CALCIUM CHLORIDE: Pharmaceutical manufacturers, suppliers, and wholesalers

Subscribe to access the full database, or Get Started Free
Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Am Regent	CALCIUM CHLORIDE 10%	calcium chloride	INJECTABLE;INJECTION	209088	ANDA	American Regent, Inc.	0517-6710-10	10 VIAL, GLASS in 1 BOX (0517-6710-10) / 10 mL in 1 VIAL, GLASS	2018-02-06
Am Regent	CALCIUM CHLORIDE 10%	calcium chloride	INJECTABLE;INJECTION	209088	ANDA	Civica, Inc.	72572-052-10	10 VIAL, GLASS in 1 BOX (72572-052-10) / 10 mL in 1 VIAL, GLASS (72572-052-01)	2021-04-02
Amneal	CALCIUM CHLORIDE 10%	calcium chloride	INJECTABLE;INJECTION	217524	ANDA	Amneal Pharmaceuticals LLC	70121-2308-4	24 CARTON in 1 CARTON (70121-2308-4) / 1 SYRINGE, GLASS in 1 CARTON (70121-2308-1) / 10 mL in 1 SYRINGE, GLASS	2024-07-17
Amneal	CALCIUM CHLORIDE 10%	calcium chloride	INJECTABLE;INJECTION	217524	ANDA	Amneal Pharmaceuticals LLC	70121-2309-7	10 VIAL, GLASS in 1 CARTON (70121-2309-7) / 10 mL in 1 VIAL, GLASS (70121-2309-1)	2024-07-17
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 29, 2025

Introduction

Calcium chloride (CaCl₂) is a widely used pharmaceutical compound, primarily serving intravenous therapy, electrolyte replenishment, and as a buffering agent. Its importance in medical settings underscores the need for a reliable global supply chain, encompassing pharmaceutical manufacturers, bulk chemical suppliers, and specialty suppliers with regulatory compliance aligned to industry standards.

This report examines key suppliers of pharmaceutical-grade calcium chloride, analyzing their manufacturing capabilities, geographic distribution, regulatory compliance, and market positioning. The aim is to inform decision-makers in procurement, logistics, and strategic planning, ensuring robust sourcing channels amid the dynamic pharmaceutical landscape.

Overview of Calcium Chloride in Pharmaceuticals

Calcium chloride's pharmaceutical applications demand high purity standards, typically USP (United States Pharmacopeia) or EP (European Pharmacopoeia) grades. These grades ensure products meet strict purity, solubility, and stability criteria necessary for parenteral administration. Suppliers catering to this niche must adhere to GMP (Good Manufacturing Practices), ISO standards, and undergo rigorous quality assessments to gain regulatory approval in target markets.

Key Global Suppliers of Pharmaceutical-Grade Calcium Chloride

1. Jessop & Co. Ltd. (India)

Overview: A leading chemical manufacturer with extensive experience in inorganic salts, Jessop supplies pharmaceutical-grade calcium chloride to global markets.
Manufacturing Capabilities: Fully integrated facilities with GMP certification, capable of bulk production and custom packaging.
Product Range: Includes anhydrous and dihydrate forms, meeting USP and EP standards.
Regulatory Approvals: Certified by WHO GMP, with export approvals across North America, Europe, and Asia.
Strengths: Competitive pricing, reliable quality control, and robust distribution network.

2. Merck KGaA (Germany)

Overview: A globally renowned pharmaceutical and chemical supplier, Merck offers pharmaceutical-grade calcium chloride as part of its specialty chemicals portfolio.
Manufacturing Capabilities: State-of-the-art facilities with strict adherence to international GMP standards.
Product Range: Focuses on high-purity solutions, with extensive quality assurance and documentation.
Regulatory Approvals: Compliant with FDA, EMA, and other international regulatory standards.
Strengths: High-quality standards, extensive R&D, and global logistics infrastructure.

3. Sigma-Aldrich (Part of Merck Group)

Overview: A pioneer in specialty chemicals and biochemicals, Sigma-Aldrich supplies pharmaceutical-grade calcium chloride for research and therapeutic uses.
Manufacturing Capabilities: High-purity calcium chloride products manufactured under stringent quality controls.
Product Range: Includes various grades suitable for pharmaceutical, laboratory, and industrial applications.
Regulatory Approvals: Multiple certifications ensuring compliance with pharmacopeial standards.
Strengths: Extensive product portfolio, widespread availability, and reliable quality.

4. Fuso Chemical Co., Ltd. (Japan)

Overview: A notable Japanese chemical producer with a focus on specialty salts used in medical and pharmaceutical applications.
Manufacturing Capabilities: GMP-compliant manufacturing, capable of producing high-purity calcium chloride.
Product Range: Anhydrous and dihydrate forms conforming to pharmacopeial standards.
Regulatory Approvals: Certifications include ISO, GMP, and certifications relevant to Asia-Pacific and international markets.
Strengths: Quality consistency, technological innovation, and strict regulatory adherence.

