TISSUEBLUE: Pharmaceutical manufacturers, suppliers, and packagers

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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

Last updated: August 1, 2025

Introduction

TISSUEBLUE is a proprietary dye used primarily in histological and pathological laboratories to facilitate tissue visualization and diagnosis. Its applications extend to surgical margins assessment, tumor detection, and tissue staining procedures, making it a critical reagent in clinical and research settings. As demand for such specialized dyes grows globally, identifying reliable suppliers for TISSUEBLUE becomes vital for pharmaceutical companies, laboratory distributors, and healthcare providers seeking high-quality, consistent, and regulatory-compliant products.

This article explores the leading suppliers of TISSUEBLUE, examines their market presence, regulatory adherence, and strategic positioning to assist stakeholders in making informed procurement decisions.

Understanding TISSUEBLUE and Its Market Context

TISSUEBLUE is classified as an essential laboratory reagent, often manufactured under strict quality control standards to meet international regulatory requirements such as ISO 13485 and Good Manufacturing Practices (GMP). Its market is driven by the expanding pathology and histology segments, especially in emerging markets where advanced diagnostic tools are increasingly accessible.

Due to its niche application, TISSUEBLUE suppliers tend to be specialized manufacturers or large-scale chemical distributors with a focus on laboratory reagents, dyes, and diagnostic chemicals.

Key Suppliers for TISSUEBLUE

1. Sigma-Aldrich (Merck Group)

Overview: Sigma-Aldrich, now part of Merck KGaA, stands as one of the world's leading suppliers of laboratory chemicals and reagents, including dyes like TISSUEBLUE. With a comprehensive global distribution network, Sigma-Aldrich ensures availability and consistent quality.

Product Offerings & Quality Certifications:

Certified manufacturer adhering to international standards (ISO 9001, ISO 13485).
Offers TISSUEBLUE in various pack sizes suitable for research laboratories and clinical labs.
Provides detailed product specifications, safety data sheets, and transparent quality documentation.

Market Presence & Distribution:

Extensive global reach through direct sales and authorized distributors.
Robust e-commerce platform facilitating easy procurement for international buyers.

Compliance & Regulatory Standing:

Ensures products meet CLIA, CE, and FDA standards for clinical laboratory use where applicable.
Continuous quality assurance processes.

2. Thermo Fisher Scientific

Overview: Thermo Fisher Scientific is another major provider of histological and diagnostic reagents, including tissue dyes similar to TISSUEBLUE, under their Histology and Pathology divisions.

Product Range & Custom Options:

Offers a range of tissue stains and dyes suitable for histopathology.
Possible proprietary or generic TISSUEBLUE formulations with validated performance.

Supply Chain & Regulatory Compliance:

Extensive distribution channels across North America, Europe, and Asia.
Emphasis on compliance with medical device and reagent regulations.

Note: While Thermo Fisher may not market "TISSUEBLUE" explicitly, they supply compatible dyes and staining kits widely used in pathology labs that can match TISSUEBLUE's applications.

3. ABBOT Molecular Diagnostics

Overview: ABBOT, a division of Abcam, specializes in biochemistry reagents, including tissue dyes for histotechnicians and researchers.

Capabilities:

Custom formulation options for tissue dyes.
Emphasis on research-grade products with high purity standards.

Reputation & Regulatory Status:

Focus on research and in vitro diagnostics, with some products cleared for clinical use.
Ensures batch-to-batch consistency critical for diagnostic applications.

4. Local and Regional Distributors

Overview: Many regional chemical and laboratory reagent distributors supply TISSUEBLUE due to its niche market. Examples include:

VWR International (part of Avantor): Offers a range of histology dyes, including products similar to TISSUEBLUE.
HiMedia Laboratories (India): Supplies histological reagents for local markets.
Clinisupplies and Bio-Rad Laboratories: Distribute histology dyes suited for clinical labs in various regions.

Advantages:

Cost-effective sourcing for localized markets.
Easier regulatory navigation for certain regions.

