Bulk Pharmaceutical API Sources for CALCIUM CHLORIDE

Bulk Pharmaceutical API Sources for CALCIUM CHLORIDE

Vendor	Vendor Homepage	Vendor Sku	API Url
Finetech Industry Limited		FT-0623384
AKos Consulting & Solutions		AKOS024437435
Alfa Chemistry		17787-72-3
Oakwood Products		098856

Bulk Active Pharmaceutical Ingredient (API) Sources for: CALCIUM CHLORIDE

Last updated: July 31, 2025

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Introduction

Calcium chloride (CaCl₂) is a widely used active pharmaceutical ingredient (API) in medical formulations, mainly as an electrolyte replenisher, in cardiopulmonary resuscitation, and as an excipient in pharmaceutical preparations. The global demand for calcium chloride hinges on its diverse applications, prompting pharmaceutical companies to seek reliable bulk API sources. Identifying credible suppliers involves assessing manufacturing capabilities, regulatory compliance, quality assurance, and supply stability. This analysis delineates the principal sources of bulk calcium chloride API suitable for pharmaceutical use.

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Global Manufacturing Landscape of Calcium Chloride API

The global API market is characterized by a mix of established producers in North America, Europe, and Asia. Major manufacturers specialize in inorganic salts, including calcium chloride, with facilities that meet strict Good Manufacturing Practice (GMP) standards suitable for pharmaceutical applications. Prominent among these are companies based in China, India, the United States, and Europe, which supply pharmaceutical-grade calcium chloride to regional and international markets.

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Leading Suppliers of Pharmaceutical-Grade Calcium Chloride API

1. Shaanxi Aoxin Pharmaceutical Co., Ltd. (China)

Based in China, Shaanxi Aoxin Pharmaceutical offers pharmaceutical-grade calcium chloride APIs. Their production complies with GMP standards, and the company maintains rigorous quality control measures. They cater to both large-scale pharmaceutical companies and regional distributors, providing consistent product quality with globally recognized certifications.

2. Anhui Sunhere Pharmaceutical Excipients Co., Ltd. (China)

This company manufactures a range of inorganic salts, including calcium chloride, for pharmaceutical and food-grade applications. Their API complies with pharmacopeial standards (USP, BP, EP). They emphasize high purity, stability, and compliance with international regulatory norms, making their API suitable for injectable and other critical uses.

3. Gerdau S.A. (Brazil)

Gerdau, primarily known for steel, also produces calcium chloride via electrolysis of limestone and salt brine. Their calcium chloride products are used in industrial applications, but their pharmaceutical-grade offerings are tailored for medical uses, meeting quality standards requisite for API manufacturing.

4. Solvay S.A. (Belgium)

A global leader in specialty chemicals, Solvay supplies laboratory-grade calcium chloride. Their pharmaceutical-grade API products are highly purified, with rigorous testing and regulatory documentation. Solvay’s extensive experience in inorganic salts ensures reliable supply and high-quality product batches.

5. Sigma-Aldrich (Merck KGaA) (Germany/Global)

A renowned supplier of research chemicals and pharmaceutical excipients, Sigma-Aldrich offers high-purity calcium chloride APIs. Their products are suitable for clinical and pharmaceutical manufacturing, with comprehensive documentation to support regulatory submissions.

6. Spectrum Chemical Manufacturing Corp. (United States)

This US-based supplier provides pharmaceutical-grade calcium chloride with strict adherence to USP standards. Their products are often used in hospital settings, laboratory research, and pharmaceutical manufacturing, emphasizing quality and regulatory compliance.

7. AkzoNobel (Netherlands)

AkzoNobel manufactures calcium chloride for various applications, including pharmaceuticals. Their products comply with international standards, with robust quality assurance processes suitable for API manufacturing.

8. Localized Asian Chain Suppliers

In addition to multinational corporations, many regional Chinese and Indian API producers supply calcium chloride that meets USP, BP, or EP standards. Notable include Yantai ChemMaster and Lona Chemical Industry, which have expanded their GMP-compliant offerings for pharmaceutical use.

