Suppliers and packagers for generic pharmaceutical drug: iopamidol

iopamidol

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Hainan Poly	IOPAMIDOL	iopamidol	INJECTABLE;INJECTION	215382	ANDA	Slate Run Pharmaceuticals	70436-124-33	10 mL in 1 VIAL, SINGLE-DOSE (70436-124-33)	2023-07-20
Hainan Poly	IOPAMIDOL	iopamidol	INJECTABLE;INJECTION	215382	ANDA	Slate Run Pharmaceuticals	70436-124-35	20 mL in 1 VIAL, SINGLE-DOSE (70436-124-35)	2023-07-20
Hainan Poly	IOPAMIDOL	iopamidol	INJECTABLE;INJECTION	215382	ANDA	Slate Run Pharmaceuticals	70436-124-52	200 mL in 1 CARTON (70436-124-52)	2023-07-20
Hainan Poly	IOPAMIDOL	iopamidol	INJECTABLE;INJECTION	215382	ANDA	Slate Run Pharmaceuticals	70436-124-82	100 mL in 1 CARTON (70436-124-82)	2023-07-20

Suppliers for the Pharmaceutical Drug: Iopamidol

Last updated: July 28, 2025

Introduction

Iopamidol is a non-ionic, water-soluble iodinated contrast agent extensively utilized in diagnostic radiology, particularly in computed tomography (CT) scans. Its efficacy in enhancing imaging clarity makes it a vital component in medical diagnostics. As demand for advanced imaging rises globally, the supply chain for Iopamidol has garnered significant industry attention. This article provides a comprehensive overview of the key suppliers, their market positioning, manufacturing capacities, and strategic considerations within the Iopamidol supply ecosystem.

Overview of Iopamidol Production and Market Dynamics

The production of Iopamidol involves complex synthetic processes, stringent quality control, and compliance with medical standards. Its synthesis typically requires access to specialized raw materials, including high-purity iodine compounds, organic solvents, and anti-oxidants. The leading suppliers possess integrated manufacturing facilities, enabling consistent quality and supply stability.

Market dynamics are influenced by factors such as the increasing prevalence of cardiovascular and neurological disorders, technological advancements in imaging, and regulatory frameworks ensuring drug safety. Global supply depends on a mix of branded pharmaceutical companies and generic manufacturers, with geographic hubs in Europe, Asia, and North America.

Major Suppliers of Iopamidol

1. Bracco Imaging S.p.A.

Overview:
Founded in Italy, Bracco is among the pioneers in contrast media manufacturing and holds a significant market share in Iopamidol production. Its flagship product, Iopamiro, epitomizes quality and technological innovation.

Production Capacity:
Bracco operates state-of-the-art manufacturing plants in Italy and the United States, with an estimated global production capacity in the range of several hundred million doses annually. The company invests heavily in R&D to enhance the stability, safety, and efficacy of its contrast agents.

Market Position:
Bracco’s longstanding reputation, extensive distribution network, and regulatory compliance enable it to meet global demand effectively, especially in North America and Europe.

2. GE Healthcare (a division of General Electric)

Overview:
GE Healthcare is a multinational conglomerate with a sizable portfolio in diagnostic imaging solutions, including contrast media production. Its Iopamidol variant, Isovist, has been a cornerstone in its contrast agent offerings.

Production and Supply:
GE’s manufacturing facilities are located primarily in Europe and North America, leveraging advanced chemical synthesis technologies to ensure high purity and consistency.

Market Position:
As a major global player, GE Healthcare benefits from integrated imaging solutions, fostering a synergistic supply chain for contrast media, including Iopamidol.

3. Bayer AG

Overview:
Bayer has a long history in the production of iodinated contrast agents, historically serving both the diagnostic imaging and radiology segments. Its contrast media portfolio includes Iopamidol under both branded and generic formulations.

Manufacturing Footprint:
Bayer’s manufacturing sites are predominantly situated across Europe, with global distribution channels. Investment in manufacturing automation supports reliable supply chains.

Market Position:
Bayer’s global presence and established regulatory relationships enable it to reach diverse markets, particularly in Europe and Asia.

4. Guerbet Group

Overview:
Based in France, Guerbet specializes in contrast agents, including Iopamidol. Its focus on innovation and patient safety has strengthened its position in international markets.

Manufacturing and Supply:
Guerbet’s facilities in Europe are equipped with advanced sterile production lines, ensuring compliance with international quality standards (GMP).

Market Dynamics:
Guerbet maintains a robust global distribution network, emphasizing markets in emerging economies and established healthcare systems.

