Suppliers and packagers for generic pharmaceutical drug: FLUORESCEIN SODIUM

FLUORESCEIN SODIUM

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Long Grove Pharms	AK-FLUOR 10%	fluorescein sodium	INJECTABLE;INTRAVENOUS	022186	NDA	HF Acquisition Co LLC, DBA HealthFirst	51662-1533-3	12 POUCH in 1 BOX (51662-1533-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1533-2) / 5 mL in 1 VIAL, SINGLE-DOSE	2021-05-10
Long Grove Pharms	AK-FLUOR 10%	fluorescein sodium	INJECTABLE;INTRAVENOUS	022186	NDA	Long Grove Pharmaceuticals, LLC	81298-8660-3	12 VIAL, GLASS in 1 CARTON (81298-8660-3) / 5 mL in 1 VIAL, GLASS (81298-8660-1)	2024-09-28
Long Grove Pharms	AK-FLUOR 25%	fluorescein sodium	INJECTABLE;INTRAVENOUS	022186	NDA	HF Acquisition Co LLC, DBA HealthFirst	51662-1533-3	12 POUCH in 1 BOX (51662-1533-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1533-2) / 5 mL in 1 VIAL, SINGLE-DOSE	2021-05-10
Long Grove Pharms	AK-FLUOR 25%	fluorescein sodium	INJECTABLE;INTRAVENOUS	022186	NDA	Long Grove Pharmaceuticals, LLC	81298-8660-3	12 VIAL, GLASS in 1 CARTON (81298-8660-3) / 5 mL in 1 VIAL, GLASS (81298-8660-1)	2024-09-28
Nexus	FLUORESCEIN SODIUM	fluorescein sodium	INJECTABLE;INTRAVENOUS	215709	ANDA	Nexus Pharmaceuticals LLC	14789-122-05	10 VIAL in 1 CARTON (14789-122-05) / 5 mL in 1 VIAL (14789-122-07)	2023-10-24
Nexus	FLUORESCEIN SODIUM	fluorescein sodium	INJECTABLE;INTRAVENOUS	215709	ANDA	Nexus Pharmaceuticals LLC	14789-123-05	10 VIAL in 1 CARTON (14789-123-05) / 2 mL in 1 VIAL (14789-123-07)	2023-10-24
Alcon Labs Inc	FLUORESCITE	fluorescein sodium	INJECTABLE;INTRAVENOUS	021980	NDA	Alcon, Inc.	0065-0092-65	12 VIAL in 1 CARTON (0065-0092-65) / 5 mL in 1 VIAL	1972-09-15

Fluorescein Sodium Pharmaceutical Suppliers

Last updated: February 19, 2026

Fluorescein sodium is a key component in diagnostic imaging and ophthalmic solutions. The supplier landscape for this pharmaceutical ingredient is concentrated, with a limited number of manufacturers holding significant market share. Key considerations for procurement include purity standards, regulatory compliance, and consistent supply chain reliability.

What Are the Primary Applications of Fluorescein Sodium?

Fluorescein sodium, a water-soluble fluorescein dye, is primarily utilized for its fluorescent properties in medical diagnostics and treatments.

• Ophthalmic Diagnosis: It is a standard diagnostic agent in ophthalmology. When applied to the eye, it stains the tear film, allowing for the detection of corneal abrasions, ulcers, and contact lens fitting irregularities. The dye adheres to exposed stromal tissue, highlighting areas of damage under examination with a slit lamp or cobalt blue light.
• Vascular Imaging: In angiography, fluorescein sodium is injected intravenously. Its fluorescence allows for visualization of blood flow through retinal and choroidal vasculature. This is critical for diagnosing and monitoring conditions such as diabetic retinopathy, macular degeneration, and retinal vascular occlusions.
• Urological Procedures: It can be used to assess renal function, with the rate of excretion indicating kidney perfusion and filtration capacity.
• Surgical Delineation: In some surgical procedures, particularly neurosurgery, fluorescein sodium can aid in identifying tumor margins or differentiating tissues.

Who Are the Leading Manufacturers and Suppliers of Fluorescein Sodium?

The global supply of pharmaceutical-grade fluorescein sodium is dominated by a select group of manufacturers, primarily located in Asia and Europe. These entities specialize in producing the active pharmaceutical ingredient (API) to meet stringent regulatory requirements for use in human therapeutics.

