Last updated: August 8, 2025
Introduction
OMNIPAQUE 180, known generically as iohexol, is a contrast agent widely used in diagnostic imaging, particularly in computed tomography (CT) procedures. Its ability to enhance imaging clarity makes it integral in medical diagnostics. As a crucial pharmaceutical product, OMNIPAQUE 180's supply chain is vital to healthcare providers worldwide. This article explores the primary suppliers, manufacturing landscape, and market dynamics pivotal to the procurement and distribution of OMNIPAQUE 180.
Overview of OMNIPAQUE 180
OMNIPAQUE 180 is a nonionic, iodine-based contrast agent developed by GE Healthcare, a unit of General Electric. It is formulated to provide high-quality imaging enhancement with a favorable safety profile. Approved by regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), OMNIPAQUE 180 meets stringent quality standards necessary for clinical use.
The formulation contains 180 mg/mL of iodine, suitable for various diagnostic procedures. Its stability, compatibility, and safety profile have established it as a preferred contrast agent in numerous healthcare settings globally.
Major Manufacturers and Licensed Suppliers
1. GE Healthcare
Primary Manufacturer
GE Healthcare remains the dominant producer and supplier of OMNIPAQUE 180, with manufacturing facilities spanning North America, Europe, and Asia. The company's production sites adhere to Good Manufacturing Practices (GMP), ensuring consistent quality and compliance with international standards.
Distribution Channels
GE Healthcare distributes OMNIPAQUE 180 through direct channels and authorized distributors worldwide. Its extensive logistics network facilitates timely delivery to hospitals, diagnostic clinics, and wholesalers.
2. Authorized Distributors and Regional Suppliers
Although GE Healthcare supplies the product directly to significant markets, numerous authorized regional distributors facilitate its distribution, especially in emerging markets:
- Asia-Pacific Region: Several local distributors in countries such as India, China, and Southeast Asian nations hold licensing agreements or authorized distributorships with GE Healthcare.
- Europe and North America: Major medical supply companies and pharmaceutical distributors serve as authorized channels.
Notable Distributors include:
- Becton Dickinson & Co. (BD): Provides distribution in certain regions under licensing agreements.
- Local regional distributors: These often operate under GE Healthcare's authorized network, ensuring compliance with regulatory requirements.
3. Contract Manufacturing and Licensing
In some jurisdictions, licensing agreements enable local pharmaceutical manufacturers to produce or distribute OMNIPAQUE 180 under authorized terms. Such partnerships expand the product's availability while maintaining quality standards.
Example:
- In certain Asian markets, regional companies hold licensing rights to manufacture iohexol formulations, ensuring affordability and supply chain resilience.
Market Dynamics and Supply Chain Considerations
Regulatory Approvals and Market Entry
To distribute OMNIPAQUE 180, suppliers must secure approval from relevant regulatory agencies such as the FDA, EMA, and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). These approvals ensure manufacturing practices, clinical safety, and efficacy standards are met.
Manufacturing Capacity and Challenges
The capacity of GE Healthcare’s manufacturing units influences supply stability. Disruptions such as the COVID-19 pandemic highlighted vulnerabilities in the supply chain, prompting the industry to diversify sourcing and bolster regional manufacturing efforts.
Global Demand and Supply Constraints
Increasing demand driven by the proliferation of diagnostic imaging procedures, especially in emerging markets, strains supply chains. Additionally, the complexity of manufacturing iohexol, requiring sensitive chemical processes, constrains rapid scaling.
Intellectual Property and Licensing
Within the pharmaceutical industry, patent protections and licensing agreements regulate the production and distribution rights of IOHEXOL. This control fosters quality assurance but may limit the number of suppliers, affecting pricing and availability.
Emerging Alternatives and Market Competition
While GE Healthcare remains the market leader, competition arises from other contrast agents:
- Iodixanol (Visipaque): A closed-configuration, iso-osmolar contrast agent, produced by GE Healthcare and other manufacturers.
