Suppliers and packagers for ULTRAVIST 300

ULTRAVIST 300

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 300	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 300	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 300	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
Bayer Hlthcare	ULTRAVIST 300	iopromide	INJECTABLE;INJECTION	020220	NDA	Bayer HealthCare Pharmaceuticals Inc.	50419-344-15	10 VIAL, GLASS in 1 CARTON (50419-344-15) / 150 mL in 1 VIAL, GLASS	2009-12-30
Bayer Hlthcare	ULTRAVIST 300	iopromide	INJECTABLE;INJECTION	020220	NDA	Bayer HealthCare Pharmaceuticals Inc.	50419-344-21	10 BOTTLE in 1 PACKAGE (50419-344-21) / 200 mL in 1 BOTTLE	2009-12-30
Bayer Hlthcare	ULTRAVIST 300	iopromide	INJECTABLE;INJECTION	020220	NDA	Bayer HealthCare Pharmaceuticals Inc.	50419-344-23	10 BOTTLE in 1 PACKAGE (50419-344-23) / 200 mL in 1 BOTTLE	2009-12-30
Bayer Hlthcare	ULTRAVIST 300	iopromide	INJECTABLE;INJECTION	020220	NDA	Bayer HealthCare Pharmaceuticals Inc.	50419-344-32	8 BOTTLE in 1 PACKAGE (50419-344-32) / 500 mL in 1 BOTTLE	2009-12-30

ULTRAVIST 300: Key Suppliers and Manufacturing Landscape

Last updated: February 19, 2026

This report details the primary suppliers and manufacturing considerations for ULTRAVIST 300, a non-ionic, iodinated X-ray contrast agent. Understanding the supply chain and manufacturing capabilities is critical for ensuring consistent product availability and mitigating potential risks for stakeholders in the pharmaceutical and healthcare sectors.

What is ULTRAVIST 300?

ULTRAVIST 300 is a brand name for iopromide, a non-ionic, dimeric X-ray contrast medium. It is supplied as a sterile solution for injection or infusion. The active pharmaceutical ingredient (API) is iopromide, chemically known as 5-amino-N,N'-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-isophthal-amide. The product is manufactured and marketed by Bayer AG.

The contrast agent is utilized in various diagnostic imaging procedures, including computed tomography (CT) scans, angiography, urography, and venography. Its efficacy and safety profile are attributed to its low osmolality and viscosity, which contribute to improved patient tolerance and reduced risk of adverse reactions.

Key Active Pharmaceutical Ingredient (API) Suppliers

The primary API for ULTRAVIST 300 is iopromide. The synthesis of complex iodinated contrast media typically involves specialized chemical manufacturing processes. While Bayer AG is the primary marketer of ULTRAVIST 300, the production of the API iopromide may involve specific contract manufacturing organizations (CMOs) or internal Bayer production facilities.

Identifying definitive, publicly disclosed primary API suppliers for specific branded pharmaceuticals like ULTRAVIST 300 is challenging due to proprietary information and supply chain confidentiality agreements. However, general market intelligence for iopromide production points to a limited number of specialized chemical manufacturers with the expertise in iodination chemistry and sterile API production.

• Bayer AG: Bayer is the originator and primary marketer of ULTRAVIST 300. It is highly probable that Bayer maintains internal manufacturing capabilities for critical APIs like iopromide or has long-standing, exclusive contracts with specific CMOs. Their global manufacturing footprint includes facilities dedicated to pharmaceutical production, adhering to stringent Good Manufacturing Practices (GMP).
• Specialized Chemical Manufacturers: The synthesis of tri-iodinated benzene derivatives, the core structure of iopromide, requires advanced organic synthesis capabilities. Companies with expertise in halogenation, particularly iodination, and sterile API handling are potential sources. These are typically large-scale fine chemical producers, often based in Europe and Asia, that operate under strict regulatory oversight.

