Suppliers and packagers for generic pharmaceutical drug: TRYPAN BLUE
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TRYPAN BLUE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Dorc | MEMBRANEBLUE | trypan blue | SOLUTION;OPHTHALMIC | 022278 | NDA | Dutch Ophthalmic Research Center (International) B.V. | 68803-672-05 | 5 POUCH in 1 CARTON (68803-672-05) / 1 SYRINGE, GLASS in 1 POUCH / .5 mL in 1 SYRINGE, GLASS | 2009-02-20 |
| Dorc | VISIONBLUE | trypan blue | SOLUTION;OPHTHALMIC | 021670 | NDA | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | 68803-612-10 | 10 POUCH in 1 CARTON (68803-612-10) / 1 SYRINGE, GLASS in 1 POUCH / .5 mL in 1 SYRINGE, GLASS | 2004-12-16 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Trypan Blue
Introduction
Trypan blue is a vital dye widely used in biomedical research and certain clinical applications, primarily for cell viability assays. Its importance spans histology, cellular biology, and surgical procedures, particularly in ophthalmology for staining the anterior capsule of the lens. While not a pharmaceutical drug in the traditional sense, it remains a critical reagent supplied by multiple manufacturers worldwide. This article delineates the key suppliers, explores their offerings, and examines the market landscape for trypan blue, providing insights for stakeholders in research, clinical, and manufacturing sectors.
Market Overview of Trypan Blue
Trypan blue functions as a vital dye that selectively stains dead cells, enabling researchers and clinicians to distinguish viable from non-viable cells effectively. Despite the broad utility, the compound's regulatory and sourcing processes differ based on regional medical standards, commercial availability, and purity requirements. Suppliers are typically pharmaceutical grade or research grade, and some companies offer formulations tailored to specific uses such as ophthalmic surgery.
Major Suppliers of Trypan Blue
1. Sigma-Aldrich (Merck KGaA)
As one of the global leaders in chemical and biological products, Sigma-Aldrich supplies high-quality trypan blue for research and clinical purposes. Their offerings include prepared solutions with specified concentrations suitable for cell viability assays, histological staining, and specialized biomedical applications. Sigma-Aldrich’s trypan blue is recognized for consistent purity, stability, and compliance with regulatory standards such as USP and European Pharmacopoeia. The company's extensive distribution network ensures wide accessibility across North America, Europe, and Asia.
2. Thermo Fisher Scientific
Thermo Fisher is another prominent supplier providing research-grade trypan blue, primarily aimed at academia and biotech firms. Their catalog features Trypan Blue Solution, which is sterile, ready-to-use, and available in various volume configurations. Thermo Fisher emphasizes quality assurance, with traceable batches and certificates of analysis, underscoring compliance with Good Manufacturing Practice (GMP) standards where applicable.
3. Merck (Darmstadt, Germany)
Apart from Sigma-Aldrich, Merck offers an array of biochemical reagents, including trypan blue suitable for research and clinical purposes. Their supply chain ensures reliable sourcing and adherence to quality standards. Merck's formulations are tailored for cell biology and histology, often being used in research institutions and hospitals equipped for intricate cellular analysis.
4. GIBCO (Thermo Fisher Scientific)
GIBCO’s offerings include specialized solutions for cell viability assessments. Their trypan blue solutions come with optimized formulations for cell counting and viability assays, distinguished by their consistent quality and low endotoxin levels. GIBCO’s reputation in the biomedical sector makes their reagents a preferred choice in sensitive applications like regenerative medicine.
5. Local and Regional Suppliers
Beyond multinational corporations, regional suppliers often provide trypan blue formulations suited for local regulatory standards and specific application needs. These include suppliers in India (e.g., HiMedia), China, and Southeast Asia, which supply both research-grade and clinical-grade trypan blue. Such suppliers typically provide cost-effective options with varying levels of quality assurance depending on the intended use.
Regulatory Considerations and Certification
For clinical and pharmaceutical applications, suppliers must comply with stringent regulatory frameworks, including the European Pharmacopoeia, U.S. Pharmacopeia (USP), and FDA regulations. Suppliers often provide Certificates of Analysis (CoA), Certificates of Suitability (CoS), and Good Manufacturing Practice (GMP) certification to ensure product quality and safety. These certifications are particularly vital for ophthalmic applications where purity and sterility are paramount.
Market Dynamics and Supply Chain Challenges
The supply chain for trypan blue faces certain challenges, including raw material availability, quality control, and geopolitical factors. Fluctuations in raw material prices and tight regulatory controls have sometimes caused supply shortages or delays, affecting research timelines and clinical procedures. As demand from pharmaceutical research, regenerative medicine, and surgical applications continues to grow, suppliers are investing in expanding production capacity and maintaining comprehensive quality assurance systems.
Emerging Trends and Future Outlook
The future of trypan blue supply involves increasing focus on regulatory compliance, purity, and formulation customization. Innovations such as sterile, endotoxin-free, and high-purity formulations are gaining prominence. Additionally, efforts to develop alternative dyes with similar efficacy but improved safety profiles are underway, although trypan blue remains dominant due to its proven efficacy and cost-effectiveness.
Conclusion
Multiple suppliers cater to the global demand for trypan blue, spanning major multinational corporations to regional providers. Ensuring sourcing from reputable suppliers with appropriate regulatory compliance is critical for clinical and research applications. As the biomedical sector expands, the supply landscape will likely evolve towards higher purity standards, better quality assurance, and diversified formulations to meet specific application needs.
Key Takeaways
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