Suppliers and packagers for ISOVUE-200

ISOVUE-200

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bracco	ISOVUE-200	iopamidol	INJECTABLE;INJECTION	018735	NDA	BRACCO DIAGNOSTICS INC	0270-1314-15	10 BOTTLE in 1 BOX (0270-1314-15) / 200 mL in 1 BOTTLE	1985-12-31
Bracco	ISOVUE-200	iopamidol	INJECTABLE;INJECTION	018735	NDA	BRACCO DIAGNOSTICS INC	0270-1315-25	10 VIAL, SINGLE-DOSE in 1 BOX (0270-1315-25) / 30 mL in 1 VIAL, SINGLE-DOSE	1985-12-31
Bracco	ISOVUE-200	iopamidol	INJECTABLE;INJECTION	018735	NDA	BRACCO DIAGNOSTICS INC	0270-1315-30	10 VIAL, SINGLE-DOSE in 1 BOX (0270-1315-30) / 50 mL in 1 VIAL, SINGLE-DOSE	1985-12-31

Suppliers for the Pharmaceutical Drug: Isovue-200

Last updated: August 3, 2025

Introduction

Isovue-200, whose generic name is iopamidol, is a non-ionic, water-soluble radiographic contrast agent primarily used in diagnostic imaging procedures such as computed tomography (CT) scans. Its clinical utility hinges on its high iodine content, enabling enhanced vascular and tissue visualization. Given its critical role in medical diagnostics, a reliable and diversified supplier base for Isovue-200 is essential for healthcare providers and pharmaceutical companies to ensure operational continuity, competitive pricing, and supply security. This article provides a comprehensive overview of the primary suppliers for Isovue-200, examining manufacturing sources, market dynamics, and strategic considerations for stakeholders.

Manufacturers and Suppliers of Isovue-200

1. Bracco Imaging S.p.A.

Overview:
Bracco Imaging, an Italian pharmaceutical company, is the sole manufacturer of Isovue-200 and its related contrast agents. The company specializes in diagnostic imaging agents and has a global presence encompassing North America, Europe, and Asia.

Manufacturing and Distribution:
Bracco operates extensive manufacturing facilities equipped with state-of-the-art synthesis and purification processes for iopamidol. Its strategic distribution network ensures the availability of Isovue-200 worldwide, including in markets like the U.S., Europe, and Asia. The company’s integrated supply chain management emphasizes quality control, regulatory compliance, and prompt delivery.

Market Position:
As the original producer, Bracco holds a dominant position, with exclusive manufacturing rights for Isovue-200. Their global footprint and longstanding industry presence give them a competitive advantage in market access and brand recognition.

2. Other Iodinated Contrast Agents Suppliers

While Bracco maintains exclusive rights for Isovue-200, multiple global manufacturers produce generic or alternative iodinated contrast media (ICM). These companies, while not direct suppliers of Isovue-200, influence the overall iodinated contrast market landscape, impacting supply chain strategies.

Key Players Include:

• Liebel-Flarsheim (part of Teleflex): Produces a range of iodinated contrast agents but not the branded Isovue line.
• GE Healthcare: Offers their own contrast media products but not Isovue-200.
• E-Z-EM (now part of Bracco): Historically supplied contrast media but has integrated into Bracco’s manufacturing operations.

Implication:
The presence of generic iodinated contrast agents provides options for hospitals and imaging centers, but for branded Isovue-200, Bracco remains the singular source.

Supply Chain Dynamics

a. Exclusivity of Manufacturing

Bracco’s exclusive manufacturing rights mean that no other suppliers produce Isovue-200 currently. This exclusivity underscores the importance of strategic inventory management for healthcare facilities to prevent interruptions, especially given the global supply chain disruptions witnessed during the COVID-19 pandemic.

b. Geographic Considerations

Bracco’s global manufacturing facilities and distribution channels enable widespread availability. However, regional regulatory approvals, import restrictions, and logistical challenges can influence local supply, especially in emerging markets or during geopolitical tensions.

c. Regulatory Environment

The regulatory landscape significantly impacts supply stability. During regulatory delays or compliance issues, supply constraints may arise. Bracco’s adherence to rigorous quality standards (e.g., FDA, EMA approvals) mitigates risks but also enforces the need for continuous compliance to sustain global distribution rights.

