INDIGOTINDISULFONATE SODIUM: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Provepharm Sas	BLUDIGO	indigotindisulfonate sodium	SOLUTION;INTRAVENOUS	216264	NDA	Provepharm Inc.	81284-315-05	5 AMPULE in 1 CARTON (81284-315-05) / 5 mL in 1 AMPULE (81284-315-00)	2022-09-06
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: February 19, 2026

This report identifies key global suppliers of indigotindisulfonate sodium, a pharmaceutical ingredient. The analysis focuses on production capacity, regulatory compliance, and supply chain resilience to inform strategic sourcing decisions for drug manufacturers.

What is Indigotindisulfonate Sodium?

Indigotindisulfonate sodium, also known as sodium indigotindisulfonate or indigo carmine, is a synthetic blue dye used in various medical applications. Its primary use is as a diagnostic agent. It functions as a tracer dye for surgical procedures, particularly in urology and plastic surgery, to visualize and assess urinary tract patency or identify lymphatic vessels. It is also used as a coloring agent in some pharmaceutical preparations.

The chemical structure of indigotindisulfonate sodium is derived from indigo. It is the disulfonated derivative, which enhances its water solubility and makes it suitable for parenteral administration.

Chemical Properties and Specifications

Chemical Name: Indigotindisulfonate sodium
CAS Number: 860-22-0
Molecular Formula: C₁₆H₈N₂Na₂O₈S₂
Molecular Weight: 454.35 g/mol
Appearance: Dark blue to violet crystalline powder
Solubility: Freely soluble in water, practically insoluble in ethanol and ether.
Purity: Pharmaceutical grade typically requires purity levels exceeding 95%, with specific limits on impurities such as heavy metals, arsenic, and related sulfonated indigo derivatives.
Regulatory Status: Approved by regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for specific medical uses.

Global Supply Landscape

The production of pharmaceutical-grade indigotindisulfonate sodium is concentrated among a limited number of manufacturers, primarily in Asia and Europe. These suppliers must adhere to stringent Good Manufacturing Practices (GMP) to meet pharmaceutical quality standards.

Key Manufacturing Regions and Companies

The following companies and regions are identified as significant players in the supply of indigotindisulfonate sodium:

China: This region is a major hub for active pharmaceutical ingredient (API) and intermediate manufacturing. Several Chinese chemical companies produce indigotindisulfonate sodium, often exporting globally.
- Key Companies: Focus on companies with established GMP certifications and a history of API export. Specific company names can vary due to market dynamics and contract manufacturing arrangements. Due diligence on individual suppliers is critical.
India: Similar to China, India possesses a robust chemical and pharmaceutical manufacturing sector. Indian suppliers are active in the global API market.
- Key Companies: Companies specializing in dyes and pharmaceutical intermediates are likely candidates. Again, GMP compliance and regulatory filings are paramount.
Europe: European manufacturers often focus on high-purity, specialized pharmaceutical ingredients. Production costs may be higher, but regulatory compliance and quality assurance are typically very strong.
- Key Companies: Look for companies with a long history in fine chemical synthesis and pharmaceutical excipients.

Production Capacity and Scale

Specific production capacities for indigotindisulfonate sodium are often proprietary. However, the market is characterized by:

Batch Production: Indigotindisulfonate sodium is generally produced in batch processes, allowing for flexibility but requiring careful quality control at each stage.
Intermediate Synthesis: Manufacturers may specialize in the synthesis of indigo derivatives or the final sulfonation and salt formation steps.
Scalability: Larger manufacturers are capable of scaling production to meet significant commercial demand, while smaller specialized firms may focus on niche or research quantities.

Regulatory Compliance and Quality Assurance

Suppliers of indigotindisulfonate sodium for pharmaceutical use must demonstrate rigorous adherence to international regulatory standards.

Good Manufacturing Practices (GMP)

Requirement: Pharmaceutical-grade indigotindisulfonate sodium production facilities must operate under cGMP (current Good Manufacturing Practices). This includes controls over personnel, facilities, equipment, raw materials, production processes, laboratory testing, packaging, and labeling.
Audits: Pharmaceutical companies typically conduct supplier audits to verify GMP compliance and assess the supplier's quality management system.
Certifications: Suppliers may hold certifications from regulatory bodies or third-party auditors.

Drug Master Files (DMFs) and Regulatory Submissions

DMFs: Suppliers often file Drug Master Files (DMFs) with regulatory agencies like the U.S. FDA. A DMF contains confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drugs. This allows regulatory agencies to review proprietary information without disclosing it to the drug manufacturer.
CEP (Certificate of Suitability to the monographs of the European Pharmacopoeia): For the European market, a CEP is often sought by suppliers to demonstrate compliance with European Pharmacopoeia (Ph. Eur.) standards.
Inspections: Regulatory agencies conduct facility inspections to ensure ongoing compliance with GMP and the information provided in regulatory filings.

Quality Control and Testing

Suppliers must implement comprehensive quality control procedures, including:

Raw Material Testing: Verification of incoming raw materials against established specifications.
In-Process Controls: Monitoring of critical process parameters during manufacturing.
Finished Product Testing: Analysis of the final indigotindisulfonate sodium for identity, purity, assay, and absence of impurities.
Stability Testing: Data demonstrating the shelf-life of the product under defined storage conditions.

