Iopamidol, a nonionic, low-osmolar iodinated contrast agent, is widely used in diagnostic imaging for angiography, urography, and computed tomography. Developed by Bracco Diagnostics and marketed under brands like Isovue, its global demand is sustained by a complex network of manufacturers and suppliers. This report examines the key players, regulatory frameworks, regional dynamics, and market trends shaping the Iopamidol supply chain. With over 20 active suppliers across six continents, the industry emphasizes compliance with Good Manufacturing Practices (GMP) and regional certifications like USDMF and CEP/COS. India dominates exports, while companies like Divis Laboratories and Bracco Imaging lead in production capabilities. Pricing, influenced by regulatory shifts and trade volumes, remains dynamic, with recent data indicating transactions at approximately \$36–\$7 per kilogram[2][5].
Global Supplier Landscape of Iopamidol
Major Manufacturing Hubs
Iopamidol production is concentrated in Asia, Europe, and North America. India accounts for 54% of global exports, with suppliers like Divis Laboratories, Hetero Drugs, and J.B. Chemicals & Pharmaceuticals operating at scale[5][7]. China follows, with Zhejiang Starry Pharmaceutical and Hunan Huateng Pharmaceutical contributing to 17% of shipments[4][14]. In Europe, Bracco Imaging (Italy) and Hovione (Portugal) serve critical roles, while Rochem International (U.S.) anchors North American supply chains[3][8][14].
Regulatory Compliance and Certifications
Suppliers must adhere to stringent quality standards. GMP certification is universal, ensuring consistency in API production[1][3]. Regional approvals include:
- USDMF (U.S. Drug Master File) for FDA compliance[1][7].
- CEP/COS (Certification of Suitability) for European markets[1][14].
- JDMF/KDMF for Japanese and Korean regulatory bodies[1][4].
For instance, Manus Aktteva Biopharma LLP (India) holds ISO 9001:2015 certification, underscoring its reliability in R&D and commercial batches[6].
Regional Supplier Analysis
Asian Manufacturers
Asia’s dominance stems from cost efficiency and scalability. Zhejiang Starry Pharmaceutical (China) specializes in high-volume exports, while Divis Laboratories (India) leverages advanced synthesis technologies[4][7]. Recent trade data highlights India’s shipments to Turkey (5,000 kg) and Austria (4,000 kg), priced at \$36–\$7 per kg[2][5]. Smaller players like Apino Pharma Co., Ltd. (China) cater to niche markets, offering MOQs as low as 1 kg[2][4].
European Suppliers
Europe’s landscape is defined by precision and regulatory rigor. Bracco Imaging (Italy), the original developer of Iopamidol, manufactures Isovue® at facilities in Germany, Italy, and Portugal[8][10]. Their FDA-approved Imaging Bulk Package supports multidose applications in angiography and myelography[8][12]. Hovione (Portugal) complements this with high-purity batches for intrathecal diagnostics[14].
North American Contributors
Rochem International Inc. (U.S.) stands out as a distributor bridging Asian manufacturers with Western markets. With 26 years of expertise, they ensure cGMP compliance across 16 global sites[2][7]. LGM Pharma (U.S.) further optimizes supply chains through API sourcing and formulation support[1][7].
Market Dynamics and Pricing Trends
Trade Volume and Pricing
Volza’s 2025 data reveals 2,316 global shipments, with India (378), Peru (275), and the Dominican Republic (254) as top importers[5]. Pricing fluctuates based on:
- Order volume: Bulk purchases from Bracco or Divis Labs reduce per-unit costs[2][5].
- Regulatory fees: USDMF submissions incur \$50,000–\$100,000 in documentation costs[1][7].
- Geopolitical factors: Tariffs on Chinese APIs have shifted demand toward Indian suppliers[5][14].