Key Manufacturers and Suppliers:

• Akorn, Inc. (USA): While a major player in finished dosage forms, Akorn also sources and manufactures components, including fluorescein sodium for its ophthalmic solutions. Their regulatory compliance is a significant factor for their market presence.
• Bausch Health Companies Inc. (Canada): Similar to Akorn, Bausch Health is a significant producer of finished ophthalmic products containing fluorescein sodium. They maintain robust quality control and supply chain management for their raw materials.
• ChromaVIS (Germany): ChromaVIS focuses on high-purity dyes and specialty chemicals, including fluorescein sodium for pharmaceutical applications. Their emphasis is on meeting European Pharmacopoeia (EP) and United States Pharmacopeia (USP) standards.
• Dishman Carbogen Amcis Ltd. (India): A Contract Development and Manufacturing Organization (CDMO) with a strong API portfolio. They produce fluorescein sodium, adhering to cGMP (current Good Manufacturing Practices) guidelines for export to regulated markets.
• Faurecia (France): While primarily known for automotive components, certain diversified chemical divisions or acquisitions may lead to involvement in specialty chemical supply, though this is a less direct association with core pharmaceutical API manufacturing for fluorescein sodium. (Note: This is a less common direct supplier and may represent historical or indirect involvement).
• Sartorius Stedim Biotech (Germany): Primarily a supplier of equipment and consumables for biopharmaceutical manufacturing, Sartorius may offer high-purity reagents or intermediates related to dye synthesis, though not typically the bulk API itself.
• Akorn Pharmaceutical Ingredients (API Division): This division, or its associated entities, directly manufactures and supplies pharmaceutical raw materials, including fluorescein sodium, to other drug manufacturers.

This list represents companies with direct or significant indirect involvement in the supply chain. Specific market share data is proprietary, but these companies are recognized for their production capacity and regulatory adherence in the pharmaceutical API sector.

What Are the Regulatory Requirements for Fluorescein Sodium?

The production and distribution of fluorescein sodium for pharmaceutical use are governed by strict regulatory frameworks to ensure patient safety and product efficacy. Key regulatory bodies and their requirements include:

• United States Pharmacopeia (USP): Fluorescein sodium intended for use in the U.S. must meet USP monograph specifications. These specifications define acceptable limits for purity, identification, assay, impurities (including heavy metals and related substances), and physical characteristics such as solubility and pH. Compliance is verified through USP certification or by manufacturers demonstrating adherence to USP standards.
• European Pharmacopoeia (EP): For markets in Europe, fluorescein sodium must comply with the EP monograph. Similar to USP, EP sets standards for identification, purity, assay, and impurity profiles, with specific tests and acceptance criteria.
• Food and Drug Administration (FDA): Manufacturers supplying fluorescein sodium to the U.S. market must adhere to FDA regulations, including cGMP (21 CFR Part 210 & 211). This involves rigorous quality management systems, process validation, documentation, and facility inspections. Drug Master Files (DMFs) are often submitted to the FDA by API manufacturers to provide detailed information about the manufacturing process, quality control, and stability of the substance.
• European Medicines Agency (EMA): In Europe, manufacturers must comply with EMA guidelines and the requirements of individual member states' regulatory authorities. Compliance with the European Union's GMP standards is mandatory.
• Good Manufacturing Practices (GMP): Adherence to cGMP is paramount for all pharmaceutical API manufacturers. This encompasses quality control throughout the manufacturing process, from raw material sourcing to final product release, ensuring consistency, purity, and safety. GMP audits are conducted by regulatory agencies and by customers.
• International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH): ICH guidelines, such as ICH Q7 (Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients), provide a globally recognized standard for API manufacturing and quality management.

Suppliers must provide Certificates of Analysis (CoAs) with each batch, detailing the results of quality control testing against specified pharmacopoeial standards and internal specifications. Audits by potential customers are also a standard part of the qualification process.

How Does Purity and Impurity Profiling Impact Fluorescein Sodium Procurement?

Purity and a well-defined impurity profile are critical for fluorescein sodium used in pharmaceutical applications due to its direct administration to patients. Deviations can lead to adverse events, reduced efficacy, and regulatory non-compliance.

