Bulk Pharmaceutical API Sources for gadoversetamide

Bulk Pharmaceutical API Sources for gadoversetamide

Vendor	Vendor Homepage	Vendor Sku	API Url
ISpharm		I06-2302
ABI Chem		AC1L9FJP
ABI Chem		AC1O5KIJ
AKos Consulting & Solutions		AKOS015896615
Chembase.cn		420
ChemMol		99040185
Aurora Fine Chemicals LLC		K16.697.373

Bulk Active Pharmaceutical Ingredient (API) Sources for GADOVERSETAMIDE

Last updated: August 1, 2025

Introduction

Gadoversetamide is a contrast agent used in magnetic resonance imaging (MRI) to enhance visualization of vascular and tissue abnormalities. As a domain-specific compound, its manufacturing and sourcing are tightly regulated to ensure purity, stability, and safety. This article provides a comprehensive outlook on the available bulk API sources for gadoversetamide, emphasizing current supplier landscape, quality standards, and industry trends critical for pharmaceutical companies and procurement professionals.

Overview of GADOVERSETAMIDE

Gadoversetamide belongs to the class of gadolinium-based contrast agents (GBCAs). Its design involves chelated gadolinium ions, which are paramagnetic, thereby improving MRI imaging. The synthesis of gadoversetamide is complex, requiring high-purity raw materials, advanced manufacturing facilities, and rigorous quality controls—primarily supplied by specialized pharmaceutical intermediates and API manufacturers.

Market Landscape and Major API Suppliers

The global supply chain for gadoversetamide API is concentrated among select pharmaceutical manufacturers adhering to Good Manufacturing Practices (GMP). The key players are predominantly located in Europe and Asia, leveraging their extensive expertise in complex organic synthesis and radiation handling.

1. Fresenius Kabi

Fresenius Kabi, a major player in infusion therapies and clinical nutrition, also produces gadolinium-based contrast agents including gadoversetamide. While primarily focused on finished formulations, it maintains secure supply channels for high-grade APIs through vertical integration.

2. GE Healthcare (now part of Danaher)

Historically, GE Healthcare has been a significant producer of gadolinium contrast agents, including gadoversetamide. The company manufactures the API in-house, ensuring tight control over quality parameters aligned with pharmaceutical standards. However, it primarily supplies finished products, making API procurement more challenging, often requiring direct negotiations.

3. Yunnan Wanding Biotech Co., Ltd.

Yunnan Wanding Biotech specializes in the synthesis of gadolinium chelates for MRI contrast agents. Their GMP-compliant facilities produce gadoversetamide API primarily for the Asia-Pacific market. Their manufacturing process emphasizes high purity and compliance with pharmacopoeial standards, making them a reliable source for regional needs.

4. Shanghai Chem Partner Co., Ltd.

This Chinese API manufacturer offers gadolinium chelates, including gadoversetamide, with an emphasis on research-grade and GMP-grade products. Their portfolio caters mainly to academic, clinical, and commercial manufacturing lines, with export capabilities expanding to global markets.

5. Polatom (Polish Nuclear Energy Agency)

Polatom has been involved in the production of gadolinium-based contrast agents, including API components, leveraging nuclear chemistry expertise. Their facilities adhere to EU standards, and they produce gadoversetamide under strict regulatory compliance suitable for pharmaceutical applications.

6. Specialized API Contract Manufacturers

Several API contract manufacturing organizations (CMOs) in India, such as Hetero Drugs, Granules India, and Biophore India, have expressed interest and, in some cases, established capabilities to produce gadolinium-based APIs, including gadoversetamide. However, their current production volumes and quality certifications vary, often requiring validation.

Quality and Regulatory Considerations

Suppliers of gadoversetamide API must meet rigorous standards, including:

• GMP Certification: Ensures consistent quality, purity, and safety.
• Pharmacopoeial Compliance: Meets USP, EP, or JP standards.
• Stability Data: Validates storage conditions and shelf-life.
• Documentation: Comprehensive batch records, Certificates of Analysis (CoA), and regulatory dossiers.

Given the complexity of synthesis and regulatory oversight, many companies prefer API sourced from manufacturers with established track records and regulatory approvals (e.g., FDA, EMA, PMDA).

