Bulk Pharmaceutical API Sources for CYSTARAN

Bulk Pharmaceutical API Sources for CYSTARAN

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		M6500_SIGMA
TCI (Tokyo Chemical Industry)		A0296
Molport		MolPort-000-145-902
Hangzhou APIChem Technology		AC-301
Oakwood Products		003420
Amadis Chemical		A809757
AKos Consulting & Solutions		AKOS007929948

Bulk Active Pharmaceutical Ingredient (API) Sources for CYSTARAN

Last updated: July 28, 2025

Introduction

CYSTARAN (fluorescein sodium) is a diagnostic agent used predominantly in ophthalmology to visualize the corneal and conjunctival epithelium and assess tear break-up time. Its pharmaceutical application as a diagnostic dye necessitates the use of high-quality active pharmaceutical ingredients (APIs). As the global demand for ophthalmic diagnostics grows, reliable sources of bulk fluoresein sodium are crucial for pharmaceutical developers, distributors, and healthcare providers ensuring product efficacy, safety, and regulatory compliance.

Overview of Fluorescein Sodium as an API

Fluorescein sodium is a synthetic organic compound with a molecular weight of approximately 376.27 g/mol. It belongs to the class of xanthene dyes characterized by high fluorescence when exposed to blue light. The API is synthesized via complex chemical reactions involving chlorinated benzene derivatives and subsequent sulfonation, producing a highly purified compound suitable for pharmaceutical and diagnostic applications.

The purity standards for API manufacturing are strict, typically requiring pharmaceutical grade quality, including specifications for residual solvents, heavy metals, and other impurities as outlined by pharmacopeial standards such as the United States Pharmacopeia (USP) and the European Pharmacopoeia (Ph. Eur.).

Global API Suppliers for Fluorescein Sodium

Several key suppliers operate internationally, providing bulk APIs for pharmaceutical companies and diagnostic manufacturers. Their reputation hinges on product quality, compliance with Good Manufacturing Practices (GMP), supply reliability, and regulatory approvals.

1. TCI Chemicals

Based in Japan, Tokyo Chemical Industry (TCI) offers pharmaceutical-grade fluorescein sodium under rigorous quality standards. TCI's manufacturing facilities adhere to global GMP protocols, ensuring high purity suitable for injectable ophthalmic formulations.

Key Highlights:

• GMP-compliant production
• Full certificate of analysis (COA) with each batch
• Extensive quality certifications for pharmaceutical exports
• Established distribution network globally

Applications: API used in both diagnostic dyes and specialized ophthalmic formulations.

2. Sigma-Aldrich (Merck Group)

Part of Merck KGaA, Sigma-Aldrich is a prominent supplier of various chemical intermediates, including fluorescein sodium. Their products meet the standards for pharmaceutical and diagnostic use, often supplied with detailed specifications and regulatory documentation.

Key Highlights:

• Pharmaceutical grade (USP/EP compliant)
• Available with customizable packaging options
• Well-established logistics for global delivery

Applications: Widely used in diagnostic kits, ophthalmic dyes, and research applications.

3. Thermo Fisher Scientific

Thermo Fisher Scientific supplies fluorescein sodium suitable for pharmaceutical and diagnostic applications. Their API manufacturing processes emphasize high purity and stability, facilitating compliance with regulatory requirements.

Key Highlights:

• Certified GMP manufacturing
• Reliable supply chain management
• Extensive technical support

Applications: Used in diagnostic imaging, ophthalmology, and research settings.

4. Spectrum Chemical Manufacturing Corp

Based in the United States, Spectrum Chemical offers bulk fluorescein sodium with specifications aligned with pharmaceutical standards. Their manufacturing facilities are FDA-registered, ensuring high-quality products for consumer safety.

Key Highlights:

• USP-grade API availability
• Focus on custom synthesis and bulk supply for pharmaceutical manufacturers
• Rapid order fulfillment

Applications: Diagnostic assay development, ophthalmic diagnostic solutions, and research.

5. Beijing SL Pharmaceutical Co., Ltd.

Beijing SL Pharmaceutical is a Chinese API manufacturer specializing in fluorescein sodium with an export track record to North America and Europe. Their production facilities meet ISO quality standards, with a focus on affordable yet high-quality APIs.

