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Suppliers and packagers for generic pharmaceutical drug: gadodiamide
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gadodiamide
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Ge Healthcare | OMNISCAN | gadodiamide | INJECTABLE;INJECTION | 020123 | NDA | GE Healthcare Inc. | 0407-0690-10 | 10 VIAL in 1 BOX (0407-0690-10) / 10 mL in 1 VIAL | 2002-04-19 |
| Ge Healthcare | OMNISCAN | gadodiamide | INJECTABLE;INJECTION | 020123 | NDA | GE Healthcare Inc. | 0407-0690-15 | 10 VIAL in 1 BOX (0407-0690-15) / 15 mL in 1 VIAL | 2002-04-19 |
| Ge Healthcare | OMNISCAN | gadodiamide | INJECTABLE;INJECTION | 020123 | NDA | GE Healthcare Inc. | 0407-0690-20 | 10 VIAL in 1 BOX (0407-0690-20) / 20 mL in 1 VIAL | 2002-04-19 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: GADODIAMIDE
Introduction
Gadodiamide is a macrocyclic, non-ionic iodinated contrast agent used predominantly in magnetic resonance imaging (MRI) for enhancing vascular and tissue visualization. Its unique chemical properties enable rapid excretion via renal pathways and provide high-quality imaging results. As a specialized pharmaceutical agent, gadodiamide's supply chain is critical for healthcare providers, diagnostic laboratories, and medical imaging centers worldwide. This article explores the global landscape of gadodiamide suppliers, the manufacturing dynamics, regulatory considerations, and strategic insights for stakeholders involved in sourcing or investing in this contrast agent.
Overview of Gadolinium-Based Contrast Agents (GBCAs)
Gadodiamide belongs to the family of gadolinium-based contrast agents (GBCAs), which are classified broadly into linear and macrocyclic agents. Gadolinium's paramagnetic properties facilitate MRI contrast enhancement. Gadolodiamide is a non-ionic, linear GBCA, with the molecular formula C20H23GdN4O8, and is marketed under brand names such as Omniscan by GE Healthcare.
The manufacturing process involves complex coordination chemistry, integrating gadolinium ions with ligand molecules to minimize toxicity and maximize imaging efficacy. The global demand for gadodiamide aligns with the expanding MRI diagnostic applications, especially in neurology, cardiology, and oncology.
Key Global Suppliers of GADODIAMIDE
1. GE Healthcare
Market Position: As the original developer of Omniscan, GE Healthcare remains the leading producer of gadodiamide globally. Their manufacturing facilities, primarily based in the United States, Europe, and Asia, produce high-quality gadolinium contrast agents that meet stringent regulatory standards.
Supply Capabilities: GE Healthcare invests heavily in manufacturing capacity, ensuring steady supplies to meet global demand. Their distribution network spans North America, Europe, Asia-Pacific, and emerging markets.
Regulatory Compliance: The company adheres to regulatory standards set by the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and other country-specific authorities. This compliance guarantees the quality, safety, and reliability of their products.
2. Guerbet Group
Market Position: Guerbet, based in France, is a significant player in the global contrast agent market, offering alternatives like OptiMARK (gadodiamide). Although primarily known for other contrast agents, Guerbet's portfolio components include gadodiamide formulations.
Supply Capabilities: Guerbet's expansive manufacturing facilities in Europe and investments in supply chain robustness position it as a reliable gadodiamide source in Europe and select markets.
Regulatory Footprint: The company's products are approved across numerous jurisdictions, with robust pharmacovigilance infrastructure.
3. ICI (Historical context)
Note: ICI Pharmaceuticals was an early manufacturer of gadodiamide before merging with other entities; now part of Merck Group. As such, ICI's original gadodiamide supply chain has been integrated into other pharmaceutical companies.
4. Contract Manufacturing Organizations (CMOs) and Regional Producers
While few companies produce gadodiamide at a large scale outside of industry giants, certain regional manufacturers and CMOs in Asia and Eastern Europe may produce gadolinium contrast agents under licensing agreements. However, regulatory approval and trustworthiness vary significantly.
Emerging Manufacturers and Market Entry
The scarcity of new entrants stems from high regulatory barriers, complex synthesis processes, and safety considerations. Nonetheless, emerging biotech firms exploring next-generation GBCAs may partner with existing manufacturers or develop alternative contrast agents.