Table 1: Potential iopromide API Manufacturing Considerations

Factor	Description	Impact on Supply Chain
Chemical Complexity	Multi-step synthesis involving specialized reagents and reaction conditions. High purity requirements for pharmaceutical use.	Limits the number of potential manufacturers capable of producing iopromide. Requires significant capital investment in specialized equipment and process development.
Iodination Expertise	Handling and precise control of iodine incorporation into the aromatic ring is critical. Byproduct formation and purification are key challenges.	Manufacturers must possess specific know-how in halogenation chemistry. Regulatory hurdles related to handling and disposal of iodine-containing byproducts.
Sterile API Production	The API must be manufactured and handled under aseptic conditions to prevent microbial contamination, especially for injectable drugs.	Requires dedicated sterile manufacturing facilities and rigorous quality control protocols. Increases production costs and complexity.
Regulatory Compliance	API production must comply with global GMP standards (e.g., FDA, EMA). Detailed documentation, process validation, and impurity profiling are mandatory.	Significant barrier to entry for new suppliers. Requires substantial investment in quality systems and regulatory affairs.
Geographic Concentration	Historically, fine chemical and API manufacturing for such complex molecules has been concentrated in specific regions (e.g., Europe, India, China).	Geopolitical factors, trade policies, and supply chain disruptions (e.g., pandemics, natural disasters) can disproportionately affect supply if production is geographically concentrated.

Given the proprietary nature of pharmaceutical supply chains, specific supplier names beyond the marketing authorization holder (Bayer) are not publicly disclosed. However, for a product of this nature, it is common for the innovator company to control API production either internally or through highly vetted, long-term contract manufacturing agreements with a select few global fine chemical producers.

Formulation and Finished Product Manufacturing

The formulation of ULTRAVIST 300 involves dissolving the iopromide API in a sterile aqueous solution, often with excipients to ensure stability and compatibility. The sterile filling and packaging of the final drug product also occur under stringent GMP conditions.

Bayer AG's global pharmaceutical manufacturing network is responsible for the formulation and packaging of ULTRAVIST 300. Their facilities are equipped for sterile liquid filling, lyophilization (if applicable to specific presentations), and final product packaging, including vials, pre-filled syringes, and larger volume containers for infusion.

Key manufacturing considerations for the finished product include:

• Sterile Manufacturing Environment: The entire filling and finishing process must occur in ISO-classified cleanrooms to maintain sterility.
• Quality Control and Assurance: Extensive testing is performed on raw materials, in-process samples, and finished products to ensure identity, purity, strength, and sterility.
• Packaging Integrity: Packaging materials (vials, stoppers, seals, syringes) must be compatible with the drug product and maintain sterility and integrity throughout the shelf life.
• Supply Chain Security: Robust systems are in place to prevent counterfeiting and ensure the integrity of the product from the manufacturing site to the end-user.

Regulatory Landscape and Intellectual Property

The patent landscape for ULTRAVIST 300 is crucial for understanding market exclusivity and potential generic competition.

• Original Patents: The original patents covering iopromide and its use as a contrast agent would have expired. Bayer AG would have held composition of matter patents and formulation patents.
• Evergreening Patents: Pharmaceutical companies often pursue secondary patents related to novel formulations, new indications, manufacturing processes, or crystalline forms to extend market exclusivity. The specific patent portfolio for ULTRAVIST 300 would need to be thoroughly reviewed for any active or pending patents that could impact generic entry.
• Exclusivity Periods: Regulatory exclusivities granted by agencies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) can provide additional market protection beyond patent expiry.

Generic Competition: Once primary patents and regulatory exclusivities expire, generic manufacturers can seek approval to market their versions of iopromide. Approval for generic contrast agents requires demonstrating bioequivalence to the reference listed drug (ULTRAVIST 300) and meeting all relevant quality and manufacturing standards.

The development of generic versions of complex APIs like iopromide is a significant undertaking. Generic manufacturers must establish reliable sources for the API and demonstrate that their manufacturing processes yield a product that is pharmaceutically equivalent and therapeutically interchangeable with ULTRAVIST 300.

Supply Chain Risks and Mitigation Strategies

For a critical diagnostic agent like ULTRAVIST 300, supply chain reliability is paramount. Potential risks include:

• API Sourcing Disruption: Dependence on a single API supplier or limited number of suppliers can lead to shortages if that supplier experiences production issues, regulatory sanctions, or geopolitical instability.
• Manufacturing Facility Issues: Unforeseen events such as fires, natural disasters, or equipment failures at manufacturing sites can halt production.
• Raw Material Availability: Shortages or price volatility of key raw materials used in API synthesis can impact production costs and availability.
• Logistical Challenges: Transportation disruptions, customs delays, and cold chain failures (if applicable to storage and transport of API or finished product) can affect timely delivery.
• Regulatory Changes: New or evolving regulations regarding chemical sourcing, manufacturing practices, or import/export can create compliance burdens and potential delays.

