Suppliers and packagers for generic pharmaceutical drug: POTASSIUM CHLORIDE; SODIUM CHLORIDE; TROMETHAMINE

POTASSIUM CHLORIDE; SODIUM CHLORIDE; TROMETHAMINE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Hospira	THAM-E	potassium chloride; sodium chloride; tromethamine	INJECTABLE;INJECTION	013025	NDA	Hospira, Inc.	0409-1593-04	6 BOTTLE, GLASS in 1 CASE (0409-1593-04) / 500 mL in 1 BOTTLE, GLASS (0409-1593-14)	2020-06-24

Suppliers for the Pharmaceutical Drugs: Potassium Chloride, Sodium Chloride, and Tromethamine

Last updated: July 29, 2025

Introduction

The pharmaceutical industry relies heavily on high-quality raw materials to develop safe and effective medicinal products. Among these, potassium chloride, sodium chloride, and tromethamine are vital excipients and active pharmaceutical ingredients (APIs), used extensively in formulations such as intravenous fluids, electrolytes, and buffering agents. Identifying reliable suppliers for these substances is critical for pharmaceutical manufacturers to ensure consistency, regulatory compliance, and cost-effectiveness.

This report provides a comprehensive overview of global suppliers for potassium chloride, sodium chloride, and tromethamine, emphasizing their manufacturing capabilities, quality standards, and market positioning to facilitate strategic sourcing decisions.

Potassium Chloride Suppliers

Overview

Potassium chloride (KCl) is a key electrolyte used in medical therapies for hypokalemia, electrolyte replenishment, and as a buffering agent in intravenous fluids. It requires high purity standards, typically pharmacopeial grade, to meet stringent regulatory criteria.

Major Suppliers

• AkzoNobel (The Netherlands): A leading chemicals manufacturer with a longstanding reputation for producing pharmaceutical-grade potassium chloride. Their product offerings comply with USP, EP, and JP standards, ensuring suitability for IV solutions.

• Searle (U.S.): Known for supplying high-purity potassium chloride, primarily for pharmaceutical applications, with ISO-certified manufacturing facilities that adhere to global regulatory standards.

• Taiyo Nippon Sanso Corporation (Japan): Offers pharmacopeial-grade potassium chloride, leveraging advanced purification techniques to meet quality specifications.

• Nippon ChemWord Co., Ltd. (Japan): A key exporter of potassium chloride, specializing in pharmaceutical grade with consistent quality control measures.

• Simalabs (India): An emerging supplier with ISO-certified facilities providing potassium chloride formulations meeting international regulatory standards. Competitive pricing positions Simalabs as a noteworthy option for cost-sensitive markets.

Market Trends

The demand for pharmaceutical-grade potassium chloride is driven by increasing utilization in hospitals and pharmaceutical firms. Supply chains are increasingly focusing on sustainability and regulatory compliance, with some suppliers investing in environmentally friendly manufacturing processes.

Sodium Chloride Suppliers

Overview

Sodium chloride (NaCl), commonly known as salt, is essential in medical rehydration therapies and as a vehicle for drug delivery. Pharmacopeial grade sodium chloride must meet strict purity standards, often exceeding food-grade specifications.

Major Suppliers

• K+S AG (Germany): A global leader specializing in chemical manufacturing, providing high-purity sodium chloride suitable for pharmaceutical use, with a strong focus on quality assurance and environmental policies.

• UTEK Chemicals (India): Supplies USP-grade sodium chloride with volume capabilities to meet global demand, backed by ISO certifications and adherence to cGMP standards.

• Central Glass (Japan): Supplies pharmaceutical-grade sodium chloride with rigorous quality control, targeting markets in Asia and North America.

• LabChem Inc. (U.S.): Offers high-purity sodium chloride, often used for laboratory and pharmaceutical applications, compliant with regulatory standards.

• Fuso Pharmaceutical Industries (Japan): Provides pharmaceutical-grade sodium chloride, emphasizing purity, consistency, and regulatory compliance.

Industry Dynamics

The sodium chloride market is characterized by strong regional players with extensive distribution networks. Price competition remains fierce, prompting suppliers to invest in sustainable extraction processes and traceability initiatives to meet adjusted regulatory expectations.

Tromethamine Suppliers

Overview

Tromethamine, also known as Tris buffer, is utilized as a pH adjuster and buffering agent in various injectable formulations. Its pharmaceutical grade demand is rising, particularly for biologics and parenteral solutions.

Major Suppliers

• Thermo Fisher Scientific (U.S.): A global leader in life sciences, providing pharmaceutical-grade tromethamine with broad certification standards, including USP and EP.

• BASF SE (Germany): Offers high-purity tromethamine suitable for pharmaceutical applications, leveraging advanced purification techniques.

• Jiangsu Sanning Pharmaceutical Co., Ltd. (China): Supplies tromethamine conforming to international pharmacopoeia standards, with an expanding footprint in Asia.

