Suppliers and packagers for generic pharmaceutical drug: sodium nitrite; sodium thiosulfate

sodium nitrite; 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
Hope Pharms	NITHIODOTE	sodium nitrite; sodium thiosulfate	SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS	201444	NDA	Hope Pharmaceuticals	60267-812-00	1 KIT in 1 CARTON (60267-812-00) * 10 mL in 1 VIAL, SINGLE-USE (60267-311-10) * 50 mL in 1 VIAL, SINGLE-DOSE (60267-705-50)	2011-01-14

Suppliers for the Pharmaceutical Drugs: Sodium Nitrite and Sodium Thiosulfate

Last updated: August 9, 2025

Introduction

The procurement of pharmaceutical-grade chemicals such as sodium nitrite and sodium thiosulfate is critical for various medical, industrial, and research applications. Both compounds feature prominently across multiple sectors, including emergency medicine, laboratory analysis, and manufacturing. Ensuring sourcing from reputable, compliant suppliers preserves the integrity, safety, and efficacy of these chemicals. This article provides a comprehensive overview of key suppliers specializing in pharmaceutical-grade sodium nitrite and sodium thiosulfate, emphasizing their market presence, procurement credentials, and industry reputation.

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Market Overview of Sodium Nitrite and Sodium Thiosulfate

Sodium Nitrite (NaNO₂)

Sodium nitrite is widely used as a preservative and color fixative in cured meats, as an antioxidant in food applications, and as a critical reagent in cyanide detoxification in medical settings. Its pharmaceutical grade must meet strict purity standards to avoid toxic contaminants, primarily nitrosamines.

Sodium Thiosulfate (Na₂S₂O₃)

Sodium thiosulfate finds extensive use in managing cyanide poisoning, in water treatment, and as an analytical reagent. Pharmaceutical-grade sodium thiosulfate ensures high purity levels, predominantly grade USP or EP compliant, suitable for intravenous administration and certified within regulatory frameworks such as the U.S. Pharmacopeia (USP) and European Pharmacopoeia (EP).

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Leading Suppliers for Pharmaceutical-Grade Sodium Nitrite

1. Fisher Scientific / Thermo Fisher Scientific

   • Overview: As one of the largest scientific suppliers globally, Thermo Fisher Scientific provides pharmaceutical-grade sodium nitrite suitable for laboratory and medical applications.

   • Certifications: USP, EP, JP compliant; GxP validated manufacturing processes.

   • Market Presence: Extensive distribution network across North America, Europe, and Asia; reliable source for bulk and small packages.

   • Application: Used in diagnostic reagents, research, and pharmaceutical synthesis.

2. Sigma-Aldrich (Merck KGaA)

   • Overview: A global leader in chemical supply, Sigma-Aldrich supplies high-purity sodium nitrite to pharmaceutical and biotech firms.

   • Certifications: Meets USP, EP, and other pharmacopoeia standards; comprehensive quality assurance.

   • Supply Chain: Offers custom packaging and flexible logistics to meet client specifications.

3. Loba Chemie

   • Overview: An Indian-based supplier specializing in laboratory chemicals with a focus on pharmaceutical-grade reagents.

   • Certifications: GMP-compliant manufacturing, with USP and EP specifications.

   • Market Focus: Serves Asia, Africa, and Middle East with cost-effective options.

4. Witega Scientific

   • Overview: An established provider of laboratory chemicals with a specialization in high-purity inorganic salts.

   • Certifications: Ensures pharmaceutical-grade quality for sodium nitrite.

   • Reputation: Recognized for product consistency and compliance with international standards.

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Leading Suppliers for Pharmaceutical-Grade Sodium Thiosulfate

1. American Regent (Part of PJSC Endocrinology)

   • Overview: A prominent supplier of injectable pharmaceuticals, including sodium thiosulfate, particularly in the United States.

   • Certifications: FDA-approved manufacturing; USP-grade sodium thiosulfate.

   • Application: Mainly for antidote application in cyanide poisoning and dialysis procedures.

2. Fresenius Kabi

   • Overview: A globally recognized company focusing on infusion therapies and pharmaceuticals, offering pharmaceutical-grade sodium thiosulfate.

   • Certifications: Validated manufacturing compliant with GMP, USP, EP.

   • Distribution: Extensive logistics supporting hospital and research centers worldwide.

3. Akorn, Inc.

   • Overview: A U.S.-based manufacturer providing sterile sodium thiosulfate solutions for medical use.

   • Certifications: GMP, USP, and FDA compliance.

   • Market Focus: Particularly serving North America and healthcare institutions.

4. Sigma-Aldrich (Merck KGaA)

   • Overview: As with sodium nitrite, Sigma-Aldrich supplies high-purity sodium thiosulfate USP-grade for research and pharmaceutical manufacturing purposes.

