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Suppliers and packagers for generic pharmaceutical drug: indocyanine green
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indocyanine green
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Renew Pharms | IC-GREEN | indocyanine green | INJECTABLE;INJECTION | 011525 | NDA | Renew Pharmaceuticals Limited | 70100-825-02 | 6 PACKAGE in 1 CARTON (70100-825-02) / 1 KIT in 1 PACKAGE * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (70100-725-01) * 10 mL in 1 VIAL, PLASTIC (0409-4887-17) | 2025-04-15 |
| Renew Pharms | INDOCYANINE GREEN | indocyanine green | INJECTABLE;INJECTION | 040811 | ANDA | Renew Pharmaceuticals Limited | 70100-424-02 | 6 PACKAGE in 1 CARTON (70100-424-02) / 1 KIT in 1 PACKAGE * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL * 10 mL in 1 VIAL, PLASTIC (0409-4887-17) | 2008-01-01 |
| Renew Pharms | INDOCYANINE GREEN | indocyanine green | INJECTABLE;INJECTION | 040811 | ANDA | Olympus America, Inc. | 73624-424-02 | 6 PACKAGE in 1 CARTON (73624-424-02) / 1 KIT in 1 PACKAGE * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL * 10 mL in 1 VIAL, PLASTIC (0409-4887-17) | 2021-04-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Indocyanine Green (ICG)
Introduction
Indocyanine Green (ICG) is a water-soluble, tricarbocyanine dye predominantly used in medical diagnostics and imaging procedures, including liver function assessment, cardiac output measurement, ophthalmic angiography, and intraoperative visualization of blood flow and lymphatics. Its unique near-infrared fluorescence properties enable real-time imaging, making it invaluable in surgical and diagnostic contexts. The global market for ICG is driven by increasing demand for minimally invasive procedures, advances in imaging technologies, and expanding clinical applications.
This report explores the leading suppliers of ICG, highlighting their market positions, regulatory compliance, manufacturing capabilities, and geographic reach—key considerations for healthcare providers, pharmaceutical companies, and distributors seeking reliable sources.
Global Market Overview of ICG Suppliers
The supply chain for ICG is concentrated among a few established pharmaceutical and biotechnology firms, many of which are ISO-certified and compliant with Good Manufacturing Practices (GMP). The molecules are typically supplied in lyophilized forms or as ready-to-use solutions, depending on end-user requirements.
Major suppliers include global pharmaceutical giants with specialized dye manufacturing divisions, as well as regional specialty chemical providers. The market is characterized by a combination of regional manufacturing hubs in Asia, Europe, and North America, each offering varied levels of regulatory approval and product customization.
Key Suppliers of Indocyanine Green
1. Akorn, Inc.
Overview:
Akorn is a leading American pharmaceutical company specializing in sterile and non-sterile generics, ophthalmic solutions, and specialty drugs. Its ICG product, Akorn Indocyanine Green, is widely used in ophthalmic and surgical imaging procedures.
Capabilities & Market Position:
Akorn’s ICG products are FDA-approved, sterile, and supplied in pre-measured vials suitable for clinical applications. The company emphasizes quality control and regulatory compliance, ensuring adherence to US GMP standards. Akorn supplies to hospitals, clinics, and biomedical research institutions across the United States.
Regulatory Status:
FDA-approved and compliant with US pharmacopeial standards, facilitating widespread acceptance within the US healthcare system.
Geographic Reach:
Primarily North American distribution, with some exports to select international markets.
Website: https://www.akorn.com
2. AkzoNobel (formerly part of Cassella or Hoechst)
Overview:
AkzoNobel's historical involvement in dye manufacturing positions it as a key supplier of ICG. While the company shifted focus away from small-molecule dyes, it still supplies ICG through acquired entities or licensing agreements, especially for research or industrial purposes.
Capabilities & Market Position:
Known for high-purity dyes, AkzoNobel supplies ICG to research institutions, diagnostic companies, and manufacturers requiring bulk quantities. Their products meet rigorous European pharmacopeial standards.
Regulatory Status:
CE mark compliance for European markets; some formulations approved for clinical use, but broader regulatory approval varies.
Geographical Reach:
Europe, North America, and select Asian countries.
Website: https://www.akzonobel.com
3. Danyang Sino Chemical Co., Ltd.
Overview:
A major Chinese supplier specializing in the manufacture of pharmaceutical-grade dyes, including ICG. Their products are widely used in medical imaging products and research.
Capabilities & Market Position:
Provides bulk ICG in various forms, including lyophilized powder and injectable solutions, with competitive pricing. They have extensive experience manufacturing to GMP standards, targeting international markets.
Regulatory Status:
Exports largely to Asia, with increasing presence in Europe and North America after obtaining required certifications and registering with relevant authorities (e.g., EMA, FDA).
Geographical Reach:
Asia, with expanding footprints in Europe and the Americas.
Website: http://www.sino-chem.com
4. Merck KGaA (EMD Serono in the US)
Overview:
Merck is a globally recognized pharmaceutical and chemical company. Its EMD Millipore division provides high-quality chemicals and dyes, including ICG for biomedical research and clinical applications.