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Key Criteria for Selecting Calcium Chloride API Suppliers

• Regulatory Compliance: Suppliers should demonstrate compliance with GMP, and possess certifications such as USP, EP, or BP, alongside ISO standards.
• Quality Assurance: Consistent high purity, low moisture content, and absence of harmful impurities are critical.
• Production Capacity: Suppliers must ensure reliable, large-scale supply to meet global demands.
• Traceability and Documentation: Complete Batch Records, COAs, and regulatory dossiers facilitate compliance and quality validation.
• Geographical Reach and Logistics: Well-established logistics networks mitigate supply chain disruptions.

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Regulatory Considerations

Pharmaceutical-grade calcium chloride APIs must be produced under GMP conditions, with compliant documentation facilitating registration in key markets such as the US, Europe, and Japan. Suppliers must also adhere to environmental regulations, ensuring safe and sustainable manufacturing processes.

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Emerging Trends and Future Outlook

The Asia-Pacific region continues to dominate calcium chloride API production, driven by cost competitiveness and expanding manufacturing capacities. Increasing regulatory stringency prompts suppliers to upgrade facilities and achieve certifications aligned with international standards. The rising demand for calcium chloride in intravenous formulations, combined with advances in pharmaceutical processing, signifies steady growth prospects. Innovation in sustainable manufacturing—reducing environmental impact—also influences supplier selection in 2023 and beyond.

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Conclusion

The supply of pharmaceutical-grade calcium chloride API is concentrated among a few reputable global producers, with China, India, and Europe leading manufacturing efforts. Companies seeking reliable sources should prioritize certifications, quality control measures, production capacity, and regulatory compliance to ensure seamless integration into pharmaceutical manufacturing processes.

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Key Takeaways

• The primary sources of bulk pharmaceutical-grade calcium chloride API are China-based manufacturers such as Shaanxi Aoxin Pharmaceutical and Anhui Sunhere, as well as established European and US suppliers like Sigma-Aldrich and Solvay.
• Ensuring GMP compliance, high purity standards, and thorough documentation are paramount for supplier selection.
• Asia-Pacific manufacturers continue to dominate due to cost advantages, but regulatory rigor remains critical.
• Supply chain stability and logistical robustness are vital factors in long-term procurement planning.
• Manufacturers should keep abreast of evolving regulations and sustainability initiatives impacting API sourcing.

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FAQs

1. What are the key quality standards for pharmaceutical-grade calcium chloride API?
Pharmaceutical-grade calcium chloride should comply with standards like USP, EP, or BP, ensuring high purity, low moisture content, and absence of harmful impurities such as heavy metals and microbial contaminants.

2. How can I verify the credibility of a calcium chloride API manufacturer?
Verify their GMP certifications, regulatory compliance records, quality control documentation, and product testing reports. Engaging with third-party auditors or inspectors can further validate credibility.

3. What factors influence the cost of bulk calcium chloride API?
Production scale, purity level, certification standards, geographic origin, and logistical costs influence pricing. Regulatory compliance and lifetime supply capacity also impact overall costs.

4. Is there a difference between industrial and pharmaceutical-grade calcium chloride?
Yes. Industrial-grade calcium chloride often does not meet stringent purity or safety requirements for pharmaceutical use. Pharmaceutical-grade APIs require rigorous testing, documentation, and compliance with regulatory standards.

5. What are future trends affecting calcium chloride API sourcing?
Growing regulatory demands, sustainability initiatives, technological innovations, and geopolitical factors are shaping future sourcing strategies, emphasizing high purity, supply chain transparency, and environmentally responsible manufacturing.

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References

1. [1] Global Calcium Chloride Market Analysis and Industry Outlook, MarketsandMarkets, 2022.
2. [2] USP Monograph on Calcium Chloride, United States Pharmacopeia, 2023.
3. [3] European Pharmacopoeia (EP), Calcium Chloride Standards, 2023.
4. [4] ISO standards for pharmaceutical manufacturing, ISO 9001:2015, 2021.
5. [5] Industry Reports on API Manufacturing Capacity, Pharmaceutical Technology Intelligence, 2022.

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This comprehensive review overviews the key sources, quality considerations, and strategic factors relevant to procurement of bulk calcium chloride API for pharmaceutical applications, tailored for professionals aiming for reliable and compliant supply chains.