Last updated: August 3, 2025
Introduction
ISOVUE-370, a specialized contrast agent used in medical imaging, particularly in computed tomography (CT) scans, is a product of significant clinical importance. Primarily containing iodinated contrast media, ISOVUE-370 facilitates enhanced visualization of vascular structures and organs, optimizing diagnostic accuracy. Given its critical role, identifying reliable suppliers for ISOVUE-370 is essential for healthcare providers, hospitals, and distributors seeking consistent quality, compliance, and efficient supply chain management.
This article provides an authoritative overview of the key suppliers for ISOVUE-370, exploring manufacturing origins, distribution channels, and strategic considerations relevant to stakeholders across the pharmaceutical and medical supply sectors.
Manufacturers and Suppliers
1. Bracco Imaging S.p.A.
Overview: Bracco, headquartered in Italy, is the original manufacturer of ISOVUE-370. As a global leader in contrast media, Bracco has pioneered numerous innovative imaging solutions and maintains a robust manufacturing footprint across continents.
Manufacturing and Distribution: Bracco produces ISOVUE-370 at multiple facilities, ensuring compliance with stringent international regulatory standards such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Their distribution network spans North America, Europe, Asia, and Latin America through direct subsidiaries and authorized distributors.
Partnerships & Exclusivity: As the patent holder, Bracco retains exclusive rights to manufacture and supply ISOVUE-370. The company's extensive global presence ensures broad availability, with supply contracts often negotiated through regional distributors.
2. Authorized Distributors and Regional Suppliers
Although Bracco directly supplies ISOVUE-370, regional distribution agreements facilitate market access through authorized partners. Notable distributors include:
- McKesson Corporation (USA): A leading healthcare distributor, McKesson handles the procurement and distribution of ISOVUE-370 to hospitals and clinics throughout the United States.
- Fresenius Kabi (Europe and International Markets): This German healthcare company supplies contrast media, including exclusive distribution rights for ISOVUE-370 in select European countries.
- AliHealth (China): As part of the Alibaba Group, AliHealth distributes ISOVUE-370 within China, complying with local regulatory requirements.
- Medline Industries (North America): Engages in procurement and distribution, serving hospitals and outpatient clinics.
3. Regional Regulatory Approvals and Supply Dynamics
Regulatory approval is a critical factor in supply reliability. ISOVUE-370 holds FDA approval in the U.S., CE marking for the European Economic Area, and other regional approvals. These designations influence which suppliers are authorized and capable of distributing the product regionally.
Strategic Considerations in Supplier Selection
Regulatory Compliance and Quality Control
Choosing suppliers with verified compliance (e.g., Good Manufacturing Practice, GMP) ensures high-quality standards. Bracco's manufacturing facilities undergo rigorous audits, and authorized distributors must follow strict handling and storage protocols.
Supply Chain Security
Given the critical nature of contrast agents, supply stability is paramount. Maintaining multiple supply sources, including regional distributors, mitigates risks related to manufacturing disruptions, regulatory delays, or geopolitical factors.
Pricing and Contractual Agreements
Pricing negotiations are influenced by purchasing volumes, regional demand, and licensing terms. Long-term contracts with Bracco or authorized distributors facilitate predictable pricing and uninterrupted supply.
Emerging Trends and Future Outlook
Supply Chain Optimization
The ongoing pandemic underscored the importance of resilient supply chains. Bracco and its distribution partners are investing in integrated logistics solutions, inventory management, and digital traceability to prevent shortages of ISOVUE-370.
Regulatory Developments
Regulatory agencies prioritize safety and transparency, leading to increased scrutiny of contrast media manufacturing and distribution. Suppliers are adapting by enhancing quality assurance protocols, which may influence procurement considerations.
Market Competition
Although ISOVUE-370 remains the flagship product of Bracco, biosimilars and alternative contrast agents are emerging, potentially affecting supplier dynamics. Nonetheless, Bracco’s market dominance and regulatory approvals sustain its leadership in supply stability.
Conclusion
Reliable supply of ISOVUE-370 hinges on a tightly controlled manufacturing process led by Bracco Imaging S.p.A., complemented by a network of regional authorized distributors. Stakeholders must prioritize regulatory compliance, supply chain resilience, and strategic partnerships to ensure continuous access to this vital contrast agent.
Key Takeaways
- Bracco Imaging is the sole manufacturer of ISOVUE-370, with a global distribution network supporting broad availability.
- Authorized regional distributors play a crucial role in ensuring supply accessibility within specific markets.
- Regulatory compliance and quality assurance are foundational in supplier selection to guarantee product safety and efficacy.
- Supply chain resilience and logistics innovation are increasingly critical in mitigating shortages and disruptions.
- Market evolution, including biosimilar emergence, may influence future supplier arrangements but currently solidifies Bracco’s market position.
FAQs
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Who manufactures ISOVUE-370?
Bracco Imaging S.p.A., an Italian multinational, is the exclusive manufacturer of ISOVUE-370.
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Can I purchase ISOVUE-370 directly from Bracco?
Typically, healthcare providers acquire ISOVUE-370 through authorized distributors or regional partners rather than direct procurement from Bracco.
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Are there alternative suppliers or generics for ISOVUE-370?
Currently, no approved generic equivalents or biosimilars match ISOVUE-370’s specific formulation, emphasizing Bracco’s exclusivity.
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How do regional regulations impact supplier choice?
Regulatory approvals determine authorized suppliers; products must meet regional standards (e.g., FDA, EMA) to ensure legal and safe distribution.
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What should hospitals consider when selecting a supplier for ISOVUE-370?
Hospitals should prioritize suppliers’ regulatory compliance, supply reliability, pricing, and the credentials of regional distributors.
Sources
- Bracco Group Corporate Website. (2023). Products and Manufacturing.
- U.S. Food and Drug Administration (FDA). (2022). Approval documentation for ISOVUE-370.
- European Medicines Agency (EMA). (2022). Marketing authorizations for iodinated contrast media.
- McKesson Corporation. (2023). Healthcare distribution services.
- Fresenius Kabi. (2023). Regional pharmaceutical product distribution.
