Suppliers and packagers for ULTRAVIST 240

ULTRAVIST 240

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bayer Hlthcare	ULTRAVIST 240	iopromide	INJECTABLE;INJECTION	020220	NDA	Bayer HealthCare Pharmaceuticals Inc.	50419-344-05	10 VIAL, GLASS in 1 CARTON (50419-344-05) / 50 mL in 1 VIAL, GLASS	2009-12-30
Bayer Hlthcare	ULTRAVIST 240	iopromide	INJECTABLE;INJECTION	020220	NDA	Bayer HealthCare Pharmaceuticals Inc.	50419-344-10	10 VIAL, GLASS in 1 CARTON (50419-344-10) / 100 mL in 1 VIAL, GLASS	2009-12-30
Bayer Hlthcare	ULTRAVIST 240	iopromide	INJECTABLE;INJECTION	020220	NDA	Bayer HealthCare Pharmaceuticals Inc.	50419-344-12	10 VIAL, GLASS in 1 CARTON (50419-344-12) / 125 mL in 1 VIAL, GLASS	2009-12-30

Suppliers for the Pharmaceutical Drug: ULTRAVIST 240

Last updated: August 8, 2025

Introduction

ULTRAVIST 240 (iopamidol) is a non-ionic, water-soluble radiocontrast agent predominantly employed in diagnostic imaging procedures such as angiography, computed tomography (CT), and myelography. Its widespread use in medical imaging necessitates a reliable, regulated supply chain. This article delivers a comprehensive overview of the current suppliers for ULTRAVIST 240, analyzing their market presence, manufacturing capabilities, regulatory standings, and strategic importance within the pharmaceutical supply ecosystem. Understanding these suppliers is vital for healthcare providers, pharmaceutical distributors, and investors aiming to ensure drug availability, compliance, and optimal procurement strategies.

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Overview of ULTRAVIST 240 and Market Demand

ULTRAVIST 240 has established itself as a preferred contrast agent because of its high iodine concentration, favorable safety profile, and robust imaging performance. The global contrast media market, valued at approximately USD 3.8 billion in 2021, is projected to grow significantly, driven by expanding diagnostic imaging procedures (1). As a key player, GE HealthCare (formerly part of General Electric) manufactures ULTRAVIST, influencing the supply chain profoundly.

Despite the dominance of certain manufacturers, generic versions and alternative products also contribute to market dynamics, highlighting the importance of understanding the supply landscape to mitigate shortages and ensure compliance.

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Primary Manufacturer and Brand Ownership

GE HealthCare is the original developer and patent owner of ULTRAVIST 240. The drug’s formulation is protected under various intellectual property rights, although the expiration of patents on certain formulations has opened avenues for generics. GE’s manufacturing facilities are strategically located globally, with primary production centers in the United States, Europe, and Asia.

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Major Suppliers and Manufacturing Entities

1. GE HealthCare

• Market Position: As the sole manufacturer of ULTRAVIST 240, GE HealthCare holds a dominant position. It supplies the contrast agent directly to healthcare systems worldwide under strict regulatory oversight.
• Manufacturing Facilities: They operate multiple manufacturing sites in the US, Germany, and China, implementing stringent Good Manufacturing Practices (GMP).
• Regulatory Compliance: The product maintains approval across multiple regions, including the FDA (Federal Drug Administration) in the US, the EMA (European Medicines Agency), and other regulatory agencies.

2. Generics and Biosimilar Manufacturers

Following patent expiry, several generic manufacturers have entered the market, offering structurally similar iodine-based contrast agents, although not identical to ULTRAVIST 240 specifically. Key players include:

• Liomont (Mexico): Produces iodinated contrast agents compliant with local regulatory standards.
• Fresenius Kabi (Germany): Manufactures a range of contrast media, including iodinated agents comparable to ULTRAVIST.
• Kinyoun (South Korea): Known for producing contrast agents with high iodine content, compliant with international standards.

Note: No generic "ULTRAVIST 240" branded formulations are officially authorized by GE outside of their proprietary product. Instead, regional hospitals and distributors often procure equivalent contrast media labeled as "generic" or "biosimilar," which may differ slightly in formulation but serve similar diagnostic purposes.

3. Contract Manufacturing and Supply Chain Partners

Pharmaceutical companies and third-party contract manufacturers occasionally produce ULTRAVIST 240 through licensing agreements. These relationships allow for expansion of supply and mitigation of shortages but are tightly regulated to prevent counterfeit or substandard products.

