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Suppliers and packagers for IODIXANOL
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IODIXANOL
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Hengrui Pharma | IODIXANOL | iodixanol | INJECTABLE;INJECTION | 214271 | ANDA | FRESENIUS KABI USA, LLC | 65219-381-10 | 10 BOTTLE, PLASTIC in 1 BOX (65219-381-10) / 100 mL in 1 BOTTLE, PLASTIC (65219-381-03) | 2022-06-21 |
| Hengrui Pharma | IODIXANOL | iodixanol | INJECTABLE;INJECTION | 214271 | ANDA | FRESENIUS KABI USA, LLC | 65219-381-50 | 10 BOTTLE, PLASTIC in 1 BOX (65219-381-50) / 150 mL in 1 BOTTLE, PLASTIC (65219-381-05) | 2022-06-21 |
| Hengrui Pharma | IODIXANOL | iodixanol | INJECTABLE;INJECTION | 214271 | ANDA | FRESENIUS KABI USA, LLC | 65219-383-05 | 10 BOTTLE, PLASTIC in 1 BOX (65219-383-05) / 50 mL in 1 BOTTLE, PLASTIC (65219-383-02) | 2022-06-21 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Iodixanol
Introduction
Iodixanol is a nonionic, iodinated derivative of D-glucitol used primarily as a contrast agent in radiographic imaging procedures such as computed tomography (CT) scans. Its high osmolality and low viscosity distinguish it from other iodine-based contrast agents, making it a preferred choice for certain diagnostic procedures. The demand for iodixanol drives a complex supply chain centered around specialized manufacturers, raw material producers, and regional distributors. This article offers a comprehensive overview of the leading suppliers, their manufacturing capabilities, geographic distribution, and strategic significance within the pharmaceutical and diagnostic imaging markets.
Market Overview of Iodixanol Suppliers
The global iodixanol market is characterized by a limited number of suppliers, predominantly because of the stringent regulatory landscape, high research and development (R&D) costs, and complex manufacturing processes involved. These factors deter new entrants and consolidate market power among established companies. Key players in the iodixanol supply chain include major pharmaceutical corporations and specialized biotech firms with proven expertise in manufacturing iodinated contrast agents.
Major Suppliers of Iodixanol
1. GE Healthcare (A Subsidiary of General Electric Company)
GE Healthcare is a principal global supplier of iodixanol under the brand name Visipaque. Since its FDA approval in 2004, Visipaque has become one of the most recognized iodixanol formulations. The company boasts extensive manufacturing facilities across North America, Europe, and Asia, ensuring widespread availability.
- Manufacturing Capabilities: GE Healthcare invests heavily in advanced production facilities equipped with state-of-the-art chromatography and purification technologies. These facilities adhere to Good Manufacturing Practices (GMP) to meet regulatory standards worldwide.
- Market Reach: As a market leader, GE Healthcare supplies iodixanol to over 150 countries, serving hospitals, clinics, and diagnostic imaging centers.
- Strategic Advantages: The company's global distribution network, robust R&D pipeline, and consistent quality assurance underpin its dominance.
2. Guerbet Group
Guerbet is a French-based pharmaceutical firm specializing in contrast agents and imaging solutions. Its flagship iodixanol product, branded as Visipaque, is a direct competitor to GE Healthcare's offering.
- Manufacturing Footprint: Guerbet has manufacturing sites in France, the U.S., and Asia, ensuring regional supply security.
- Product Portfolio: Besides iodixanol, Guerbet offers a diversified portfolio of contrast media, integrating iodixanol into its suite of imaging solutions.
- Strategic Focus: Guerbet emphasizes innovation in reducing contrast media-related side effects and enhancing patient safety.
3. Bayer AG
While Bayer's primary focus remains on other contrast agents such as iohexol, the company has historically supplied iodinated contrast media, including iodixanol variants, especially across European markets.
- Supply Chain Role: Bayer's role in iodixanol supply is declining due to strategic transition toward other imaging agents, but it remains a significant regional supplier.
- Manufacturing and Distribution: Bayer maintains manufacturing facilities in Germany and collaborates with regional distributors to ensure supply continuity.
4. Other Notable Suppliers
- Liebel-Flarsheim Company (Part of Monteris Medical): Smaller-scale but specialized in contrast media for specific segments.
