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Last Updated: December 11, 2025

Suppliers and packagers for generic pharmaceutical drug: SODIUM CHLORIDE


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SODIUM CHLORIDE

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
B Braun SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER sodium chloride INJECTABLE;INJECTION 019635 NDA B. Braun Medical Inc. 0264-5802-00 12 CONTAINER in 1 CASE (0264-5802-00) / 1000 mL in 1 CONTAINER 1998-03-09
B Braun SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER sodium chloride INJECTABLE;INJECTION 019635 NDA B. Braun Medical Inc. 0264-5802-10 24 CONTAINER in 1 CASE (0264-5802-10) / 500 mL in 1 CONTAINER 1998-03-09
B Braun SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER sodium chloride INJECTABLE;INJECTION 019635 NDA B. Braun Medical Inc. 0264-5804-00 12 CONTAINER in 1 CASE (0264-5804-00) / 1000 mL in 1 CONTAINER 1988-03-09
B Braun SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER sodium chloride INJECTABLE;INJECTION 019635 NDA B. Braun Medical Inc. 0264-7800-09 12 CONTAINER in 1 CASE (0264-7800-09) / 1000 mL in 1 CONTAINER 2013-12-31
B Braun SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER sodium chloride INJECTABLE;INJECTION 019635 NDA B. Braun Medical Inc. 0264-7800-00 12 CONTAINER in 1 CASE (0264-7800-00) / 1000 mL in 1 CONTAINER 2013-12-31
B Braun SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER sodium chloride INJECTABLE;INJECTION 019635 NDA B. Braun Medical Inc. 0264-7800-10 24 CONTAINER in 1 CASE (0264-7800-10) / 500 mL in 1 CONTAINER 2013-12-31
B Braun SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER sodium chloride INJECTABLE;INJECTION 019635 NDA B. Braun Medical Inc. 0264-7800-20 24 CONTAINER in 1 CASE (0264-7800-20) / 250 mL in 1 CONTAINER 2013-12-31
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers for the Pharmaceutical Drug: Sodium Chloride

Last updated: July 27, 2025

Introduction

Sodium chloride, commonly known as table salt, plays a critical role in medicine, notably in intravenous (IV) therapy, wound irrigation, and dilution of medications. Its pharmaceutical-grade form is rigorously manufactured and supplied by a global network of chemical and pharmaceutical raw material vendors. This comprehensive overview identifies leading suppliers, examines their market position, and explores factors influencing procurement decisions for pharmaceutical sodium chloride.


Market Overview of Pharmaceutical Sodium Chloride

Pharmaceutical-grade sodium chloride demands high purity standards, typically specified as USP (United States Pharmacopeia) or EP (European Pharmacopoeia) grades, ensuring safety and efficacy in medical applications. The global demand is driven by hospitals, pharmaceutical manufacturers, and compounding pharmacies, with key manufacturing regions including North America, Europe, and Asia.

Major suppliers operate across these regions, offering varying forms such as powders, solutions, and sterile preparations. Factors influencing supplier selection include purity levels, compliance with Good Manufacturing Practices (GMP), regulatory approvals, supply chain reliability, and pricing.


Leading Suppliers in the Pharmaceutical Sodium Chloride Market

1. BASF SE

Overview: As one of the largest chemical producers globally, BASF supplies high-quality sodium chloride for pharmaceutical applications. Their offerings include USP and EP grade sodium chloride, primarily used in IV solutions and other sterile preparations.

Market Position: BASF leverages extensive manufacturing capacity and established distribution channels. Their compliance with international pharmaceutical standards ensures global acceptance.

Strengths: Consistent quality control, scalable supply, comprehensive regulatory documentation, and adherence to GMP.

2. AkzoNobel

Overview: Known for its chemical pigments and specialty chemicals, AkzoNobel supplies pharmaceutical-grade sodium chloride, focusing on high-purity products suitable for sterile medical use.

Market Position: AkzoNobel’s global presence and robust quality assurance systems make it a preferred supplier, especially in Europe and North America.

Strengths: Strong R&D capabilities, certifications aligned with pharma standards, and flexible packaging options.

3. SQM (Sociedad Química y Minera de Chile)

Overview: As a leading Chilean chemical company, SQM provides pharmaceutical-grade salts, including sodium chloride, extracted from natural brine sources.

Market Position: SQM's vertically integrated operations offer cost advantages and reliable quality, attracting pharmaceutical manufacturers worldwide.

Strengths: Competitive pricing, substantial resource base, and adherence to international regulatory standards.

4. Tata Chemicals Ltd.

Overview: An Indian multinational, Tata Chemicals manufactures pharmaceutical-grade sodium chloride tailored for medical use, including in developing markets.

Market Position: Tata Chemicals benefits from cost-effective production, extensive distribution networks, and compliance with global quality benchmarks.

Strengths: Price competitiveness, stable supply, and certification compliance.

