Last updated: August 6, 2025
Introduction
OMNIPAQUE 210 is a contrast agent primarily used for imaging procedures such as computed tomography (CT). Its active ingredient, iohexol, is a non-ionic, iodinated contrast medium designed to enhance the visibility of vascular structures and tissues during diagnostic imaging. The global supply chain for OMNIPAQUE 210 is managed by multiple pharmaceutical manufacturers, wholesalers, and authorized distributors, ensuring the availability of this critical diagnostic tool worldwide. Understanding the key suppliers, their roles, and the broader market landscape is essential for healthcare providers, procurement professionals, and stakeholders aiming to assure supply security and compliance.
Manufacturing and Approved Suppliers of OMNIPAQUE 210
Market Overview
Cilag AG, a subsidiary of GE Healthcare, developed OMNIPAQUE 210 (also listed as Iohexol 210 mg I/mL), which has received regulatory approvals from the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other national agencies. These approvals authorize manufacturers to produce and distribute the drug within designated jurisdictions.
Multiple pharmaceutical firms hold manufacturing licenses for OMNIPAQUE 210 globally, with regional variations based on licensing agreements, patent safety, and manufacturing capacity.
Primary Manufacturers
1. GE Healthcare (Cilag AG)
GE Healthcare, through Cilag AG, is the principal manufacturer and marketer of OMNIPAQUE 210. Their facilities in Europe and North America produce both the drug and its formulation components, fulfilling global demand. GE Healthcare's reputation and extensive distribution network make it the primary supplier for many markets.
2. Other Licensed Manufacturers
While GE holds the majority of manufacturing rights, some regional markets leverage licensed production from authorized contract manufacturers under strict quality controls and regulatory oversight. These include certified generic companies and regional pharmaceutical producers authorized by regulatory agencies to produce iohexol formulations.
Distribution Channels
Suppliers distribute OMNIPAQUE 210 via a wide network comprising:
- Direct Sales: GE Healthcare's own sales force supplies large hospitals, imaging centers, and specialty clinics directly.
- Regional Distributors: Authorized regional distributors handle logistics, warehousing, and local compliance.
- Pharmaceutical Wholesalers: Major healthcare distributors such as McKesson, Cardinal Health, and AmerisourceBergen stock and supply OMNIPAQUE 210 to healthcare providers.
Global and Regional Supplier Landscape
North America
In North America, GE Healthcare is the predominant supplier, authorized to distribute OMNIPAQUE 210 through direct channels and major national distributors. The FDA approval facilitates its widespread procurement by hospitals and imaging centers.
European Market
In Europe, Cilag AG’s manufacturing facilities supply OMNIPAQUE 210 under the CE mark and other regional certifications. Several licensed generic manufacturers also operate within the EU, adhering to strict Good Manufacturing Practice (GMP) standards, ensuring supply continuity.
Asia-Pacific
Asia-Pacific markets feature a mix of regional subsidiaries of GE Healthcare and third-party licensed manufacturers. Local regulatory approval processes influence the number and capacity of suppliers, with large healthcare providers often sourcing directly from GE or licensed regional producers.
Emerging Markets
Emerging markets typically depend on regional authorized distributors and generic manufacturers licensed under local regulatory authorities. Such countries may experience fluctuating supply levels, emphasizing the importance of strategic procurement planning.
Regulatory and Supply Chain Considerations
Maintaining a steady supply of OMNIPAQUE 210 hinges on regulatory compliance, patent protections, and manufacturing capacity. Any disruptions, such as factory outages, regulatory actions, or global shortages of raw iodinated contrast agents, can impact availability.
Enhanced manufacturing alliances and diversification strategies are common among healthcare providers and procurement agencies to mitigate such risks. Notably, the COVID-19 pandemic underscored vulnerabilities in global supply chains, prompting more robust supplier vetting and inventory management protocols.
Notable Suppliers and Distribution Partnerships
| Supplier/Distributor |
Region |
Notes |
| GE Healthcare |
Global |
Principal manufacturer and primary supplier |
| McKesson |
North America |
Major distributor, broad hospital network |
| Cardinal Health |
North America |
Extensive logistics and supply chain expertise |
| Fuji Pharma Group |
Asia-Pacific |
Licensed regional manufacturer |
| Sanofi-Aventis |
Some markets |
Licensed generic producer in select regions |
Future Outlook
The pharmaceutical landscape forecasts increased manufacturing capacity through technology upgrades and regional production hubs. Moreover, global health initiatives emphasize supply chain resilience, encouraging suppliers to bolster inventories and diversify sources.
Advancements in contrast agent formulations and increasing regulatory scrutiny demand ongoing compliance and licensing renewals, which influence the availability of OMNIPAQUE 210.
Key Takeaways
- Dominant Manufacturer: GE Healthcare remains the primary global supplier of OMNIPAQUE 210, supported by a network of authorized regional distributors.
- Regional Variance: Supply chains differ substantially by region, with local manufacturers and distributors playing pivotal roles, especially in emerging markets.
- Supply Chain Resilience: Diversification and strategic inventory management are critical in mitigating disruptions caused by manufacturing issues or regulatory changes.
- Regulatory Impact: Continued compliance with FDA, EMA, and local authorities ensures uninterrupted supply.
Frequently Asked Questions (FAQs)
1. Who are the main suppliers of OMNIPAQUE 210 globally?
The principal supplier is GE Healthcare (Cilag AG), with additional licensed manufacturers and authorized distributors operating regionally.
2. How does supply vary across different regions?
Supply chains are region-specific, with GE Healthcare dominating developed markets, while emerging economies depend more heavily on licensed local manufacturers and distributors.
3. Are there alternative contrast agents to OMNIPAQUE 210?
Yes. Other iodinated contrast media such as Isovue, Ultravist, and Telebrix are used depending on clinical needs; however, supply continuity for OMNIPAQUE 210 depends on the primary suppliers and licensing agreements.
4. What factors influence the availability of OMNIPAQUE 210?
Manufacturing capacity, regulatory approvals, raw material supply (iodinated compounds), and logistical logistics significantly influence product availability.
5. Can healthcare providers switch between contrast agents easily?
Switching involves clinical considerations, approval processes, and procurement adjustments. Physicians must evaluate compatibility, patient safety, and regulatory guidelines.
References
- GE Healthcare. (2022). OMNIPAQUE Product Information. [Online] Available at: https://www.gehealthcare.com/products/medical-imaging/contrast-agents/omnipaque
- U.S. Food and Drug Administration. (2021). FDA Approval of Iohexol. [Online] Available at: https://www.fda.gov
- European Medicines Agency. (2020). Marketing Authorization for Iohexol. [Online] Available at: https://www.ema.europa.eu
- Market research reports on contrast media production and distribution.
- Industry expert analyses on global contrast agent supply chains.