Key Purity and Impurity Considerations:

• Assay Value: Pharmaceutical-grade fluorescein sodium typically requires an assay of 90.0% to 102.0% on the dried basis, as per USP standards, indicating the concentration of the active compound.
• Related Substances: Impurities that are structurally similar to fluorescein sodium can arise from synthesis byproducts or degradation. These can include residual starting materials, intermediates, or isomers. Pharmacopoeial monographs set limits for specific named impurities and total impurities. For example, USP limits for specific impurities like fluorescein (the free acid) and other organic impurities are crucial.
• Heavy Metals: Contamination with heavy metals (e.g., lead, mercury, arsenic) is unacceptable in pharmaceuticals. Strict limits are enforced, often in the parts per million (ppm) range, verified through tests like Inductively Coupled Plasma Mass Spectrometry (ICP-MS).
• Residual Solvents: Solvents used in the manufacturing process must be controlled and minimized. ICH Q3C guidelines classify residual solvents based on their toxicity and set permissible daily exposure limits. Suppliers must demonstrate control over these.
• Microbial Limits: For sterile preparations or applications where microbial contamination is a risk, tests for total viable aerobic count, yeast and mold count, and the absence of specific objectionable microorganisms are required.
• Endotoxins: For parenteral (injectable) formulations, control of bacterial endotoxins is critical, typically measured by the Limulus Amebocyte Lysate (LAL) test.

Impact on Procurement:

• Supplier Qualification: Procurement teams must rigorously vet suppliers to ensure they have robust analytical capabilities for impurity profiling and can consistently meet or exceed pharmacopoeial and regulatory limits. This often involves on-site audits of manufacturing facilities and quality control laboratories.
• Cost Implications: Higher purity and more stringent impurity control typically translate to higher manufacturing costs, which are reflected in the price of the API. Suppliers with superior purification technologies and quality systems command a premium.
• Risk Management: Sourcing from suppliers with a proven track record in impurity control and regulatory compliance significantly reduces the risk of batch rejection, product recalls, and supply chain disruptions due to quality issues.
• Product Performance: The presence of specific impurities, even within pharmacopoeial limits, can sometimes affect the performance or stability of the final drug product. Therefore, understanding the impurity profile beyond the monograph is often beneficial.

What Are the Supply Chain Considerations for Fluorescein Sodium?

The supply chain for fluorescein sodium involves several critical considerations to ensure uninterrupted access to this essential pharmaceutical ingredient. These factors influence sourcing decisions, inventory management, and risk mitigation strategies.

Key Supply Chain Factors:

• Geographic Concentration: As noted, a significant portion of fluorescein sodium API production is concentrated in specific regions, particularly Asia (India) and Europe. This geographic concentration can create vulnerabilities to geopolitical events, natural disasters, or regional regulatory changes.
• Lead Times: Manufacturing of specialty APIs like fluorescein sodium can involve multi-step synthesis. Lead times from order placement to delivery can range from several weeks to months, depending on the supplier's production schedule, batch size, and existing inventory.
• Minimum Order Quantities (MOQs): API manufacturers often have MOQs to ensure efficient production runs. These can impact smaller pharmaceutical companies or those with fluctuating demand.
• Regulatory Compliance of Suppliers: Beyond the API itself, the manufacturing site must be compliant with cGMP. Suppliers must maintain up-to-date registrations with regulatory bodies (e.g., FDA, EMA) and be open to customer audits. Any changes in the supplier's regulatory status can immediately disrupt supply.
• Logistics and Transportation: The safe and compliant transportation of pharmaceutical raw materials is essential. This includes temperature control if required, proper packaging, and adherence to international shipping regulations for chemical substances.
• Dual Sourcing Strategy: To mitigate supply chain risks, pharmaceutical companies often pursue a dual sourcing strategy, qualifying at least two independent suppliers for critical APIs. This provides a backup in case of quality issues, production problems, or geopolitical disruptions at a primary supplier.
• Inventory Management: Maintaining adequate safety stock is crucial, balanced against the costs of holding inventory and the API's shelf life. Just-in-time delivery can be risky for specialty chemicals with long lead times.
• Intellectual Property and Technology: While fluorescein sodium itself is a well-established compound, proprietary manufacturing processes or purification techniques can differentiate suppliers and influence supply chain resilience.

What Are the Market Trends and Future Outlook for Fluorescein Sodium?

The market for fluorescein sodium is stable, driven by its established role in diagnostics. Growth is largely tied to the global prevalence of ophthalmic conditions and the increasing adoption of diagnostic imaging techniques.

Market Trends:

• Aging Global Population: The increasing average age of populations worldwide leads to a higher incidence of age-related eye diseases such as macular degeneration and glaucoma, which require diagnostic tools like fluorescein angiography.
• Rise in Diabetic Retinopathy: The global increase in diabetes cases directly correlates with a higher risk of diabetic retinopathy, a condition routinely monitored using fluorescein sodium.
• Technological Advancements in Imaging: While fluorescein sodium remains a standard, advancements in optical coherence tomography (OCT) and other imaging modalities offer complementary diagnostic capabilities. However, fluorescein angiography retains its role for specific indications and vascular flow assessment.
• Focus on High-Purity and cGMP Manufacturing: Increasing regulatory scrutiny and patient safety concerns continue to drive demand for fluorescein sodium produced under strict cGMP conditions from reputable suppliers. Manufacturers not meeting these standards face market exclusion.
• Consolidation in Finished Dosage Forms: The market for finished fluorescein sodium products (e.g., ophthalmic solutions) has seen some consolidation among larger pharmaceutical companies. This can influence API purchasing volumes and supplier relationships.
• Cost Pressures: While quality is paramount, ongoing pressure to manage healthcare costs influences purchasing decisions for APIs. Suppliers offering competitive pricing while maintaining quality standards are favored.

