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Suppliers and packagers for E-Z-PAQUE
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E-Z-PAQUE
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 | E-Z-PAQUE | barium sulfate | FOR SUSPENSION;ORAL | 208036 | NDA | E-Z-EM Canada Inc | 32909-105-10 | 24 BOTTLE, PLASTIC in 1 CASE (32909-105-10) / 148 g in 1 BOTTLE, PLASTIC | 2019-04-30 |
| Bracco | E-Z-PAQUE | barium sulfate | FOR SUSPENSION;ORAL | 208036 | NDA | E-Z-EM Canada Inc | 32909-750-03 | 24 BOTTLE, PLASTIC in 1 CARTON (32909-750-03) / 176 g in 1 BOTTLE, PLASTIC | 2017-06-01 |
| Bracco | E-Z-PAQUE | barium sulfate | FOR SUSPENSION;ORAL | 208036 | NDA | E-Z-EM Canada Inc | 32909-764-01 | 24 BOTTLE in 1 CARTON (32909-764-01) / 340 g in 1 BOTTLE | 2016-01-11 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: E-Z-PAQUE
Introduction
E-Z-PAQUE is a well-recognized contrast medium used predominantly in fluoroscopic imaging procedures, particularly for gastrointestinal studies. It is an iodine-based radiopaque contrast agent primarily utilized in radiology to enhance the visibility of internal structures, aiding accurate diagnosis. The procurement landscape for E-Z-PAQUE is crucial for healthcare providers, radiology centers, and pharmaceutical distributors seeking reliable suppliers that meet regulatory standards, ensure quality, and maintain consistent supply chains.
This comprehensive analysis delineates the leading suppliers of E-Z-PAQUE, evaluates the market landscape, and highlights the strategic considerations for stakeholders engaged in sourcing this critical radiopaque agent.
Overview of E-Z-PAQUE
E-Z-PAQUE (also known by its generic name, diatrizoate meglumine and diatrizoate sodium) facilitates diagnostic clarity during imaging. Its formulation is characterized by a high iodine concentration, which provides excellent radiopacity. Manufactured by various pharmaceutical firms globally, E-Z-PAQUE's predominant suppliers cater to markets across North America, Europe, Asia, and other regions, ensuring accessibility for healthcare institutions.
The drug is often supplied in pre-filled syringes, vials, or bulk packages, conforming to the standards laid out by regulatory authorities such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and other governing bodies.
Major Suppliers of E-Z-PAQUE
1. Bracco Diagnostics Inc.
Overview:
Bracco Diagnostics Inc., a subsidiary of Bracco Imaging S.p.A., is a significant player in the global contrast media market. Headquartered in the United States, Bracco is renowned for manufacturing a broad portfolio of contrast agents, including E-Z-PAQUE.
Product Offerings:
Bracco supplies E-Z-PAQUE in sterile, single-use syringes intended for hospital use in gastrointestinal imaging. Their manufacturing facilities adhere to Good Manufacturing Practices (GMP) and hold approvals from regulatory bodies like the FDA.
Market Penetration:
In North America, Bracco is a dominant supplier, often favored by hospitals and imaging centers due to its established product quality and extensive distribution network.
2. Guerbet Group
Overview:
Guerbet, headquartered in France, is a global leader in contrast agents and radiology solutions. The company's portfolio includes a variety of radiopaque substances for diagnostic imaging, including products comparable or similar to E-Z-PAQUE.
Product Portfolio:
Though Guerbet's focus is more prominent on iodine-based contrasts like Visipaque, they also distribute alternative formulations fitting the same medical applications as E-Z-PAQUE. In some markets, Guerbet supplies E-Z-PAQUE through licensing or distribution agreements.
Regulatory Status:
Guerbet products are commonly registered with the EMA and other regulatory bodies. Their global reach ensures supply chain robustness.
3. PharmaNet/iTec
Overview:
PharmaNet/iTec, a division within FUJIFILM Holdings Corporation, specializes in pharmaceutical and radiology products, including contrast media.
Relevance to E-Z-PAQUE:
Though primarily focused on other contrast agents, PharmaNet/iTec serves as an important distributor in North America and Asia, offering E-Z-PAQUE through authorized channels and partnering with local manufacturers.
4. Local and Regional Manufacturers
In addition to global giants, several regional pharmaceutical firms manufacture and supply E-Z-PAQUE or equivalent iodine-based contrast agents. Examples include:
- SinoPharm Group (China): Produces iodine-based contrast media used domestically and exported worldwide.
