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Suppliers and packagers for generic pharmaceutical drug: diatrizoate meglumine
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diatrizoate meglumine
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 | DIATRIZOATE MEGLUMINE | diatrizoate meglumine | INJECTABLE;INJECTION | 010040 | NDA | BRACCO DIAGNOSTICS INC | 0270-0149-57 | 10 BOTTLE in 1 PACKAGE (0270-0149-57) / 300 mL in 1 BOTTLE | 1970-11-03 |
| Bracco | DIATRIZOATE MEGLUMINE | diatrizoate meglumine | INJECTABLE;INJECTION | 010040 | NDA | BRACCO DIAGNOSTICS INC | 0270-0149-60 | 10 BOTTLE in 1 PACKAGE (0270-0149-60) / 100 mL in 1 BOTTLE | 1970-11-03 |
| Bracco | DIATRIZOATE MEGLUMINE | diatrizoate meglumine | INJECTABLE;INJECTION | 010040 | NDA | BRACCO DIAGNOSTICS INC | 0270-1410-30 | 10 BOTTLE in 1 PACKAGE (0270-1410-30) / 300 mL in 1 BOTTLE | 1982-11-09 |
| Bracco | RENO-60 | diatrizoate meglumine | INJECTABLE;INJECTION | 010040 | NDA | BRACCO DIAGNOSTICS INC | 0270-0149-57 | 10 BOTTLE in 1 PACKAGE (0270-0149-57) / 300 mL in 1 BOTTLE | 1970-11-03 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Diatrizoate Meglumine
Introduction
Diatrizoate Meglumine, a radiopaque iodine-based contrast agent, plays a pivotal role in diagnostic imaging, notably in X-ray and computed tomography (CT) procedures. Its utility in enhancing radiographic visualization of internal body structures makes it critical in medical diagnostics. The global demand for Diatrizoate Meglumine hinges on its suppliers, who ensure manufacturing quality, regulatory compliance, and consistent supply chains. This analysis provides an in-depth overview of primary suppliers, their manufacturing capacities, sourcing backgrounds, and market positioning within the pharmaceutical landscape.
Overview of Diatrizoate Meglumine
Diatrizoate Meglumine, chemically known as sodium diatrizoate with meglumine, is an iodinated contrast medium mainly used in radiographic imaging of the gastrointestinal, urinary, and vascular systems. Its approval by regulatory agencies such as the FDA (Food and Drug Administration) and EMA (European Medicines Agency) underscores its safety and efficacy when used under medical supervision. The compound is predominantly supplied in injectable form as a sterile solution, requiring strict manufacturing standards.
Leading Suppliers in the Global Market
1. Bracco Imaging S.p.A.
Market Position & Capabilities:
Bracco is an Italian multinational pharmaceutical company recognized as one of the leading producers of iodinated contrast agents globally. Their flagship products include Xenetix and Lumatrol, which contain Diatrizoate Meglumine. Bracco's extensive manufacturing facilities in Europe and the United States ensure a broad distribution network and technological prowess in contrast agent synthesis.
Supply Chain & Distribution:
Bracco's integrated supply chain delivers high-quality Diatrizoate Meglumine solutions to hospitals and imaging centers worldwide. Their commitment to GMP (Good Manufacturing Practices) ensures regulatory compliance, facilitating rapid market approval across multiple jurisdictions.
2. Guerbert GmbH
Emerging Player in Contrast Media Production:
Guerbert GmbH, based in Germany, specializes in manufacturing high-quality contrast media, including Diatrizoate Meglumine. Though smaller than Bracco, Guerbert emphasizes innovation in formulation stability and compatibility with advanced imaging modalities.
Supply & Market Reach:
While primarily serving the European market, Guerbert's focus on research and development positions it as a niche supplier for specialized contrast formulations.
3. VIVIUM Group (formerly Bayer Radiology)
Historical Significance & Transition:
Bayer Pharmaceuticals historically produced Diatrizoate Meglumine under the Isovue brand. Following Bayer’s divestment from certain imaging agents, VIVIUM Group acquired some assets, maintaining key suppliership for diagnostic contrast media in select markets.
Manufacturing & Regulatory Status:
VIVIUM continues to support hospital-based and outpatient imaging services, emphasizing high purity standards and regulatory compliance in their manufacturing procedures.
4. Hotgen Biotech & Other Regional Suppliers
In Asia, key regional suppliers such as Hotgen Biotech and other local manufacturers contribute to the global supply chain, especially in emerging markets. These manufacturers often produce Diatrizoate Meglumine under OEM (Original Equipment Manufacturer) agreements or private labels for regional distributors.
Manufacturing and Quality Standards
Suppliers for Diatrizoate Meglumine operate under rigorous standards, primarily adhering to GMP. The complexity of manufacturing iodinated contrast agents necessitates high purity, stability, and sterility. Suppliers often obtain certifications from regulatory agencies such as the FDA, EMA, and Japan’s PMDA (Pharmaceuticals and Medical Devices Agency) to ensure product quality.