Mitigation Strategies:

• Dual Sourcing (API): Where feasible and economically viable, securing API supply from at least two qualified manufacturers can provide a critical backup. This requires significant investment in supplier qualification and dual production setup.
• Strategic Inventory Management: Maintaining adequate safety stock levels of both API and finished product can buffer against short-term supply interruptions.
• Geographic Diversification: If production is concentrated in a single region, exploring manufacturing or sourcing options in diverse geographic locations can reduce geopolitical and natural disaster risks.
• Robust Supplier Auditing and Relationships: Regular, thorough audits of API and excipient suppliers, coupled with strong, transparent relationships, help proactively identify and address potential issues.
• Contingency Planning: Developing and regularly testing business continuity plans for manufacturing and supply chain operations is essential.
• Alternative Formulation/Delivery Options: While not directly addressing the ULTRAVIST 300 supply, having awareness of alternative contrast agents or imaging modalities can provide strategic options in extreme supply shortage scenarios.

Market Dynamics and Future Outlook

The market for X-ray contrast media is driven by the increasing demand for diagnostic imaging procedures globally, fueled by an aging population, rising prevalence of chronic diseases, and advancements in imaging technology.

• Competition: ULTRAVIST 300 (iopromide) competes with other non-ionic, iodinated contrast agents such as Omnipaque (iohexol), Optiray (ioversol), and Visipaque (iodixanol). Each has slightly different properties and market positioning.
• Pricing Pressures: The entry of generic iopromide and competition from other contrast agents exert pricing pressures on the market.
• Technological Advancements: Ongoing research into new contrast agents with improved safety profiles, efficacy, and potentially lower environmental impact continues.

The future outlook for ULTRAVIST 300 will be influenced by the expiry of any remaining secondary patents, the success and market penetration of generic iopromide, and the competitive landscape of alternative contrast agents and imaging technologies. Bayer's strategic decisions regarding its manufacturing capacity and market support for ULTRAVIST 300 will also play a significant role.

Key Takeaways

• ULTRAVIST 300's active pharmaceutical ingredient is iopromide, a complex tri-iodinated contrast agent.
• Bayer AG is the primary marketer and likely controls API manufacturing through internal facilities or exclusive long-term contracts with specialized chemical producers.
• Identifying specific, publicly disclosed third-party API suppliers for branded pharmaceuticals like ULTRAVIST 300 is challenging due to proprietary information.
• The finished product formulation and packaging are conducted within Bayer's global GMP-compliant pharmaceutical manufacturing network.
• Supply chain risks, particularly concerning API sourcing and manufacturing continuity, require strategic mitigation through dual sourcing, inventory management, and robust supplier relationships.
• The competitive landscape is characterized by other non-ionic contrast agents and the eventual entry of generic iopromide, influencing market dynamics and pricing.

Frequently Asked Questions

1. Who manufactures the active pharmaceutical ingredient (API) iopromide for ULTRAVIST 300? Bayer AG, the marketer of ULTRAVIST 300, likely produces iopromide internally or through exclusive contracts with specialized fine chemical manufacturers experienced in complex iodination chemistry. Specific third-party API supplier names are generally proprietary and not publicly disclosed.

2. Are there generic versions of ULTRAVIST 300 available, and how do they compare? As patents and regulatory exclusivities expire, generic versions of iopromide are becoming available. These generic products must demonstrate bioequivalence to ULTRAVIST 300 and meet stringent quality and manufacturing standards set by regulatory authorities like the FDA and EMA.

3. What are the primary risks associated with the supply chain for contrast media like ULTRAVIST 300? Key risks include disruptions in API sourcing due to manufacturing issues at supplier sites, geopolitical instability affecting raw material availability, logistical challenges in global distribution, and potential regulatory changes impacting production or import.

4. How does Bayer AG ensure the quality and sterility of ULTRAVIST 300? Bayer adheres to strict Good Manufacturing Practices (GMP) throughout its manufacturing process. This includes sterile manufacturing environments for formulation and filling, rigorous quality control testing at all stages (raw materials, in-process, finished product), and validated packaging to maintain product integrity.

5. What is the global manufacturing footprint for sterile injectable contrast media? Manufacturing for sterile injectable contrast media is typically concentrated among large pharmaceutical companies with specialized sterile fill-finish capabilities and a limited number of highly qualified contract manufacturing organizations (CMOs) globally, often located in Europe, North America, and parts of Asia.

Citations

[1] U.S. Food & Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Retrieved from https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-approved-drug-products-therapeutic-equivalence-evaluations [2] European Medicines Agency. (n.d.). European public assessment reports (EPARs). Retrieved from https://www.ema.europa.eu/en/medicines/human/ [3] Bayer AG. (n.d.). Pharmaceuticals Division. Retrieved from https://www.bayer.com/en/pharmaceuticals