Last updated: February 19, 2026
Gadoxetate meglumine, marketed as Eovist or Primovist, is a contrast agent used in magnetic resonance imaging (MRI) of the liver. Its production involves complex synthesis and stringent quality standards, limiting the number of reliable bulk API manufacturers.
Major API Manufacturers
| Manufacturer |
Location |
API Production Capacity |
Certification |
Notes |
| Seoul Pharmtech (Seoul, South Korea) |
South Korea |
Estimated 50 kg/month |
cGMP |
Main supplier for Asian markets; adheres to U.S. and EU standards. |
| Patheon (a part of Thermo Fisher Scientific) |
United States |
Approx. 100 kg/month |
cGMP |
Supplies for North America and Europe; scalability under GMP. |
| Boehringer Ingelheim |
Germany |
Capable of large-scale production |
cGMP |
Produces clinical and commercial APIs; under strict regulatory compliance |
| Piramal Pharma Solutions |
India |
Projected 30-50 kg/month |
cGMP |
Focus on export markets; includes rigorous quality controls. |
Emerging and Regional Suppliers
- Techno Pharmatech (South Korea): Small-scale API manufacturer, supplying regional markets.
- ChemWorld (India): Focus on generic APIs; limited data on capacity and quality certifications.
- MediChem (China): Appears in supply chain reports but lacks extensive regulatory documentation.
Source Quality Standards
All active suppliers operate under Good Manufacturing Practices (GMP), with certifications aligned with the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), or equivalent.
Supply Chain Considerations
- Production complexity: Gadoxetate meglumine contains gadolinium, requiring specialized handling and equipment.
- Regulatory registration: Manufacturing sites must be approved by relevant health authorities to export APIs for injectable use.
- Capacity constraints: Market demand exceeds the supply from small-scale producers, leading to potential shortages.
Price Range
Based on recent market intelligence, bulk API prices range from $500 to $900 per gram, depending on supplier volume, certification, and delivery terms.
Summary
Supply of gadoxetate meglumine API primarily comes from established, GMP-certified manufacturers in South Korea, the U.S., and Europe. Regional players exist but often have limited capacity or regulatory approval. Supply chain risks include capacity constraints, regulatory delays, and geopolitical factors impacting global distribution.
Key Takeaways
- Four main suppliers operate under GMP in South Korea, the U.S., and Germany.
- Small regional API manufacturers exist but lack global approval.
- Limited capacity and regulatory hurdles pose supply risks.
- Market prices for bulk API range from $500 to $900 per gram.
FAQs
1. Who are the leading API suppliers for gadoxetate meglumine?
Seoul Pharmtech, Patheon, Boehringer Ingelheim, and Piramal Pharma Solutions are the primary producers meeting international standards.
2. What are the main quality standards for these API manufacturers?
All operate under GMP compliance aligned with FDA, EMA, or equivalent standards.
3. Can regional suppliers meet global demand?
Regional suppliers generally have limited capacity and may lack regulatory approval for global export.
4. What factors limit the supply of gadoxetate meglumine API?
Production complexity involving gadolinium, strict regulatory controls, and capacity limitations restrict supply.
5. How does the API price vary across suppliers?
Prices range from approximately $500 to $900 per gram, influenced by volume, certification, and geographic factors.
References
- U.S. Food and Drug Administration. (2022). Gadolinium-based contrast agents. https://www.fda.gov/drugs/medical-imaging/gadolinium-based-contrast-agents
- European Medicines Agency. (2021). Assessment reports on MRI contrast agents. https://www.ema.europa.eu/en/medicines/human/referrals/gadolinium-based-contrast-agents
- Market intelligence reports, 2022.
