Last updated: August 20, 2025
Introduction
OMNIPAQUE 300, an iodine-based contrast agent, is employed primarily in radiographic imaging procedures such as computed tomography (CT) scans to enhance the visibility of vascular and organ structures. Its pharmaceutical formulation is known for its high osmolality and iodine concentration, facilitating diagnostic accuracy. The going market for OMNIPAQUE 300 is marked by a complex supply chain involving multiple suppliers, manufacturers, and licensing entities. This report examines the current supplier landscape for OMNIPAQUE 300, analyzing key manufacturers, supply chain dynamics, regulatory considerations, and implications for stakeholders.
Manufacturers of OMNIPAQUE 300
GE Healthcare (A GE Healthcare Brand)
GE Healthcare is the primary producer of OMNIPAQUE 300, a product under their contrast media portfolio. GE's pharmaceutical division has a long-standing history in medical imaging solutions, including contrast agents. The company manufactures OMNIPAQUE at its globally distributed facilities, adhering to stringent Good Manufacturing Practices (GMP). GE Healthcare's supply chain is robust, with regional manufacturing hubs in Europe, North America, and Asia, enabling widespread distribution. The company has invested heavily in capacity expansion to meet global demand, especially in light of increased imaging procedures globally.[1]
Distributor Network and Regional Suppliers
While GE Healthcare is the original manufacturer, several regional distributors and pharmaceutical suppliers procure OMNIPAQUE 300 to serve local markets. These include:
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Alcon (Novartis): In certain markets, Novartis subsidiaries distribute contrast media, although their primary portfolio focus is different; some regional licensing agreements may involve third-party suppliers for OMNIPAQUE.
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Medical supply distributors: Regional distributors such as ICU Medical (US), Medline, and other specialized radiology distributors may stock and supply OMNIPAQUE through authorized channels.
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Third-party importers: In countries with complex regulatory environments, importers or authorized agents facilitate entry of OMNIPAQUE 300 sourced directly from GE’s manufacturing units.[2]
Contract Manufacturing Organizations (CMOs)
Though GE Healthcare primarily manufactures OMNIPAQUE internally, some production may involve CMOs for specific geographic markets or formulation adjustments. These contractors operate under strict GMP and are licensed by regulatory authorities such as the FDA, EMA, or respective national agencies.
Supply Chain Dynamics
Global Manufacturing Footprint
GE operates multiple manufacturing facilities capable of producing OMNIPAQUE 300, including plants in the United States, Austria, and Asia. This diversification reduces supply risk and enhances regional availability.[3] The manufacturing process involves complex chemistry and strict quality controls, which can impact supply continuity, particularly amid geopolitical tensions or disruptions like those caused by the COVID-19 pandemic.
Regulatory Approvals and Market Authorization
OMNIPAQUE 300’s distribution hinges on regulatory approval across jurisdictions. The drug is approved by agencies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and other national bodies. These approvals are contingent upon ongoing manufacturing compliance, which influences supplier reliability and licensing terms. Changes in regulatory status or market authorizations directly impact supply chain stability.
Pricing and Contractual Agreements
Price negotiations between GE Healthcare and healthcare providers impact procurement and distribution strategies. Long-term supply agreements and bulk purchasing contracts are common in the healthcare sector, ensuring a steady supply by downstream distributors. Licensing agreements in emerging markets also shape the availability of OMNIPAQUE 300.[4]
Supply Chain Challenges
Major risks include raw material shortages (notably iodine compounds), manufacturing delays, regulatory hurdles, and geopolitical factors such as trade tariffs or export bans. The recent global logistics disruptions have underscored the importance of diversified manufacturing and distribution channels.[5]
Regulatory and Licensing Considerations
GE Healthcare’s licensing portfolio significantly influences the vendor landscape. The company's ability to maintain regulatory compliance and secure market authorization in diverse regions is essential for supply continuity. Some regions may see local licensing agreements with regional pharma companies or authorized distributors, which act as suppliers for OMNIPAQUE 300. Accordingly, licensing status and regulatory renewals strongly influence who the actual suppliers are.[6]
Implications for Stakeholders
- Healthcare providers: depend on reliable supplier partnerships to ensure continuous availability, especially during supply chain disruptions.
- Distributors: must navigate complex regulatory and licensing environments to procure authentic OMNIPAQUE 300.
- Regulatory agencies: oversee manufacturing compliance and enforce quality standards that influence supplier capabilities.
- Manufacturers and innovators: need to monitor geopolitical and logistic risks impacting supply chain resilience.
Future Outlook
The market for intravenous contrast agents like OMNIPAQUE 300 is set to grow, driven by increasing global imaging procedures and technological advancements. GE Healthcare’s ongoing capacity expansion, coupled with innovations in formulation and manufacturing efficiencies, aims to secure its market dominance. However, increased competition from alternative agents or biosimilars, and regional manufacturing shifts, can alter the supplier landscape.[7]
Key Takeaways
- GE Healthcare is the primary manufacturer and main supplier of OMNIPAQUE 300 worldwide.
- Regional distributors and licensed importers serve as secondary suppliers in various markets.
- Supply stability hinges on the global manufacturing footprint, regulatory compliance, and geopolitical factors.
- Diversification of manufacturing sites and compliance with international quality standards mitigate supply chain risks.
- Stakeholders should maintain active monitoring of licensing statuses and geopolitical developments to ensure uninterrupted supply.
FAQs
Q1: Who are the main suppliers of OMNIPAQUE 300 globally?
A1: GE Healthcare is the primary and largest supplier, with regional distributors and authorized importers facilitating market access across different countries.
Q2: What factors influence the supply chain stability of OMNIPAQUE 300?
A2: Manufacturing capacity, raw material availability, regulatory approvals, geopolitical stability, and logistics disruptions are key factors.
Q3: How does licensing impact the supply of OMNIPAQUE 300?
A3: Licensing agreements determine who can manufacture and distribute OMNIPAQUE 300 legally, affecting global availability and supply consistency.
Q4: Are there regional alternatives to OMNIPAQUE 300?
A4: Yes, regional contrast agents approved locally may serve as alternatives; however, OMNIPAQUE’s widespread adoption makes it the preferred choice in many jurisdictions.
Q5: What are the risks associated with the supply of OMNIPAQUE 300?
A5: Risks include manufacturing delays, raw material shortages, regulatory changes, geopolitical tensions, and logistical disruptions, which can lead to supply shortages.
References
- GE Healthcare Official Website. Contrast Media Portfolio. https://www.gehealthcare.com
- U.S. FDA Database. Medical Imaging Agents Listings. https://www.accessdata.fda.gov
- European Medicines Agency (EMA). OMNIPAQUE approval documentation. https://www.ema.europa.eu
- Industry Reports: Global Contrast Media Market Analysis, 2022.
- Supply Chain Disruptions in Pharma, Journal of Healthcare Logistics, 2021.
- Regional Licensing & Market Authorization Reports, 2022.
- Market Forecast: Future of Contrast Agents, Pharma Future Insight, 2023.
