Bulk Pharmaceutical API Sources for SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

Bulk Pharmaceutical API Sources for SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		02589_FLUKA
Sigma-Aldrich		03370_FLUKA
Sigma-Aldrich		07982_FLUKA
Sigma-Aldrich		13423_RIEDEL
Sigma-Aldrich		204439_ALDRICH
Sigma-Aldrich		310166_SIAL

Bulk Active Pharmaceutical Ingredient (API) Sources for: Sodium Chloride 0.45% in Plastic Container

Last updated: August 3, 2025

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Introduction

Sodium chloride 0.45%, often termed half-normal saline, is a widely used isotonic solution in medical practice, primarily for intravenous (IV) infusion. Its application spans hydration therapy, electrolyte replenishment, and as a diluent for medications. Ensuring a reliable supply of high-quality API – the bulk sodium chloride used in manufacturing these solutions – is vital for pharmaceutical companies, healthcare providers, and distributors. The procurement process depends on identifying reputable bulk API suppliers who comply with stringent regulatory standards, such as cGMP (current Good Manufacturing Practice), and provide consistent, pharmaceutical-grade products.

This detailed overview examines current market sources of pharmaceutical-grade sodium chloride 0.45%, emphasizing key suppliers, geographic regions, compliance standards, and procurement considerations.

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Regulatory and Quality Standards for APIs

Prior to sourcing, understanding the regulatory landscape is crucial. API manufacturers must adhere to strict standards, including:

• Pharmacopoeial Compliance: Monographs from USP, EP, or JP outline purity, residual impurities, and performance criteria.
• Good Manufacturing Practices (cGMP): Ensures quality, safety, and efficacy.
• Certifications: Certificate of Analysis (COA), Certificate of Suitability (CEP), and compliance with ISO standards bolster supplier credibility.

Sodium chloride APIs must meet microbiological and chemical purity criteria, including low endotoxin levels and absence of contaminants such as heavy metals.

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Major Global Sources of Sodium Chloride API

1. China

China remains a dominant global supplier of pharmaceutical-grade sodium chloride. Large manufacturers operate at scale, offering competitive pricing and ample supply.

• Chemloom Co., Ltd.
• Shandong Yuhuang Chemical Co., Ltd.
• Zhejiang Medicine Co., Ltd.

These companies have established cGMP facilities, produce USP/EP grades, and export globally. Suppliers typically provide detailed COAs and comply with international standards such as ISO 9001 and ISO 13485.

2. India

India is another key player, with several reputable API manufacturers catering to international markets.

• Sodium Chloride Manufacturers in India:

  • Vishnu Chemicals
  • S. S. Chemicals
  • Sun Pharma Advanced Research

Indian suppliers emphasize high purity standards, with many facilities certified by USFDA and API-specific certifications.

3. Europe

European manufacturers leverage strict regulatory environments and high-purity manufacturing processes.

• Kemira Chemicals (Finland)
• VWR International (France/UK)

European APIs often meet or exceed EP, USP, and BP standards and are favored for markets with high compliance demands.

4. United States

While most sodium chloride 0.45% solutions are produced domestically from API, some companies manufacture the API domestically or import from high-standard international suppliers.

• Fresenius Kabi (manufactures in compliance with US and EU standards)
• Plymouth Artificial Salt Works (historically supplies bulk sodium chloride)

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Key Factors in API Selection for Sodium Chloride

• Purity Grade: USP Grade is the standard for injectable solutions, requiring high purity and low endotoxin levels.
• Certification: Prefer suppliers with cGMP compliance, FDA approvals, or certifications from pharmacopoeias.
• Supply Stability: Long-term supply agreements, capacity for large-volume orders, and reliable logistics.
• Pricing: Competitive pricing balanced against quality standards.
• Regulatory Support: Availability of detailed documentation, including COA, stability data, and compliance statements.

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Emerging Trends and Considerations

• Sustainability and Green Manufacturing: Increasing emphasis on environmentally friendly production methods influences supplier selection.
• Supply Chain Resilience: Recent global disruptions highlight the importance of diversified sourcing, including multiple regional suppliers.
• Verification and Auditing: Due diligence through audits, site visits, and third-party assessments remains vital for qualification.

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Procurement Pathways

• Direct Engagement: Establish relationships directly with manufacturers or authorized distributors.
• Trading Companies: Utilize regional or international API trading firms experienced in pharmaceutical APIs.
• Contract Manufacturers (CMOs): Some pharmaceutical companies outsource API procurement to specialized CMOs with verified quality records.

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Conclusion

The reliable sourcing of sodium chloride 0.45% API hinges on selecting suppliers with proven quality, regulatory compliance, and logistical efficiency. China and India dominate global supply chains, offering cost-effective options, while Europe and North America cater to markets with stringent quality demands. Professional procurement involves balancing quality assurance, cost, and supply security—crucial for pharmaceutical manufacturers engaged in sterile product production or infusion therapies.

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Key Takeaways

• Secure API from suppliers with cGMP compliance, USP or EP standards, and verified certifications.
• Chinese and Indian suppliers continue to dominate global APIs, with European and North American sources serving high-regulatory markets.
• Regular audits, supplier qualification programs, and comprehensive documentation mitigate risks.
• Diversify sourcing strategies to enhance supply resilience amid global disruptions.
• Innovate procurement processes by leveraging verified third-party validation and transparent supply chains for assured quality.

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FAQs

Q1: What quality standards must sodium chloride API meet for injectable use?
A1: USP Grade, with specifications meeting USP or EP monographs, including limits on endotoxins, heavy metals, and microbial contaminants.

Q2: Which regions provide the most cost-effective sodium chloride API?
A2: China and India offer competitive pricing due to large-scale manufacturing and lower production costs.

Q3: How do I verify supplier compliance with regulatory standards?
A3: Request detailed COAs, certificates of GMP compliance, and review third-party audits or validations.

Q4: Are there any concerns with sourcing from emerging markets?
A4: Risks include variability in quality control, regulatory oversight, and supply chain transparency; thorough qualification is essential.

Q5: How can supply chain risks be mitigated for sodium chloride API?
A5: Diversify suppliers across regions, establish long-term contracts, and conduct regular supplier audits to ensure consistent quality.

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References

1. United States Pharmacopeia (USP). Monograph for Sodium Chloride Injection, USP.
2. European Pharmacopoeia (EP). Sodium Chloride Monograph.
3. FDA. Guidance for Industry: Chemistry, Manufacturing, and Controls Documentation.
4. Global API Market Reports. Industry analyses from IQVIA, CPhI, and ChemAnalyst.
5. ISO Certifications. ISO 9001 and ISO 13485 standards for pharmaceutical manufacturing.

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Ensure continuous monitoring of supplier compliance, quality standards, and global regulatory updates to sustain supply chain integrity for sodium chloride 0.45% API.