Suppliers and packagers for generic pharmaceutical drug: SODIUM THIOSULFATE

SODIUM THIOSULFATE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Fennec Pharms Inc	PEDMARK	sodium thiosulfate	SOLUTION;INTRAVENOUS	212937	NDA	Fennec Pharmaceuticals Inc.	73077-010-01	1 VIAL, SINGLE-DOSE in 1 BOX, UNIT-DOSE (73077-010-01) / 100 mL in 1 VIAL, SINGLE-DOSE	2022-10-03
Hope Pharms	SODIUM THIOSULFATE	sodium thiosulfate	SOLUTION;INTRAVENOUS	203923	NDA	Hope Pharmaceuticals	60267-705-50	50 mL in 1 VIAL, SINGLE-DOSE (60267-705-50)	2012-02-14

Suppliers for the Pharmaceutical Drug: Sodium Thiosulfate

Last updated: August 1, 2025

Introduction

Sodium thiosulfate, a versatile inorganic compound with the chemical formula Na₂S₂O₃, plays a pivotal role in various pharmaceutical applications, including cyanide poisoning treatment, neutralization of chlorine and bromine in water, and as an antioxidant in certain medical formulations. Its increasing demand in clinical and industrial sectors underscores the importance of reliable suppliers capable of delivering pharmaceutical-grade quality. This analysis explores the key suppliers of sodium thiosulfate, the factors influencing procurement decisions, and the emerging trends shaping the supply landscape.

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Global Supply Landscape

The global supply of pharmaceutical-grade sodium thiosulfate is concentrated among a handful of chemical manufacturing giants and specialty chemical companies. Major players operate across North America, Europe, and Asia, leveraging extensive manufacturing capacities and strict regulatory compliance to meet pharmaceutical standards. The supply chain complexity is compounded by quality assurance, batch consistency, and regulatory approvals mandated by agencies such as the FDA (Food and Drug Administration), EMA (European Medicines Agency), and other national authorities.

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Leading Suppliers of Pharmaceutical-Grade Sodium Thiosulfate

1. Sigma-Aldrich (Merck Group)

A dominant player in the global chemical and pharmaceutical ingredients market, Sigma-Aldrich supplies high-purity sodium thiosulfate suitable for pharmaceutical and laboratory applications. Their products adhere to stringent quality standards, including USP (United States Pharmacopeia) and EP (European Pharmacopoeia). Their extensive distribution network ensures timely global delivery, critical for pharmaceutical manufacturing.

2. Thermo Fisher Scientific

Thermo Fisher provides pharmaceutical-grade sodium thiosulfate among its comprehensive catalog of chemicals. Their manufacturing facilities ensure compliance with cGMP (current Good Manufacturing Practices), making their products suitable for injectable formulations and other sensitive pharmaceutical uses.

3. AkzoNobel Specialty Chemicals

Known for its broad portfolio of specialty chemicals, AkzoNobel offers high-quality sodium thiosulfate, primarily catering to industrial and pharmaceutical clients. Their rigorous quality control and sustainable manufacturing practices strengthen their position as a reliable supplier.

4. Zhejiang Medicine Co., Ltd. (China)

A significant Asian manufacturer, Zhejiang Medicine supplies bulk quantities of pharmaceutical-grade sodium thiosulfate. Their products meet international standards, supported by certifications like GMP and pharmacopoeial compliance, which are crucial for global distribution.

5. Tianjin Tianan Pharmaceutical Co., Ltd.

Based in China, Tianjin Tianan specializes in active pharmaceutical ingredients (APIs), including sodium thiosulfate. Their competitive pricing, extensive production capacity, and adherence to quality norms have made them a favored choice in emerging markets.

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Emerging and Niche Suppliers

In addition to established giants, new entrants focus on niche markets such as customized formulations, expedited supply chains, or sustainable manufacturing practices. Small and medium-sized enterprises (SMEs) in India, South Korea, and Southeast Asia are increasingly gaining traction, driven by cost advantages and rapid production capabilities.

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Key Criteria for Supplier Selection

Choosing a supplier for pharmaceutical-grade sodium thiosulfate involves rigorous evaluation based on those factors:

• Regulatory Compliance: cGMP, ISO certifications, and pharmacopoeial standards ensure product safety and efficacy.

• Quality Assurance: Verification through batch testing, stability data, and documented quality control protocols.

