Bulk Pharmaceutical API Sources for MANGAFODIPIR TRISODIUM

Bulk Pharmaceutical API Sources for MANGAFODIPIR TRISODIUM

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		160036
AAA Chemistry		AR-1J3842
AAA Chemistry		AR-1J3843

Bulk Active Pharmaceutical Ingredient (API) Sources for: Mangafodipir Trisodium

Last updated: July 28, 2025

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Introduction

Mangafodipir trisodium (brand name: Teslascan) is an MRI contrast agent designed to enhance imaging of the liver. It is a paramagnetic contrast agent comprising manganese ions chelated with fodipir (dipyridoxyl diphosphate). Its unique properties stem from its manganese core, facilitating liver-specific imaging. As with other specialty pharmaceuticals, sourcing high-quality bulk API is critical for manufacturing efficacy, safety, and regulatory compliance. This article explores the current landscape of API suppliers for mangafodipir trisodium, assessing their capabilities, market presence, and implications for stakeholders.

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Market Overview and Demand Drivers

Mangafodipir trisodium, approved predominantly in select markets such as Europe and Asia, faces a niche but vital demand within diagnostic imaging. The API's production demands rigorous parameters, including high purity, stability, and consistent batch-to-batch quality, aligned with Good Manufacturing Practices (GMP). Sourcing reliably from reputable suppliers influences not just operational continuity but also regulatory adherence.

However, the API’s limited market shares and specialized synthesis route limit the number of active manufacturers globally. The primary demand drivers include increasing MRI utilization, liver pathology diagnosis advancements, and regulatory approvals in emerging markets. Given these factors, sourcing strategies must balance cost, quality assurance, and supply chain robustness.

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Key API Suppliers for Mangafodipir Trisodium

1. Specialty Pharmaceutical Manufacturers

Most API suppliers for mangafodipir trisodium are niche pharmaceutical companies with expertise in complex chelated metal compounds. These organizations often engage in customized synthesis, adhering to stringent quality standards:

• Fresenius Kabi: Historically, Fresenius Kabi engaged in the production of mangafodipir trisodium, leveraging its extensive experience in contrast agents. The company's focus on high-quality APIs for diagnostic imaging supports reliable supply chains, though their current manufacturing status requires clarification due to market shifts.

• Bracco Imaging: As a leading global provider of contrast agents, Bracco has had involvement in the development and distribution of mangafodipir-based products. Their integrated supply chain includes in-house API manufacturing, emphasizing strict compliance and quality control. Whether they are currently active in API synthesis remains uncertain, necessitating engagement for supply negotiations.

• GE Healthcare: Historically involved in contrast agent development, GE's role in API supply for mangafodipir is limited and may be more focused on finished formulations. Their R&D and manufacturing capabilities in specialty APIs suggest potential but not confirmed production lines.

2. Contract Manufacturing Organizations (CMOs)

• LTS Lohmann Therapy Systems: A European CMO specializing in complex chelates and specialty APIs, with capabilities to produce manganese-based contrast agents. Their GMP facilities and expertise in metal-chelate synthesis make them a viable source for mangafodipir API, pending validation.

• Sterling Pharmaceutical Solutions: Known for custom synthesis of active pharmaceutical ingredients, including chelated metal compounds, Sterling offers scalable manufacturing processes, although their specific experience with mangafodipir remains proprietary.

• Fresenius Medical Care: Similar to Fresenius Kabi, this organization has manufacturing capacity aligned with diagnostic material production, potentially serving as a source for mangafodipir APIs under partnership agreements.

3. Emerging Suppliers and Academic Collaborators

Limited but notable are smaller biotech firms and academic collaborations focusing on novel synthesis methods for manganese chelates:

• Academic Labs and Research Partnerships: Some institutions develop proprietary synthesis processes for mangafodipir, but these are not commercialized or scaled for supply.

• Startups: Few startups have begun exploring alternative routes for manganese-based contrast agents, primarily in early R&D phases. Their contributions might influence future supply landscapes but are not immediate sources.

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Supply Chain Considerations

• Regulatory Compliance & Quality Control: Suppliers must adhere to strict GMP standards, with robust documentation and validation protocols. Given the clinical significance of mangafodipir trisodium, regulatory agencies scrutinize production quality, especially for APIs integrating metal chelates.