Market Trends and Future Considerations

1. Generics and Biosimilars

Although Bracco is the sole producer of Isovue-200, increasing interest in generic alternatives for iodinated contrast media could influence market dynamics in the future. Regulatory pathways for biosimilars and generics may eventually enable other manufacturers to produce similar formulations, potentially affecting supply costs and availability.

2. Supply Chain Resilience

To mitigate potential disruptions, healthcare providers and procurement agencies are exploring diversified sourcing strategies, including stockpiling and negotiating long-term supply agreements with Bracco. Investment in supply chain resilience plans is becoming standard practice amid recent global uncertainties in logistics.

3. Technological Advances and Alternative Agents

Emerging imaging techniques and novel contrast agents, such as gadolinium-based or metal-free options, threaten the long-term dominance of iodinated contrast media. Nevertheless, Isovue-200 remains a mainstay in CT imaging due to its proven efficacy.

Key Considerations for Stakeholders

• For Healthcare Providers: Maintain strategic inventory to navigate supply variability, especially given Bracco’s market exclusivity.
• For Distributors: Establish reliable logistics channels aligned with Bracco’s distribution networks.
• For Regulators: Ensure continuous oversight for manufacturing compliance, safeguarding supply integrity.
• For Competitors: Focus on developing alternative contrast agents or biosimilars pending regulatory approval pathways.

Key Takeaways

• Bracco Imaging S.p.A. is the sole manufacturer and primary supplier of Isovue-200 globally, holding exclusive rights to its production.
• The global supply chain resilience for Isovue-200 is primarily dependent on Bracco’s manufacturing capacity and distribution network.
• Regional regulatory environments and logistical factors significantly influence its availability, necessitating proactive procurement strategies.
• The market landscape could evolve with the advent of generic contrast agents, although currently, alternatives are not directly interchangeable with Isovue-200.
• Healthcare stakeholders should prioritize inventory management, supplier relationships, and regulatory compliance to ensure uninterrupted access.

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FAQs

1. Who is the primary manufacturer of Isovue-200?
Bracco Imaging S.p.A. is the exclusive manufacturer and supplier of Isovue-200, holding global rights to produce and distribute the contrast agent.

2. Are there generic alternatives to Isovue-200?
Currently, no FDA- or EMA-approved generic versions of Isovue-200 are available. Several other iodinated contrast agents exist but are not direct equivalents.

3. How does supply chain disruption affect Isovue-200 availability?
Disruptions at Bracco’s manufacturing facilities or logistical challenges can lead to shortages, highlighting the importance of strategic inventory planning for healthcare providers.

4. Can other companies produce similar contrast agents?
While other firms manufacture iodinated contrast media, they do not produce Isovue-200 specifically. Future biosimilar or generic entries could alter the landscape.

5. What are the key regulatory considerations for Isovue-200 supply?
Regulatory approvals from agencies like the FDA and EMA are critical for manufacturing and distribution. Non-compliance can lead to supply interruptions and market restrictions.

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References

1. Bracco Imaging. (2023). About Us. Retrieved from https://www.bracco.com
2. U.S. Food and Drug Administration. (2022). Iodinated Contrast Media. FDA Regulatory Documents.
3. European Medicines Agency. (2023). Assessment Report for Iopamidol. EMA Documentation.
4. MarketWatch. (2023). Contrast Media Market Trends.
5. Advanced Medical Imaging Journal. (2022). Supply Chain Strategies for Diagnostic Agents.

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This detailed analysis equips industry professionals with insights into the primary supply sources of Isovue-200, underpinning informed procurement and strategic planning in the diagnostic imaging market.