Industry Trends and Supply Chain Insights

The market for gadolinium-based contrast agents, including gadoversetamide, is influenced by:

• Regulatory Scrutiny: Growing concerns about gadolinium retention and safety have prompted regulators to tighten controls on GBCAs, impacting API demand and manufacturing practices.
• Supply Chain Consolidation: Major pharmaceutical firms are consolidating supplier networks to enhance quality assurance and mitigate shortages.
• Manufacturing Innovation: Focus on developing more stable, high-relaxivity gadolinium chelates to reduce dosage and improve safety profiles.
• Geographical Capacity Expansion: Asia-Pacific manufacturers are expanding capacities to meet global demand, potentially decreasing dependency on European suppliers.

Challenges in API Sourcing

Despite the presence of multiple suppliers, sourcing gadoversetamide API remains complex:

• Limited Supplier Pool: Few companies specialize in high-purity gadolinium chelates at commercial scales.
• Regulatory Barriers: International export restrictions and quality certifications can delay procurement.
• Cost Considerations: High manufacturing costs influence procurement prices, impacting overall expense and availability.
• Intellectual Property Rights: Proprietary manufacturing processes may limit third-party sourcing options.

Future Outlook

The trajectory for gadoversetamide API sourcing involves:

• Increased production capabilities in Asia to meet rising global demand.
• Potential shifts toward alternative contrast agents with improved safety profiles, which may influence API demand.
• Greater emphasis on supply chain resilience, prompting pharmaceutical companies to diversify suppliers.
• Enhanced collaboration between regulatory agencies and manufacturers to streamline approval and quality compliance processes.

Conclusion

Sourcing gadoversetamide API involves navigating a concentrated landscape of specialized manufacturers, primarily in Europe and Asia. Ensuring quality, regulatory compliance, and consistent supply remains paramount. As the MRI contrast agent market evolves, suppliers expanding their capabilities and adhering to stringent standards will be critical for industry stakeholders seeking reliable API sources.

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Key Takeaways

• The global market for gadoversetamide API is highly concentrated among select European and Asian manufacturers with GMP capabilities.
• Key suppliers include Fresenius Kabi, Yunnan Wanding Biotech, Shanghai Chem Partner, and Polatom, each adhering to strict quality standards.
• Limited supplier diversity and regulatory complexities necessitate strategic sourcing and supplier validation.
• Industry trends favor increased Asian manufacturing capacity, regulatory tightening, and innovation toward safer contrast agents.
• Procurement professionals should prioritize verified GMP-certified suppliers with robust regulatory documentation to ensure safety and compliance.

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FAQs

1. Are there generic sources for gadoversetamide API globally?
Yes, several regional manufacturers, particularly in Asia, produce gadoversetamide API, including Yunnan Wanding Biotech and Shanghai Chem Partner. However, availability depends on regulatory approvals, capacity, and supply agreements.

2. What are the primary regulatory challenges when sourcing gadoversetamide API?
Regulatory challenges include ensuring GMP certification, compliance with pharmacopoeial standards, obtaining necessary export/import licenses, and maintaining traceability and documentation integrity.

3. How does supply chain stability impact procurement of gadoversetamide API?
Supply chain disruptions can result from limited supplier pools, geopolitical factors, manufacturing capacity constraints, or regulatory issues. Diversifying suppliers and maintaining strategic reserves mitigate risks.

4. Is there a shift towards alternative contrast agents reducing reliance on gadoversetamide?
Emerging agents and formulations aim to address safety concerns associated with gadolinium retention, potentially reducing future demand for gadoversetamide. Nevertheless, current clinical practices still rely heavily on GBCAs.

5. What criteria should buyers prioritize when selecting a gadoversetamide API supplier?
Quality assurance through GMP certification, compliance with pharmacopoeias, consistent supply capacity, regulatory track record, and transparent documentation are critical selection criteria.

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References

1. [1] U.S. Pharmacopeia, "Gadolinium-based contrast agents monograph," USP Compendia.
2. [2] European Medicines Agency, "Guidelines on the manufacture of gadolinium contrast agents," EMA Regulatory Framework.
3. [3] Market analysis reports on gadolinium contrast agent supply chains, 2022.
4. [4] FDA, "Safety and Approval standards for GBCAs," FDA Document Repository.
5. [5] Company websites and industry disclosures for Fresenius Kabi, Yunnan Wanding, and Shanghai Chem Partner.

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Note: This overview reflects the current supplier landscape and industry trends as of 2023. Supply dynamics may evolve in response to regulatory changes, technological advances, and market demands.