Regulatory and Quality Considerations
Gadodiamide’s manufacturing and supply are heavily regulated under pharmacopeial standards (e.g., USP, EP, JP). Suppliers must ensure Good Manufacturing Practice (GMP), source gadolinium supplies from certified vendors, and maintain rigorous quality control.
Notably, concerns about gadolinium deposition in tissues have prompted regulatory bodies to re-evaluate the safety profiles of GBCAs, indirectly impacting gadodiamide supply chain considerations—especially regarding phase-out strategies, alternative agents, and disposal protocols.
Supply Chain Challenges
- Regulatory Restrictions: Due to concerns about gadolinium retention, some markets have imposed usage restrictions, impacting demand and supply dynamics.
- Material Scarcity: Gadolinium is a rare earth element with geopolitical concentration issues, predominantly mined in China, Australia, Russia, and the United States.
- Manufacturing Complexity: The chemical synthesis of gadodiamide requires specialized facilities, limiting the number of competent producers.
- Market Dynamics: Patent expirations and generic production have increased competition, but high regulatory barriers sustain a limited supplier pool.
Strategic Insights for Stakeholders
- For Healthcare Providers and Distributors: Establish partnerships with trusted suppliers like GE Healthcare or Guerbet to ensure supply continuity. Consider regional inventory buffers in anticipation of regulatory shifts or supply chain disruptions.
- For Investors and Market Analysts: The market is characterized by monopolistic tendencies due to high entry barriers. Monopolists like GE Healthcare maintain dominant positions, but emerging regulatory trends and safety concerns may alter competitive dynamics.
- For Policymakers and Regulators: Balancing safety concerns against supply robustness is crucial. Encouraging diverse manufacturing sources and supporting innovation in contrast agents can stabilize the supply chain.
Future Outlook
The gadodiamide supply landscape faces crucial transformations driven by evolving safety regulations, innovation in MRI contrast agents, and supply chain shifts for rare earth elements. The industry is gradually pivoting towards macrocyclic GBCAs perceived as safer, potentially reducing gadodiamide demand. Nevertheless, existing supply chains remain vital for current clinical needs.
Development of next-generation contrast agents, including novel gadolinium complexes and alternative imaging modalities, may influence the long-term landscape of gadodiamide suppliers. Strategic partnerships, regulatory compliance, and ongoing innovation will underpin supply stability in this specialized sector.
Key Takeaways
- Limited Global Suppliers: Major producers include GE Healthcare and Guerbet, with few credible regional manufacturers due to complex manufacturing and regulatory hurdles.
- Regulatory Impact: Safety evaluations influence manufacturing, supply stability, and market demand for gadodiamide.
- Supply Chain Risks: Gadolinium's scarcity, high regulatory standards, and geopolitical factors necessitate diversified sourcing and strategic inventory management.
- Market Dynamics: Patent expirations and safety concerns are fueling shifts toward alternative contrast agents, impacting gadodiamide's market penetration.
- Future Trends: Advancements in imaging technology and regulatory developments guide the evolution of gadodiamide supply, with a focus on safety, compliance, and innovation.
FAQs
1. Who are the primary global suppliers of gadodiamide?
GE Healthcare and Guerbet Group are the leading suppliers, with manufacturing facilities supporting global and regional markets.
2. Are there regional differences in gadodiamide sourcing?
Yes. Western markets predominantly rely on GE Healthcare and Guerbet. In some Asian and Eastern European markets, local or regional CMOs may supplement supply, though with variable regulatory assurance.
3. How do regulatory changes affect gadodiamide suppliers?
Regulatory reassessment of gadolinium retention concerns can lead to restrictions on use, impacting production, demand, and supply planning across suppliers.
4. Is gadodiamide manufacturing at risk due to rare earth element shortages?
While the scarcity of gadolinium isotope could impact supply, production is currently maintained through established procurement channels; geopolitical stability remains a critical factor.
5. What is the outlook for gadodiamide supply in the future?
Supply stability depends on regulatory trends, safety profiles, and advances in alternative contrast agents. Existing suppliers are likely to maintain focus on compliance and quality to sustain market presence.
References
- [1] "Gadodiamide." U.S. Food and Drug Administration (FDA).
- [2] "Contrast Media: Pharmacology and Clinical Applications," American Journal of Roentgenology, 2020.
- [3] "The Role of Gadolinium Contrast Agents in MRI," Radiology Business, 2021.
- [4] "Market Analysis of Gadolinium-Based Contrast Agents," Global Data, 2022.
- [5] "Safety and Regulatory Aspects of Gadolinium Agents," European Medicines Agency (EMA), 2021.
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