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Suppliers and packagers for RENOVIST II
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RENOVIST 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 |
|---|---|---|---|---|---|---|---|---|---|
| Bracco | RENOVIST II | diatrizoate meglumine; diatrizoate sodium | INJECTABLE;INJECTION | 010040 | NDA | BRACCO DIAGNOSTICS INC | 0270-0149-57 | 10 BOTTLE in 1 PACKAGE (0270-0149-57) / 300 mL in 1 BOTTLE | 1970-11-03 |
| Bracco | RENOVIST II | diatrizoate meglumine; diatrizoate sodium | INJECTABLE;INJECTION | 010040 | NDA | BRACCO DIAGNOSTICS INC | 0270-0149-60 | 10 BOTTLE in 1 PACKAGE (0270-0149-60) / 100 mL in 1 BOTTLE | 1970-11-03 |
| Bracco | RENOVIST II | diatrizoate meglumine; diatrizoate sodium | INJECTABLE;INJECTION | 010040 | NDA | BRACCO DIAGNOSTICS INC | 0270-1410-30 | 10 BOTTLE in 1 PACKAGE (0270-1410-30) / 300 mL in 1 BOTTLE | 1982-11-09 |
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Suppliers for the Pharmaceutical Drug: RENOVIST II
Introduction
RENOVIST II is a contrast agent primarily used in medical imaging procedures such as computed tomography (CT) scans. It is a niche pharmaceutical product produced by specific manufacturers with regulated supply chains. The importance of reliable suppliers for RENOVIST II hinges on regulatory compliance, consistent drug quality, and timely distribution to healthcare providers. This report offers a comprehensive overview of the key suppliers and manufacturing entities for RENOVIST II, elucidates the regulatory landscape affecting supply chains, and assesses strategic considerations for stakeholders.
Overview of RENOVIST II
RENOVIST II, known generically as a contrast agent containing ioversol, is a non-ionic, amino-sugar derivative developed by Bracco Imaging. It functions by enhancing imaging contrast in vascular and tissue structures during diagnostic imaging procedures. As a contrast medium, RENOVIST II’s production involves complex chemical synthesis, stringent quality controls, and adherence to regulatory standards (e.g., EMA, FDA).
Major Manufacturers and Suppliers
1. Bracco Imaging S.p.A.
Primary Manufacturer and Proprietor
As the originator, Bracco Imaging S.p.A. (Italy) has the exclusive rights for the production and global distribution of RENOVIST II. Their manufacturing facilities in Europe are equipped with advanced biopharmaceutical manufacturing capabilities compliant with Good Manufacturing Practice (GMP) standards. Bracco’s global supply network is extensive, serving hospitals and imaging centers worldwide.
Supply Chain Specifics
- Bracco maintains centralized production of ioversol, which is then formulated into RENOVIST II.
- The company employs a just-in-time manufacturing process to meet global demand.
- It collaborates with certified third-party logistics providers for distribution.
2. Contract Manufacturing Organizations (CMOs)
While Bracco retains control of core manufacturing processes, it also leverages CMOs for specific components or pharmaceutical stages to scale production or reduce costs. Notably:
- GE Healthcare and Novartis have supplied similar contrast agents, but there is limited evidence of their involvement in RENOVIST II production explicitly.
- CMOs specializing in sterile fill-finish and formulation processes are employed by Bracco, including European-based facilities adhering to EU-GMP standards.
3. Regional Distributors and Local Suppliers
- Regional Distributors: In various markets, local distributors act as intermediaries, ensuring supply to healthcare providers.
- Authorized Distributors: Bracco’s authorized distributors are certified under international distribution standards, ensuring supply chain integrity.
Regulatory and Certification Impact on Suppliers
The supply chain for RENOVIST II is heavily regulated:
- European Medicines Agency (EMA): Approves manufacturing sites and distribution licenses within the EU.
- U.S. Food and Drug Administration (FDA): For markets in the United States, FDA approval and inspection records are critical.