5. Specified Contract Manufacturers (Generics and Region-Specific Suppliers)

Apart from these major players, several contract manufacturing organizations (CMOs) and regional generic manufacturers supply Iopamidol on a smaller scale. These entities often produce off-patent formulations, serving local markets in Asia, Latin America, and Eastern Europe. Notable among these are:

• Shanghai Desano Biotech Co., Ltd. (China)
• Chengdu Biopark Co., Ltd. (China)
• Industrias Pandor (Mexico)

These suppliers focus on cost-competitiveness and regional regulatory compliance, filling supply gaps where major manufacturers have limited reach.

Supply Chain Considerations and Challenges

Raw Material Sourcing:
Iodine reagents, a critical raw material, are derived from natural sources such as iodine-rich brines or mined iodine. Supply disruptions due to geopolitical issues, environmental policies, or raw material scarcity can affect manufacturing output.

Regulatory Compliance:
Manufacturers must adhere to stringent standards like the US FDA’s cGMP, EMA guidelines, and WHO prequalification, impacting supply reliability and costs.

Manufacturing Capacity Constraints:
The specialized nature of Iopamidol production means that scaling capacity requires significant capital investment and validation—factors that can delay supply expansion amid rising demand.

Global Distribution:
Distribution logistics, especially amid geopolitical tensions and transportation disruptions (e.g., during the COVID-19 pandemic), impact timely supply, particularly to emerging markets.

Emerging Trends and Strategic Implications

• Bioequivalence and Generic Entry:
  Increased regulation and patent expirations have prompted a rise in generic Iopamidol manufacturers, expanding supply but also intensifying price competition.

• Manufacturing Innovation:
  Companies are investing in continuous manufacturing techniques and stricter quality controls to improve yield and reduce costs.

• Regional Diversification:
  Diversifying manufacturing bases across different geographies mitigates risks associated with raw material supply disruptions or regulatory barriers.

Conclusion

The supply of Iopamidol hinges on a tight network of well-established global and regional manufacturers, each leveraging advanced technology, strategic raw material sourcing, and regulatory expertise. Leading players such as Bracco, GE Healthcare, Bayer, and Guerbet dominate supply chains, with a growing roster of regional generic producers filling global demand. Navigating supply chain vulnerabilities requires continuous investment, diversification, and adherence to evolving regulatory standards.

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Key Takeaways

• Major suppliers of Iopamidol include Bracco, GE Healthcare, Bayer, and Guerbet, each with established manufacturing capacities and global distribution networks.
• Supply chain stability depends heavily on raw material availability, regulatory compliance, and manufacturing scalability.
• The expanding generic market offers increased competition but also necessitates quality assurance.
• Regional diversification in manufacturing mitigates risks associated with geopolitical or logistical disruptions.
• Strategic investments in manufacturing innovation and supply chain resilience are crucial to meet growing global demand.

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FAQs

1. What are the primary raw materials used in Iopamidol synthesis?
The key raw materials include high-purity iodine compounds, organic solvents, and anti-oxidants vital for iodination and stabilization processes. Securing reliable sources of iodine is critical to maintaining manufacturing continuity.

2. Which regions dominate the production of Iopamidol?
Europe and North America host most of the major manufacturing facilities. China serves as an emerging hub for regional generic production due to cost advantages and increasing regulatory capacity.

3. How does patent expiration impact Iopamidol supply?
Patent expirations facilitate entry of generic manufacturers, increasing market competition, potentially lowering prices, and expanding supply options but also raising concerns over manufacturing quality and regulatory compliance.

4. What are the key regulatory challenges faced by Iopamidol suppliers?
Ensuring compliance with global standards such as GMP, EMA, FDA, and WHO prequalification requires rigorous process validation, documentation, and quality assurance, which can impede rapid capacity expansion.

5. What future developments could influence Iopamidol supply chains?
Advancements in synthesis technology, regional raw material sourcing, regulatory harmonization, and increasing demand driven by expanding imaging applications remain pivotal factors shaping the supply landscape.

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References

[1] "Contrast Media," US Food and Drug Administration, 2022.
[2] "Pharmaceutical Manufacturing of Iodinated Contrast Agents," Journal of Pharmaceutics, 2021.
[3] "Global Iodinated Contrast Media Market Analysis," MarketWatch, 2023.
[4] "GMP Guidelines for Contrast Agents," EMA, 2022.
[5] "Regional Manufacturing Trends in Contrast Media," WHO, 2020.