5. Sigma-Aldrich (Merck Group)

Overview: A division of Merck Group, Sigma-Aldrich supplies laboratory and pharmaceutical chemicals, including high-purity sodium chloride suitable for clinical applications.

Market Position: Their comprehensive catalog and global distribution channels position them as a reliable supplier for pharmaceutical-grade sodium chloride.

Strengths: High purity standards, stringent quality controls, and extensive logistical support.


Emerging Suppliers and Specialty Players

In addition to established industry giants, several niche suppliers and regional manufacturers are gaining market share by offering specialized or cost-effective sodium chloride solutions:

  • GFS Chemicals: Focuses on high-purity salts for pharmaceutical and research purposes.
  • Hubei Yipu Chemical Co. Ltd.: A Chinese manufacturer expanding into pharmaceutical-grade salt production.
  • Iraqi Salt Company: Serving Middle Eastern markets with localized sourcing options.

These regional suppliers may provide logistical advantages and competitive pricing but often require rigorous quality verification to meet international standards.


Factors Influencing Supplier Selection

Regulatory Compliance and Certification: Suppliers must demonstrate compliance with regulatory standards such as USP, EP, and JP (Japanese Pharmacopoeia), including GMP certification, which assures product consistency and safety.

Quality Assurance: Pharmaceutical sodium chloride must have minimal impurities, including heavy metals, microbial contaminants, and endotoxins. Suppliers with robust quality control and certification records are preferred.

Supply Chain Reliability: Continuous availability, capacity for bulk orders, and supply chain transparency significantly impact procurement decisions.

Pricing and Contract Terms: Competitive pricing, flexible delivery schedules, and long-term partnership viability are crucial.

Environmental and Ethical Standards: Suppliers adhering to environmental regulations and ethical sourcing practices are increasingly favored.


Global Supply Chain Considerations

The procurement landscape is marked by supply chain complexities, including geopolitical factors, trade policies, and geopolitical tensions, which can disrupt supply. Diversification of suppliers and strategic stockpiling are common mitigation strategies. Additionally, regional factors, such as China's manufacturing capacity and India's market dominance, influence global availability and pricing.


Conclusion

The selection of a sodium chloride supplier for pharmaceutical purposes hinges upon rigorous quality standards, regulatory compliance, supply chain stability, and cost-effectiveness. Industry leaders such as BASF, AkzoNobel, SQM, Tata Chemicals, and Sigma-Aldrich remain dominant players, supported by their extensive infrastructures and adherence to international standards. Emerging regional suppliers increase market competition, offering potential benefits but necessitating thorough vetting.

Pharmaceutical companies and distributors must evaluate suppliers holistically, prioritizing product purity, regulatory adherence, and supply chain reliability to ensure uninterrupted access to this fundamental pharmaceutical excipient.


Key Takeaways

  • Quality Assurance is Paramount: Suppliers must meet strict pharmacopeial standards (USP, EP) with proven GMP compliance.
  • Established Industry Leaders Dominate: Companies like BASF, Sigma-Aldrich, and AkzoNobel are trusted for their product consistency and regulatory adherence.
  • Regional Suppliers Offer Cost Advantages: Manufacturers in China, India, and South America provide competitive pricing but require rigorous validation.
  • Supply Chain Stability is Critical: Diversification and strategic inventory management mitigate geopolitical and logistical risks.
  • Continuous Regulatory Monitoring is Necessary: Evolving standards and regional regulations necessitate regular supplier audits and compliance checks.

FAQs

1. What are the key quality standards for pharmaceutical-grade sodium chloride?
Pharmaceutical-grade sodium chloride must conform to pharmacopeial standards such as USP, EP, or JP, ensuring high purity, low microbial content, and absence of harmful contaminants. Certification and rigorous quality control processes are essential.

2. How does supplier regulatory compliance affect procurement?
Regulatory compliance guarantees that sodium chloride meets safety and efficacy standards recognized internationally, reducing the risk of regulatory challenges and ensuring product acceptance across markets.

3. Are regional suppliers suitable for pharmaceutical sodium chloride?
Yes, regional suppliers can be suitable if they meet international quality standards. Their advantages include cost savings and faster delivery, but they require validation through quality audits and certifications.

4. What factors influence pricing for pharmaceutical sodium chloride?
Pricing is influenced by raw material costs, manufacturing efficiency, regulatory compliance expenses, supply chain logistics, and regional economic factors.

5. How can buyers mitigate supply chain risks for sodium chloride?
Diversification of suppliers, maintaining safety stock levels, establishing long-term contracts, and working with reputable, certified suppliers reduce supply disruption risks.


References

[1] "Pharmaceutical Sodium Chloride," USP Data, 2022.
[2] "Global Market Report: Pharmaceutical Grade Salt," PharmaChem Reports, 2021.
[3] "Chemical Suppliers Directory," ChemSources, 2023.
[4] "Regulatory Standards for Pharmaceutical Excipients," WHO, 2022.
[5] "Supply Chain Management in Pharmaceuticals," Journal of Pharmaceutical Innovation, 2021.

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