• Manufacturing Capacity: Ability to meet volume demands, especially during pandemics or emergent medical crises.

• Supply Chain Reliability: Consistent delivery schedules, geographic diversification, and contingency plans mitigate risks.

• Pricing and Contract Terms: Competitive pricing without compromising quality, coupled with flexible contractual arrangements.

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Supply Chain Challenges and Opportunities

The supply of sodium thiosulfate faces challenges such as geopolitical tensions, raw material shortages, regulatory hurdles, and environmental sustainability concerns. The COVID-19 pandemic underscored vulnerabilities in global supply chains, prompting pharmaceutical companies to diversify their supplier base and explore local manufacturing options.

Opportunities lie in integrating advanced manufacturing technologies, enhancing traceability through blockchain, and adopting greener production processes to meet sustainability goals. These innovations can lead to improved quality, transparency, and reduced lead times.

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Regulatory Landscape and Its Impact

Regulatory oversight significantly influences supplier qualification and procurement decisions. Compliance with the U.S. FDA's Current Good Manufacturing Practice (cGMP), European Pharmacopoeia monographs, and Good Manufacturing Practices in China ensures that sodium thiosulfate products are suitable for medical use. Suppliers maintaining robust quality systems and regulatory approvals are preferred partners for pharmaceutical companies.

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Market Demand and Future Outlook

Demand for sodium thiosulfate is expected to grow driven by:

• Expanded use in cyanide poisoning treatment (notably in mining regions).

• Increasing chlorination of water supplies requiring neutralization agents.

• Growing applications in oncology and other emerging therapeutic areas.

Manufacturers are investing in scaling production capacity, improving purity levels, and fostering innovation to meet rising global demand.

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Key Considerations for Buyers

Procuring sodium thiosulfate requires balancing cost, quality, and supply chain robustness. Buyers should prioritize suppliers with proven regulatory compliance and traceable quality documentation. Strategic partnerships and long-term agreements can ensure supply continuity amid fluctuating global markets.

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Key Takeaways

• The primary suppliers for pharmaceutical-grade sodium thiosulfate include industry leaders such as Sigma-Aldrich, Thermo Fisher Scientific, AkzoNobel, and major Asian manufacturers like Zhejiang Medicine and Tianjin Tianan Pharmaceutical.

• Regulatory compliance, product quality, manufacturing capacity, and supply reliability are critical factors in supplier selection.

• The evolving market landscape emphasizes diversification, technological innovation, and sustainable practices to mitigate risks and meet rising global demand.

• Emerging regional manufacturers are gaining prominence, offering competitive pricing and flexible supply options.

• Current geopolitical and environmental considerations necessitate proactive strategic sourcing to ensure uninterrupted supply chains.

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FAQs

1. What are the primary industries that utilize sodium thiosulfate in pharmaceuticals?
Sodium thiosulfate is mainly used in emergency treatments for cyanide poisoning, as an antioxidant in clinical formulations, and in water treatment applications with pharmaceutical-grade standards.

2. How does the quality assurance process influence procurement?
Suppliers must provide comprehensive quality documentation, including Certificates of Analysis (COA), batch testing results, and compliance with pharmacopoeial standards to guarantee product safety and efficacy.

3. Are there regional variations in suppliers for sodium thiosulfate?
Yes, Western markets primarily rely on established multinational suppliers, while Asia hosts numerous manufacturers offering competitive pricing and flexible supply options.

4. What regulatory standards must pharmaceutical-grade sodium thiosulfate meet?
Manufacturers should comply with cGMP, USP, EP, or equivalent standards depending on the market; certification and regulatory approvals are essential for global distribution.

5. How has recent geopolitical tension affected the sodium thiosulfate supply chain?
Political tensions and trade restrictions have prompted companies to diversify their supplier base, increase stockpiles, and explore local manufacturing to mitigate supply disruptions.

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References

[1] U.S. Food and Drug Administration - Guidance for Industry: Quality System Approach to Pharmaceutical Manufacturing.
[2] European Medicines Agency - Pharmaceutical Quality System Framework.
[3] Market research reports from IQVIA and GlobalData on pharmaceutical ingredient supply chains.
[4] Company websites and product datasheets (Sigma-Aldrich, Thermo Fisher Scientific, AkzoNobel, Zhejiang Medicine, Tianjin Tianan).