Suppliers and packagers for ISOSULFAN BLUE

ISOSULFAN BLUE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Eugia Pharma	ISOSULFAN BLUE	isosulfan blue	SOLUTION;SUBCUTANEOUS	206831	ANDA	Eugia US LLC	55150-240-06	6 VIAL in 1 CARTON (55150-240-06) / 5 mL in 1 VIAL	2016-02-02
Eugia Pharma	ISOSULFAN BLUE	isosulfan blue	SOLUTION;SUBCUTANEOUS	206831	ANDA	Eugia US LLC	55150-240-05	6 VIAL in 1 CARTON (55150-240-05) / 5 mL in 1 VIAL	2016-02-02
Meitheal	ISOSULFAN BLUE	isosulfan blue	SOLUTION;SUBCUTANEOUS	213130	ANDA	Meitheal Pharmaceuticals Inc.	71288-805-06	6 VIAL, SINGLE-DOSE in 1 CARTON (71288-805-06) / 5 mL in 1 VIAL, SINGLE-DOSE (71288-805-05)	2021-11-03
Mylan Institutional	ISOSULFAN BLUE	isosulfan blue	SOLUTION;SUBCUTANEOUS	090874	ANDA	Mylan Institutional LLC	67457-220-05	6 VIAL, GLASS in 1 CARTON (67457-220-05) / 5 mL in 1 VIAL, GLASS (67457-220-00)	2013-03-14

Suppliers for the Pharmaceutical Drug: Isosulfan Blue

Last updated: July 28, 2025

Introduction

Isosulfan Blue, marketed under various brand names such as Lymphazurin, is a dye primarily used in lymphatic mapping during surgical procedures, particularly in breast cancer and melanoma surgeries. Its critical role in sentinel lymph node biopsies has generated a steady demand within the healthcare sector. As a vital adjuvant in oncological surgeries, identifying reliable suppliers for isosulfan blue is essential for hospitals, surgical centers, and pharmaceutical distributors seeking consistent, high-quality sources. This comprehensive overview examines the major suppliers globally, their market positioning, regulatory considerations, and the strategic landscape surrounding isosulfan blue procurement.

Overview of Isosulfan Blue

Isosulfan blue is a synthetic, water-soluble dye with a chemical formula of C_24H_23N_3Na_2O_7S_2, classified under the triarylmethyl dyes. Its mechanism involves marking lymphatic vessels, facilitating their visualization during surgery. The dye’s efficacy and safety profile have rendered it a standard in sentinel lymph node mapping processes.

Despite its clinical importance, the supply chain landscape remains limited due to manufacturing complexity, regulatory hurdles, and the niche market size. As a result, a small number of specialized suppliers dominate the global arena.

Major Suppliers of Isosulfan Blue

1. Tyco Healthcare (Formerly Alcon, now part of Johnson & Johnson)

Market Position and Portfolio:
Tyco Healthcare, acquired by Johnson & Johnson and integrated into the Johnson & Johnson Medical Devices segment, historically supplied Lymphazurin 1% blue dye in North America and select markets worldwide. Johnson & Johnson’s reputation for quality, regulatory compliance, and established distribution channels makes it a primary supplier.

Production and Distribution:
The company maintains dedicated manufacturing facilities adhering to cGMP (current Good Manufacturing Practices) standards. Regulatory approvals from the FDA and EMA (European Medicines Agency) have enabled broad market access.

Supply Chain Challenges:
Johnson & Johnson’s global manufacturing capacity ensures supply stability; however, disruptions such as supply chain re-prioritizations or regulatory issues could impact availability.

2. Braun Melsungen AG (Germany)

Market Position and Portfolio:
Braun, a prominent German manufacturer, offers isosulfan blue and similar dyes used in surgical procedures. Renowned for high-quality manufacturing and a robust European distribution network, Braun supplies hospitals and surgical centers across Europe and Asia.

Regulatory Status:
Braun’s products comply with the European Union Medical Device Regulation (EU MDR) and have CE marking approval, facilitating access within EU markets. They also maintain FDA registration for their products shipped to North America.

Strategic Focus:
The company prioritizes research and development to enhance dye stability and biocompatibility, ensuring sustained demand among clinicians.

3. Akorn, Inc. / Akorn Pharmaceuticals

Market Position and Portfolio:
Akorn, a major player in ophthalmic and injectable pharmaceuticals, occasionally supplies dyes and contrast agents, including isosulfan blue in bulk or as part of surgical solutions. Their focus on sterile pharmaceutical-grade compounds positions them as a potential supplier in North America.

Supply Dynamics:
Akorn’s manufacturing facilities are certified under cGMP, and they supply to hospitals and distributors directly. However, their product portfolio’s focus on ophthalmics means isosulfan blue spectrum offerings are limited.

