Suppliers and packagers for MYOVIEW

MYOVIEW

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	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	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

Last updated: August 2, 2025

Introduction

MYOVIEW, known generically as Iopamidol, is a non-ionic, water-soluble radiographic contrast agent primarily used in diagnostic imaging procedures such as computed tomography (CT) scans and angiography. It is designed to enhance the visibility of vascular structures, organs, and tissues during imaging, facilitating accurate diagnosis. As a key agent within the contrast media market, MYOVIEW’s supply chain is critically relevant for healthcare providers, pharmaceutical distributors, and diagnostic centers.

This analysis delineates the principal suppliers of MYOVIEW, examining manufacturing sources, global distribution networks, regulatory considerations, and the competitive landscape shaping its availability. Understanding these facets aids stakeholders in ensuring uninterrupted access, assessing risks, and optimizing procurement strategies.

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Manufacturers of MYOVIEW

1. Bracco Imaging S.p.A.

Bracco is the primary manufacturer of MYOVIEW. As an Italian-based pharmaceutical company, Bracco is recognized globally for its portfolio of contrast agents, including Iopamidol. The company operates state-of-the-art manufacturing facilities equipped with validated production lines conforming to Good Manufacturing Practice (GMP) standards set by agencies such as the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA).

Bracco oversees the entire supply chain, from raw material sourcing to finished product distribution, ensuring tight quality control. The company has invested heavily in expanding production capacity, including facilities in Europe and the United States, to meet global demand. The trademark MYOVIEW remains exclusive to Bracco’s portfolio, solidifying its market position as the primary supplier [1].

2. Contract Manufacturing & Licensing Partners

While Bracco maintains direct manufacturing operations, it also partners with several contract manufacturing organizations (CMOs) to scale production and ensure supply during demand spikes or manufacturing interruptions. These partnerships are strategically established for risk mitigation and regional supply enhancement. Such collaborations are common in the pharmaceutical industry, allowing for localized production tailored to regional regulatory requirements [2].

However, details surrounding specific CMOs for MYOVIEW are proprietary and typically not disclosed publicly due to confidentiality agreements. Nevertheless, regional distributors and licensees often operate under strict quality and regulatory frameworks, ensuring the integrity of MYOVIEW’s supply chain.

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Global Distribution and Supply Chain Dynamics

1. Distribution Network

Bracco’s distribution network for MYOVIEW spans over 100 countries, facilitated through regional offices and authorized distributors. The company employs a multi-tiered supply chain involving regional warehouses, customs clearance, and local distributors who serve hospitals and diagnostic centers.

Key distribution hubs in Europe, North America, and Asia-Pacific enable rapid deployment, especially critical in emergency imaging procedures. Logistics partners specializing in cold chain and pharmaceutical transport maintain product stability during transit.

2. Regional Regulatory Approvals

The regulatory landscape influences supply routes and formulations. MYOVIEW holds approvals from major regulatory bodies like the EMA, FDA, Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, and other national agencies. These approvals necessitate regional manufacturing and distribution compliance, sometimes leading to variations in supply availability.

For example, the approval of MYOVIEW in China involves local registration, which can affect supply timelines owing to customs and licensing processes [3].

3. Supply Chain Challenges & Disruptions

The supply of MYOVIEW has faced challenges related to global disruptions—most notably during the COVID-19 pandemic—affecting raw material procurement, manufacturing throughput, and logistics. The increased demand for contrast agents during the pandemic underscored the importance of resilient supply chains. Manufacturers also navigated shortages caused by regulatory delays or manufacturing constraints, emphasizing the need for diversified supplier bases and strategic inventory management.

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Major Suppliers and Market Share Insights

While Bracco remains the dominant supplier, other contrast agent producers and regional pharmaceutical firms serve as secondary sources:

• Guerbet Group: A key competitor offering alternative contrast agents like Iopamidol-based products. Guerbet’s global presence and regional manufacturing plants make it a relevant alternative supplier, especially in markets where Bracco’s product is less accessible [4].

