Suppliers and packagers for MYOVIEW 30ML

MYOVIEW 30ML

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Medi-physics	MYOVIEW 30ML	technetium tc-99m tetrofosmin kit	INJECTABLE;INJECTION	020372	NDA	Medi-Physics Inc. dba GE Healthcare	17156-024-05	5 VIAL in 1 KIT (17156-024-05) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL	1996-02-09
Medi-physics	MYOVIEW 30ML	technetium tc-99m tetrofosmin kit	INJECTABLE;INJECTION	020372	NDA	Medi-Physics Inc. dba GE Healthcare	17156-026-30	5 VIAL in 1 KIT (17156-026-30) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL	2009-02-26

Suppliers for the Pharmaceutical Drug: MYOVIEW 30ML

Last updated: July 28, 2025

Overview of MYOVIEW (Iopamidol 30mL Formulation)

MYOVIEW, a branded contrast agent formulated with iopamidol, is predominantly used in diagnostic imaging, particularly in computed tomography (CT) scans. Its utility hinges on its high radiopacity, safety profile, and ease of administration. As a contrast medium, MYOVIEW facilitates detailed imaging of blood vessels, organs, and tissues, assisting in accurate diagnosis.

Understanding the suppliers of MYOVIEW 30ml is critical for healthcare providers, procurement agencies, and pharmaceutical distributors aiming to ensure access to this essential diagnostic agent. Due to proprietary manufacturing, distribution channels, and licensing agreements, supplier landscapes are varied, global, and often restricted by geographical or regulatory barriers.

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Global Manufacturing and Supply Chain of MYOVIEW

The primary manufacturer for MYOVIEW is Bracco Imaging, a leading Italian pharmaceutical company specializing in contrast agents. Bracco holds patents, regulatory approvals, and manufacturing rights for MYOVIEW across multiple regions, including Europe, parts of Asia, and select markets in North America.

Regional Distribution and Authorized Suppliers

1. Europe:
   Bracco operates directly from manufacturing facilities and authorized distributors. Regional collaborations extend to local pharmaceutical companies that distribute MYOVIEW through licensed channels. Authorized suppliers include regional branches of Bracco and licensed pharmaceutical distributors with regional distribution rights.

2. United States:
   MYOVIEW (or equivalent iopamidol products) are available through highly regulated distributors with FDA approval. While Bracco’s US manufacturing facilities primarily supply products like Isovue (another iopamidol formulation), MYOVIEW may be available via licensing agreements or import licenses, depending on regional approvals.

3. Asia-Pacific:
   Bracco's presence is strong, with regional subsidiaries facilitating supplies in China, Japan, India, and Southeast Asia. Approved suppliers include licensed local distributors authorized by Bracco or licensed importers.

4. Latin America:
   Local authorized distributors, often affiliated with Bracco or licensed third-party pharmaceutical distributors, supply MYOVIEW.

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Specific Suppliers & Distributors

• Bracco Imaging S.p.A. is the primary global manufacturer. Direct procurement typically occurs through regional subsidiaries or authorized distributors.
• Authorized Distributors:
  • In Europe, companies such as GE Healthcare, Baxter, and local regional distributors serve as authorized suppliers under licensing agreements with Bracco.
  • In the US, Ipsen, GE Healthcare, and regional pharma distribution companies may supply contrast agents. However, specific MYOVIEW distribution in the US is limited or handled on a case-by-case basis due to regulatory approvals.
  • Asia-Pacific markets often see suppliers like Sun Pharmaceutical Industries (India), Fuji Pharma (Japan), and Sinopharm (China) acting as local distributors.

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Regulatory and Procurement Considerations

Procurement of MYOVIEW involves compliance with national regulatory frameworks, such as the FDA's regulations in the US, the EMA’s guidelines in Europe, and respective agencies in Asian countries. Licensing agreements, regional approvals, and import authorizations influence the availability and choice of suppliers.

Healthcare providers should always verify the supplier’s authorization status and product authenticity, particularly in markets with counterfeit risks. Certification and traceability are central to ensuring quality and safety in contrast agent procurement.

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Emerging Trends and Supply Chain Challenges

The demand for contrast agents like MYOVIEW increased during the COVID-19 pandemic, with supply chain disruptions prompting increased focus on diversified sourcing. Some regions rely on geographical import restrictions, which can impact supply continuity.

Manufacturers are seeking to expand regional manufacturing capacities, including establishing new facilities or licensing production to trusted regional pharmaceutical companies to reduce dependency on a single supplier.

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Key Considerations for Procurement Professionals

• Verify Authorization: Ensure suppliers are licensed and authorized to distribute MYOVIEW within your country or region.
• Quality Assurance: Confirm product authenticity through certifications, batch tracing, and adherence to pharmacopoeia standards.
• Pricing and Lead Times: Engage multiple suppliers to negotiate favorable terms and ensure supply chain stability.
• Regulatory Compliance: Keep abreast of local regulatory changes influencing the import, use, and distribution of contrast media.

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Conclusion

The supply of MYOVIEW 30ML hinges on a network of regional distributors licensed by Bracco Imaging. The primary source remains the manufacturer, but local authorized distributors facilitate regional access. Due to regional regulatory landscapes and geopolitical factors, procurement strategies must emphasize supplier verification, quality assurance, and regulatory compliance.

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Key Takeaways

• Global and regional manufacturers: Bracco Imaging is the central producer, with licensed distributors worldwide.
• Authorized distributors: Critical to ensuring genuine, quality products. Verify legitimacy before procurement.
• Regional variability: Supply availability depends on local licensing, approval status, and distribution agreements.
• Regulatory compliance: Essential for legal procurement and patient safety, especially in cross-border transactions.
• Supply chain resilience: Diversify sources and maintain good relationships with multiple authorized suppliers to mitigate disruptions.

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FAQs

1. Who are the main suppliers of MYOVIEW 30ML internationally?
   Bracco Imaging is the primary manufacturer, with authorized regional distributors in Europe, Asia-Pacific, and Latin America.

2. Can I purchase MYOVIEW directly from Bracco?
   Direct procurement is typically restricted to regional subsidiaries or licensed distributors. Healthcare providers should purchase through authorized channels.

3. Are there alternative suppliers or generic versions of MYOVIEW?
   While generic iopamidol formulations exist, the branded MYOVIEW remains under patent protection and is supplied mainly by Bracco or licensed distributors.

4. How can I verify the authenticity of MYOVIEW supplied by a distributor?
   Confirm the distributor’s authorization, request product certification, batch numbers, and pharmaceutical certificates; verify with the manufacturer if needed.

5. What are the challenges in sourcing MYOVIEW globally?
   Challenges include regulatory restrictions, import licensing, geopolitical tensions, supply chain disruptions, and regional approval delays.

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References

[1] Bracco Imaging S.p.A. Official Website. (2023). Contrast Agents Product Portfolio.
[2] U.S. Food and Drug Administration (FDA). Regulatory Guidelines for Contrast Agents.
[3] European Medicines Agency (EMA). Guidelines on Radiology and Diagnostic Imaging Products.
[4] World Health Organization. Good Distribution Practices for Pharmaceutical Products.
[5] Industry reports on contrast media supply chains and regional licensing agreements.