MULTIHANCE MULTIPACK: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bracco	MULTIHANCE MULTIPACK	gadobenate dimeglumine	INJECTABLE;INTRAVENOUS	021358	NDA	BRACCO DIAGNOSTICS INC	0270-5264-16	5 BOTTLE, GLASS in 1 BOX (0270-5264-16) / 50 mL in 1 BOTTLE, GLASS	2004-11-23
Bracco	MULTIHANCE MULTIPACK	gadobenate dimeglumine	INJECTABLE;INTRAVENOUS	021358	NDA	BRACCO DIAGNOSTICS INC	0270-5264-17	5 BOTTLE, GLASS in 1 BOX (0270-5264-17) / 100 mL in 1 BOTTLE, GLASS	2004-11-23
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 3, 2025

Introduction

In the pharmaceutical industry, identifying reliable suppliers for medications like MULTIHANCE MULTIPACK is critical for healthcare providers, distributors, and regulatory agencies. MULTIHANCE, the brand name for gadobenate dimeglumine, is an intravenous contrast agent used primarily in magnetic resonance imaging (MRI). This article examines the key suppliers for MULTIHANCE MULTIPACK, considering manufacturing origins, distribution networks, and regulatory compliance, to provide a comprehensive overview for stakeholders seeking secure procurement channels.

Overview of MULTIHANCE and its Market Context

MULTIHANCE (gadobenate dimeglumine) is a gadolinium-based contrast agent (GBCA) approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). It is distinguished by its high relaxivity, which enhances MRI imaging quality. The drug's global demand is driven by its use in neuro, cardiovascular, and body imaging diagnostics.

The patent and exclusivity timeline influence the availability of MULTIHANCE from various suppliers. While the original manufacturer develops and markets the drug, authorized distributors and regional suppliers play essential roles in global supply chains.

Manufacturers and Original Equipment Suppliers

Bracco Imaging S.p.A. is the original developer and primary manufacturer of MULTIHANCE. An Italian-based pharmaceutical company specializing in contrast agents and diagnostic imaging products, Bracco holds the proprietary rights and manufacturing licenses for MULTIHANCE globally.

Bracco’s manufacturing facilities adhere to Good Manufacturing Practices (GMP) standards, authorized and inspected by regulatory agencies such as the FDA, EMA, and local authorities in different countries. Their global distribution network ensures consistent supply across continents, including North America, Europe, and Asia.

Authorized Distributors and Supply Chain Networks

While Bracco directly supplies some regions, in others, authorized third-party distributors facilitate distribution to hospitals, clinics, and pharmacies.

United States: In the U.S., Bracco Diagnostics Inc., a subsidiary of the parent company, manages distribution in compliance with FDA regulations. It functions as the primary supplier for the North American market.
European Union: Bracco Deutschland AG and other regional subsidiaries oversee distribution channels within the EU, ensuring adherence to EMA standards.
Asia-Pacific: Regional partners and distributors, such as those in Japan, South Korea, and China, hold valid licenses for import and sale.
Emerging Markets: Bracco often collaborates with regional third-party distributors with validated supply chain capabilities, ensuring regional availability and compliance.

Global Suppliers and Market Dynamics

The global supply of MULTIHANCE MULTIPACK is relatively concentrated given the specialized nature of gadolinium contrast agents. However, the market has experienced shifts triggered by regulatory restrictions on gadolinium-based agents, primarily due to safety concerns like gadolinium retention in tissues.

In 2018, the EMA and FDA issued warnings on certain linear GBCAs, leading to increased demand for macrocyclic agents such as MULTIHANCE, offered as a high-relaxivity, macrocyclic contrast agent with a favorable safety profile. Consequently, suppliers aligned with regulatory standards have experienced growth.

Importers and Regional Suppliers

In regions where Bracco lacks direct presence, authorized importers and regional suppliers facilitate access:

Latin America: Certified regional partners import MULTIHANCE, ensuring compliance with local health authorities.
Middle East and Africa: Distributors with regional licensing and validation handle procurement.
Australia and New Zealand: Local suppliers and hospitals often source directly through regional distributors approved by the Therapeutic Goods Administration (TGA).

Regulatory and Certification Considerations

Suppliers must hold valid licenses, manufacturing certifications, and import/export permits to distribute MULTIHANCE legally. Key requirements include:

GMP adherence
Product registration with local health authorities
Traceability and batch tracking

Manufacturers such as Bracco invest heavily in sustaining these certifications, which serve as quality assurance indicators for procurement professionals.

Emerging Supply Chain Challenges and Risks

The primary risks involve:

Regulatory restrictions: Post-2018 safety warnings led to temporary market shortages and increased demand, affecting the supply chain stability.
Gadolinium safety concerns: Suspected accumulation in tissues has prompted further regulatory scrutiny, possibly affecting future availability.
Manufacturing disruptions: Like many pharmaceuticals, manufacturing interruptions due to quality issues or pandemic-related logistics can impact suppliers' ability to meet demand.

Mitigation strategies involve diversified supplier networks, inventory management, and maintaining compliance with evolving regulations.

Conclusion

The principal supplier for MULTIHANCE MULTIPACK is Bracco Imaging, a globally recognized manufacturer with extensive regional distribution partnerships. In addition to Bracco's direct supply, authorized regional distributors and importers facilitate access across different markets, especially where regulatory approval is managed locally.

Given the regulatory environment and safety concerns surrounding gadolinium agents, stakeholders should prioritize suppliers with validated GMP compliance, proper certifications, and transparent supply chain practices. Ensuring the integrity of the procurement process is vital amid dynamic regulatory updates and market fluctuations.

Key Takeaways

Bracco Imaging is the primary global manufacturer and supplier of MULTIHANCE MULTIPACK, supported by regional subsidiaries and authorized distributors.
Regulatory compliance and quality certifications are critical when selecting suppliers.
The supply chain is influenced by evolving safety regulations and market demand, requiring proactive risk management.
Emerging safety concerns concerning gadolinium retention continue to influence market dynamics and supplier strategies.
Maintaining diversified supplier relationships and adhering to regional licensing standards safeguard procurement stability.

FAQs

Q1: Is MULTIHANCE available through generic manufacturers?
A1: Currently, MULTIHANCE is a branded product with limited generic equivalents due to patent protections. However, regional regulatory approvals may vary, and some markets may have alternative gadolinium agents.

Q2: How can I verify a supplier’s authenticity for MULTIHANCE?
A2: Confirm licensing, GMP certification, and registration with local health authorities. Verify supply chain documentation and ensure the supplier is authorized by Bracco or regional regulatory bodies.

Q3: Are there recent regulatory restrictions on MULTIHANCE?
A3: No significant restrictions have been imposed on MULTIHANCE specifically. Nonetheless, ongoing safety evaluations of GBCAs influence regulatory environments globally.

Q4: What are the primary risks in the supply chain for MULTIHANCE?
A4: Risks include manufacturing delays, regulatory restrictions, safety warnings, and logistical disruptions, all of which can impact supply continuity.

Q5: How does regional regulation influence supplier selection?
A5: Suppliers must meet country-specific licensing, certification, and import/export standards to legally distribute MULTIHANCE within each region.

References

FDA Approval and Labeling Information – FDA
EMA Gadolinium-based Contrast Agents Review – European Medicines Agency
Bracco Official Website – Bracco
Market Reports on Gadolinium-based Contrast Agents – IQVIA
Regulatory Updates on GBCAs Safety – US FDA safety communications

Suppliers and packagers for MULTIHANCE MULTIPACK