Bulk Pharmaceutical API Sources for GADOFOSVESET TRISODIUM

Bulk Pharmaceutical API Sources for GADOFOSVESET TRISODIUM

Vendor	Vendor Homepage	Vendor Sku	API Url
Chembase.cn		4442
ChemTik		CTK8H4466
Achemtek		0102-014318
BLD Pharm		BD106626

Bulk Active Pharmaceutical Ingredient (API) Sources for Gadofosveset Trisodium

Last updated: July 28, 2025

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Introduction

Gadofosveset trisodium is a gadolinium-based MRI contrast agent widely used for vascular imaging, particularly for its unique property of remaining intravascular for an extended period. As a specialized pharmaceutical ingredient, its sourcing is critical for manufacturers aiming to ensure high quality, regulatory compliance, and cost efficiency. This article examines the various sources selling bulk API of gadofosveset trisodium, emphasizing global manufacturing landscape, sourcing considerations, and strategic procurement insights.

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Global Manufacturing Landscape and Key Suppliers

The manufacturing of gadofosveset trisodium involves complex chemical synthesis under stringent GMP standards adhering to global regulatory bodies such as the FDA, EMA, and other regional agencies. The API's synthesis relies on proprietary processes often held by a few pharmaceutical innovators, which directly influences sourcing options and availability in the marketplace.

Authorized Manufacturers and Key Suppliers

Most commercially available gadofosveset trisodium APIs are supplied by select pharmaceutical companies with extensive radiology and imaging drug portfolios. Notably:

• Lantheus Medical Imaging
  As the original patent holder and marketer of gadofosveset trisodium (marketed as ABLAVAR®), Lantheus supplies the API primarily through licensed partners or authorized distributors. Direct procurement from Lantheus is often limited to large-scale pharmaceutical manufacturers or authorized entities.

• Contract Manufacturing Organizations (CMOs)
  Several CMOs with expertise in gadolinium-based contrast agents produce gadofosveset trisodium under contract, ensuring supply continuity for licensed pharmaceutical companies. Examples include companies from India, China, and Europe with established GxP-compliant facilities.

• Regional Distributors and Traders
  Regional bulk suppliers may source from authorized manufacturers and distribute to local pharmaceutical companies, imaging centers, or compounding pharmacies. These entities often provide flexible quantity options but require rigorous quality verification due to variability.

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Sources of Bulk API: Regional and Global Considerations

Asia-Pacific Region

India and China have emerged as significant manufacturing hubs for gadolinium-based contrast agents (GBCAs). Leading firms like Lupin, JSR Corporation (Japan), and other regional players produce APIs that meet international standards. These suppliers often offer more competitive pricing, but caution is advised to verify regulatory compliance and quality certifications.

Europe and North America

In North America and Europe, API sourcing usually involves established pharmaceutical manufacturers with stringent adherence to GMP. Companies such as Bayer Healthcare and Mallinckrodt have historically produced gadolinium chelates, though specific APIs like gadofosveset trisodium are often procured through authorized distributors rather than raw material sales.

Emerging Suppliers

Emerging vendors from Eastern Europe and Southeast Asia claim to supply bulk gadofosveset trisodium, but buyers must undertake due diligence. Regulatory filings, FDA or EMA approvals, and third-party audits are essential to validate supplier credibility.

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Criteria for Selecting API Suppliers

Given the specialized nature of gadofosveset trisodium, procurement involves meticulous supplier vetting:

• Regulatory Compliance
  Ensure suppliers possess valid documentation, including certificates of suitability, Good Manufacturing Practices (GMP) certification, and batch release approvals.

• Quality Assurance
  Confirm purity (>99%), residual solvent levels, endotoxin levels, and sterility. Certificates of analysis (COA) and analytical data are vital.

• Traceability and Documentation
  Verify sourcing origin, manufacturing records, and batch traceability to mitigate supply chain risks.

• Pricing and Lead Times
  Balance cost considerations with quality and regulatory adherence. Establish reliable lead times for fulfillment to prevent manufacturing disruptions.

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Recent Trends and Challenges in API Sourcing

The scarcity of gadofosveset trisodium, compounded by regulatory constraints on gadolinium-based agents (such as nephrogenic systemic fibrosis concerns), influences global supply chains. Manufacturers face challenges related to:

• Regulatory New Entrants: Stringent approval processes may limit new suppliers' entries into the market.

• Supply Chain Disruptions: COVID-19 pandemic and geopolitical factors have impacted raw material and API manufacturing continuity.

• Environmental and Safety Regulations: Increased focus on environmental impact controls for gadolinium chelates influences manufacturing practices and supplier standards.

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Key Takeaways

• The production and sourcing of gadofosveset trisodium API are concentrated among a few specialized manufacturers, with regional variations influencing supply chains.
• Due diligence regarding regulatory compliance, quality standards, and supply guarantees remains paramount for procurement.
• Asia-Pacific manufacturers offer competitive pricing, but buyers must verify compliance and certification.
• Procurement strategies should include establishing relationships with authorized suppliers and integrating quality assurance measures.
• Market dynamics, regulatory changes, and supply chain disruptions necessitate continuous monitoring for effective API sourcing.

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FAQs

1. Who are the primary global manufacturers of gadofosveset trisodium API?
Mainly, the original patent holder, Lantheus Medical Imaging, supplies the API through authorized channels. Other regional manufacturers, especially in India and China, produce the API under contract or through licensing agreements, provided they meet GMP standards.

2. How can buyers verify the quality of gadofosveset trisodium API from regional suppliers?
Buyers should request comprehensive Certificates of Analysis, ISO certifications, GMP compliance documentation, and conduct audits or third-party testing to confirm purity, residual solvents, endotoxins, and sterility.

3. What are the regulatory considerations when sourcing gadofosveset trisodium API?
Sourcing must align with regional regulatory approvals, including CE marking in Europe and FDA approval in the US. Suppliers should provide documentation demonstrating compliance with these standards.

4. Is it possible to obtain gadofosveset trisodium API directly from the manufacturer?
Direct procurement is generally restricted to licensed pharmaceutical companies and large-scale partners. Most buyers work through authorized distributors or brokers.

5. What are the main challenges in sourcing gadofosveset trisodium API?
Challenges include limited supplier diversity due to patent restrictions, fluctuating regulatory environments, supply chain disruptions, and ensuring quality amid regional variability.

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Conclusion

The sourcing landscape for gadofosveset trisodium API is characterized by a limited number of specialized manufacturers operating globally, with regional variations driven by regulatory frameworks and market demand. Buyers and manufacturers should prioritize stringent quality assurance, due diligence, and strategic supplier partnerships to secure a reliable supply chain. As the markets for gadolinium-based contrast agents evolve, maintaining awareness of regulatory changes and supply dynamics remains essential for informed procurement decisions.

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References

[1] Lantheus Medical Imaging. (2022). Gadofosveset trisodium (ABLAVAR®) API details.
[2] U.S. Food & Drug Administration. (2022). Guide to Gadolinium-based Contrast Agents.
[3] European Medicines Agency. (2022). EMA Guideline for Gadolinium Contrast Agents.
[4] Market research reports on gadolinium-based contrast agents manufacturing and supply.
[5] Industry publications on API procurement and quality standards in radiological pharmaceuticals.