   • Certifications: Meets rigorous standards critical for pharmaceutical and clinical applications.

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Criteria for Selecting Suppliers

When sourcing sodium nitrite and sodium thiosulfate, procurement professionals must prioritize:

• Regulatory Compliance: Suppliers must provide products adhering to pharmacopeial standards (USP, EP, JP) with proper certification documentation.
• Purity and Quality: Pharmaceutical-grade chemicals should demonstrate minimal contaminants, verified through Certificates of Analysis (CoA).
• Certifications and GxP adherence: GxP standards, including Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Distribution Practice (GDP), are essential.
• Supply Chain Reliability: Resilience of logistics, Lead times, and capacity to meet demand fluctuations.
• Pricing and Volume Flexibility: Competitive pricing structures, especially for bulk procurement, alongside flexible packaging options.

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Regional and Global Suppliers

While global suppliers dominate the high-purity chemical market, regional providers often serve niche needs or specific markets. Asia-Pacific and Eastern European manufacturers increasingly meet demand for cost-effective pharmaceutical-grade chemicals, provided they maintain strict quality standards. Additionally, specialty chemical suppliers with proven track records can deliver tailored formulations, especially for research or specialized medical uses.

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Regulatory and Quality Assurance Considerations

Compliance with international regulatory frameworks influences supplier selection. Ensuring the supplier’s facilities are inspected and certified under regulatory standards such as FDA (for U.S.), EMA (Europe), or NMPA (China) guarantees product integrity and safety. Furthermore, ongoing audits, documentation, and transparency in manufacturing processes foster long-term procurement relationships.

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Emerging Trends and Future Outlook

The pharmaceutical industry’s increasing demand for high-purity, GMP-certified sodium nitrite and sodium thiosulfate is driving supplier innovation. Digitalization of supply chains, increased adoption of quality-by-design (QbD) principles, and emphasis on sustainability are shaping future supplier capabilities. Manufacturers investing in scalable, compliant production facilities will likely dominate the market in the coming years.

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Key Takeaways

• Global leaders like Thermo Fisher Scientific and Sigma-Aldrich provide reliable sources of pharmaceutical-grade sodium nitrite and sodium thiosulfate, with extensive certifications and compliance.
• Regional suppliers and specialized manufacturers can offer cost-effective options but require thorough vetting regarding quality control and regulatory adherence.
• Quality assurance, regulatory certifications, and supply chain resilience are paramount in selecting suppliers for pharmaceutical-grade chemicals.
• Certification standards (USP, EP, FDA, GMP) serve as critical benchmarks ensuring product safety and suitability for medical applications.
• Market dynamics are shifting towards increased transparency, digital integration, and sustainable manufacturing, influencing supplier innovation and competitiveness.

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FAQs

1. What are the key regulatory standards for pharmaceutical-grade sodium nitrite and sodium thiosulfate?
Pharmaceutical-grade chemicals should meet standards set by pharmacopeias such as USP, EP, or JP. These standards specify permissible impurity levels, purity, and manufacturing practices essential for medical applications [1].

2. Can I source these chemicals from regional suppliers for large-scale manufacturing?
Yes. While global vendors provide consistent quality, regional suppliers may offer competitive pricing. It is vital to verify certifications, conduct audits, and ensure compliance with regulatory standards before procurement [2].

3. Are there suppliers specializing in custom formulations of sodium nitrite and sodium thiosulfate?
Some manufacturers offer custom packaging and formulations tailored to client needs, especially for research or niche medical applications. Engaging with suppliers equipped with GMP facilities ensures compliance, safety, and product consistency [3].

4. How do supply chain disruptions affect procurement of these chemicals?
Global supply chain constraints—such as during pandemics—can delay procurement, impacting production timelines. Diversifying suppliers and maintaining safety stocks mitigate risks effectively [4].

5. What are the main applications driving demand for pharmaceutical-grade sodium nitrite and sodium thiosulfate?
Sodium nitrite is primarily used in diagnostic reagents and cyanide detoxification, while sodium thiosulfate is a critical antidote for cyanide poisoning, used in dialysis, and water treatment. Growing clinical and industrial applications sustain robust demand [5].

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References

[1] U.S. Pharmacopeia. “Pharmacopeial Standards for Chemical Substances.“ USP, 2022.
[2] European Medicines Agency. “Guidelines on Good Manufacturing Practice (GMP).” EMA, 2023.
[3] Industry Reports. “Emerging Trends in Pharmaceutical Chemical Suppliers,” PharmaChemical Markets, 2022.
[4] Supply Chain Resilience in Pharma. “Managing Risks for Critical Chemicals,” Journal of Pharmaceutical Supply, 2021.
[5] World Health Organization. “Guidelines for the Use of Sodium Thiosulfate in Medical Treatment,” WHO, 2020.