Last updated: August 1, 2025
Introduction
OMNIPAQUE 12% (iohexol) is a widely used contrast agent in diagnostic imaging, particularly in computed tomography (CT) scans. Its medical efficacy hinges on its high-quality manufacturing and reliable supply chain, making suppliers’ credibility and capacity crucial for healthcare providers and pharmaceutical distributors. This article provides an in-depth analysis of the key suppliers for OMNIPAQUE 12%, highlighting their roles, market presence, and strategic significance within the global pharmaceutical supply chain.
Overview of OMNIPAQUE 12%
OMNIPAQUE 12% is an iodine-based contrast agent designed to enhance imaging of vascular and anatomical structures during diagnostic procedures. It is manufactured by GE Healthcare, a division of General Electric, which holds patent rights and relies on a network of manufacturing and distribution partners for supply consistency.
Manufactured under strict regulatory standards, OMNIPAQUE 12% is essential for radiologists and hospitals worldwide, necessitating a dependable supply chain to prevent shortages that could impact clinical outcomes.
Primary Manufacturer and In-House Production
GE Healthcare is the primary producer of OMNIPAQUE 12%. The company operates advanced manufacturing facilities globally, particularly in the United States and Europe. These facilities are certified under Good Manufacturing Practices (GMP) and regularly inspected by regulatory authorities such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
GE Healthcare ensures quality and consistency, leveraging a sophisticated quality control framework that encompasses raw material sourcing, production processes, and distribution logistics (see [1]).
Key Suppliers and Raw Material Procurement
The production of iohexol (the active pharmaceutical ingredient in OMNIPAQUE) depends on the procurement of high-grade raw materials, primarily iodine compounds, stabilizers, and excipients.
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Iodine Sources: Suppliers such as Ferro Corporation and Iofina provide pharmaceutical-grade iodine derivatives. These compounds are critical for the contrast agent's imaging properties and must comply with pharmaceutical purity standards.
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Excipients and Stabilizers: Contract manufacturers and chemical suppliers like Merck KGaA and BASF supply pharmaceutical excipients and stabilizing agents essential for formulation stability and shelf life.
The upstream supply chain’s robustness directly affects OMNIPAQUE 12%'s availability, with GE Healthcare maintaining long-term vendor relationships and contingency plans to mitigate risks associated with raw material shortages.
Distribution Partners and Regional Suppliers
While GE Healthcare manages the core manufacturing, distribution is facilitated through an expansive network of regional partners and distributors to ensure global reach.
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Global Distributors: Leading pharmaceutical distributors such as McKesson, Cardinal Health, and Medtronic serve as intermediaries, distributing OMNIPAQUE 12% to hospitals, imaging centers, and clinics worldwide.
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Regional Suppliers: In certain regions, local distributors and licensed pharmacies serve as primary suppliers. For example, in Europe, agents like Novartis and Lilly are involved in local distribution and regulatory compliance.
This multi-tiered distribution network ensures supply resilience and availability, especially in emerging markets.
Regulatory and Market Dynamics
The global supply of OMNIPAQUE 12% faces regulatory oversight that influences supplier selection and quality assurance. Manufacturers and distributors must adhere to regional regulatory frameworks such as the FDA’s Title 21 CFR and EMA directives.
Additionally, market dynamics—such as shortages due to manufacturing disruptions, raw material scarcity, or regulatory changes—can affect supplier capacity. Recent events such as the COVID-19 pandemic exposed vulnerabilities in global supply chains, prompting increased reliance on diversified suppliers and strategic stockpiles.
Emerging and Alternative Suppliers
Although GE Healthcare remains the dominant supplier, some competitors and biosimilar developers explore alternative contrast agents and generic versions, potentially impacting OMNIPAQUE 12%'s market share and supply consistency.
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Generics Manufacturers: Companies like Bayer Healthcare and local generic pharmaceutical firms are developing similar iodine-based contrast agents, which, if approved, could diversify supply sources.
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Innovation and Biosimilars: Research institutes and biotech firms are exploring new formulations and reduced iodine dose agents, possibly influencing future supplier landscapes.
However, regulatory hurdles and the need for extensive clinical validation limit rapid market entry of these alternatives.
Supply Chain Challenges and mitigation strategies
The supply of OMNIPAQUE 12% faces specific challenges:
- Raw Material Volatility: Fluctuations in iodine supply due to geopolitical factors can compromise manufacturing stability.
- Manufacturing Disruptions: Plant outages or quality control issues at GE or raw material suppliers cause temporary shortages.
- Regulatory Compliance: Stringent approvals and compliance requirements can delay distribution channels and volume capabilities.
To counteract disruptions, GE Healthcare and its partners invest in supply chain diversification, holding strategic inventories and establishing multiple sourcing options globally.
Conclusion
The supply of OMNIPAQUE 12% is predominantly anchored by GE Healthcare’s manufacturing capability, supplemented by raw material suppliers like Ferro Corporation and Iofina. The distribution network spans global pharmaceutical distributors and regional partners, ensuring broad availability. Market and regulatory challenges necessitate a resilient, diversified supply chain to sustain clinical demand.
Healthcare industry stakeholders should monitor raw material markets and regulatory developments to ensure uninterrupted access to this vital contrast agent.
Key Takeaways
- GE Healthcare dominates OMNIPAQUE 12% production, ensuring quality control and regulatory compliance.
- Raw material suppliers like Ferro Corporation and Iofina are crucial to maintaining production capacity.
- Global distribution networks comprising major pharmaceutical distributors facilitate widespread delivery.
- Supply chain risks include raw material shortages, manufacturing disruptions, and regulatory delays.
- Diversification strategies and inventory management are critical in mitigating supply chain vulnerabilities.
FAQs
1. Who are the main suppliers of raw materials for OMNIPAQUE 12%?
Ferro Corporation and Iofina are primary suppliers of pharmaceutical-grade iodine derivatives used in manufacturing OMNIPAQUE 12%.
2. Does GE Healthcare rely on third-party manufacturers for OMNIPAQUE 12%?
While GE Healthcare manages core manufacturing internally, it collaborates with various regional distributors and logistics partners for distribution, though the core production facilities are primarily owned and operated by GE.
3. Are there any competitors to OMNIPAQUE 12%?
Yes, other iodine-based contrast agents from companies like Bayer Healthcare and emerging generics serve as alternatives, though OMNIPAQUE maintains a significant market share due to its efficacy and regulatory approval.
4. How does supply chain disruption affect OMNIPAQUE availability?
Disruptions in raw material supply, manufacturing capacity, or regulatory compliance can lead to shortages, impacting clinical procedures relying on this contrast agent.
5. What strategies are employed to ensure continuous supply of OMNIPAQUE 12%?
GE Healthcare employs supply chain diversification, inventory management, and contingency planning to mitigate risks and maintain steady availability.
Sources
- GE Healthcare, "Manufacturing and Quality Standards," GE Healthcare Corporate Website.
