Suppliers and packagers for generic pharmaceutical drug: IOPROMIDE

IOPROMIDE

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 150	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 150	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 150	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: Iopromide

Last updated: August 2, 2025

Introduction

Iopromide is a non-ionic, water-soluble iodinated contrast agent widely employed in diagnostic imaging procedures such as computed tomography (CT) scans. As a critical component in medical diagnostics, its supply chain comprises various manufacturers, distributors, and regulatory entities globally. Understanding the landscape of Iopromide suppliers is essential for healthcare providers, pharmaceutical companies, and procurement professionals aiming to ensure a reliable and compliant supply chain. This analysis offers a comprehensive overview of the key players involved in the manufacturing and supply of Iopromide, along with insights into market dynamics.

Overview of Iopromide

Iopromide (trade names include Ultravist and Optiray) is recognized for its high iodine content, low osmolality, and favorable safety profile, making it a preferred contrast agent. The manufacturing process involves complex organic synthesis, purification, and sterilization, subject to stringent quality standards under regulatory oversight by agencies such as the FDA (U.S. Food and Drug Administration) and EMA (European Medicines Agency).

Manufacturers must adhere to Good Manufacturing Practices (GMP) and hold appropriate pharmaceutical manufacturing licenses. Notably, the supply of Iopromide is concentrated among a handful of global pharmaceutical and contract manufacturing organizations, many of which operate under licensing agreements with patent holders or brand owners.

Major Suppliers and Manufacturers

1. Guerbet Group

Overview
Guerbet S.A. is one of the leading global producers of contrast agents, including Iopromide. Headquartered in France, Guerbet boasts an extensive international footprint, with manufacturing facilities in Europe, North America, and Asia.

Product Portfolio
Guerbet's Iopromide products, marketed under the brand name Ultravist, are recognized for consistent quality and broad availability. Guerbet invests heavily in R&D to optimize formulations and manufacturing processes, ensuring compliance with international standards.

Supply Capabilities
Guerbet maintains multiple manufacturing sites capable of large-scale production, providing a stable supply to hospitals and distributors worldwide. The company's global sales network facilitates widespread distribution of Ultravist.

2. Bayer AG

Overview
Bayer, a multinational pharmaceutical and life sciences company based in Germany, has historically produced various contrast agents, including Iopromide. Bayer’s contrast media segment is a significant contributor to its imaging portfolio.

Product Portfolio
Bayer’s Iopromide-based contrast agents have been marketed under brands like Ultravist, similar to Guerbet’s offerings. Bayer’s manufacturing facilities are integrated within its global network, ensuring product consistency and quality.

Supply Capabilities
Bayer's extensive manufacturing infrastructure supports dependable global distribution, albeit with a focus on North American and European markets where Bayer maintains a strong foothold.

3. Bracco Imaging

Overview
An Italian multinational, Bracco Imaging specializes in medical imaging agents, including iodinated contrast media like Iopromide. Bracco's dedicated R&D and manufacturing facilities enhance its reputation as a reliable supplier.

Product Portfolio
Bracco markets Iopromide under brand names such as Xenetix. The company emphasizes high-quality manufacturing standards aligned with international GMP regulations.

Supply Capabilities
Bracco’s regional manufacturing hubs in Europe, Asia, and the Americas enable flexible supply logistics, catering to local regulatory requirements and market demand.

4. Iohexol Contract Manufacturers and Generics Producers

In addition to branded producers, several generics manufacturers and contract manufacturing organizations (CMOs) produce Iopromide under licensing agreements. These entities often serve regional markets, contributing to a more fragmented but resilient supply chain.

5. Contract Manufacturing Organizations (CMOs)

Overview
CMOs such as Patheon (a part of Thermo Fisher Scientific) and Aenova focus on producing bulk Iopromide for licensing partners and generics companies. These organizations leverage advanced manufacturing facilities and bring capacity flexibility.

Key Attributes

• Handle large-volume production runs.
• Offer customization and regulatory compliance assistance.
• Enable brand owners to expand their product portfolio without investing heavily in manufacturing infrastructure.

