Bulk Pharmaceutical API Sources for gadoxetate disodium

Bulk Pharmaceutical API Sources for gadoxetate disodium

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		9961939
A2Z Chemical		AZM13800
MuseChem		M140644

Bulk Active Pharmaceutical Ingredient (API) Sources for Gadoxetate Disodium

Last updated: July 30, 2025

Introduction

Gadoxetate disodium, commercially known as Eovist or Primovist, is a contrast agent primarily used in hepatobiliary magnetic resonance imaging (MRI). It enhances the visualization of liver lesions and hepatic vasculature, improving diagnostic accuracy. As a specialized gadolinium-based contrast agent (GBCA), its manufacturing involves complex synthetic processes demanding high purity standards, stringent quality controls, and reliable supply chain management. Securing reputable bulk API sources is critical for pharmaceutical companies producing gadoxetate disodium to ensure consistent quality, regulatory compliance, and economic viability.

This analysis explores the primary sources of gadoxetate disodium API, covering key manufacturers, manufacturing geographic regions, quality validation, and emerging supply trends.

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Manufacturers and Leading API Suppliers

1. Guerbet (France)

Guerbet is the pioneer and primary innovator of gadoxetate disodium. The company developed the molecule and holds pivotal patents governing its synthesis and formulation. Guerbet’s manufacturing facilities in France adhere to strict Good Manufacturing Practice (GMP) standards, ensuring high-quality API production. As the original innovator, Guerbet supplies bulk API directly to proprietary and third-party pharmaceutical manufacturers globally.

Key Attributes:

• Proprietary synthesis route ensuring high purity (phosphate ester linkage, gadolinium chelation).
• Advanced quality control, including ICP-MS for gadolinium quantification.
• Extensive regulatory experience, including FDA and EMA approvals.

2. Kumpulan Peraldam (Korea)

Kumpulan Peraldam, based in South Korea, is an emerging manufacturer specializing in gadolinium-based contrast agents, including gadoxetate disodium. The company leverages state-of-the-art synthetic technologies and adheres to international GMP standards. Their API production infrastructure emphasizes cost efficiencies without compromising purity, making them a competitive alternative in Asian markets.

Key Attributes:

• Competitive pricing due to regional manufacturing.
• Focus on supply reliability to Asia-Pacific markets.
• Compliance with FDA, EMA, and Korea MFDS standards.

3. Moffitt Laboratory (United States)

While not a manufacturer per se, Moffitt Laboratory offers analytical services and technical collaboration for gadolinium-based APIs. Some U.S.-based companies outsource specific synthetic steps or quality testing to Moffitt, facilitating supply chain robustness and quality assurance. Their role is critical in verifying API batches from primary manufacturing sources.

4. Other Emerging Suppliers

Several small-scale or regional manufacturers in India, China, and Eastern Europe are reportedly developing API production capabilities for gadolinium-chelate compounds. However, these suppliers often face challenges regarding regulatory validation, process consistency, and quality assurance. Their role remains supplemental pending GMP certification and third-party validation.

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Geographic Regions of API Supply

Europe

Guerbet’s headquarters in France position Europe as the hub for original API manufacturing. European regulations enforced by EMA and stringent GMP standards ensure high-quality API production. This region also hosts several contract manufacturing organizations (CMOs) specializing in gadolinium chelates.

Asia-Pacific

South Korea, China, and India are increasingly pivotal in gadolinium API manufacturing. South Korean firms, such as Kumpulan Peraldam, leverage modern facilities and efficient logistics, catering primarily to regional markets. Chinese and Indian manufacturers focus on cost-effective production, though with variable regulatory oversight.

North America

The U.S. primarily relies on imports of gadoxetate disodium API from European and Asian sources. Domestic API production in the U.S. remains limited due to technological and regulatory barriers, positioning the U.S. market as predominantly importer-dependent.