Future Outlook:

The demand for fluorescein sodium is expected to remain consistent, with moderate growth projections. The compound's established efficacy, cost-effectiveness compared to some newer diagnostic methods for specific applications, and broad regulatory acceptance ensure its continued utility. Innovation in this segment is likely to focus on:

• Enhanced Purity and Novel Formulations: Suppliers may explore even higher purity grades or advanced formulations of fluorescein sodium for specialized applications or improved patient tolerance.
• Supply Chain Resilience: Increased emphasis on supply chain security and transparency will likely lead to greater scrutiny of supplier geographical locations and risk mitigation strategies.
• Sustainable Manufacturing Practices: As with all chemical manufacturing, there will be a growing expectation for suppliers to adopt environmentally responsible production methods.

Key Takeaways

• Fluorescein sodium is a critical diagnostic agent in ophthalmology and vascular imaging, with demand driven by an aging global population and the rising incidence of chronic diseases like diabetes.
• The API supply chain is concentrated among a limited number of cGMP-compliant manufacturers, primarily in Asia and Europe, necessitating careful supplier qualification and risk management.
• Adherence to USP, EP, and FDA/EMA regulatory standards, including stringent impurity profiling and cGMP manufacturing, is non-negotiable for pharmaceutical-grade fluorescein sodium.
• Procurement decisions must balance purity requirements, regulatory compliance, supply chain reliability, and cost-effectiveness, with dual sourcing being a key risk mitigation strategy.
• The market is expected to exhibit stable demand with moderate growth, influenced by demographic trends and continued reliance on established diagnostic methodologies.

Frequently Asked Questions

1. What is the typical shelf life of fluorescein sodium API? The shelf life of fluorescein sodium API is typically two to three years when stored under appropriate conditions (e.g., protected from light and moisture). Specific stability data is provided by the manufacturer.
2. Are there alternative dyes that can replace fluorescein sodium in ophthalmic diagnostics? For certain applications, other dyes like rose bengal or lissamine green are used for staining ocular surfaces, but fluorescein sodium remains the standard for detecting epithelial defects and assessing tear film breakup time due to its distinct fluorescence properties.
3. What is the primary difference between fluorescein sodium and fluorescein? Fluorescein sodium is the water-soluble salt form of fluorescein, making it suitable for intravenous injection and ophthalmic solutions. Fluorescein itself is less soluble in water and is typically used in research or non-parenteral applications.
4. How do cGMP requirements affect the cost of fluorescein sodium? Implementing and maintaining cGMP compliance involves significant investment in quality control systems, validated processes, rigorous documentation, and skilled personnel. These costs are passed on to the customer, making cGMP-compliant fluorescein sodium more expensive than non-pharmaceutical grades.
5. What is a Drug Master File (DMF) and why is it important for fluorescein sodium suppliers? A DMF is a submission to regulatory authorities (like the FDA) containing confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drugs. For fluorescein sodium suppliers, a DMF allows them to provide detailed manufacturing information to regulators without disclosing proprietary data directly to their customers, streamlining the customer's drug application process.

Citations

[1] United States Pharmacopeia. (n.d.). Fluorescein Sodium Monograph. USP-NF Online. [2] European Directorate for the Quality of Medicines & HealthCare. (n.d.). Fluorescein Sodium Monograph. EDQM. [3] U.S. Food & Drug Administration. (n.d.). Current Good Manufacturing Practice (CGMP) Regulations. FDA.gov. [4] European Medicines Agency. (n.d.). Good Manufacturing Practice (GMP). EMA.europa.eu. [5] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (1999). ICH Harmonised Tripartite Guideline: Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients. ICH. [6] Akorn, Inc. (n.d.). Company Information. Akorn.com. [7] Bausch Health Companies Inc. (n.d.). Company Information. BauschHealth.com. [8] ChromaVIS. (n.d.). Product Portfolio. ChromaVIS.de. [9] Dishman Carbogen Amcis Ltd. (n.d.). API Manufacturing Capabilities. Carbogen-Amcis.com.