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Suppliers and packagers for generic pharmaceutical drug: SODIUM NITRITE
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SODIUM NITRITE
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 | SODIUM NITRITE | sodium nitrite | SOLUTION;INTRAVENOUS | 203922 | NDA | Hope Pharmaceuticals | 60267-311-10 | 10 mL in 1 VIAL, SINGLE-USE (60267-311-10) | 2012-02-14 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: SODIUM NITRITE
Introduction
Sodium nitrite is a crucial chemical compound with a broad spectrum of applications, especially in the pharmaceutical and medical sectors. It is primarily used as an antidote for cyanide poisoning, a preservative in food products, and in various industrial processes. Its significance in medicine is grounded in its ability to induce vasodilation and its role in the detoxification of cyanide. Given its complex manufacturing process and regulatory scrutiny, identifying reliable suppliers capable of meeting pharmaceutical standards is essential for players across the pharmaceutical supply chain. This report provides an in-depth overview of the leading suppliers of pharmaceutical-grade sodium nitrite, the factors influencing sourcing decisions, and the current market landscape.
Overview of Sodium Nitrite in Pharmaceuticals
Sodium nitrite (NaNO₂) is a white to slightly yellowish crystalline powder. In pharmaceutical contexts, it must meet rigorous purity standards, typically adhering to USP (United States Pharmacopeia), EP (European Pharmacopoeia), or other regulatory quality requirements. Its primary medical indication is in the emergency treatment of cyanide poisoning, where it acts by converting hemoglobin into methemoglobin, which traps cyanide ions and facilitates detoxification. Beyond pharmaceuticals, sodium nitrite is also used in food preservation and in manufacturing processes such as electronics and dyes, but this report concentrates on pharmaceutical-grade sources.
Market Landscape for Pharmaceutical Sodium Nitrite Suppliers
1. Global Suppliers and Regions
The sourcing of pharmaceutical-grade sodium nitrite predominantly revolves around suppliers in North America, Europe, and Asia. These regions have established chemical manufacturing infrastructure capable of producing high-purity compounds in compliance with strict regulatory standards. Leading countries include the United States, Germany, China, and India, which are key players in the chemical and pharmaceutical raw materials industry.
2. Key Attributes in Supplier Selection
Sourcing decisions hinge on multiple factors such as:
- Regulatory compliance: Certification (ISO, cGMP compliance)
- Product purity and quality standards: USP, EP, CL (chemical purity)
- Manufacturing capacity and consistency
- Supply chain reliability and logistics
- Pricing and procurement terms
- Regulatory approvals and documentation
Leading Suppliers of Pharmaceutical-Grade Sodium Nitrite
1. TCI Chemicals
Overview:
Tokyo Chemical Industry (TCI) is a prominent Japanese supplier known for its diverse portfolio of chemicals, including high-quality pharmaceutical and reagent-grade sodium nitrite. TCI emphasizes rigorous quality control and regulatory compliance, making it a preferred partner in pharmaceutical applications.
Strengths:
- ISO-certified manufacturing facilities
- Consistent supply of USP and analytical reagent-grade sodium nitrite
- Global distribution network
- Strong R&D support
Applications:
Primarily used in research, diagnostic, and pharmaceutical formulations including cyanide antidotes.
2. Sigma-Aldrich (Part of Merck Group)
Overview:
A global leader in chemical and biochemical supplies, Sigma-Aldrich provides pharmaceutical-grade sodium nitrite with stringent quality assurance. Their extensive catalog caters to research institutions, pharmaceutical manufacturers, and clinical laboratories.
Strengths:
- Compliance with USP, EP, and other pharmacopoeias
- Broad product portfolio and ready availability
- Robust quality assurance protocols
- Reliable logistics network
Applications:
Research, diagnostics, and as a pharmaceutical excipient in specific formulations.
3. Pan-Continental Chemical Suppliers (e.g., Anhui Shunlong Chemical)
Overview:
Chinese manufacturers such as Anhui Shunlong Chemical Co., Ltd. have increased their capacity and compliance standards to supply pharmaceutical-grade chemicals, including sodium nitrite. These firms focus on meeting international standards to serve global pharmaceutical companies.
Strengths:
- Competitive pricing due to manufacturing scale
- Increasing adherence to international certification standards
- Variety of pharmaceutical and food grades
Considerations:
Regulatory due diligence is essential to verify quality certifications and supply chain integrity.
