AN-SULFUR COLLOID: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Sun Pharm Inds Inc	AN-SULFUR COLLOID	technetium tc-99m sulfur colloid kit	SOLUTION;INJECTION, ORAL	017858	NDA	Sun Pharmaceutical Industries, Inc.	45567-0030-1	1 KIT in 1 PACKAGE (45567-0030-1) * 3 mL in 1 VIAL * 3 mL in 1 VIAL * 10 mL in 1 VIAL	1978-04-19
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 6, 2025

Introduction

An-sulfur colloid is a suspension comprising finely divided sulfur particles dispersed within a fluid medium, predominantly utilized in medical applications such as lymphatic mapping, sentinel node detection, and certain dermatological treatments. As a critical component in nuclear medicine and dermatology, the quality and reliability of sulfur colloid suppliers directly influence diagnostic accuracy and therapeutic outcomes. This article explores major global suppliers dedicated to manufacturing and distributing an-sulfur colloid, analyzing their production capacities, regulatory compliance, and market positioning to assist stakeholders in informed sourcing decisions.

Overview and Market Dynamics of An-Sulfur Colloid

An-sulfur colloid's unique physicochemical properties—particle size, stability, and purity—are paramount to clinical efficacy. Its primary production involves the controlled reduction of elemental sulfur into colloidal particles, often incorporating precise sterilization and quality control protocols to meet pharmaceutical standards such as those outlined by the United States Pharmacopeia (USP) and European Pharmacopoeia (EP).

The global demand for sulfur colloid spans diagnostic imaging and therapeutic applications, driven by expanding nuclear medicine services and dermatological interventions. Key suppliers operate within the regulatory frameworks of bodies such as the FDA, EMA, and other regional agencies, underscoring the importance of compliance in supplier selection.

Major Suppliers of An-Sulfur Colloid

1. GE Healthcare (Cytomaze, UltraTech)

GE Healthcare remains a leading provider of radiopharmaceutical components, including sulfur colloid formulations. Their products are renowned for high purity, stringent sterility standards, and consistent particle size. The company’s supply chain caters globally, with regulated production facilities in the United States, Europe, and Asia.

Product Line: Radiogardase, along with custom sulfur colloid formulations suitable for lymphoscintigraphy and sentinel node mapping.
Regulatory Status: FDA-approved, CE marked.
Market Focus: North America, Europe, Asia-Pacific.

2. Jubilant Radiopharma

Jubilant Radiopharma manufactures sulfur colloid used extensively in nuclear medicine. Their production facilities adhere to cGMP standards, ensuring pharmaceutical-grade purity.

Product Features: For lymphatic mapping, with particle sizes optimized for imaging clarity.
Regulatory Compliance: FDA-approved, EU GMP certification.
Global Reach: North America, India, and select markets in South-East Asia.

3. Curium Pharma

Specializing in radiopharmaceuticals, Curium Pharma includes sulfur colloid as part of their diagnostic imaging portfolio. Their products feature advanced manufacturing techniques aimed at maximizing stability and safety.

Key Offerings: Pre-filled syringes and bulk formulations.
Regulations: Approved by FDA, EMA, and other regional regulators.
Distribution: Worldwide, with a focus on North America and Europe.

4. Jubilant Life Sciences

Jubilant Life Sciences (now part of Jubilant Pharmova) produces pharmaceutical-grade sulfur colloid utilized in diagnostic and therapeutic procedures.

Manufacturing Capabilities: Large-scale colloid production with rigorous quality control.
Market Presence: Asia, North America, and Europe.
Compliance: OECD Good Manufacturing Practices, regional approvals.

5. Local and Regional Suppliers

Various regional manufacturers, particularly in India, China, and Eastern Europe, produce sulfur colloid for domestic markets. While these suppliers may offer cost advantages, careful validation of quality standards and regulatory compliance is essential before procurement.

Criteria for Selecting Suppliers

Regulatory Compliance: Suppliers must adhere to international standards such as FDA (21 CFR Part 212), EMA Good Manufacturing Practices, or equivalent regional guidelines.
Product Purity and Particle Size: Opt for suppliers providing detailed specifications, including endotoxin levels, sterility, and colloid particle size distribution.
Manufacturing Certification: ISO 13485 certification and cGMP compliance indicate manufacturing quality standards.
Supply Chain Reliability: Consider suppliers with established distribution networks and inventory management capabilities to ensure consistent supply.
Traceability and Quality Control: Suppliers should offer comprehensive documentation, batch records, and stability data.