- Sun Pharmaceutical Industries Limited (India): Offers pharmaceutical contrast agents, including iodine-based radiopaque solutions.
These regional suppliers often cater to local demand and might export to neighboring markets, especially where regulatory approvals are aligned.
Supply Chain Dynamics and Market Considerations
Regulatory Compliance and Quality Assurance
Suppliers must meet stringent regulatory standards, including FDA approval (U.S.), EMA certification (Europe), and respective national regulatory compliance. Certificates of analysis, stability data, and Good Manufacturing Practices (GMP) adherence are critical for procurement decisions.
Manufacturing Capacity and Lead Times
The COVID-19 pandemic underscored vulnerabilities in pharmaceutical supply chains. Suppliers with diversified manufacturing sites and robust inventory management are better positioned to meet fluctuating demand for E-Z-PAQUE.
Pricing and Procurement Strategies
Price sensitivity varies across markets. Large-volume procurement often involves negotiated contracts that favor long-term stability. Suppliers offering flexible delivery schedules and comprehensive support tend to be preferred partners.
Distribution and Logistics
E-Z-PAQUE requires cold chain logistics and careful handling. Suppliers with established distribution networks and logistical expertise mitigate risks of spoilage and delays.
Market Challenges and Considerations for Procurement
- Supply Shortages: Periodic shortages may arise from manufacturing issues, regulatory delays, or raw material shortages.
- Regulatory Restrictions: Changes in medical regulations or product classifications can impact supplier availability.
- Counterfeit Risks: Counterfeit contrast agents pose safety concerns; hence sourcing exclusively from validated suppliers is critical.
- Environmental and Sustainability Factors: Increasing focus on eco-friendly manufacturing practices influences supplier selection.
Emerging Trends and Future Outlook
- Generic and Biosimilar Competition: Entry of generic manufacturers could enhance supply options and reduce costs.
- Innovation in Contrast Media: Advances towards lower iodine doses or alternative, non-iodine-based contrasts.
Conclusion
The primary suppliers of E-Z-PAQUE are globally recognized pharmaceutical firms like Bracco Diagnostics and Guerbet, supported by regional manufacturers and distributors. Ensuring quality, regulatory compliance, and reliable logistics are paramount for effective procurement. Stakeholders should maintain diversified supplier relationships to mitigate supply chain risks, stay abreast of evolving regulatory landscapes, and leverage economies of scale through strategic purchasing.
Key Takeaways
- Leading suppliers of E-Z-PAQUE include Bracco Diagnostics (U.S.), Guerbet Group (France), and regional manufacturers such as SinoPharm and Sun Pharma.
- Regulatory approval and manufacturing capacity are critical factors influencing supplier selection.
- Supply chain robustness depends on diversified sourcing, logistical expertise, and adherence to pharmaceutical standards.
- Market dynamics are shifting towards increased competition from generics and innovation in contrast media formulations.
- Proactive procurement strategies enhance supply security amid potential shortages and regulatory changes.
FAQs
1. Who are the top global suppliers of E-Z-PAQUE?
Bracco Diagnostics and Guerbet Group are the leading global suppliers, with regional manufacturers supporting local markets.
2. What should healthcare providers consider when sourcing E-Z-PAQUE?
Regulatory compliance, product quality, manufacturing capacity, delivery logistics, and supplier reliability are key considerations.
3. Are there alternative contrast agents to E-Z-PAQUE?
Yes, other iodine-based contrast media like Visipaque (Guerbet) and Omnipaque (GE Healthcare) can serve similar purposes, depending on clinical requirements.
4. How do supply chain disruptions impact E-Z-PAQUE availability?
Disruptions may cause shortages, delays, or increased prices, emphasizing the importance of diversified sourcing and inventory management.
5. Can regional manufacturers supply E-Z-PAQUE internationally?
Some regional manufacturers export to other markets, but regulatory approvals and global distribution capabilities influence their international reach.
References
- [1] Bracco Diagnostics. Product portfolio and regulatory filings.
- [2] Guerbet Group. Contrast media offerings and global presence.
- [3] U.S. Food and Drug Administration (FDA). Approvals and quality standards.
- [4] European Medicines Agency (EMA). Regulatory compliance overview.
- [5] Market analysis reports on contrast media suppliers, 2022-2023.
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