4. Burgoyne (UK)
Overview:
Specializing in the supply of laboratory chemicals, Burgoyne provides high-purity sodium nitrite suitable for pharmaceutical and diagnostic use. Their operational standards align with Good Manufacturing Practices (GMP), ensuring reliable product quality.
Strengths:
- GMP-compliant production facilities
- Custom packaging options
- Focus on sensitive applications
5. Other Notable Suppliers
- FAR Chemistry Ltd. (India)
- Lach-D International (Germany)
- Thermo Fisher Scientific (for research-grade supplies)
These companies have established reputations for quality and supply reliability.
Regulatory and Quality Compliance Considerations
Suppliers must meet strict regulatory frameworks such as cGMP (current Good Manufacturing Practice), ICH guidelines, and pharmacopoeial standards. The sourcing process should include:
- Verification of GMP certificates
- Access to batch-specific Certificates of Analysis (CoA)
- Documentation supporting impurity profiles and purity levels
- Proven track record of regulatory audits and inspections
Failure to adhere to these standards risks regulatory actions, product recalls, and liability issues.
Emerging Trends and Market Dynamics
The demand for pharmaceutical-grade sodium nitrite is expected to grow in tandem with the demand for cyanide antidotes, which gained prominence amid increased industrial accidents and chemical attacks. Additionally, expanded use in biomedical research and diagnostics continues to drive procurement from established suppliers. Supply chain disruptions, geopolitical factors, and environmental regulations influence market dynamics, prompting pharmaceutical firms to diversify their supplier base and emphasize quality assurance.
Conclusion
Reliable sourcing of pharmaceutical-grade sodium nitrite necessitates a focus on supplier quality standards, regulatory compliance, supply chain robustness, and competitive pricing. Leading global suppliers such as TCI Chemicals and Merck's Sigma-Aldrich are recognized for their high standards and comprehensive product offerings. Chinese manufacturers are increasingly entering the market, providing cost-effective alternatives when quality certifications are verified. Engaging with known, certified suppliers ensures pharmaceutical companies and research institutions adhere to regulatory standards and mitigate supply risks.
Key Takeaways
- Regulatory Compliance is Paramount: Ensure suppliers meet cGMP, USP, and other relevant standards to guarantee pharmaceutical-grade quality.
- Diversify Supply Sources: Reducing dependency on single-region suppliers mitigates risk amid geopolitical and logistical disruptions.
- Verify Certifications and Documentation: Require detailed CoA, purity profiles, and compliance certificates before procurement.
- Focus on Quality and Reliability: Prioritize suppliers with proven track records, robust supply chains, and regulatory audits.
- Monitor Market Trends: Stay informed of increasing demand due to new medical applications and ensure procurement channels adapt accordingly.
FAQs
1. What are the primary applications of pharmaceutical-grade sodium nitrite?
Sodium nitrite is chiefly used in the medical field as an antidote for cyanide poisoning, in diagnostic assays, and occasionally as a preservative or additive in pharmaceutical preparations.
2. How does regulatory compliance impact sodium nitrite suppliers?
Suppliers must adhere to strict standards such as cGMP and pharmacopoeial requirements to ensure the safety, efficacy, and quality of sodium nitrite used in pharmaceuticals. Non-compliance risks regulatory action and product recalls.
3. Which regions are the main producers of pharmaceutical-grade sodium nitrite?
Major production regions include North America (U.S.), Europe (Germany, UK), and Asia (China, India), owing to their advanced chemical manufacturing infrastructure and regulatory frameworks.
4. What factors should a pharmaceutical company consider when selecting a sodium nitrite supplier?
Key factors include product purity, regulatory certifications, supply capacity, pricing, logistical reliability, and past compliance history.
5. Are there alternative suppliers in emerging markets for sodium nitrite?
Yes, several manufacturers in China and India focus on meeting international standards for pharmaceutical applications. Due diligence and verification of certifications are essential when working with these suppliers.
Sources
[1] U.S. Pharmacopeia, Sodium Nitrite Monograph.
[2] European Pharmacopoeia, Sodium Nitrite Standards.
[3] Market analysis reports on specialty chemicals and pharmaceutical raw materials.
[4] Company websites and certification documentation of TCI Chemicals, Sigma-Aldrich, Anhui Shunlong Chemical.
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