Bulk Pharmaceutical API Sources for MULTIHANCE MULTIPACK

Bulk Pharmaceutical API Sources for MULTIHANCE MULTIPACK

Vendor	Vendor Homepage	Vendor Sku	API Url
BOC Sciences		127000-20-8
J&H Chemical Co.,ltd		JH625179
J&H Chemical Co.,ltd		JH625183
J&H Chemical Co.,ltd		JH625187

Bulk Active Pharmaceutical Ingredient (API) Sources for: MULTIHANCE MULTIPACK

Last updated: August 8, 2025

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Introduction

MULTIHANCE MULTIPACK, a contrast agent primarily used in magnetic resonance imaging (MRI), contains gadobenate dimeglumine as its active pharmaceutical ingredient (API). Ensuring a reliable supply of gadobenate dimeglumine is critical for manufactuers, healthcare providers, and pharmaceutical companies, especially considering global demand for contrast agents used in diagnostic imaging. This article provides an authoritative analysis of potential bulk API sources for gadobenate dimeglumine, considering regulatory landscape, manufacturing capabilities, quality standards, and market dynamics.

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Understanding Gadobenate Dimeglumine: The API Profile

Gadobenate dimeglumine (Magnevist, branded by Bayer) is a gadolinium-based contrast agent (GBCA) that enhances diagnostic imaging clarity. Its chemical formula is C24H29GdN4O9, with a molecular weight of approximately 1,056.69 g/mol. As a specialty pharmaceutical ingredient, gadobenate dimeglumine demands strict adherence to quality, purity, and safety standards such as those mandated by the U.S. FDA, EMA, and other regulatory bodies.

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Manufacturers of Gadolinium-Based Contrast Agents (GBCAs)

Given the complexity and regulatory sensitivities, bulk API sourcing is typically from established manufacturers with proven expertise in chelated gadolinium complexes. Major industry players include:

1. Bayer AG (Germany)
2. Bracco Imaging (Italy)
3. Fujifilm Holdings Corporation (Japan)
4. Guerbet Group (France)
5. Lantheus Medical Imaging (USA)

These companies are not only producers of finished contrast agents but also develop core APIs and intermediate raw materials necessary for the synthesis of gadolinium chelates.

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Key API Suppliers for Gadolinium Contrast Agents

1. Bayer AG

• Market Position: Bayer is the original developer of gadobenate dimeglumine and continues as a primary supplier of its API.
• API Supply: Bayer's manufacturing facilities in Germany and the U.S. produce gadolinium-based chelates with high purity, conforming to rigorous regulatory standards.
• Availability: Direct procurement of API from Bayer involves strict licensing and quality agreements. Supply stability depends on Bayer’s manufacturing capacity and strategic priorities.
• Regulatory Compliance: Bayer ensures its APIs meet pharmacopeia standards (USP, EP, JP) and Good Manufacturing Practices (GMP).

2. Bracco Imaging

• Overview: As a major player in contrast agent manufacturing, Bracco produces gadolinium chelates and may supply bulk API or intermediates.
• API Capabilities: Bracco focuses on high-quality, GMP-compliant gadolinium complexes suitable for pharmaceutical formulation.
• Supply Chain: Typically supplies finished drug products; API sourcing may involve strategic partnerships or licensing agreements.

3. Fujifilm Holdings Corporation

• Background: Fujifilm develops and supplies contrast agents as part of its imaging portfolio, with investments in gadolinium chemistry.
• API Production: While primarily providing final formulations, Fujifilm’s R&D endeavors extend into API development, potentially offering bulk gadolinium chelates via licensing partners.

4. Guerbet Group

• Profile: French-based Guerbet specializes in contrast media production, with in-house API development.
• API Sources: They manufacture gadolinium chelates that conform to international standards, with potential for bulk API procurement through authorized supply channels.

5. Contract Manufacturing and Licensed API Suppliers

In addition to the primary manufacturers, several contract manufacturing organizations (CMOs) operate under licensing agreements to produce gadolinium chelates. These include:

• Lonza Group: A global CMO capable of custom synthesis of gadolinium complexes.
• Siegfried AG: Known for biopharmaceutical ingredients, including specialty chelated Gd compounds.
• Nitto Denko: Has capabilities in gadolinium chelate synthesis, though primarily targeted at regional markets.

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Regional API Sourcing and Regulatory Considerations

Sourcing APIs globally involves vetting suppliers against strict regulatory criteria. Companies seeking gadolinium API might consider:

• North American Suppliers: U.S.-based vendors generally comply with FDA cGMP standards; procurement from these sources simplifies regulatory filings.
• European Suppliers: Bayer, Guerbet, and CMOs in Europe meet EMA standards, providing access to high-quality APIs suitable for European markets.
• Asian Suppliers: Fujifilm and other Asian manufacturers can offer competitive pricing. However, validation of their GMP compliance is essential.