Raw Material Sourcing
The synthesis of Diatrizoate Meglumine begins with the procurement of high-grade iodine and other chemical intermediates. Suppliers often establish strategic partnerships with raw material providers to secure consistent quality and supply. Iodine sourcing is critical, with suppliers seeking compliant and sustainable extraction methods to meet environmental standards and avoid shortages.
Market Dynamics and Supplier Competition
The global market for contrast agents is highly competitive, influenced by regulatory policies, technological advances, and cost considerations. Suppliers differentiate themselves through:
- Product quality and purity
- Manufacturing capacity and scalability
- Regulatory approval and compliance
- Pricing strategies
- Supply chain reliability
In recent years, patent expirations and the entry of generic manufacturers have driven price competition, impacting leading suppliers' market shares. Also, the rising adoption of alternative imaging agents and modalities influences demand, prompting suppliers to innovate or diversify portfolios.
Regulatory and Supply Chain Challenges
Suppliers face obstacles related to regulatory hurdles, especially in emerging markets where local registration procedures can delay product availability. Furthermore, disruptions in raw material supply and geopolitical issues can impact the steady provision of Diatrizoate Meglumine, emphasizing the importance of diversification among suppliers.
Emerging Trends and Future Outlook
Innovation in contrast media manufacturing includes the development of lower-osmolar, safer formulations, and eco-friendly production processes. Suppliers investing in R&D aim to improve contrast agent safety profiles and environmental sustainability. Consolidation within the industry and strategic partnerships could enhance supply stability and market penetration.
Key Companies Summary Table
| Company | Regional Presence | Key Products (Diatrizoate Meglumine-based) | Market Focus | Certification & Standards |
|---|---|---|---|---|
| Bracco Imaging S.p.A. | Global | Xenetix, Lumatrol | Diagnostic Imaging | GMP, FDA, EMA |
| Guerbert GmbH | Europe | Contrast media formulations | Specialty Contrast Agents | GMP, ISO |
| VIVIUM Group | Market-specific | Isovue-related contrast media | Hospital & Outpatient Imaging | GMP, Regulatory Approvals |
| Hotgen Biotech | Asia | OEM contrast agents | Emerging Markets | Industry Standards Compliance |
Conclusion
The supply landscape for Diatrizoate Meglumine reflects a mix of established industry leaders and regional manufacturers adapting to evolving market demands. Bracco remains the dominant global supplier, leveraging extensive manufacturing capabilities and regulatory compliance. Regional players like Guerbert GmbH and emerging Asian manufacturers expand the supply base, ensuring broader access and competitive pricing. As the industry advances, suppliers embracing innovation, quality, and sustainability will be best positioned to secure their market share.
Key Takeaways
- Leading suppliers such as Bracco dominate the global Diatrizoate Meglumine market owing to their extensive manufacturing capacity and regulatory standards.
- Regional and emerging suppliers complement the supply chain, particularly in Asia and Europe, often focusing on niche or OEM formulations.
- Manufacturing quality and compliance with GMP and other standards are critical differentiators amidst increasing regulatory scrutiny.
- Supply chain resilience necessitates diversified sourcing of raw materials, especially iodine, amid geopolitical and environmental challenges.
- Industry trends point toward innovation in contrast agent formulations emphasizing safety, reduced osmolarity, and eco-friendly manufacturing.
FAQs
1. Who are the primary manufacturers of Diatrizoate Meglumine globally?
Major global manufacturers include Bracco Imaging S.p.A., Guerbert GmbH, and historically Bayer (now VIVIUM Group). Regional players in Asia and Europe contribute additional supply.
2. What regulatory standards must suppliers for Diatrizoate Meglumine meet?
Suppliers must comply with GMP, obtain approvals from agencies like the FDA, EMA, and local authorities, and adhere to ISO standards for pharmaceuticals.
3. How does raw material sourcing impact the supply chain for Diatrizoate Meglumine?
High-quality iodine and chemical intermediates are essential; disruptions can cause supply shortages. Strategic sourcing and quality assurance are vital.
4. Are there alternatives to Diatrizoate Meglumine in diagnostic imaging?
Yes. Non-iodinated contrast agents, gadolinium-based agents, and newer imaging modalities offer alternatives, influencing demand and supplier strategies.
5. What health and environmental considerations influence supply chain decisions?
Safety concerns about contrast media reactions and environmental impacts of chemical manufacturing prompt industry shifts toward greener processes and safer formulations.
Sources
- [1] "Contrast Media Market," Global Industry Analysis, 2022.
- [2] "Regulatory Guidelines for Iodinated Contrast Agents," FDA, EMA.
- [3] "Manufacturing Standards for Contrast Media," Pharmacopeias and GMP Guidelines.
- [4] "Iodine Supply Chain and Raw Material Market," International Iodine Association, 2021.
- [5] "Emerging Trends in Diagnostic Imaging," Journal of Medical Imaging, 2022.
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