Suppliers and packagers for choletec

choletec

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	CHOLETEC	technetium tc-99m mebrofenin kit	INJECTABLE;INJECTION	018963	NDA	Bracco Diagnostics Inc	0270-0083-20	10 VIAL in 1 CARTON (0270-0083-20) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL	1987-01-21

Suppliers for the Pharmaceutical Drug: Choletec

Last updated: August 6, 2025

Introduction

Choletec, known generically as meglumine iodipamide, is a diagnostic radiopaque agent used in cholangiography to visualize the biliary tract during imaging procedures. As an essential compound in hepatobiliary imaging, its supply chain involves a complex network of manufacturers, distributors, and authorized suppliers. Understanding these suppliers, their geographic distribution, regulatory compliance, and market dynamics provides valuable insights for stakeholders intending to secure reliable procurement channels or assess market competition.

Manufacturers Producing Choletec

The primary manufacturer of Choletec is Bracco Diagnostics Inc., a subsidiary of the Bracco Group, headquartered in Italy. Bracco has established itself as a leading global provider of contrast agents for medical imaging, including both iodinated contrast media and hepatobiliary agents such as Choletec.

• Bracco Diagnostics Inc.: As the exclusive producer, Bracco maintains proprietary manufacturing processes ensuring the drug's quality and efficacy. Their manufacturing facilities are compliant with stringent Good Manufacturing Practices (GMP) mandated by regulatory agencies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Distribution and Supply Channels

While Bracco is the sole manufacturer, distribution of Choletec involves a network of authorized pharmaceutical distributors and regional suppliers.

• Authorized Distributors: Bracco collaborates with global and regional distributors approved through regulatory channels. In the United States, distributors like Cardinal Health, McKesson, and Owens & Minor often serve as primary channels for distributing Choletec to hospitals, imaging centers, and clinics.

• Regional Suppliers: In Europe, local pharmaceutical wholesalers—such as Famar, Medifarma, and regional authorized importers—serve as intermediaries, ensuring compliance with local regulations and facilitating the drug's availability.

• Importers and Exporters: Countries with regulatory approval for Choletec often rely on importers authorized by health authorities to secure drug supplies. This includes both direct imports from Bracco and regional procurement.

Regulatory Approvals and Market Access

Approval status is critical in establishing authorized suppliers for Choletec. The drug has secured approval from agencies such as the FDA, EMA, and other national regulatory bodies, enabling licensed distribution within respective jurisdictions.

• FDA Approval: Choletec (meglumine iodipamide) is FDA-approved in the United States, with clear guidelines for procurement from certified distributors.

• EMA Authorization: European approval is maintained through the EMA, with national agencies like the Medicines and Healthcare products Regulatory Agency (MHRA) overseeing distribution.

• Other Markets: In countries like Japan, Canada, and Australia, local regulatory authorities (e.g., PMDA, Health Canada, TGA) authorize the drug, dictating specific supplier networks.

Key Suppliers in the Global Market

1. Bracco Diagnostics Inc. (Italy/USA)
As the manufacturer, Bracco is the authoritative supplier of Choletec worldwide. They control manufacturing, quality assurance, and direct distribution agreements.

2. Regional Distributors and Wholesalers
Major global pharmaceutical distributors acting as authorized suppliers include:

• Cardinal Health: Provides distribution services in North America, with comprehensive logistics networks for radiocontrast agents.

• McKesson Corporation: Serves as a key distributor across North America, ensuring prompt supply to healthcare providers.

• Asia Pacific Suppliers: Companies like Medifarma (Brazil), or local distributors in Asia, serve regional markets under regulatory licenses.

3. Licensed Importers and Local Suppliers
Depending on jurisdictional approval, local pharmaceutical companies or licensed importers act as authorized suppliers, especially in emerging markets with smaller distribution channels.

Supply Chain Challenges and Considerations

The supply of Choletec faces typical industry challenges:

• Regulatory Compliance: Strict adherence to GMP, batch testing, and documentation ensure supply continuity. Any regulatory change can impact supplier operations.

• Manufacturing Capacity: As Choletec is a specialized contrast agent, manufacturing is limited to select facilities, potentially risking shortages if production disruptions occur.

• Global Demand Fluctuations: Increased demand due to rising imaging procedures strains existing suppliers, emphasizing the importance of diversified supply channels.

• Supply Security and Stock Management: Hospitals and providers must engage with authorized suppliers to prevent shortages, especially during periods of high demand or supply chain disruptions.

Emerging Trends and Market Dynamics

• Market Consolidation: Bracco's dominance in production consolidates market control, potentially reducing competition but providing stability.

• Regulatory Diversification: As new markets open, local approvals create additional licensed suppliers, expanding supply options.

• Technological Advances: Innovations in imaging techniques and alternative agents may influence long-term demand and, consequently, supplier focus.

Conclusion

The supply chain for Choletec centers around Bracco Diagnostics as the sole manufacturer, complemented by a network of authorized regional distributors and importers. Ensuring reliable procurement necessitates engagement with licensed suppliers compliant with regulatory standards. Market stability depends on manufacturing capacity, regulatory adherence, and the evolving landscape of diagnostic imaging technologies.

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Key Takeaways

• Bracco Diagnostics Inc. is the sole manufacturer and primary supplier of Choletec globally, under strict regulatory compliance.

• Distribution channels include authorized regional wholesalers, importers licensed by local authorities, and large pharmaceutical distributors like Cardinal Health and McKesson.

• Supply security hinges on regulatory approvals, manufacturing capacity, and effective inventory management by healthcare providers.

• Emerging markets are expanding the supplier base through new approvals, though supply stability remains influenced by regulatory and manufacturing dynamics.

• Strategic engagement with authorized, compliant suppliers is crucial for uninterrupted access to Choletec in medical imaging procedures.

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FAQs

1. Is Bracco Diagnostics the only supplier of Choletec globally?
Yes. Bracco Diagnostics Inc. is the sole manufacturer of Choletec, with distribution handled through authorized regional distributors and importers.

2. How can healthcare providers ensure a reliable supply of Choletec?
By establishing relationships with authorized distributors and importers licensed in their jurisdiction, and maintaining adequate inventory levels considering demand fluctuations.

3. Are there alternative agents to Choletec for biliary imaging?
Yes. Other contrast agents like Visipaque (iodixanol) and different radiopaque substances are alternatives but may vary in efficacy and regulatory approval depending on the region.

4. What regulatory agencies oversee the approval and supply of Choletec?
The FDA (United States), EMA (European Union), and respective national agencies such as MHRA (UK), TGA (Australia), and PMDA (Japan).

5. Are there supply risks associated with Choletec?
Potential risks include manufacturing disruptions, regulatory changes, and global demand increases, underscoring the importance of diversified authorized suppliers.

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Sources
[1] Bracco Group official website, product information on Choletec.
[2] FDA Drug Database, Choletec (meglumine iodipamide).
[3] European Medicines Agency (EMA), product authorization details.
[4] Major pharmaceutical distributor websites, including Cardinal Health and McKesson.