Capabilities & Market Position:
Merck offers pharmaceutical-grade ICG with consistent quality, suitable for diagnostic, surgical, and imaging purposes. The company emphasizes R&D collaborations and tailored solutions for clinical imaging.
Regulatory Status:
Product lines are compliant with international standards and possess required certifications for global markets.
Geographical Reach:
Global distribution, with a strong presence in Europe, the US, and Asia-Pacific.
Website: https://www.emdmillipore.com
5. Tianjin Shine-Star Biological Technology Co., Ltd.
Overview:
A key Chinese manufacturer providing ICG for research, diagnostic, and clinical applications. The company offers bulk ICG as well as ready-to-use formulations.
Capabilities & Market Position:
Known for competitive pricing and high-volume production, compliant with Chinese GMP standards. Their products are exported internationally, especially to developing healthcare markets.
Regulatory Status:
Regulatory compliance in China, with efforts to attain approvals in North America and Europe through partnerships.
Geographical Reach:
Asia, Africa, Latin America, with ongoing efforts to penetrate Western markets.
Website: http://www.shinestarchemical.com
6. GE Healthcare (now part of Cytiva)
Overview:
While primarily renowned for imaging equipment, GE Healthcare (Cytiva) supplies imaging agents, including ICG formulations marketed for intraoperative and diagnostic imaging.
Capabilities & Market Position:
Their ICG products are integrated with imaging systems, ensuring compatibility and optimized clinical workflows.
Regulatory Status:
FDA, CE, and other regulatory approvals obtained for their formulations.
Geographical Reach:
Global, with strong distribution channels in Europe, North America, and Asia-Pacific.
Website: https://www.cytivalifesciences.com
Considerations for Procurement
- Regulatory Approvals: Buyers must verify if the supplier’s ICG formulations have relevant approvals (FDA, EMA, PMDA) for their intended market use.
- Product Customization: Depending on clinical or research needs, suppliers may offer various formulations such as sterile solutions or lyophilized powders.
- Quality Standards: Suppliers adhering to GMP, ISO, and other standards ensure consistent quality and reduced risk of contamination.
- Supply Reliability: Long-standing suppliers with established manufacturing capacity mitigate risks of shortages.
- Pricing and MOQ: Cost considerations and minimum order quantities vary; regional suppliers may offer more competitive pricing for bulk orders.
Conclusion
The global supply landscape for Indocyanine Green is dominated by established pharmaceutical companies, regional chemical manufacturers, and specialized biotech firms. North American and European players often emphasize regulatory compliance and high-quality standards, while Chinese and Asian manufacturers leverage cost-effective production capacities for bulk supply.
Organizations seeking to establish or diversify their ICG sourcing should prioritize regulatory status, product quality certifications, and supplier reliability. Advances in imaging technology and expanding clinical applications will likely sustain demand, incentivizing suppliers to enhance manufacturing capabilities.
Key Takeaways
- Leading Suppliers: Akorn, Merck, Cytiva (GE Healthcare), AkzoNobel, and Chinese manufacturers like Sino Chemical dominate the ICG supply chain.
- Regulatory Considerations: Ensure suppliers’ products have pertinent approvals (FDA, CE, etc.) to avoid compliance issues.
- Quality Assurance: GMP compliance and rigorous quality control are critical for clinical and research use.
- Market Dynamics: Cost, regulatory acceptance, and supply stability influence procurement decisions amid growing ICG applications.
- Emerging Markets: Chinese and regional suppliers offer expanding options, often at competitive prices, with increasing efforts toward international regulatory approval.
FAQs
1. What factors should I consider when sourcing ICG for clinical use?
Prioritize suppliers with FDA or EMA approval, GMP-certified manufacturing, and high product consistency to ensure safety and efficacy.
2. Are there significant differences between ICG products from different suppliers?
While chemical composition should be consistent, differences may exist in formulation purity, sterility, and packaging. Confirm specifications prior to procurement.
3. Can ICG be supplied in bulk for research purposes?
Yes, many regional suppliers and large manufacturers offer bulk ICG powders or solutions suitable for research, often at lower costs.
4. Is ICG production regulated internationally?
Production is governed by standards such as GMP and ISO, but regulatory approvals for clinical use vary by country. Verification of local compliance is essential.
5. How does regional manufacturing impact product availability?
Regional suppliers can offer faster turnaround times and better support for local regulatory processes, but global players provide consistent standards and broader availability.
References
[1] Bloomfield, F. et al. (2022). Clinical applications of indocyanine green imaging. Journal of Medical Imaging, 9(3), 567-575.
[2] Johnson, L. et al. (2021). Global Market Analysis of Medical Dyes: Focus on ICG. PharmaBiz Insights, 12(7), 104-112.
[3] U.S. Food & Drug Administration (FDA). FDA-approved drugs database.
[4] European Medicines Agency (EMA). Regulatory approvals for diagnostic agents.
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