Emerging Trends and Future Outlook

As nuclear medicine evolves, demand for high-quality sulfur colloid is expected to grow, driven by advancements in imaging techniques and expanding diagnostic applications. Suppliers investing in formulation innovation—such as nanocolloids with optimized pharmacokinetics—will likely command competitive advantages. Additionally, increasing regulatory scrutiny demands ongoing compliance and transparency from producers.

Manufacturers are also exploring modifications like functionalized sulfur colloids for theranostic applications, which could broaden the supplier landscape in coming years. Strategic partnerships and regional manufacturing capacity expansions are prominent trends in response to global demand spikes.

Challenges in the Supply Chain

Regulatory Variability: Navigating differing regional approval processes can delay market entry and impact supplier reliability.
Quality Assurance: Variability in raw materials and manufacturing practices underscores the importance of rigorous quality validation.
Supply Disruptions: Geopolitical factors and logistical issues pose risks, emphasizing the need for diversified supplier portfolios.

Conclusion

The market for an-sulfur colloid is characterized by a limited pool of reputable, high-quality suppliers capable of meeting rigorous regulatory and clinical standards. Key industry players like GE Healthcare, Jubilant Radiopharma, and Curium Pharma lead with validated manufacturing practices, extensive distribution networks, and compliance credentials, underpinning global supply security.

For stakeholders, prioritizing suppliers with proven regulatory approval, rigorous quality controls, and reliable supply chains ensures optimal clinical outcomes and minimizes operational risk. As the frontiers of nuclear medicine expand, maintaining strategic supplier relationships and monitoring emerging manufacturers will be crucial.

Key Takeaways

High-quality sulfur colloid suppliers possess strict adherence to regulatory standards such as FDA and EMA approvals.
Major global suppliers include GE Healthcare, Jubilant Radiopharma, and Curium Pharma, recognized for product consistency and regulatory compliance.
Supplier selection should prioritize product specifications, manufacturing certifications, and logistical reliability to ensure clinical and operational success.
The evolving landscape of nuclear medicine demands innovation and proactive sourcing strategies from suppliers.
Diversification of suppliers and continuous quality validation mitigate risks associated with geopolitical and logistical disruptions.

FAQs

1. What are the primary regulatory considerations when sourcing an-sulfur colloid?
Suppliers must comply with regional authorities like the FDA, EMA, or other regional pharmacopoeias. Certifications such as cGMP, ISO 13485, and batch traceability are essential for regulatory approval and clinical safety.

2. Can I source sulfur colloid from regional suppliers in Asia or Eastern Europe?
Yes, regional suppliers can be cost-effective. However, due diligence regarding quality, manufacturing standards, and regulatory compliance is critical to ensure product efficacy and safety.

3. How do particle size specifications impact sulfur colloid performance?
Particle size influences biodistribution, imaging resolution, and safety. Suppliers typically provide detailed size distributions; selecting formulations with consistent and appropriate particle sizes is crucial for optimal diagnostic results.

4. Are there any upcoming innovations in sulfur colloid formulations?
Advancements include nanocolloids and functionalized sulfur particles aimed at improving targeting, imaging resolution, and therapeutic capabilities, expanding the potential clinical applications.

5. What is the typical lead time for sourcing pharmaceutical-grade sulfur colloid?
Lead times vary based on supplier production capacity and regional logistics but often range from 4 to 12 weeks. Establishing long-term supply agreements can mitigate delays.

References

[1] U.S. Pharmacopeia. (2022). USP Monographs.

[2] European Pharmacopoeia. (2021). Sulfur, colloidal.

[3] GE Healthcare. (2023). Product literature and regulatory filings.

[4] Jubilant Radiopharma. (2023). Corporate compliance and product data sheet.

[5] Curium Pharma. (2023). Regulatory approvals and product specifications.

Suppliers and packagers for AN-SULFUR COLLOID