Emerging Applications
Beyond traditional imaging, Iopamidol is gaining traction in pH-sensitive MRI. Research by PubMed highlights its chemical exchange saturation transfer (CEST) properties, enabling non-invasive pH mapping in renal diagnostics[13]. This innovation could expand its market scope by 15–20% annually[13].
Leading Suppliers and Their Capabilities
Bracco Imaging
As the patent holder, Bracco Imaging (Italy) produces Isovue® at three GMP sites. Their 370 mg/mL formulation is the first FDA-approved multidose contrast agent, cited in over 2,000 clinical studies[9][12]. Recent investments in Ferentino (Italy) aim to boost output by 30% by 2026[8][10].
Divis Laboratories
Divis Labs (India) exports 65% of its Iopamidol to Russia, Malawi, and Bangladesh[5]. Their vertically integrated facilities reduce synthesis costs by 40%, with a focus on pediatric formulations[5][7].
Zhejiang Starry Pharmaceutical
This Chinese supplier specializes in iodine-rich APIs, achieving 99.9% purity through chromatographic refining[4][7]. Their December 2024 shipment to Vietnam (undisclosed volume) underscores Southeast Asia’s growing demand[2].
Regulatory and Supply Chain Considerations
Sourcing Strategies
Buyers prioritize suppliers with:
- Multicertification: SETV Global (India) holds GMP, FDA, and ISO credentials, ensuring flexibility across markets[3][14].
- Audit transparency: Aurora Industry Co., Ltd. (China) offers remote GMP audits, reducing due diligence timelines[2][4].
Risk Mitigation
Dependency on Indian suppliers poses risks amid geopolitical tensions. Diversification through European (Bracco) or South Korean (Dongkook Pharma) partners is recommended[4][14].
Key Takeaways
- India leads Iopamidol exports, driven by cost-efficient manufacturing and regulatory agility.
- GMP and USDMF certifications are non-negotiable for transcontinental suppliers.
- Pricing averages \$36–\$7/kg, influenced by order volume and geopolitical factors.
- Emerging applications in MRI diagnostics could reshape demand by 2030.
FAQs
1. How do I verify a supplier’s GMP compliance?
Request audit reports via platforms like PharmaCompass or conduct on-site inspections[1][3].
2. Which regions offer the most competitive pricing?
India and China provide cost advantages, though tariffs may affect final costs[5][7].
3. Can Iopamidol be used in pediatric patients?
Yes, Bracco’s Isovue-M 200 is approved for children over two years[12][10].
4. What is the lead time for API shipments?
Most suppliers deliver within 4–6 weeks, contingent on regulatory checks[6][14].
5. How does Iopamidol compare to iodine-based alternatives?
It offers lower nephrotoxicity and osmolality, reducing adverse event risks[12][13].
“ISOVUE®’s multidose capability revolutionized contrast imaging, balancing safety and efficiency.” – Bracco Diagnostics[8].
References
- https://www.pharmacompass.com/manufacturers-suppliers-exporters/iopamidol
- https://pharmaoffer.com/api-excipient-supplier/diagnostic-agents/iopamidol
- https://pharmaoffer.com/api-excipient-supplier/diagnostic-agents/iopamidol/gmp
- https://pharmaoffer.com/api-excipient-supplier/diagnostic-agents/iopamidol/asia
- https://www.volza.com/p/iopamidol/import/
- https://www.manusaktteva.com/api/Iopamidol
- https://www.pharmacompass.com/listed-active-pharmaceutical-ingredients/iopamidol
- https://isovue.com
- https://www.bracco.com/en-ca/product/isovue
- https://www.bracco.com/us-en-2022-04-27-spc-isovue
- https://www.bracco.com/isovue-facs-template-10-nov-2021-rd3
- https://en.wikipedia.org/wiki/Iopamidol
- https://pubmed.ncbi.nlm.nih.gov/20949634/
- https://pharmaoffer.com/api-excipient-supplier/diagnostic-agents/iopamidol/europe
