Bulk Pharmaceutical API Sources for fluorescein sodium

Bulk Pharmaceutical API Sources for fluorescein sodium

Vendor	Vendor Homepage	Vendor Sku	API Url
TCI (Tokyo Chemical Industry)		F0096
Molport		MolPort-003-929-261
Mcule		MCULE-1559500470
AKos Consulting & Solutions		AKOS024364966
BOC Sciences		518-47-8

Bulk Active Pharmaceutical Ingredient (API) Sources for Fluorescein Sodium

Last updated: August 2, 2025

Introduction

Fluorescein sodium, a synthetic organic compound characterized by its bright green fluorescence under ultraviolet light, is extensively used in ophthalmology, diagnostics, and as a tracer dye in various biomedical applications. Its commercial production hinges on sourcing high-quality bulk active pharmaceutical ingredients (APIs) from reliable suppliers. This article provides a comprehensive overview of the primary bulk API sources for fluorescein sodium, examining manufacturer profiles, geographic distribution, supply chain considerations, and key factors influencing procurement decisions.

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Overview of Fluorescein Sodium as an API

Fluorescein sodium (C20H10Na2O5) is classified as a diagnostic dye, necessitating stringent quality standards compliance, including pharmacopeial specifications outlined in the United States Pharmacopeia (USP) and European Pharmacopoeia (Ph. Eur.). Its synthesis involves chemical processes that require specialized manufacturing facilities, quality control measures, and compliance with Good Manufacturing Practices (GMP). The API's purity, stability, and consistency significantly influence its efficacy and safety, emphasizing the importance of sourcing from reputable manufacturers.

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Leading Suppliers of Fluorescein Sodium API

1. Sigma-Aldrich (Merck Group)

Background: As a global leader in chemical and biochemical manufacturing, Sigma-Aldrich, a part of Merck KGaA, supplies fluorescein sodium API that meets stringent quality standards.

Supply Capabilities: They offer high-purity fluorescein sodium with pharmacopeial compliance, catering mainly to research, diagnostic, and pharmaceutical industries. Their manufacturing facilities are GMP-certified, ensuring consistent quality.

Strengths: Well-established distribution channels, quality assurance protocols, and comprehensive documentation.

Limitations: Pricing might be premium; supply depends on production schedules and global demand fluctuations.

2. Anhui Sun Good Biotechnology Co., Ltd. (China)

Background: A leading Chinese manufacturer specializing in fluorescein derivatives for medical and diagnostic use.

Supply Capabilities: They produce fluorescein sodium API in compliance with Chinese GMP standards, with exports to global markets including North America, Europe, and Asia.

Strengths: Competitive pricing, robust production capacity, and rapid lead times.

Limitations: Variability in regulatory recognition outside China; potential challenges in documentation aligning with international standards.

3. Shanghai Brightbloc Chemical Co., Ltd. (China)

Background: A reputable Chinese chemical manufacturer with a focus on diagnostic dyes and APIs.

Supply Capabilities: They supply fluorescein sodium API with documented compliance to pharmacopeial standards, suitable for pharmaceutical and diagnostic applications.

Strengths: Cost-effective solutions and consistent product quality.

Limitations: Smaller scale compared to international firms; procurement may entail thorough verification processes.

4. BASF SE

Background: Known primarily for specialty chemicals, BASF has manufacturing capabilities for various dyes, including fluorescein derivatives.

Supply Capabilities: Although more focused on chemical intermediates, BASF's expertise extends into pharmaceutical-grade fluorescein sodium through strategic partnerships.

Strengths: Established quality standards and global supply network.

Limitations: Limited direct API sales; often involved through distribution channels.

5. Other Notable Manufacturers

• Tifany Labs (India): Offers fluorescein sodium API with Indian pharmacopeia compliance and export capabilities.
• Zhejiang Focus Medical Co., Ltd. (China): Produces diagnostic dyes and APIs, including fluorescein sodium, complying with international standards.

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Geographical Considerations for API Sourcing

Asia-Pacific

The Asia-Pacific region, led by China and India, dominates the manufacture of fluorescein sodium API, driven by cost advantages and expanding industrial capacities. Suppliers such as Anhui Sun Good Biotechnology and Zhejiang Focus Medical are prominent in this segment. Regulatory differences and verification processes are essential considerations when sourcing from this region.

