Bulk Pharmaceutical API Sources for EOVIST

Bulk Pharmaceutical API Sources for EOVIST

Vendor	Vendor Homepage	Vendor Sku	API Url
ABI Chem		AC1L9OPS
Ark Pharm, Inc.		AK676660
BLD Pharm		BD756303
BioChemPartner		BCP09445
Ambeed		A429813

Bulk Active Pharmaceutical Ingredient (API) Sources for: EOVIST (Gadoteric Acid)

Last updated: July 29, 2025

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Introduction

EOVIST, marketed as Gadoteric Acid, is a gadolinium-based contrast agent (GBCA) primarily used in magnetic resonance imaging (MRI) to enhance vascular and tissue imaging. Approved by various regulatory agencies, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), EOVIST’s efficacy hinges on the reliable supply of its active pharmaceutical ingredient (API) — gadoteric acid. Securing bulk API sources is critical for manufacturers, healthcare providers, and supply chain managers to ensure continued availability and compliance with quality standards.

This article provides a comprehensive overview of the global API landscape for gadoteric acid, emphasizing key manufacturers, geopolitical considerations, quality standards, and market dynamics shaping supply options.

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1. Overview of API Manufacturing for Gadolinium-Based Contrast Agents

Gadoteric acid is a macrocyclic, ionic gadolinium complex that requires specialized synthesis, stringent quality control, and adherence to Good Manufacturing Practices (GMP). The API manufacturing process involves:

• Complexation of gadolinium with a macrocyclic chelating agent.
• Purification to remove unreacted gadolinium and by-products.
• Rigorous testing for residual solvents, elemental impurities, and endotoxins.

Because of these complexities, only select chemical manufacturers with advanced facilities and expertise supply gadoteric acid API. The pipeline of suppliers is predominantly concentrated in regions with developed pharmaceutical manufacturing hubs, notably Europe, North America, and parts of Asia.

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2. Leading Global API Suppliers for EOVIST

A. Mallinckrodt Pharmaceuticals (USA)

Mallinckrodt is a leading provider of gadoteric acid API, with longstanding experience in contrast agent manufacturing. Their facilities in the United States manufacture high-purity APIs that meet stringent GMP standards. As a primary source for EOVIST API, Mallinckrodt offers consistent quality, supported by robust regulatory compliance.

B. Guerbet Group (France)

Guerbet, a pioneer in contrast media, operates one of the largest GMP-compliant production facilities for gadolinium-based contrast agents globally. Their manufacturing capabilities include gadoteric acid API, supplied to various market segments. Guerbet’s strategic position in Europe and adherence to European Pharmacopoeia standards make their APIs a trusted source for multinational drug producers.

C. Bracco Imaging (Italy)

Bracco is another prominent European manufacturer supplying gadoteric acid API, largely for internal use in their contrast media formulations. Their European manufacturing plants follow rigorous GMP protocols aligned with EMA regulations, and they have a growing export footprint.

D. Qilu Pharmaceutical (China)

Qilu Pharmaceutical has emerged as a significant Asian API producer offering gadoteric acid, leveraging cost efficiencies and scaling capacity to meet domestic and international demands. While their GMP compliance is recognized in China, export approval to regions such as the US and Europe often requires additional validation.

E. Jiangsu Hengrui Medicine (China)

An expanding pharmaceutical firm specializing in complex APIs, Jiangsu Hengrui supplies gadoteric acid API for various global markets, with ongoing efforts to attain international GMP certification to access stricter regulatory markets.

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3. Regional Considerations and Supply Chain Dynamics

North America

The US market predominantly relies on Mallinckrodt and associated regional suppliers for gadoteric acid API. The North American supply chain benefits from rigorous regulatory oversight, transparent quality standards, and established logistics. However, recent geopolitical tensions and trade policies can influence supply stability and cost.

Europe

Europe’s supply of gadoteric acid API is primarily driven by Guerbet and Bracco. European manufacturers benefit from proximity to the EMA regulatory framework, facilitating easier compliance and shorter lead times. European API sources generally adhere to high GMP standards, influencing global confidence.

Asia

Asian API producers, chiefly Chinese firms such as Qilu and Jiangsu Hengrui, offer cost-competitive API production. These suppliers are rapidly expanding capacity but face challenges regarding GMP certification and regulatory acceptance in Western markets. Ongoing efforts to attain international certifications (e.g., EMA, FDA) are pivotal for expanding export capabilities.