- Ioversol (Optiray): Produced by Liebel-Flarsheim, competing in certain markets.
- Locally produced iohexol formulations: Emerging manufacturers in developing economies aim to capture market share by offering cost-effective alternatives under strict licensing.
However, the high clinical acceptance and regulatory validation of OMNIPAQUE 180 sustain its dominance.
Key Suppliers and Distribution Networks
| Supplier / Manufacturer |
Regions Covered |
Distribution Channels |
Regulatory Compliance |
| GE Healthcare |
Global |
Direct, Authorized Distributors |
FDA, EMA, PMDA approval |
| Regional Distributors |
Asia, Europe |
Local medical supply companies |
Local regulatory approvals |
| Licensed Local Manufacturers |
Asia, Latin America |
Contracted manufacturing under licensing |
Local and international standards compliance |
Supply Chain Challenges and Strategic Recommendations
- Diversify Suppliers: Dependence on a single manufacturer may pose risks; cultivating relationships with regional manufacturers under licensing agreements enhances resilience.
- Regional Manufacturing Expansion: Encouraging localized production reduces lead times and mitigates disruptions.
- Regulatory Harmonization: Streamlining approval processes accelerates market entry and supply stability.
- Inventory Management: Hospitals and distributors should adopt forecasting models to manage consumption surges and avoid shortages.
Conclusion
OMNIPAQUE 180’s supply chain is primarily anchored by GE Healthcare, supplemented by authorized regional distributors and licensed local manufacturers. The ongoing demand for diagnostic imaging maintains steady consumption and incentivizes investment in manufacturing capacity globally. However, supply chain vulnerabilities highlight the need for diversified sourcing, regional manufacturing expansion, and strategic partnerships to ensure uninterrupted availability.
Key Takeaways
- GE Healthcare remains the principal supplier of OMNIPAQUE 180, with extensive global manufacturing and distribution networks.
- Licensed regional manufacturers play a vital role in increasing accessibility, especially in emerging markets.
- Regulatory approval processes significantly influence supply availability and market entry timelines.
- Supply chain resilience can be strengthened through diversification, regional manufacturing, and inventory optimization.
- Monitoring market dynamics and technological advancements is essential for stakeholders aiming to secure a reliable supply of OMNIPAQUE 180.
FAQs
1. Who are the main global suppliers of OMNIPAQUE 180?
The primary supplier is GE Healthcare, supported by regional authorized distributors and licensed local manufacturers, especially in Asia-Pacific, Europe, and North America.
2. How does licensing impact the availability of OMNIPAQUE 180?
Licensing agreements allow local manufacturers to produce or distribute the drug, increasing regional availability while maintaining product quality and regulatory compliance.
3. What are typical supply chain challenges for OMNIPAQUE 180?
Challenges include manufacturing capacity limitations, regulatory approval processes, geopolitical factors, and global demand surges, especially during health crises like COVID-19.
4. Are there regional differences in suppliers for OMNIPAQUE 180?
Yes, regional suppliers vary, with GE Healthcare leading globally, and local distributors or licensed manufacturers filling gaps in specific markets.
5. What strategies can healthcare providers adopt to ensure continuous supply?
Providers should diversify vendor relationships, maintain safety stock, and collaborate with authorized distributors and regional manufacturers to mitigate risks.
References
- GE Healthcare. OMNIPAQUE Product Information. [Online] Available at: https://www.gehealthcare.com/products/contrast-agents/omnipaque
- U.S. Food and Drug Administration (FDA). OMNIPAQUE (iohexol) approval documentation. 2023.
- European Medicines Agency (EMA). Summary of Product Characteristics for OMNIPAQUE. 2023.
- Industry reports on contrast agent manufacturing and distribution. 2022.
- Market analysis of global pharmaceutical contrast agents. 2023.
