Last updated: July 31, 2025
Introduction
OMNIPAQUE 300 is a licensed contrast agent used primarily in radiology for diagnostic imaging procedures, notably computed tomography (CT). With a high iodine content of 300 mg/mL, it enhances the visibility of vascular and organ structures, aiding clinicians in accurate diagnosis. As a widely used product in medical imaging, the supply chain for OMNIPAQUE 300 encompasses multiple manufacturers, distributors, and authorized suppliers globally. This report provides a comprehensive overview of key suppliers, their market positioning, and the regulatory landscape influencing procurement strategies for OMNIPAQUE 300.
Manufacturers of OMNIPAQUE 300
1. GE Healthcare
Overview:
GE Healthcare is the primary manufacturer of OMNIPAQUE, under license from Bracco Imaging. The company is a global leader in medical imaging and diagnostic solutions with an extensive distribution network.
Production & Distribution:
GE Healthcare's manufacturing facilities are located across North America, Europe, and Asia, ensuring broad supply capabilities. The company maintains strict compliance with Good Manufacturing Practices (GMP) and regulatory standards from agencies such as the FDA (U.S. Food and Drug Administration) and EMA (European Medicines Agency).
Market Reach:
GE Healthcare supplies OMNIPAQUE 300 directly to hospitals, radiology centers, and authorized distributors worldwide. The company's vast logistics network ensures availability across developed and emerging markets.
2. Bracco Imaging
Overview:
Bracco Imaging, an Italy-based multinational, originally developed OMNIPAQUE (marketed as Oxilan in some regions). The company retains licensing rights in several territories and supplies the product through their regional subsidiaries and authorized distributers.
Regulatory Influence:
Bracco's global footprint is supported by a robust regulatory framework, facilitating smooth approval and distribution, especially within Europe and parts of Asia.
Supply Chain Dynamics:
Bracco manages a centralized manufacturing process in Europe, with regional distribution hubs to serve local markets efficiently.
Authorized Distributors and Regional Suppliers
While GE Healthcare and Bracco Imaging are the primary manufacturers, several regional distributors serve as crucial supply channels, especially in markets where local registration and distribution licensing are required.
North America
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McKesson Medical-Surgical:
A major distributor supplying OMNIPAQUE 300 to hospitals and clinics across the United States.
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Medline Industries:
Offers a range of diagnostic contrast agents through hospital networks and direct procurement channels.
Europe
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VWR International:
Distributes OMNIPAQUE via authorized channels, ensuring compliance with EU regulations.
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Henry Schein:
Supplies contrast media through its extensive European network.
Asia-Pacific
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Suzhou Yuyue Medical Equipment & Supply Co., Ltd.:
Authorized regional supplier that handles distribution within China.
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Alibaba and Alibaba-affiliated vendors:
Although not officially approved, some third-party vendors might sell OMNIPAQUE; however, procurement from such sources entails significant regulatory and safety risks.
Emerging Markets
- Local distributors and regional pharma companies often partner with GE or Bracco for localized distribution, especially where direct market entry is limited by regulatory or logistic barriers.
Regulatory and Supply Considerations
The supply chain for OMNIPAQU E 300 is regulated by stringent medical device and pharmaceutical standards:
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Regulatory Approvals:
Suppliers must secure approvals from relevant countries' health authorities, such as the FDA (U.S.), EMA (Europe), PMDA (Japan), and others.
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Supply Chain Integrity:
Due to the critical nature of contrast agents, suppliers must maintain cold chain logistics, accurate batch tracking, and compliance with GMP.
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Patent & Licensing:
The patent rights and licensing agreements affect the manufacturing rights and distribution channels, with modifications in certain markets due to patent expiration or licensing changes.
Emerging Trends
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Manufacturing Consolidation:
Mergers and acquisitions among pharmaceutical giants could influence market share and supply stability for OMNIPAQUE 300.
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Sourcing from Multiple Suppliers:
Hospitals increasingly diversify suppliers to mitigate geopolitical risks or supply disruptions.
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Localized Manufacturing:
Some regions are developing local or regional manufacturing to ensure supply continuity amid global disruptions such as pandemics or trade restrictions.
Key Challenges in the Supply Chain
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Regulatory Hurdles:
Variations in approval processes and safety standards can delay or limit supply.
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Supply Disruptions:
Global events, including the COVID-19 pandemic, have highlighted vulnerabilities in manufacturing and logistic chains.
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Pricing & Reimbursement Policies:
Price controls and reimbursement frameworks influence procurement strategies and supplier choice.
Conclusion
OMNIPAQUE 300's supply landscape involves a limited but strategically dispersed group of key manufacturers, primarily GE Healthcare and Bracco Imaging, complemented by a network of regional authorized distributors. Ensuring consistent, compliant procurement requires navigating regulatory frameworks, understanding regional market dynamics, and maintaining supply chain resilience. As medical imaging demands grow, the strategic sourcing of OMNIPAQUE 300 will remain critical for healthcare providers aiming to deliver accurate, timely diagnoses.
Key Takeaways
- Primary suppliers include GE Healthcare and Bracco Imaging, both with global manufacturing and distribution capabilities.
- Regional distributors serve as critical links, particularly in North America, Europe, and Asia-Pacific.
- Regulatory compliance with agencies like the FDA and EMA governs manufacturing, distribution, and procurement practices.
- Supply chain resilience is increasingly vital amid geopolitical, logistical, and pandemic-related disruptions.
- Diversification strategies and localized manufacturing are emerging trends to secure consistent supply.
FAQs
1. Who are the main manufacturers of OMNIPAQUE 300?
The primary manufacturers are GE Healthcare and Bracco Imaging, both holding licensing and production rights for this contrast agent.
2. Can I source OMNIPAQUE 300 from regional distributors directly?
Yes, hospitals and clinics typically procure through authorized regional distributors, but must ensure compliance with regional regulatory standards.
3. Are there alternative contrast agents to OMNIPAQUE 300?
Yes, alternative iodine-based contrast agents from different manufacturers exist, such as Isovue (Bracco) and Visipaque (GE), but select based on clinical suitability and procurement availability.
4. What are the regulatory challenges associated with OMNIPAQUE 300 supply?
Regulatory approvals vary by country, and modifications can impact manufacturing licenses, leading to supply delays or restrictions in certain regions.
5. How has the COVID-19 pandemic affected OMNIPAQUE 300 supply chains?
The pandemic has disrupted manufacturing and logistics, prompting suppliers and healthcare providers to diversify suppliers and build inventory buffers to ensure continuous availability.
Sources
- GE Healthcare. Omnipaque 300. [Online]. Available: https://www.gehealthcare.com/products/contrast-agents/omnipaque
- Bracco Imaging. Contrast Media Portfolio. [Online]. Available: https://www.bracco.com/contrast-media
- FDA Database. Approved Drug Products with Therapeutic Equivalence Evaluations.
- European Medicines Agency (EMA). Summary of Product Characteristics for Omnipaque.
- Industry Reports on Medical Imaging Contrast Agents Market, 2022.
