Suppliers and packagers for generic pharmaceutical drug: GADOBENATE DIMEGLUMINE

GADOBENATE DIMEGLUMINE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bracco	MULTIHANCE	gadobenate dimeglumine	INJECTABLE;INTRAVENOUS	021357	NDA	BRACCO DIAGNOSTICS INC	0270-5164-12	5 VIAL, SINGLE-DOSE in 1 BOX (0270-5164-12) / 5 mL in 1 VIAL, SINGLE-DOSE	2004-11-23
Bracco	MULTIHANCE	gadobenate dimeglumine	INJECTABLE;INTRAVENOUS	021357	NDA	BRACCO DIAGNOSTICS INC	0270-5164-13	5 VIAL, SINGLE-DOSE in 1 BOX (0270-5164-13) / 10 mL in 1 VIAL, SINGLE-DOSE	2004-11-23
Bracco	MULTIHANCE	gadobenate dimeglumine	INJECTABLE;INTRAVENOUS	021357	NDA	BRACCO DIAGNOSTICS INC	0270-5164-14	5 VIAL, SINGLE-DOSE in 1 BOX (0270-5164-14) / 15 mL in 1 VIAL, SINGLE-DOSE	2004-11-23

Suppliers for the Pharmaceutical Drug: Gadobenate Dimeglumine

Last updated: July 27, 2025

Introduction

Gadobenate dimeglumine, marketed primarily under the brand name MultiHance, is a gadolinium-based contrast agent used in magnetic resonance imaging (MRI). It enhances imaging quality by improving the visualization of vascular structures and tissue details. Given its critical role in diagnostic radiology, understanding the supply landscape of gadobenate dimeglumine is vital for pharmaceutical stakeholders, healthcare providers, and regulatory bodies. This report delineates the primary suppliers, manufacturing landscape, and market dynamics underpinning gadobenate dimeglumine supply chains.

Regulatory Status and Market Authorization

Gadobenate dimeglumine is approved by regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Its approval status impacts the number of suppliers able to market and distribute the drug within different regions. MultiHance, developed by Bracco Diagnostics, has a robust global footprint, with approval in numerous jurisdictions. The regulatory environment influences the supply chain integrity, availability, and competitive landscape.

Major Suppliers and Manufacturers

1. Bracco Diagnostics Inc.
   Bracco is the primary manufacturer and marketer of gadobenate dimeglumine. As the originator of MultiHance, Bracco holds the original patent rights and has established manufacturing facilities across North America, Europe, and Asia. The company prides itself on its integrated supply chain, ensuring consistent product quality conforming to Good Manufacturing Practices (GMP). Bracco’s extensive distribution network covers over 100 countries, making it the dominant supplier globally. Their manufacturing facilities are often located in Italy and the US, with key partnerships to meet global demand.

2. Contract Manufacturing Organizations (CMOs)
   While Bracco remains the principal producer, some regional suppliers depend on CMOs for manufacturing support. These organizations implement proprietary processes under Bracco’s oversight or licensing agreements. Notable CMOs include companies like Patheon (a Thermo Fisher Scientific company), which assist in scaling production to meet regional needs, ensuring supply continuity, especially during shortages or surges in demand.

3. Generic and Biosimilar Market Participants
   As of now, no approved generic versions of gadobenate dimeglumine are broadly available internationally. The complexity of gadolinium chelates and stringent regulatory requirements act as barriers to generic entry. Nonetheless, some regional manufacturers are engaged in development or biosimilar research, potentially expanding the supplier base in the future, contingent on successful regulatory approval.

Supply Chain Dynamics and Regional Availability

Supply chains for gadobenate dimeglumine are highly centralized due to the sophisticated manufacturing processes required for gadolinium chelates. The production involves complex chemical synthesis, purification, and strict quality control, which filters out less experienced manufacturers.