- Good Manufacturing Practice (GMP): Mandates high-quality production standards; suppliers must maintain GMP certifications.
Any disruptions or lapses in these standards may impact supply continuity or result in recalls.
Supply Challenges and Considerations
- Manufacturing Complexities: The chemical synthesis of ioversol requires high precision and strict quality control.
- Regulatory Authorizations: Gaining and maintaining marketing authorization for RENOVIST II across different regions is complex and influences manufacturing decisions.
- Supply Chain Disruptions: Political, logistical, and pandemic-induced disruptions have affected global supply chains, emphasizing the need for diversified sourcing and strategic stockpiling.
Future Outlook and Strategic Risks
The future availability of RENOVIST II hinges on:
- Patent Expiry and Generic Development: As patents expire, generic manufacturers may enter the market, increasing competition and supply sources.
- Supply Chain Diversification: Stakeholders should consider identifying alternative CMO partnerships and regional suppliers to mitigate risk.
- Regulatory Pathways: Fast-track approvals in emergent markets could expand supply options, but also introduce quality variability.
Key Takeaways
- Primacy of Bracco Imaging: As the original producer, Bracco is the central figure in the supply of RENOVIST II, with tightly controlled manufacturing and distribution.
- Supply Chain Complexity: The manufacturing process’s complexity and strict regulatory oversight limit the number of reliable suppliers.
- Global Market Dependence: The supply chain's integrity depends heavily on regional distributors and logistics providers who maintain compliance and quality.
- Risks and Opportunities: Regulatory, geopolitical, and pandemic-related disruptions pose risks, but expiration of patents and emergence of generics could diversify supply options.
- Strategic Preparedness: Healthcare providers and distributors should develop contingency plans, including diversified sourcing and inventory management strategies.
FAQs
1. Who are the primary suppliers of RENOVIST II globally?
Bracco Imaging S.p.A. remains the sole primary manufacturer and global supplier owing to proprietary manufacturing processes and regulatory approvals. The company relies on a network of authorized regional distributors to ensure product availability.
2. Can generic versions of RENOVIST II replace branded formulations?
Potentially, yes. Once patents expire, generic manufacturers can produce bioequivalent contrast agents. However, regulatory approval and clinical acceptance may take time, impacting immediate supply.
3. What regulatory bodies oversee the manufacture and supply of RENOVIST II?
The European Medicines Agency (EMA) oversees manufacturing within the EU, while the FDA regulates production and distribution within the US. Both require compliance with GMP standards.
4. Are there risks associated with supply chain disruptions for RENOVIST II?
Yes. Disruptions can originate from manufacturing issues, logistical challenges, regulatory delays, or geopolitical events. Diversification of suppliers and regional manufacturing can mitigate these risks.
5. How does patent status influence the supply of RENOVIST II?
If patents remain active, production is limited to Bracco or authorized licensees. Patent expiration opens the market to generic producers, increasing supply options but also potentially impacting pricing and quality control processes.
Conclusion
The supply landscape for RENOVIST II revolves centrally around Bracco Imaging’s manufacturing ecosystem, constrained by regulatory standards and manufacturing complexity. While the current supply chain is robust, emerging generic competition and geopolitical factors necessitate strategic planning by stakeholders. Ensuring supply security will require ongoing regulatory compliance, diversification of manufacturing sources, and vigilant market monitoring.
References
- Bracco Imaging. (2022). "About RENOVIST II." [Online] Available at: https://www.braccoimaging.com
- European Medicines Agency (EMA). "Guidelines on Good Manufacturing Practice." EMA, 2021.
- U.S. Food and Drug Administration (FDA). "Approved Drugs and Biologics." FDA, 2022.
- Market analyses on contrast agents and generics, IQVIA Reports, 2022.
- Industry Reports on Medical Imaging Contrast Agents Supply Chains, Pharma Intelligence, 2022.
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