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Suppliers and packagers for generic pharmaceutical drug: brilliant blue g
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brilliant blue g
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Dutch Ophthalmic | TISSUEBLUE | brilliant blue g | SOLUTION;OPHTHALMIC | 209569 | NDA | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | 68803-722-05 | 10 POUCH in 1 CARTON (68803-722-05) / 1 SYRINGE, GLASS in 1 POUCH / .5 mL in 1 SYRINGE, GLASS | 2019-12-31 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Brilliant Blue G (Brilliant Blue Gluconate)
Introduction
Brilliant Blue G (BBG), also known as Brilliant Blue Gluconate, is a synthetic triphenylmethane dye primarily utilized as a pharmacological agent. Its significance in both research and therapeutic contexts stems from its ability to selectively inhibit P2X7 purinergic receptors, making it valuable in neuropharmacology, immunology, and ophthalmology. The increasing demand for BBG in clinical and laboratory settings underscores the importance of understanding its supply chain and sourcing options.
This article provides an in-depth analysis of suppliers involved in manufacturing and distributing Brilliant Blue G, evaluates quality and regulatory considerations, and highlights regional market dynamics.
Overview of Brilliant Blue G
Brilliant Blue G belongs to the triphenylmethane dye family, characterized by high water solubility and stability under physiological conditions. It is primarily supplied in various forms such as powders, solutions, and pharmaceutical-grade preparations. Although initially used as a food coloring agent, its role in medicine, particularly as an antagonist of P2X7 receptors, has expanded its application scope.
The active compound’s chemical profile aligns with regulatory standards, including those outlined by the FDA and EMA, when used in pharmaceutical formulations, necessitating suppliers to meet stringent quality control measures.
Leading Manufacturers and Suppliers
1. Sigma-Aldrich/Merck
Overview:
Sigma-Aldrich, acquired by Merck KGaA, is a global leader in chemical and pharmaceutical raw materials. Its extensive catalog includes high-purity Brilliant Blue Gluconate for research and pharmaceutical use.
Product Portfolio:
- Pharmaceutical-grade BBG solutions and powders
- Custom synthesis options
- Certificates of Analysis (CoA) and regulatory documentation
Regulatory Compliance:
Their products adhere to ISO 9001 standards, and documentation complies with pharmaceutical and research-grade requirements.
Market Reach:
Sigma-Aldrich supplies to laboratories, hospitals, and pharmaceutical companies worldwide, ensuring reliable sourcing for BBG.
2. Tocris Bioscience
Overview:
Tocris specializes in neuropharmacological research compounds, including derivatives and pure forms of BBG. They focus on reagents used in neuroscience and immunology.
Product Offerings:
- High-purity Brilliant Blue G
- Research-grade compounds with batch-specific quality data
- Ready-to-use solutions for in vitro applications
Quality Assurance:
Tocris emphasizes reproducibility and stringent quality controls aligned with research standards.
3. Toronto Research Chemicals (TRC)
Overview:
TRC supplies a variety of chemical reagents, including BBG for advanced research. Their focus is on providing chemically pure and high-quality products suitable for pharmaceutical research.
Product Options:
- BBG in powder form
- Custom synthesis and assay development services
Regulatory and Certification Standards:
TRC products come with detailed technical datasheets and CoA, ensuring traceability.
4. Cayman Chemical
Overview:
Cayman Chemical manufactures biochemical reagents for research and pharmaceutical applications, including BBG. Their emphasis on quality control includes rigorous purity testing.
Product Range:
- BBG for research applications
- Analytical grade chemicals with detailed specifications
Regional Market Dynamics
North American Market
The US and Canada host numerous suppliers like Sigma-Aldrich and Cayman Chemical, driven by high demand in biomedical research institutions. Regulatory frameworks like the FDA’s cGMP standards influence sourcing quality and product registration.
European Market
Europe benefits from manufacturers like Merck KGaA and Tocris. The European Medicines Agency (EMA) influences supply chain standards, requiring compliance with high purity and safety standards.