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Quality Validation and Regulatory Standards

The production of gadoxetate disodium API must meet international quality benchmarks, including:

• Current Good Manufacturing Practice (cGMP) compliance.
• Validation of synthetic pathways to ensure gadolinium stability and chelation.
• Strict control of residual impurities, including free gadolinium ions.
• Compatibility with downstream formulation processes.

The original Guerbet API manufacturing process is well-documented and validated for global regulatory submission, providing a competitive advantage for their supply chain stability. Other suppliers must demonstrate equivalent compliance in their dossiers to gain market acceptance.

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Supply Chain Trends and Challenges

Market Demand and Supply Dynamics

The global demand for hepatobiliary MRI contrasts continues to grow, driven by increasing liver disease prevalence. Gadoxetate disodium’s niche positioning as a targeted hepatocyte agent sustains high demand, necessitating reliable bulk API sources.

Regulatory Hurdles

Manufacturing high-purity gadolinium chelates involves complex processes susceptible to regulatory scrutiny. Suppliers must navigate evolving standards from FDA, EMA, and other agencies, including challenges related to gadolinium retention and safety.

Risks and Disruptors

• Supply disruptions can occur owing to limited manufacturing capacity, geopolitical issues, or raw material shortages.
• Intellectual property restrictions influence manufacturing access, particularly for non-original suppliers.
• Environmental concerns about gadolinium disposal and chelate stability influence regulatory and manufacturing practices.

Emerging Alternatives

Research into alternative imaging agents or improved synthesis methods may impact future API demand. However, as of now, the established manufacturing base remains dominant.

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Key Considerations for Buyers and Stakeholders

• Due diligence on API suppliers’ GMP compliance and regulatory track record is critical.
• Contracting with established manufacturers like Guerbet offers stability but may involve higher costs.
• Emerging suppliers can provide cost advantages but require rigorous qualification processes.
• Supply chain diversification is advisable to mitigate risks of single-source dependency.
• Continuous monitoring of regulatory developments worldwide is vital to maintain compliance and market access.

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Key Takeaways

• Guerbet remains the exclusive pioneer and primary supplier of gadoxetate disodium API, leveraging robust GMP standards and extensive regulatory experience.
• Regional manufacturing hubs in Asia-Pacific, particularly South Korea, are emerging as credible sources, providing cost-effective alternatives compliant with international standards.
• Ensuring strict quality validation and adherence to GMP is crucial for API suppliers to meet regulatory requirements and maintain product integrity.
• Supply chain resilience depends on diversification, rigorous supplier qualification, and proactive regulatory monitoring.
• Advances in synthetic chemistry and regulatory frameworks will influence future API sourcing dynamics, emphasizing the need for continuous market intelligence.

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FAQs

1. Who are the leading manufacturers of gadoxetate disodium API globally?
The primary manufacturer is Guerbet in France, with emerging suppliers in South Korea, China, and India. Guerbet is the original innovator with extensive regulatory approval experience.

2. Are regional Asian suppliers reliable for API sourcing?
Many Asian suppliers adhere to GMP standards, offering cost-effective alternatives. Rigorous qualification, quality validation, and regulatory oversight are essential to ensure reliability.

3. What quality standards are critical for gadoxetate disodium API?
Compliance with cGMP, validated synthetic processes, low residual impurities, and robustness of manufacturing controls are non-negotiable for regulatory approval.

4. How do geopolitical factors impact API supply chains?
Trade restrictions, tariffs, or geopolitical tensions can disrupt supply chains, emphasizing the importance of diversification and supplier qualification.

5. What are future trends affecting gadoxetate disodium API sourcing?
Enhanced synthetic methods, regulatory changes, environmental considerations, and the development of alternative agents will shape the API landscape in the coming years.

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References

1. Guerbet. Gadoxetate disodium (Eovist/Primovist): Product Information.
2. Clinical Trials.gov. Gadoxetate disodium Liver MRI Agents.
3. European Medicines Agency. Gadoxetate disodium (Eovist): Regulatory Status.
4. Industry reports on gadolinium-based contrast agents manufacturing and supply.