• Synthesis Complexity: The API involves chelation of manganese with dipyridoxyl diphosphate, demanding specialized synthesis and purification steps. Potential impurities or batch variability could impact clinical safety.

• Geopolitical Factors: Sourcing from established GMP-compliant suppliers within the EU, US, or Japan offers enhanced regulatory confidence. Diversifying supply sources mitigates risks related to geopolitical disruptions or manufacturing delays.

• Pricing and Procurement Dynamics: Due to the niche market, API costs are relatively high, influenced by complexity, quality demands, and small batch sizes. Long-term procurement agreements can secure rate stability.

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Market Challenges and Opportunities

• Limited Supply Chain Players: The scarcity of dedicated mangafodipir API manufacturers constrains flexibility, elevates procurement complexity, and potentially inflates costs.

• Regulatory and Patent Barriers: Patent expirations or proprietary synthesis processes influence market entry. Manufacturers must comply with evolving regulations, including EMA and FDA standards.

• Development of Alternative Contrast Agents: The emergence of newer manganese-based or non-metallic contrast agents can impact future demand and sourcing strategies.

• Emerging Markets Growth: Increasing MRI accessibility in Asia and Latin America creates opportunities for API suppliers capable of meeting localized regulatory requirements and offering cost-effective solutions.

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Regulatory and Quality Assurance Standards

Suppliers must demonstrate adherence to:

• GMP compliance
• ICH guidelines for impurities and stability**
• Pharmacopoeia standards relevant to manganese chelates

• Consistency in batch release specifications including manganese content, impurities, and endotoxin levels

  API documentation should include stability data, detailed batch records, and vendor qualification certificates to ensure regulatory acceptability.

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Conclusion

The sourcing landscape for mangafodipir trisodium API is characterized by limited, specialized manufacturers primarily within Europe and Asia. Due to synthesis complexity and regulatory oversight, only select companies with deep expertise in chelated manganese compounds and GMP capabilities supply this niche API. Strategic procurement involves evaluating supplier quality, regulatory compliance, and supply chain resilience. As the MRI contrast agent market evolves, so too will opportunities for manufacturing partnerships, warranting continuous monitoring of supplier capabilities and market dynamics.

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Key Takeaways

• The API supply chain for mangafodipir trisodium is highly specialized, with limited manufacturers possessing GMP-authorized production facilities.
• Top suppliers include regional pharma companies like Fresenius Kabi and potential CMOs with chelation expertise, such as LTS Lohmann.
• Regulatory compliance, synthesis complexity, and quality control are paramount, influencing sourcing decisions.
• Market growth in emerging regions presents new procurement opportunities despite current supply constraints.
• Diversification, robust quality assurance, and strategic partnerships are essential for stable API sourcing.

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FAQs

1. Is mangafodipir trisodium still commercially available globally?
Availability varies by region; while it was used in Europe and Asia, some markets have discontinued or limited its use due to evolving regulatory landscapes and competition from newer contrast agents.

2. What are key factors in selecting an API supplier for mangafodipir?
Regulatory compliance, manufacturing expertise in chelated manganese compounds, GMP certification, capacity, cost, and supply reliability.

3. Are there alternative suppliers or sources emerging for mangafodipir API?
Emerging trends include specialized contract manufacturers and academic collaborations, but large-scale, validated sources remain limited.

4. What challenges exist in manufacturing mangafodipir trisodium?
The synthesis of high-purity manganese chelates involves complex steps, strict quality control, and purification to prevent impurities affecting safety and efficacy.

5. How can manufacturers mitigate supply chain disruptions for this niche API?
By securing multiple supplier relationships, engaging with CMOs with proven expertise, maintaining inventory buffers, and monitoring regulatory developments.

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References

1. [1] European Medicines Agency - Summary of Product Characteristics for Teslascan, 1996.
2. [2] Fresenius Kabi Corporate Website, 2023.
3. [3] Bracco Imaging Annual Report, 2022.
4. [4] LTS Lohmann Therapy Systems Capabilities Overview, 2023.
5. [5] ICH Guidelines for Good Manufacturing Practices, 2021.