Regionally, supply availability varies:

• North America: Dominated by Bracco through direct distribution channels, with support from regional warehouses and approved distributors.
• Europe: Bracco maintains widespread distribution, with regional offices facilitating supply and regulatory compliance.
• Asia-Pacific: Bracco and regional distributors supply gadobenate dimeglumine, with potential addition of local manufacturers as the market expands.
• Other Regions: Distribution relies heavily on Bracco and authorized distributors, with limited local production.

Market Challenges and Supply Risks

• Manufacturing Complexity: The sophisticated chemical synthesis and strict quality standards can cause production bottlenecks, leading to supply disruptions.
• Regulatory Constraints: Changes in regulatory policies or delays in approval processes can hinder manufacturing and distribution licenses, impacting supply.
• Gadolinium Shortage: Global shortages of rare earth materials, including gadolinium, can affect production capability.
• Environmental and Safety Regulations: Increasingly stringent environmental standards may require manufacturers to adapt processes, risking short-term supply disruptions.

Market Competition and Future Outlook

While Bracco maintains a dominant position, the potential entry of biosimilar developers could diversify the supply landscape. Such entrants aim to reduce costs and improve accessibility, though the regulatory path remains challenging due to the need for demonstrating biosimilarity with complex chemical agents. Additionally, innovations in MRI contrast agents—such as manganese-based compounds—might impact future demand, influencing supply strategies for gadobenate dimeglumine.

Conclusion

Bracco Diagnostics emerges as the primary and most reliable supplier of gadobenate dimeglumine globally, supported by a sophisticated manufacturing infrastructure and extensive distribution networks. While the landscape is currently centralized, ongoing technological and regulatory developments could diversify the supplier base. Stakeholders should monitor supply chain dynamics, regulatory developments, and potential regional licensing to mitigate risks and ensure uninterrupted access.

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Key Takeaways

• Dominant Supplier: Bracco Diagnostics is the sole primary manufacturer and supplier of gadobenate dimeglumine worldwide.
• Manufacturing Complexities: High barriers due to complex chemical synthesis and regulatory compliance limit the number of viable suppliers.
• Regional Distributions: Supply primarily relies on Bracco’s global network, with regional distributors supporting local availability.
• Supply Risks: Manufacturing bottlenecks, regulatory delays, and raw material shortages pose risks to consistent supply.
• Future Trends: Biosimilar development and alternative contrast agents could shape the competitive landscape in the coming years.

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FAQs

1. Who are the main suppliers of gadobenate dimeglumine globally?
Bracco Diagnostics Inc. is the primary supplier worldwide, holding the original patent and manufacturing rights for MultiHance. Regional distribution is supported by authorized distributors and contract manufacturers, but no significant generic versions are presently available.

2. Are there any generic equivalents of gadobenate dimeglumine on the market?
Currently, no approved generics are broadly available. The complexity of manufacturing gadolinium-based contrast agents acts as a barrier to generic entry, though future biosimilar candidates are under development.

3. How does supply chain complexity affect the availability of gadobenate dimeglumine?
Its complex synthesis and strict regulatory standards mean limited manufacturing sources. Any disruptions—such as raw material shortages or regulatory delays—can significantly impact supply.

4. What regional factors influence gadobenate dimeglumine availability?
Distribution depends on regional approval status, regulatory compliance, and regional supply networks. North America and Europe are well-served by Bracco’s infrastructure, while Asia relies on regional distributors, with potential for local manufacturing expansion.

5. What are future prospects for gadobenate dimeglumine supply?
Potential biosimilar development and innovations in alternative contrast agents could diversify supply sources and influence market dynamics. Regulatory changes and technological advances will shape future supply landscapes.

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References

[1] Bracco Diagnostics Inc. (2022). Product Information: MultiHance (gadobenate dimeglumine).
[2] FDA. (2022). Approved Drug Products: MultiHance.
[3] EMA. (2022). Marketing Authorization for Gadobenate Dimeglumine.
[4] MarketResearch.com. (2021). MRI Contrast Agents Market Analysis.
[5] U.S. Patent Office. (2020). Patent filings related to gadolinium chelates.