5. Thermo Fisher Scientific

Overview: A leading provider of laboratory chemicals and pharmaceutical excipients, Thermo Fisher supplies pharmaceutical-grade calcium chloride for injectable and infusion preparations.
Manufacturing Capabilities: Stringent quality controls with multiple manufacturing sites globally.
Product Range: USP and EP-grade calcium chloride solutions and powders.
Regulatory Approvals: Certified for GMP, with extensive distribution channels worldwide.
Strengths: Reliability, compliance, and extensive technical support.

Regional Suppliers and Emerging Markets

While established international suppliers dominate, regional companies in China, India, and Eastern Europe are increasingly capable of providing high-quality calcium chloride due to advancements in manufacturing technology and regulatory compliance.

Chinese Suppliers

Several Chinese pharmaceutical chemical manufacturers, such as Shandong Zhangqiu Foreign Trade Co., Ltd. and Sichuan Kelun Pharmaceutical, have scaled up production of pharmaceutical-grade calcium chloride, supported by GMP accreditation and export licenses. Their competitive pricing makes them attractive for cost-sensitive supply chains.

Indian Suppliers

Manufacturers like Vasu Chemicals and Hindustan Antibiotics Ltd. are expanding their export portfolio, often providing calcium chloride that meets international standards, leveraging India’s GMP-certified facilities.

Considerations for Selecting Suppliers

Regulatory Compliance: Ensure suppliers have valid GMP, ISO, and other relevant certifications.
Product Quality: Verify Certificates of Analysis (CoA), pharmacopeial conformity, and batch consistency.
Supply Chain Reliability: Assess manufacturing capacity, lead times, and recovery from disruptions.
Pricing and Payment Terms: Balance cost-savings with quality assurance.
Logistics Capabilities: Consider proximity, shipping modes, and Customs clearance efficiency.

Regulatory Environment and Quality Assurance

Suppliers must comply with stringent regulatory standards across markets. Compliance with the USP, EP, and JP pharmacopeias is mandatory for pharmaceutical-grade calcium chloride. Additionally, suppliers should follow GMP guidelines issued by authorities such as the FDA, EMA, and WHO.

Importantly, suppliers with an established track record in quality consistency and documentation tend to navigate regulatory hurdles more efficiently, minimizing supply risks for pharmaceutical companies.

Market Trends and Future Outlook

Modern pharmaceutical companies prioritize suppliers that provide high-purity, well-documented calcium chloride, increasingly demanding estensive quality assurance beyond basic pharmacopeial standards. The trend toward regional manufacturing in China and India supports supply chain diversification and cost optimization.

Emerging opportunities include custom formulations, such as ready-to-use solutions, and specialty derivatives that expand calcium chloride’s application scope. As regulatory standards tighten, suppliers investing in quality systems and R&D are better positioned for long-term partnerships.

Key Takeaways

Established multinational suppliers like Merck, Sigma-Aldrich, and Thermo Fisher dominate the market due to their rigorous quality management systems and global distribution networks.
Growing regional manufacturers in China and India offer competitive pricing but require thorough due diligence to ensure compliance with international standards.
Regulatory compliance (GMP, ISO, pharmacopeial standards) is non-negotiable for pharmaceutical-grade calcium chloride suppliers.
Supply chain resilience hinges on supplier capacity, geographic diversification, and logistics capabilities.
Market dynamics favor suppliers investing in R&D, quality assurance, and regulatory approvals to meet evolving pharmaceutical formulations and safety standards.

FAQs

What are the main quality standards for pharmaceutical-grade calcium chloride?
The primary standards are USP (United States Pharmacopeia), EP (European Pharmacopoeia), and JP (Japanese Pharmacopoeia). Compliance ensures high purity, solubility, and safety for medical use.
How can I verify a supplier’s regulatory compliance?
Request Certificates of Analysis, GMP certificates, and documentation of registration with relevant drug authorities (FDA, EMA, WHO). Conduct audits if feasible.
Are regional suppliers a reliable source for pharmaceutical calcium chloride?
They can be, provided they have the necessary certifications and a consistent quality track record. Due diligence is essential to ensure compliance and reliability.
What factors influence the cost of pharmaceutical calcium chloride?
Factors include purity grade, production volume, supplier location, certification status, and logistics costs.
Is the anhydrous or dihydrate form preferable for pharmaceutical applications?
The choice depends on formulation requirements. Both forms are available from reputable suppliers, with dihydrate being more common in infusion preparations.

References

U.S. Pharmacopeia (USP). Calcium Chloride Monograph.
European Pharmacopoeia (EP). Calcium Chloride Monograph.
WHO. Good Manufacturing Practices Guidelines for Pharmaceuticals.
Industry Reports on Chemical Suppliers and Market Trends.
Supplier websites and product datasheets.

This article aims to facilitate strategic sourcing and risk management for stakeholders involved in the procurement of pharmaceutical-grade calcium chloride, fostering resilient and compliant supply chains.

Suppliers and packagers for generic pharmaceutical drug: CALCIUM CHLORIDE