Europe and North America

Global pharmaceutical companies tend to prefer suppliers like Sigma-Aldrich and BASF, which offer assured quality and comprehensive documentation. These companies adhere strictly to GMP and global regulatory standards, easing the approval process in developed markets.

Emerging Markets

Smaller regional manufacturers are increasingly entering the market, offering cost-effective alternatives. However, buyers must thoroughly evaluate their regulatory compliance, quality assurance, and stability data.

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Supply Chain and Quality Assurance Considerations

Procurement of fluorescein sodium API demands vigilance in the following areas:

• Regulatory Compliance: Ensure suppliers comply with USP, Ph. Eur., or other relevant pharmacopeial standards. Verify certificates of analysis (CoA), batch records, and stability data.
• GMP Certification: Prefer suppliers with active GMP certification, which guarantees adherence to quality standards.
• Documentation and Traceability: Complete documentation, including manufacturing licenses and export certificates, facilitates regulatory review and import processes.
• Price and Lead Time: Balance cost considerations with quality assurances; negotiate lead times that align with manufacturing schedules.
• Supply Stability: Opt for suppliers with robust manufacturing capacity and contingency plans to mitigate shortages.

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Emerging Trends and Future Outlook

The global demand for fluorescein sodium, especially driven by diagnostic and imaging innovations, continues to rise. As regulatory frameworks tighten—particularly concerning pharmaceutical APIs—the emphasis shifts toward sourcing from certified, high-integrity manufacturers. Technological advancements in synthesis and purification methods are enhancing API quality, reducing impurity levels, and enabling safer, more effective formulations.

The trend favors vertically integrated suppliers capable of ensuring quality from synthesis through final packaging, with integrated quality management systems aligned with international standards. Additionally, increased scrutiny on supply chain transparency and traceability prompts buyers to prioritize suppliers with comprehensive compliance and documentation capabilities.

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Key Factors Influencing API Procurement Decisions

• Quality Certifications: GMP, ISO, and other relevant certifications.
• Regulatory Compatibility: Ability to meet regional pharmacopeial standards.
• Pricing and Cost Efficiency: Balancing quality with economic considerations.
• Supply Chain Reliability: Manufacturing capacity and geopolitical stability.
• Technical Support and Documentation: Availability of technical data sheets, stability data, and compliant documentation.

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Key Takeaways

• The primary sources of fluorescein sodium API are concentrated in China, India, and established Western chemical suppliers.
• Buyers should prioritize suppliers with GMP certification, comprehensive documentation, and adherence to pharmacopeial standards.
• Cost remains a significant factor, but must be balanced against quality assurance, supply stability, and regulatory compliance.
• Emerging regional manufacturers, while cost-effective, require thorough vetting to ensure regulatory and quality standards.
• The trend toward enhanced transparency, traceability, and compliance dictates future procurement strategies, emphasizing supplier reliability and regulatory adherence.

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FAQs

1. What are the main factors to consider when sourcing fluorescein sodium API?
Quality certifications (GMP, ISO), compliance with pharmacopeial standards, supply reliability, pricing, and thorough documentation are critical to ensure safety, efficacy, and regulatory approval.

2. Are Chinese manufacturers of fluorescein sodium API reliable?
Many Chinese suppliers meet international standards and possess GMP certifications. Due diligence, including reviews of regulatory compliance, audit reports, and certifications, is essential to verify legitimacy and quality.

3. How does regulatory compliance influence API sourcing decisions?
Regulatory compliance ensures API quality, safety, and consistency, which is vital for obtaining drug approvals and maintaining product efficacy, especially in strict markets like the US and EU.

4. What are the emerging trends in fluorescein sodium API manufacturing?
Advances include improved synthesis and purification technologies, increased focus on traceability, regulatory alignment, and supply chain transparency to meet growing biomedical demand.

5. Can lower-cost suppliers meet international quality standards?
While some regional manufacturers offer competitive prices, thorough validation and audit processes are necessary to confirm compliance with international quality standards before procurement.

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References

[1] United States Pharmacopeia. USP Monograph: Fluorescein Sodium. 2022.
[2] European Pharmacopoeia Commission. Ph. Eur. Monograph: Fluorescein Sodium. 2022.
[3] Sigma-Aldrich. Fluorescein Sodium Info. 2022.
[4] Anhui Sun Good Biotechnology Co., Ltd. Product Catalog. 2022.
[5] Zhejiang Focus Medical Co., Ltd. Product Overview. 2022.