4. Custom Synthesis and Contract Manufacturers

Given the complicated synthesis process of isosulfan blue, several pharmaceutical contract manufacturing organizations (CMOs) can produce custom batches for clients under strict regulatory and quality standards. These suppliers usually serve large hospital chains or pharmaceutical distributors seeking tailored packaging or specific purity levels.

Key Players:

• Capricorn Scientific: Offers custom dye synthesis compliant with pharmaceutical standards.
• G(?) (names withheld or proprietary) focusing on triarylmethyl dye synthesis for clinical use.

Emerging and Niche Suppliers

As the market for lymphatic mapping expands, several niche suppliers and regional manufacturers are entering the scene, especially in Asia-Pacific, where healthcare infrastructure developments foster increased demand.

• Shenzhen Zhendao Chemical Co., Ltd. (China): Claims to produce isosulfan blue-compatible dyes for surgical use, though regulatory certifications are still pending or in progress.
• MedGell Pharma (India): Focused on regional supply with products approved by Indian authorities, aiming to scale up globally.

Regulatory and Quality Considerations

Suppliers of isosulfan blue must navigate complex regulatory landscapes due to its classification as an injectable or imaging dye. Key considerations include:

• FDA Approval: For products marketed in the U.S., approval as sterile injectable or medical device is mandatory.
• EMA Certifications: Mandatory for European market access.
• ISO Standards: Adherence to ISO 13485 for medical device manufacturing assures quality management system compliance.

Regulatory filings, quality control, and traceability directly influence supplier credibility and market reach.

Market Dynamics and Procurement Strategies

The limited number of suppliers underscores a consolidated market structure, making procurement often reliant on long-term contractual relationships. Due to its niche application, price competition remains moderate, but supply chain stability is paramount to avoid procedural delays.

Healthcare providers and distributors are increasingly prioritizing:

• Supplier accreditation: Ensuring compliance with health authority standards.
• Supply security: Monitoring manufacturing capacity and contingency planning.
• Regulatory compliance: Verifying approvals and certifications.

Challenges Facing Suppliers

• Manufacturing complexity: The synthesis of isosulfan blue requires sophisticated chemistry and stringent quality checks.
• Regulatory hurdles: Evolving regulations, particularly concerning injectable dyes, impose significant compliance costs.
• Market size constraints: Limited global demand restricts manufacturing economies of scale.

Future Outlook

The global demand for lymphatic mapping agents is projected to grow with rising cancer incidence and advances in minimally invasive surgeries. Suppliers investing in manufacturing capacity expansion, regulatory navigation, and quality assurance will better position themselves in this niche yet lucrative market.

Innovations in dye chemistry, such as fluorescent or near-infrared alternatives, may influence future demand, prompting current suppliers to diversify or enhance their product lines.

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Key Takeaways

• The primary global suppliers of isosulfan blue are Johnson & Johnson (via Tyco Healthcare), Braun Melsungen AG, and select contract manufacturing organizations.
• Market entry barriers involve complex synthesis, regulatory approvals, and quality certification, limiting the number of reliable suppliers.
• Supply security and regulatory compliance remain critical considerations for healthcare providers and distributors.
• Asia-Pacific manufacturers are emerging, but regulatory and quality standards vary, affecting global market participation.
• Market growth depends on advances in surgical technology, regulatory adaptations, and potential development of alternative dyes.

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Frequently Asked Questions

1. What are the main uses of isosulfan blue in medical procedures?
Isosulfan blue is predominantly used for lymphatic mapping during sentinel lymph node biopsies in breast cancer and melanoma surgeries, enabling surgeons to visualize lymphatic vessels and identify affected lymph nodes.

2. Who are the leading global suppliers of isosulfan blue?
Top suppliers include Johnson & Johnson (via Tyco Healthcare), Braun Melsungen AG, and specialized contract manufacturing firms capable of producing pharmaceutical-grade dyes under regulatory standards.

3. What regulatory approvals are necessary for sourcing isosulfan blue?
Suppliers must have FDA clearance for the U.S. market or CE marking for the European Union, alongside ISO certifications and compliance with local health authority regulations pertaining to injectable medical dyes.

4. Are there regional differences in the availability of isosulfan blue?
Yes. North America and Europe are predominantly supplied by established multinational pharmaceutical companies, while vendors in Asia-Pacific are emerging, often with varying regulatory compliance levels.

5. What are future market trends affecting the supply of isosulfan blue?
Growth in minimally invasive surgical techniques, increased cancer detection rates, and potential alternative dyes with enhanced safety profiles could influence demand and supply dynamics. Manufacturers investing in diversification and regulatory strategy will better navigate future trends.

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References

[1] Cited clinical usage and chemical data sourced from pharmaceutical manufacturing literature and global regulatory archives.
[2] Market insights derived from industry reports such as GlobalData and IQVIA on oncological surgical agents.
[3] Regulatory standards obtained from FDA and EMA official documentation regarding medical dyes.