Supply Chain Considerations

Ensuring a reliable and consistent supply of indigotindisulfonate sodium requires careful consideration of supply chain dynamics.

Raw Material Sourcing

The synthesis of indigotindisulfonate sodium relies on precursor chemicals. Key considerations include:

Availability of Intermediates: The availability and cost of key starting materials for indigo synthesis and subsequent sulfonation are critical.
Supplier Concentration: If key intermediates are sourced from a limited number of suppliers, this can create supply chain vulnerabilities.
Geopolitical Risks: Geopolitical instability or trade restrictions in regions where raw materials are sourced can impact availability.

Logistics and Transportation

Shipping Conditions: Indigotindisulfonate sodium is a chemical compound that may require specific shipping conditions (e.g., temperature control, appropriate packaging) to maintain its integrity during transit.
Import/Export Regulations: Navigating international trade regulations, customs procedures, and tariffs is essential for global sourcing.
Lead Times: Understanding supplier lead times for order fulfillment and delivery is crucial for inventory management.

Risk Mitigation Strategies

Dual Sourcing: Engaging with multiple qualified suppliers can mitigate the risk of single-source dependency.
Supplier Audits: Regular and thorough supplier audits help identify potential quality or compliance issues before they impact production.
Inventory Management: Maintaining adequate safety stock levels can buffer against unexpected supply disruptions.
Contractual Agreements: Robust supply agreements that clearly define quality standards, delivery schedules, and responsibilities are vital.

Market Trends and Future Outlook

The demand for indigotindisulfonate sodium is largely driven by its established medical applications.

Demand Drivers

Surgical Procedures: Growth in minimally invasive surgery and diagnostic imaging contributes to the demand for tracer dyes.
Pharmaceutical Formulations: Use as a coloring agent in specific drug products, though this is a smaller segment.
Research and Development: Continued research into new diagnostic or therapeutic applications could spur future demand.

Challenges

Competition from Alternatives: While indigotindisulfonate sodium has specific uses, ongoing development of alternative diagnostic agents could present competition.
Regulatory Scrutiny: Pharmaceutical ingredients are subject to continuous regulatory oversight, requiring suppliers to maintain high compliance standards.
Price Volatility: Fluctuations in raw material costs and global supply/demand dynamics can affect pricing.

Key Takeaways

The global supply of pharmaceutical-grade indigotindisulfonate sodium is concentrated among manufacturers in China, India, and Europe.
Strict adherence to GMP and robust quality management systems are non-negotiable for suppliers.
Regulatory filings such as DMFs and CEPs are critical indicators of supplier readiness for pharmaceutical markets.
Supply chain resilience can be enhanced through dual sourcing, regular audits, and strategic inventory management.
Demand is primarily linked to surgical diagnostic applications, with potential for future growth through R&D.

Frequently Asked Questions

What are the primary regulatory requirements for indigotindisulfonate sodium suppliers?

Suppliers must comply with current Good Manufacturing Practices (cGMP) as defined by regulatory bodies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). This includes comprehensive quality control, validated manufacturing processes, and detailed documentation.

How can drug manufacturers assess the quality and reliability of indigotindisulfonate sodium suppliers?

Assessment involves conducting thorough supplier audits to evaluate their GMP compliance, quality management systems, and regulatory history. Reviewing Drug Master Files (DMFs) or Certificates of Suitability (CEPs) and checking for regulatory inspection records are also critical steps.

What are the potential risks associated with sourcing indigotindisulfonate sodium from a single supplier?

Single-source reliance exposes manufacturers to significant risks, including production disruptions due to the supplier's internal issues, quality control failures, raw material shortages, or geopolitical events. This can lead to drug shortages and production delays.

Does indigotindisulfonate sodium have any alternative uses beyond pharmaceutical diagnostics?

While its primary pharmaceutical application is as a diagnostic tracer dye and coloring agent, indigotindisulfonate sodium (indigo carmine) has historically been used as a food coloring (E132) in some regions, though its use in food has become more restricted or phased out in many markets due to regulatory changes and the availability of alternatives.

What factors influence the pricing of pharmaceutical-grade indigotindisulfonate sodium?

Pricing is influenced by raw material costs, manufacturing complexity, the supplier's regulatory compliance status, production scale, global demand, and competitive landscape. Suppliers with established GMP certifications and a proven track record often command higher prices due to the assurance of quality and reliability they provide.

Citations

[1] European Medicines Agency. (n.d.). Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP). Retrieved from [relevant EMA webpage] (Note: Specific URL would be provided if publicly accessible and static).

[2] U.S. Food & Drug Administration. (n.d.). Drug Master Files (DMFs). Retrieved from [relevant FDA webpage] (Note: Specific URL would be provided if publicly accessible and static).

[3] United States Pharmacopeia. (n.d.). Indigo Carmine Monograph. (Note: Access to USP monographs typically requires subscription).

[4] European Pharmacopoeia. (n.d.). Indigo Carmine Monograph. (Note: Access to Ph. Eur. monographs typically requires subscription).

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