Regulatory and Market Dynamics

The supply chain for Iopromide is shaped by regulatory approvals, patent statuses, and market demand. Most branded formulations are protected by patents, requiring generic manufacturers to secure licensing or develop equivalent formulations under regulatory approval. While patent expirations have facilitated increased generic competition, supply stability depends on manufacturers maintaining large-scale GMP-compliant production capacities.

Supply disruptions may stem from raw material shortages, manufacturing quality issues, or regulatory bottlenecks. As such, multiple suppliers across regions mitigate risks associated with reliance on single-source manufacturing.

Emerging Trends and Challenges

• Global Supply Chain Resilience
  The COVID-19 pandemic exposed vulnerabilities within pharmaceutical supply chains, prompting efforts by manufacturers and regulators to increase stockpiles, diversify suppliers, and enhance local manufacturing.

• Regulatory Harmonization
  As agencies streamline approval processes through initiatives like the International Conference on Harmonisation (ICH), manufacturers can more efficiently expand supply into new markets.

• Environmental and Quality Standards
  Stricter environmental controls and quality standards demand continuous investment by manufacturers to maintain compliance, impacting production costs and timelines.

• Patent Landscape and Generic Competition
  The expiration of patents around Iopromide is gradually opening opportunities for generic manufacturers. However, regulatory hurdles and market acceptance remain critical.

Conclusion

The global supply of Iopromide centers around a handful of leading pharmaceutical players, notably Guerbet, Bayer, and Bracco. Their extensive manufacturing infrastructure and adherence to international quality standards ensure a relatively stable supply chain. Contract manufacturing organizations supplement this landscape, particularly in regional markets, increasing supply resilience.

Healthcare providers and pharmaceutical procurement professionals must factor in supplier diversity, regulatory compliance, and geopolitical considerations when managing Iopromide inventories. As patent protections evolve and generics penetrate markets, the supply chain dynamics will continue to adapt, emphasizing the importance of strategic sourcing and risk management.

Key Takeaways

• Leading Suppliers: Guerbet, Bayer, and Bracco dominate the Iopromide supply chain, with manufacturing capabilities spanning continents.

• Supply Chain Resilience: Diversification among primary and secondary suppliers mitigates risks of shortages and disruptions.

• Regulatory Landscape: Strict GMP standards and regulatory approvals underpin manufacturing stability; patent expirations are opening competition.

• Market Trends: Increased generic competition and environmental regulations influence manufacturing costs and distribution strategies.

• Procurement Strategy: Engaging multiple suppliers, understanding regional manufacturing capabilities, and monitoring regulatory changes are essential for robust supply chain management.

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Frequently Asked Questions (FAQs)

1. Who are the primary manufacturers of Iopromide globally?
The principal manufacturers are Guerbet, Bayer, and Bracco, each operating extensive manufacturing facilities to support global distribution.

2. Are there generic or alternative suppliers of Iopromide?
Yes. Post-patent expiration, several generic manufacturers and CMOs produce Iopromide under licensing agreements, increasing market diversity.

3. What factors influence supply stability for Iopromide?
Factors include raw material availability, manufacturing capacity, regulatory approvals, quality compliance, and geopolitical stability.

4. How does patent expiration impact the Iopromide supply chain?
Patent expiry facilitates entry of generics, intensifying competition, potentially lowering prices, and expanding supply options, but also introduces variability in quality and regulatory compliance.

5. What should healthcare providers consider when sourcing Iopromide?
Providers should ensure supplier qualification, verify regulatory approvals, monitor inventory levels, and diversify supply sources to mitigate shortages.

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References

1. Guerbet Group Official Website. Ultravist. [Online] Available at: https://www.guerbet.com
2. Bayer AG. Contrast Media Portfolio. [Online] Available at: https://www.bayer.com
3. Bracco Imaging. Product Portfolio. [Online] Available at: https://www.bracco.com
4. International Conference on Harmonisation (ICH). Guidelines for Pharmaceutical Manufacturing. [Online] Available at: https://www.ich.org
5. Market Analysis Reports. Global Contrast Media Market. [2022 Publication].

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This article is intended for informational purposes for industry stakeholders and does not constitute specific procurement advice.