Global Supply Risks

Global supply chains for gadoteric acid API are vulnerable to geopolitical factors, regional pandemics, and raw material availability, especially gadolinium salts. Ensuring diversified sourcing and maintaining strategic inventory are crucial for manufacturers of gadolinium-based contrast agents like EOVIST.

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4. Quality and Regulatory Compliance

API suppliers for gadoteric acid must comply with multiple standards, including:

• GMP Certification: Ensures manufacturing process integrity, cleanliness, and control.
• Pharmacopoeial Standards: European Pharmacopoeia (Ph. Eur.), United States Pharmacopeia (USP), and other regional standards.
• Regulatory Approvals: Suppliers must demonstrate compliance with FDA, EMA, and other regulators if their API is intended for global markets.

Continuous validation, stability testing, and third-party audits are integral to API sourcing for EOVIST.

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5. Market Trends Influencing API Supply

• Regulatory Trends: Increasing scrutiny over gadolinium-based contrast agents has prompted tighter standards and supply chain validation.
• Pricing Pressures: Competition from regional manufacturers influences API pricing, which in turn affects formulation costs.
• Innovation & Biosynthesis: Emerging biochemical methods aim to produce gadolinium chelates more sustainably and efficiently.
• Supply Chain Consolidation: Several regional mergers and acquisitions influence API market dynamics, potentially reducing the number of suppliers.

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Key Challenges in API Sourcing

• Regulatory Barriers: Navigating differing global standards remains complex, especially for manufacturers seeking multiple market approvals.
• Supply Disruptions: Raw material shortages, geopolitical issues, and manufacturing delays pose ongoing risks.
• Quality Assurance: Maintaining consistent high-quality API amid regional variability in standards.

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Conclusion

Sourcing gadoteric acid API for EOVIST involves navigating a complex global landscape characterized by a handful of established manufacturers, regional regulatory standards, and geopolitical influences. Leading suppliers like Mallinckrodt in North America, Guerbet and Bracco in Europe, and Asian producers such as Qilu and Jiangsu Hengrui offer diverse options tailored to market needs. Ensuring compliance, quality assurance, and supply chain robustness remains paramount for stakeholders intent on delivering reliable MRI contrast media.

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Key Takeaways

• Dominant Suppliers: Mallinckrodt (USA), Guerbet (France), Bracco (Italy), and select Chinese firms lead gadoteric acid API production.
• Regional Variability: North America and Europe benefit from established GMP frameworks; Asian suppliers offer cost advantages but face regulatory certification hurdles.
• Supply Chain Risks: Geopolitical and raw material shortages necessitate diversified sourcing strategies.
• Regulatory Compliance: ISO standards, GMP adherence, and pharmacopoeial conformity are critical for market access.
• Market Trends: Evolving regulations and manufacturing innovations continue to shape API sourcing strategies.

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FAQs

1. What are the primary regions supplying gadoteric acid API for EOVIST?
North America (Mallinckrodt), Europe (Guerbet, Bracco), and Asia (Qilu, Jiangsu Hengrui) are the main sources, with regional strengths in regulatory compliance and cost efficiency.

2. How does GMP certification impact API sourcing for gadoteric acid?
GMP certification ensures the API meets quality, purity, and safety standards required by regulators, which is essential for international market approval and product consistency.

3. What are the main challenges faced by Asian suppliers of gadoteric acid API?
Challenges include attaining and maintaining GMP certification, navigating regulatory acceptance in Western markets, and ensuring quality with rapid capacity expansion.

4. How do geopolitical factors influence the gadoteric acid API supply?
Trade restrictions, tariffs, and regional political tensions can disrupt supply chains, impacting availability and pricing for manufacturers and healthcare providers.

5. Are there emerging alternatives to gadoteric acid API in MRI contrast agents?
Research is ongoing into macrocyclic and linear chelates with improved safety profiles, but gadoteric acid remains a cornerstone due to its efficacy and regulatory approvals.

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References:

[1] FDA Drug Approvals Database. (2022). EOVIST (Gadoteric Acid).
[2] European Medicines Agency (EMA). (2022). Marketing Authorization for Gadoteric Acid.
[3] Guerbet Group. (2022). Overview of Contrast Media Manufacturing Capabilities.
[4] Mallinckrodt Pharmaceuticals. (2022). API Manufacturing and Supply.
[5] MarketWatch. (2023). Global Gadolinium Contrast Agent Market Trends.