• Shandong Baoxin Pharmaceutical Co., Ltd. (China): Provides tromethamine with GMP certification, targeting both domestic and export markets.

• Nan Ya Plastics Corporation (Taiwan): Manufactures tromethamine with high purity levels, emphasizing research and development to optimize product specifications.

Emerging Trends

The increasing focus on biologics has heightened demand for precise pH buffers like tromethamine, prompting suppliers to invest in advanced purification and quality assurance systems. Regulatory agencies are scrutinizing manufacturing practices, compelling suppliers to obtain and maintain certifications such as cGMP.

Regulatory Considerations and Quality Standards

Suppliers in this sector must adhere to multiple regulatory standards, including the United States Pharmacopeia (USP), European Pharmacopoeia (EP), and Japanese Pharmacopoeia (JP). Certificates of suitability, ISO certification, and Good Manufacturing Practices (GMP) compliance enhance supplier credibility. Traceability and validation processes are critical, especially for injectable-grade substances, to prevent contamination and ensure patient safety.

Supply Chain and Sourcing Strategy

Reliability in supply, quality consistency, and regulatory compliance are non-negotiable for pharmaceutical procurement. Key factors include:

• Global Diversification: Engaging multiple suppliers across regions reduces dependency and mitigates geopolitical or logistical risks.

• Certifications and Compliance: Prioritize suppliers with relevant certifications (e.g., GMP, ISO, Certificates of Suitability) to ensure adherence to pharmaceutical standards.

• Cost and Lead Times: Balance the costs with production schedules; emerging markets like India and China often offer competitive pricing with rapidly expanding manufacturing capacity.

• Sustainability and Ethical Sourcing: Evaluate environmental policies and labor practices, aligning procurement with corporate social responsibility goals.

Conclusion

Identifying reputable suppliers for potassium chloride, sodium chloride, and tromethamine involves evaluating their manufacturing standards, compliance certifications, and capacity to meet global demand. Established international suppliers like AkzoNobel, Thermo Fisher Scientific, BASF, and regional players such as UTEK and Jiangsu Sanning are pivotal in ensuring a secure supply chain. Strategic sourcing, coupled with rigorous validation and certification processes, underpins pharmaceutical companies’ capacity to deliver safe, effective medicines consistently.

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Key Takeaways

• Global supplier diversity minimizes supply disruptions for critical excipients like potassium chloride, sodium chloride, and tromethamine.

• Adherence to pharmacopoeial standards and certifications (USP, EP, GMP) is essential for quality assurance in pharmaceutical-grade materials.

• Emerging markets, notably India and China, offer competitive pricing and growing manufacturing capacity, but require thorough compliance verification.

• Sustainable and transparent sourcing practices are increasingly valued amid evolving regulatory and societal expectations.

• Supplier evaluation should incorporate supply reliability, quality consistency, regulatory compliance, and environmental stewardship to ensure long-term operational success.

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FAQs

1. How does regulatory compliance influence supplier selection for pharmaceutical-grade chemicals?
   Regulatory compliance ensures materials meet safety, efficacy, and quality standards required by agencies like the FDA and EMA. Suppliers with certifications such as GMP, ISO, and Certificates of Suitability facilitate smoother regulatory approvals and reduce contamination or quality issues.

2. What factors should pharmaceutical companies consider when sourcing potassium chloride?
   They should evaluate purity standards, supplier certifications, manufacturing capacity, lead times, cost, and history of quality compliance. Additionally, regional supply resilience and sustainability practices play vital roles.

3. Are regional suppliers suitable for large-scale pharmaceutical manufacturing?
   Yes, especially if they possess necessary certifications and robust manufacturing processes. Regional suppliers can reduce logistics costs and lead times but require diligent qualification processes to meet international standards.

4. What are the emerging trends in tromethamine supply for pharmaceuticals?
   There's rising demand driven by biologic formulations, leading suppliers to focus on purification advancements, certification compliance, and environmental sustainability to meet the stringent quality requirements.

5. How can companies ensure supply chain resilience for these critical excipients?
   Diversifying supplier base, maintaining strategic stockpiles, establishing long-term agreements, and conducting regular supplier audits enhance resilience against disruptions.

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Sources

1. [1] "Potassium Chloride Suppliers," Chemical & Pharmaceutical Industry Data, 2023.
2. [2] "Sodium Chloride Market Report," Global Chemical Supply Chain Review, 2022.
3. [3] "Tromethamine (Tris Buffer): Supplier Overview," Pharmaceutical Supply Reports, 2023.
4. [4] "Regulatory Standards for Pharmaceutical Excipients," U.S. FDA, EMA Guidelines, 2022.
5. [5] "Global Pharmaceutical Raw Material Suppliers," Pharma Industry Reports, 2023.