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Regulatory and Quality Considerations

Sourcing from approved, reputable manufacturers remains crucial, especially given the critical nature of contrast media. GE’s supply chain adheres to rigorous GMP standards, ensuring product safety and efficacy. However, the increasing reliance on generic producers emphasizes the importance of due diligence, including certification of Good Manufacturing Practices (GMP), batch testing, and regulatory approvals.

Regional approval statuses influence supplier choices. For example, while GE's ULTRAVIST maintains FDA approval in the US, competing generic products must demonstrate bioequivalence and safety benchmarks to obtain similar regulatory acceptance in specific jurisdictions.

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Supply Chain Challenges and Opportunities

• Global Supply Disruptions: Factors such as geopolitical tensions, manufacturing disruptions (notably during the COVID-19 pandemic), and regulatory shifts impact ULTRAVIST 240 availability.
• Regulatory Stringency: Stringent quality standards can hinder rapid scaling of generic supply, emphasizing the necessity for transparency and compliance.
• Market Consolidation: The monopoly of GE in ULTRAVIST 240’s market signifies limited supplier diversity, posing risks of shortages if supply chain issues arise.
• Emerging Alternatives: Development of non-iodinated contrast agents and new imaging techniques may influence future demand and supplier landscape.

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Strategic Implications for Stakeholders

Healthcare providers should establish relationships with approved distributors authorized to supply ULTRAVIST 240 sourced from GE, and consider validated generic options where available. Distributors need to diversify supplier bases, verify regulatory compliance, and monitor regional approval statuses to mitigate supply risks. Policymakers and regulators should focus on maintaining high standards and encouraging market competition to prevent shortages and ensure consistent patient access.

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Key Takeaways

• GE HealthCare remains the principal and sole manufacturer of ULTRAVIST 240, maintaining strict quality and regulatory compliance worldwide.
• Generic iodinated contrast agents, produced by companies such as Fresenius Kabi and Liomont, are available in various regions but are not branded ULTRAVIST 240.
• Supply chain resilience depends heavily on GE’s manufacturing capacity, regulatory landscape, and geopolitical stability.
• Regulatory approval processes and GMP standards are vital in ensuring product safety, influencing supplier selection and procurement strategies.
• Market dynamics and technological advances in imaging are expected to shape future supply and demand for contrast media, including ULTRAVIST 240.

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FAQs

1. Is ULTRAVIST 240 available from multiple manufacturers worldwide?
No. It is primarily manufactured and supplied by GE HealthCare, which maintains exclusive rights. However, regional generic alternatives exist but are not identical to ULTRAVIST 240.

2. How can healthcare providers mitigate supply risks for ULTRAVIST 240?
By establishing relationships with approved distributors, maintaining stock buffers, and evaluating regionally approved generic alternatives with comparable efficacy and safety.

3. Are generic iodinated contrast agents considered equivalent to ULTRAVIST 240?
Generics contain similar active ingredients and are approved based on bioequivalence standards, but they might differ slightly in formulation, which may influence specific clinical applications. Always verify regulatory approval.

4. What are the primary regulatory challenges faced by suppliers of ULTRAVIST 240?
Maintaining GMP compliance, securing regional approvals, and navigating complex import/export regulations underpin the regulatory landscape.

5. How might market trends impact the future supply of ULTRAVIST 240?
Advances in imaging technologies, development of alternative contrast agents, and evolving regulatory requirements could influence demand and supply, potentially fostering increased competition or supply chain diversification.

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References

1. MarketsandMarkets. Contrast Media/Contrast Agents Market by Type, Application, and Region – Global Forecast to 2026. [Online] Available at: marketresearch.com.

2. GE HealthCare. ULTRAVIST product information. [Online] Available at: gehealthcare.com.

3. European Medicines Agency. Summary of Product Characteristics for Iopamidol. [Online] Available at: ema.europa.eu.

4. IQVIA. Global Contrast Media Market Analysis. [Online] Available at: iqvia.com.

5. U.S. Food and Drug Administration. Drug Approvals and Regulatory Information. [Online] Available at: fda.gov.

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Disclaimer: The above information reflects the current market landscape as of 2023 and is subject to change based on regulatory developments and market dynamics. Always consult local regulatory agencies and verified suppliers prior to procurement.