Regulatory approvals for the API often require detailed validation data, stability information, and quality certifications. Many manufacturers assist with regulatory dossiers to streamline approval processes.

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Market Dynamics and Supply Chain Considerations

The global GMP API market for gadolinium chelates is relatively concentrated with few large-scale producers. This scarcity impacts pricing and supply stability, especially amid seismic shifts such as geopolitical tensions, pandemic-related disruptions, or regulatory crackdowns.

Current supply chain vulnerabilities have prompted end-users to seek diversified suppliers, including:

• Engaging with multiple GMP-certified vendors.
• Sourcing via authorized distributors who maintain stockpiles.
• Entering into long-term contracts with licensed manufacturers.

Moreover, given the rising focus on alternative imaging modalities and regulation tightening around GBCA safety, API demand forecasts are dynamic, influencing supply availability.

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Emerging Trends and Future Outlook

1. Development of Alternative Contrast Agents: The push toward macrocyclic or gadolinium-free agents may impact API demand. This transition may create opportunities for API suppliers capable of diversifying their portfolio.

2. Regulatory Changes: Enhanced safety standards and restrictions on gadolinium retention could lead to tighter API sourcing controls, necessitating closer oversight and supplier validation.

3. Supply Chain Resilience: Strategic stockpiling, regional API production investments, and licensing agreements will serve as buffers against supply shocks.

4. Innovation in API Manufacturing: Advances in chelation technology and better yields can enable existing suppliers to meet increasing demand efficiently.

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Conclusion

The primary bulk API sources for gadobenate dimeglumine used in MULTIHANCE MULTIPACK are generally restricted to a handful of well-established manufacturers. Bayer remains the leading supplier, given their original patent and manufacturing rights. Complementing Bayer’s supply, various CMOs and regional manufacturers contribute to the global market, provided they meet stringent regulatory and quality standards.

Businesses seeking to secure API supplies should prioritize suppliers with GMP certification, proven compliance history, and scalable manufacturing capacity. Strategic partnerships, diversified sourcing strategies, and close regulatory engagement will help ensure stable, high-quality API procurement aligned with market demands and evolving safety regulations.

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Key Takeaways

• Bayer AG is the primary and most reliable source for gadobenate dimeglumine API, given their proprietary rights.
• Several high-quality GMP suppliers, including CMOs like Lonza and Siegfried, serve as alternative or secondary sources.
• Regulatory compliance and supply chain stability are critical factors when selecting API vendors.
• The evolving landscape of MRI contrast media and safety regulations may influence future API availability and sourcing strategies.
• Diversification and strategic partnerships will mitigate risks associated with API supply disruptions.

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Frequently Asked Questions

1. Who are the main manufacturers of gadobenate dimeglumine API?
Bayer AG is the original developer and the primary manufacturer of gadobenate dimeglumine API. Other suppliers include CMOs such as Lonza and Siegfried, which produce gadolinium chelates under licensing agreements.

2. What are the regulatory considerations for sourcing gadolinium-based contrast agent APIs?
Suppliers must comply with GMP standards, and APIs must meet pharmacopeia specifications (USP, EP, JP). Regulatory approval involves detailed documentation of manufacturing processes, quality control, and stability data.

3. How does supply chain stability affect the procurement of gadolinium APIs?
A concentrated supplier base and geopolitical factors can cause disruptions, making diversified sourcing and long-term contracts vital for maintaining supply continuity.

4. Are there alternatives to gadobenate dimeglumine that influence API demand?
Yes, macrocyclic GBCAs, non-gadolinium agents, and safer contrast media are emerging, potentially affecting demand for gadolinium chelates.

5. What future trends should companies monitor regarding gadolinium API sourcing?
Suppressed regulatory restrictions, technological advances in chelation, and shifts toward gadolinium-free agents will shape future API supply and sourcing strategies.

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References

1. Bayer AG. (2022). Pharmaceutical manufacturing standards. Company Website.
2. European Medicines Agency (EMA). (2022). Guidance on gadolinium-based contrast agents.
3. Bracco Imaging. (2022). Product portfolio and manufacturing capabilities.
4. FujiFilm Holdings Corporation. (2022). Imaging Division Annual Report.
5. Guerbet Group. (2022). Regulatory and manufacturing practices.

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(This article is a synthesized expert analysis based on publicly available industry data, regulatory guidelines, and market trends as of 2023. For specific sourcing, compliance, and procurement strategies, consulting directly with manufacturers and regulatory authorities is advised.)