Asian Market
Asia, particularly China and India, manufactures bulk quantities of chemical reagents, often at lower costs. However, quality assurance and regulatory compliance vary, necessitating careful supplier vetting for pharmaceutical applications.
Emerging Markets
Emerging economies are increasingly sourcing BBG for both laboratory research and emerging clinical applications. Local suppliers often provide cost-effective options but may face regulatory hurdles, affecting product acceptance and use.
Regulatory and Quality Considerations
Suppliers must provide documentation such as CoA, Certificate of Analysis, and Certificates of Origin to meet pharmaceutical-grade standards. Compliance with Good Manufacturing Practices (GMP) and adherence to regulatory agencies like the FDA or EMA are crucial, especially for pharmaceutical and clinical use.
The risk of substandard or contaminated products underscores the importance of sourcing from reputable suppliers with transparent quality assurance practices. Regulatory authorities often audit supplier facilities, requiring strict adherence to GMP, ISO standards, and traceability measures.
Challenges in Sourcing Brilliant Blue G
- Purity and Quality Variability: Variations in manufacturing processes can affect product purity, influencing biological activity and safety.
- Regulatory Compliance: Ensuring products meet regional regulatory standards is critical for clinical applications.
- Cost and Availability: Price fluctuations and supply chain disruptions can impact procurement, especially from emerging markets.
- Environmental and Ethical Standards: Increasing focus on sustainable and ethical sourcing influences supplier selection.
Future Outlook
The expanding clinical role of Brilliant Blue G as a P2X7 receptor antagonist suggests sustained or increasing demand. Innovations in synthetic manufacturing and the emergence of specialized suppliers focusing on pharmaceutical-grade compounds are likely to improve product consistency and supply reliability. Additionally, the harmonization of global regulatory standards may simplify procurement processes across regions.
Key Takeaways
- Reputable suppliers such as Sigma-Aldrich, Tocris Bioscience, TRC, and Cayman Chemical are primary sources of high-quality Brilliant Blue G.
- Ensuring compliance with GMP and regional regulatory standards is critical when sourcing BBG for clinical or pharmaceutical applications.
- The global market features regional disparities, with developed markets prioritizing strict quality controls, and emerging markets offering cost-effective options with potential quality variability.
- Thorough due diligence, including supplier audits and certificate verification, is essential to mitigate risks associated with product adulteration or contamination.
- The evolving therapeutic and research landscape will likely sustain demand, prompting ongoing innovation in manufacturing and supply chain management.
FAQs
1. What are the primary uses of Brilliant Blue G in pharmaceuticals?
Brilliant Blue G is mainly used as a P2X7 receptor antagonist in neuropharmacology, immunology, and ophthalmology research, with emerging therapeutic potential for neurodegenerative diseases and inflammation.
2. How can I verify the quality of BBG supplied by a manufacturer?
Request detailed Certificates of Analysis, evidence of GMP compliance, and batch-specific purity testing data. Preference should be given to suppliers with ISO certifications and regulatory approvals.
3. Are there regional restrictions on importing Brilliant Blue G?
Yes. Some countries regulate dyes and chemical reagents under chemical control or pharmaceutical import laws. Verify local customs and regulatory standards before importing BBG for clinical use.
4. Is Brilliant Blue G available in pharmaceutical-grade purity?
Yes. Leading suppliers offer pharmaceutical-grade BBG that complies with international standards, suitable for clinical and research applications.
5. What factors influence the choice of a supplier for Brilliant Blue G?
Product purity, regulatory compliance, certification standards, supply chain reliability, cost, and supplier reputation are key considerations.
Sources
[1] Sigma-Aldrich. "Brilliant Blue G." Accessed 2023.
[2] Tocris Bioscience. "Brilliant Blue G Product Details." accessed 2023.
[3] Toronto Research Chemicals. "Brilliant Blue G." accessed 2023.
[4] Cayman Chemical. "Brilliant Blue G." accessed 2023.
[5] European Medicines Agency (EMA) and U.S. FDA guidelines on dyes and active pharmaceutical ingredient standards.
Please refer to appropriate regulatory agencies and supplier documentation for the latest standards and product specifications.
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