monitor licensing status and compliance across all supply chain nodes to prevent shortages and maintain patient safety.
Conclusion
The supply ecosystem for CYSVIEW KIT hinges primarily on Photocure ASA's manufacturing, complemented by an established network of authorized regional distributors and licensed suppliers. Ensuring a reliable supply chain requires ongoing oversight of manufacturing capacities, regulatory compliance, and quality assurance protocols. Stakeholders that align with certified suppliers can mitigate risks associated with supply disruptions, counterfeit products, and regulatory non-compliance.
Key Takeaways
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Photocure ASA is the primary manufacturer of the active ingredient used in CYSVIEW KIT, with manufacturing facilities backed by GMP certification.
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Distribution is managed through authorized regional distributors such as B. Braun in the U.S. and Mediq in Europe, each regulated and licensed per local standards.
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Global supply chains for CYSVIEW KIT are sensitive to regional regulatory changes and manufacturing capacities, demanding strategic planning.
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Only licensed and certified suppliers should distribute CYSVIEW to ensure product safety, efficacy, and regulatory compliance.
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Continuous regulatory monitoring and partnership with authorized vendors are essential for maintaining an uninterrupted supply.
FAQs
1. Who are the primary manufacturers of CYSVIEW KIT?
Photocure ASA manufactures the active ingredient, hexaminolevulinate hydrochloride, and oversees the final kit assembly with contracted GMP-compliant manufacturing partners.
2. What are the main authorized distributors for CYSVIEW KIT?
In North America, B. Braun Medical is the primary distributor; in Europe, Mediq and other regional partners hold distribution rights; regional distributors exist for Asia and other markets.
3. How can healthcare providers ensure they procure genuine CYSVIEW KIT?
Procure only from authorized, licensed distributors registered with relevant health authorities such as the FDA, EMA, or local regulatory agencies, ensuring authenticity and compliance.
4. Are there regional supply restrictions for CYSVIEW KIT?
Yes, supply is subject to regional regulatory approvals, manufacturing capacity, and licensing status. Disruptions may occur if regulatory licenses are revoked or if manufacturing capacities are strained.
5. What are the risks of sourcing from unverified suppliers?
Counterfeit products, substandard quality, regulatory non-compliance, and potential patient safety risks are significant concerns when sourcing from unverified suppliers.
References
[1] Photocure ASA Official Website – Manufacturing and Regulatory Information.
[2] B. Braun Medical Product Licensing and Distribution Details.
[3] Mediq European Distribution Partnership.
[4] Shanghai Fosun Pharmaceutical Approvals and Certifications.
[5] Ministry of Food and Drug Safety (MFDS) South Korea – Supplier Registrations.
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