Key Highlights:

• Competitive pricing
• Good manufacturing and quality assurance protocols
• Simplified regulatory pathways for certain markets

Applications: Cost-effective API sourcing for diagnostic kit manufacturers and regional pharmaceutical companies.

---

Regulatory and Quality Considerations in API Sourcing

Choosing a reliable API supplier is fundamental to ensuring product safety and regulatory compliance. Manufacturers must verify that APIs meet standards such as USP, EP, or Ph Eur specifications. Certification for GMP compliance and batch validation reports are essential documentation during procurement.

Furthermore, suppliers should provide detailed Certificates of Analysis (COA), stability data, and impurity profiles to meet regulatory audits. The sourcing strategy should also consider geopolitical stability, logistics, lead times, and the supplier’s track record for consistent quality.

Emerging Trends and Market Dynamics

The increasing use of fluorescein-based diagnostic agents in ophthalmic procedures has expanded the market. Governments and regulatory bodies are emphasizing stringent quality controls, prompting manufacturers to prefer suppliers with validated GMP processes.

In addition, advancements in nanotechnology and targeted delivery systems are anticipated to influence future API formulations, although traditional fluorescein sodium remains prevalent due to its well-established safety profile.

The COVID-19 pandemic also impacted supply chains, emphasizing the importance of diversified sourcing strategies and multiple supplier relationships to mitigate risks of shortages.

Conclusion

The procurement of bulk fluorescein sodium API is vital for manufacturers of ophthalmic diagnostic agents, including CYSTARAN. Leading suppliers such as TCI, Sigma-Aldrich, Thermo Fisher Scientific, Spectrum Chemical, and Beijing SL Pharmaceutical provide high-quality, GMP-compliant APIs suited for global regulatory markets. Strategic sourcing, emphasizing quality assurance and regulatory compliance, ensures the consistent supply of APIs vital for maintaining product efficacy and patient safety.

---

Key Takeaways

• Reliable API sourcing for fluorescein sodium involves evaluating supplier GMP compliance, product purity, and regulatory adherence.
• Leading suppliers include TCI, Sigma-Aldrich, Thermo Fisher Scientific, Spectrum Chemical, and Beijing SL Pharmaceutical, each offering different pricing models and supply capabilities.
• Strict documentation, including Certificates of Analysis and GMP certifications, is essential to meet regulatory standards globally.
• Diversification of suppliers mitigates supply chain disruptions, a critical consideration amid geopolitical and COVID-19-related challenges.
• Emerging trends focus on enhanced formulations and improved purity standards, underpinning the importance of ongoing quality assurance.

---

Frequently Asked Questions (FAQs)

1. What are the primary quality standards for fluorescein sodium API?
   The API must meet pharmacopeial standards such as USP or European Pharmacopoeia, emphasizing high purity, consistent potency, and minimal impurities.

2. How do I verify the regulatory compliance of a fluorscetin sodium API supplier?
   Suppliers should provide GMP certificates, Certificates of Analysis, and compliance documentation aligning with regional regulatory requirements like FDA or EMA standards.

3. Are there regional differences in sourcing fluorescein sodium API?
   Yes, suppliers from North America, Europe, and Asia target different markets, with some emphasizing cost-effectiveness and others prioritizing stringent regulatory adherence.

4. What factors influence the choice of a fluorescein sodium API supplier?
   Key factors include product quality, regulatory certification, supply reliability, pricing, and logistical support.

5. Can synthetic variations impact the safety profile of fluorescein sodium?
   Variations in synthesis or impurity profiles can affect safety; thus, selecting suppliers with rigorous quality controls is critical for maintaining a safe product profile.

---

References

[1] “Fluorescein Sodium,” United States Pharmacopeia (USP), 2022.
[2] “Guidelines for API manufacturing,” World Health Organization (WHO), 2021.
[3] “Global API Market Overview,” MarketsandMarkets, 2022.
[4] “Regulatory Standards for Ophthalmic APIs,” EMA, 2022.
[5] “API Supplier Directory,” CPhI Discover, 2023.