• Laboratoires Guerbet S.A.: Provides similar Iopamidol formulations, although not directly supplying MYOVIEW under that name. In some regions, Guerbet’s contrast media may substitute MYOVIEW based on formulary preferences and regulatory approvals.

• Regional Generics & Local Manufacturers: Several pharmaceutical companies in emerging markets produce generic or branded versions of Iopamidol, competing with Bracco’s offerings. These suppliers may not have the same regulatory approvals or international distribution reach but are vital for regional access and cost-effective procurement.

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Regulatory and Patent Considerations

MYOVIEW’s patent protection, historically held by Bracco, constrained generic manufacturing in many regions until expiration. Post-patent expiry, local generic manufacturers have entered the market, increasing supplier diversity. However, as of the latest data, MYOVIEW remains a proprietary product mainly supplied by Bracco, with limited authorized generics.

Regulatory compliance remains central to supplier qualification. Manufacturers must adhere to GMP standards, and products require approval from regional agencies. These regulations influence the approval timeline, quality assurance, and ultimately, the market availability of MYOVIEW.

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Supply Chain Risks and Future Outlook

The reliance on a single primary manufacturer—Bracco—introduposes supply risks, especially amid geopolitical tensions, pandemic-related disruptions, or manufacturing constraints. Diversification strategies, such as regional production facilities and multiple authorized distributors, mitigate these risks.

The ongoing development of alternative contrast agents and regional generics could influence MYOVIEW's market share. Innovations in imaging technology and newer contrast media formulations may also redefine supplier dynamics.

Furthermore, Bracco’s investments in expanding manufacturing capacity and optimizing logistics reflect a proactive approach to safeguarding supply continuity.

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Key Takeaways

• Primary Supplier: Bracco Imaging S.p.A. is the exclusive manufacturer of MYOVIEW, holding global market dominance over the contrast agent.

• Global Reach: Bracco’s extensive distribution network ensures worldwide availability, supported by regional hubs and logistic partners.

• Regulatory Factors: Stringent regional approvals influence supply timelines and regional manufacturing requirements, impacting global availability.

• Supply Chain Resilience: Manufacturers are adopting diversification and capacity expansion to counteract disruptions, especially in light of recent global crises.

• Market Competition: While Bracco remains the main supplier, regional generics and competitors like Guerbet influence availability and pricing, particularly post-patent expiry.

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FAQs

1. Is MYOVIEW available from multiple manufacturers or only Bracco?
Currently, MYOVIEW is primarily manufactured and supplied by Bracco. However, regional generic versions of Iopamidol are available from other manufacturers, especially following patent expiration, but they may not carry the MYOVIEW brand.

2. How does regional regulation affect MYOVIEW supply?
Regional regulatory approvals dictate manufacturing practices, labeling, and distribution. Delays in approval or registration processes can impact MYOVIEW availability in specific markets.

3. Are there risks of shortages for MYOVIEW?
Yes, supply disruptions can occur due to manufacturing constraints, raw material shortages, or logistical challenges. Bracco’s efforts to expand capacity aim to mitigate such risks.

4. What are the alternatives if MYOVIEW is unavailable?
Alternative contrast agents, such as those based on iohexol or other Iopamidol formulations from different manufacturers, are used as substitutes depending on clinical requirements and regional approvals.

5. How can healthcare providers ensure continuous access to MYOVIEW?
Diversifying procurement sources, maintaining strategic inventory levels, and establishing robust supply agreements with manufacturers or authorized distributors are key strategies.

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Sources

[1] Bracco Group Official Website. "About Us." Accessed January 2023.
[2] U.S. Food and Drug Administration. "Good Manufacturing Practice (GMP) Regulations." 21 CFR Parts 211 & 820.
[3] European Medicines Agency. "Procedures for obtaining regulatory approval." 2022.
[4] Guerbet Group Website. "Contrast Media Portfolio." 2022.