- Indigenous Manufacturers: Certain regional players in Asia and Eastern Europe produce generic or locally formulated iodixanol products, often under private labels or as unbranded generics, influenced by patent expirations and regulatory approvals.
Raw Material Suppliers
The production of iodixanol requires high-purity chemical precursors, including iodine compounds and complex organic intermediates. Key raw material suppliers include:
- Iodine Producers: Companies such as Kemira and Iofina supply pharmaceutical-grade iodine, crucial for iodination steps.
- Organic Synthesis Intermediates: Specialty chemical firms like Evonik and BASF provide intermediates used in the synthesis of iodixanol.
The reliance on high-quality raw materials underscores the importance of strategic sourcing and supply chain stability, particularly given the potential for geopolitical disruptions.
Regulatory and Quality Considerations
Global regulatory agencies such as the FDA, EMA, and PMDA enforce strict controls over iodixanol manufacturing, necessitating compliance with Good Manufacturing Practices (GMP). Suppliers must maintain rigorous quality assurance protocols, including batch testing, endotoxin removal, and validation processes.
Regional Supply Dynamics
- North America and Europe: Dominated by GE Healthcare and Guerbet, supported by developed infrastructure and stringent quality controls.
- Asia-Pacific: Growing manufacturing capacity through regional subsidiaries and indigenous producers, driven by increasing demand for diagnostic imaging.
- Emerging Markets: Depend heavily on imported products from major suppliers, highlighting the importance of global logistics and distribution networks.
Strategic Implications
The limited number of primary suppliers creates a concentrated market, which can impact supply stability and pricing power. Companies investing in R&D, expanding manufacturing capacity, or forging strategic alliances can gain competitive advantages. Additionally, regional production centers help mitigate risks associated with geopolitical or supply chain disruptions.
Conclusion
The primary suppliers of iodixanol—GE Healthcare and Guerbet—command global market share, driven by their advanced manufacturing capabilities, R&D investments, and extensive distribution networks. Raw material procurement from specialized iodine producers further influences the supply chain's robustness. Despite high barriers to entry, regional manufacturers and generic producers are gradually expanding, particularly in emerging markets. Ensuring supply continuity and regulatory compliance remains critical for stakeholders navigating this specialized, high-demand segment of diagnostic imaging.
Key Takeaways
- Market Leaders: GE Healthcare and Guerbet dominate the iodixanol supply chain with extensive manufacturing and global distribution.
- Supply Chain Complexity: High-quality raw materials, strict regulatory standards, and GMP compliance define supplier selection.
- Regional Variability: North America and Europe rely primarily on established multinationals; Asia-Pacific shows increasing local production.
- Market Dynamics: Concentration among few suppliers necessitates strategic sourcing to mitigate supply risks.
- Future Outlook: Innovation and capacity expansion will likely influence supplier competitiveness and availability.
Frequently Asked Questions
1. What are the primary factors influencing iodixanol supplier selection?
Quality of raw materials, manufacturing capacity, regulatory compliance, geographical location, and cost of production are key considerations for pharmaceutical companies selecting iodixanol suppliers.
2. Are there generic or non-brand alternatives to Visipaque?
Yes, regional and generic manufacturers produce unbranded iodixanol formulations, often at lower costs, but they must meet strict regulatory standards for safety and efficacy.
3. How do regulatory standards impact iodixanol supply?
Regulatory agencies enforce quality, safety, and efficacy standards through GMP, requiring suppliers to maintain rigorous quality assurance processes, which can influence manufacturing capacity and market entry barriers.
4. Are there emerging markets for iodixanol, and who supplies them?
Yes, Asia-Pacific and Latin America show increasing demand, supplied mainly by regional manufacturing units or generic players entering the market due to patent expirations.
5. What future trends could impact iodixanol suppliers?
Advances in alternative imaging technologies, development of safer contrast agents, and regulatory shifts emphasizing patient safety could influence supplier market share and innovation strategies.
Sources:
[1] GlobalData. (2022). Market intelligence report on contrast agents.
[2] FDA Database. (2021). Approved drug products with therapeutic equivalence evaluations.
[3] Guerbet Group Official Website. (2023). Products and manufacturing overview.
[4] GE Healthcare. (2023). Visipaque product details and global manufacturing footprint.
[5] Iodine Industry Reports. (2022). Raw material supply chain analysis.
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