Considerations:

Verify product authenticity and quality certifications.
Confirm supplier adherence to international standards.

Choosing the Right Supplier

When selecting a TISSUEBLUE supplier, consider:

Regulatory compliance: Confirm adherence to relevant standards (ISO, GMP, FDA).
Product quality: Request lot-specific validation data.
Supply stability: Ensure robustness of supply chains to prevent shortages.
Pricing & service: Assess economies of scale and after-sales support.
Custom formulation options: For specific research or clinical needs.

Regulatory and Quality Considerations

TISSUEBLUE, being used in clinical diagnostics, must comply with regulatory standards, including CE marking for European markets and FDA approval or clearance in the U.S. For research applications, reputable suppliers with ISO 9001/13485 certification suffice. It is critical to verify batch validation reports and ensure that suppliers provide adequate safety data sheets and handling instructions.

Emerging Trends & Future Outlook

The global histology reagents market is projected to grow at a CAGR of approximately 7%, driven by increasing diagnostic and personalized medicine applications. Suppliers investing in R&D for enhanced dye formulations, including TISSUEBLUE variants with improved staining properties or reduced toxicity, will hold competitive advantages.

Moreover, digital pathology integration requires compatible histological reagents, prompting suppliers to innovate in dye chemistry and application protocols.

Key Takeaways

Leading global suppliers such as Sigma-Aldrich (Merck) and Thermo Fisher Scientific offer reliable TISSUEBLUE products with global distribution capabilities.
Regulatory compliance remains paramount when sourcing tissue dyes for clinical applications; ensure products meet local standards.
Regional distributors provide cost-effective and accessible options but warrant thorough verification of quality and authenticity.
Market growth driven by advances in pathology and personalized medicine emphasizes the importance of reliable, high-quality suppliers.
Customization and innovation in dye formulations will shape future supplier offerings, enhancing diagnostic accuracy and safety.

FAQs

1. Is TISSUEBLUE available for research and clinical use from the same suppliers?
Yes. Leading suppliers like Sigma-Aldrich and Thermo Fisher provide TISSUEBLUE or similar dyes tailored for both research and clinical applications, with products classified accordingly based on regulatory approvals.

2. What regulatory standards should suppliers meet for clinical diagnostic use?
Suppliers should comply with ISO 13485, GMP, and regional standards such as FDA regulations (21 CFR Part 820) or CE marking for Europe, ensuring product safety, efficacy, and traceability.

3. Can regional distributors supply authentic TISSUEBLUE?
Yes, but buyers should verify distributor credentials, supplier certifications, and batch validation data to ensure product authenticity and quality.

4. Are there alternatives to TISSUEBLUE for tissue staining?
Yes. Other tissue stains such as Methylene Blue and Toluidine Blue serve similar purposes, but TISSUEBLUE offers specific staining properties preferred in certain diagnostic protocols.

5. How do I evaluate the quality of TISSUEBLUE from different suppliers?
Request manufacturer certificates of analysis, perform testing on sample batches, review safety data sheets, and consider supplier reputation, regulatory compliance, and support services.

References

[1] MarketWatch. "Global Histology Reagents Market Growth." 2022.
[2] Merck Group. Product Catalog: Sigma-Aldrich Histology Reagents. 2023.
[3] Thermo Fisher Scientific. Histology and Pathology Product Portfolio. 2023.
[4] ISO Standards. Quality Management Systems — Requirements (ISO 9001), and Medical Devices — Quality Management Systems (ISO 13485).
[5] FDA. Regulations for In Vitro Diagnostic Products (21 CFR Part 820).

Informed procurement of TISSUEBLUE hinges on careful supplier evaluation, regulatory compliance, and quality assurance. Engaging with reputable global manufacturers and understanding regional import dynamics will ensure tissue staining protocols achieve reliable, reproducible results critical for diagnostic integrity.

Suppliers and packagers for TISSUEBLUE

TISSUEBLUE

Suppliers for the Pharmaceutical Drug: TISSUEBLUE