Bulk Pharmaceutical API Sources for POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER

Bulk Pharmaceutical API Sources for POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		204099_ALDRICH
Sigma-Aldrich		409316_ALDRICH
Sigma-Aldrich		449989_ALDRICH
Sigma-Aldrich		451029_ALDRICH

Bulk Active Pharmaceutical Ingredient (API) Sources for: POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER

Last updated: August 5, 2025

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Introduction

Potassium chloride (KCl) is an essential pharmaceutical API primarily used as a potassium supplement to treat hypokalemia, as an electrolyte replenisher, and as part of dialysis solutions. The demand for high-quality, reliable bulk sources of potassium chloride—specifically in the 40mEq in plastic container formulation—is driven by pharmaceutical manufacturers, contract manufacturing organizations (CMOs), and research institutions. Identifying reputable suppliers ensures compliance with regulatory standards, consistency in product quality, and timely procurement.

This article comprehensively examines the global landscape of API suppliers, focusing on those offering potassium chloride at a strength of 40mEq, packaged in plastic containers suitable for pharmaceutical formulation.

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Global Market Overview for Potassium Chloride API

The market for potassium chloride API is sizable, driven by its widespread application in clinical and hospital settings. The API's production is concentrated primarily in Asia, especially China and India, which host a significant portion of manufacturing capacity. Meanwhile, Europe and North America emphasize stricter regulatory oversight, higher quality standards, and often import APIs from established Asian suppliers.

Major players in this sphere are classified as large-scale manufacturers with Good Manufacturing Practice (GMP) certifications, ensuring compliance with international quality standards such as the United States Pharmacopeia (USP), European Pharmacopoeia (EP), and other regulatory frameworks.

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Major API Suppliers of Potassium Chloride (40mEq) in Plastic Container Packaging

1. Sichuan Kelina Pharmaceutical Co., Ltd. (China)

Profile:
Sichuan Kelina is among leading Chinese producers of pharmaceutical-grade potassium chloride. The company specializes in manufacturing high-purity APIs for global export, with certifications aligning with GMP standards.

Product Offerings:

• Potassium chloride USP/BP/EP grade
• Packaging options include plastic bottles, suitable for pharmaceutical use
• Strengths ranging from 10mEq to 40mEq, compliant with pharmacopeial standards

Reputation & Certification:

• GMP certified by China Food and Drug Administration (CFDA)
• Export licenses to North America, Europe, and emerging markets

Notes:
Kelina's ability to supply bulk quantities at competitive prices makes it a crucial supplier for formulators seeking reliable sources.

2. Anhui Biochem Company (China)

Profile:
Anhui Biochem specializes in bulk APIs, with a focus on electrolytes such as potassium chloride. Their manufacturing facilities comply with international standards, and they hold multiple certifications.

Product Offerings:

• Potassium chloride in various pack sizes, including plastic containers
• USP/BP/EP compliant grades
• 40mEq formulations available for bulk purchase

Reputation & Certification:

• ISO 9001 and GMP certifications
• Products used in global pharmaceutical markets, including North America and Europe

Notes:
Their large-scale production capabilities and quality control processes ensure consistent product performance.

3. Sigma-Aldrich/Merck (Germany/Global)

Profile:
As a global leader in specialty chemicals and pharmaceutical ingredients, Merck (formerly Sigma-Aldrich) supplies high-purity potassium chloride APIs.

Product Offerings:

• Pharmaceutical-grade potassium chloride (USP-grade)
• Packaged in sterile, pharmaceutical-grade containers, including plastics suitable for further formulation

Reputation & Certification:

• Complies with strict Good Manufacturing Practices
• Extensive regulatory documentation and batch testing

Notes:
While primarily catering to research and pharmaceutical manufacturers, their products are trusted globally for quality and consistency.

4. Sanofi (France/Global)

Profile:
Sanofi is not only a leading pharmaceutical manufacturer but also supplies bulk APIs through its dedicated supply chain.

Product Offerings:

• Potassium chloride APIs with pharmaceutical-grade specifications
• Packaged in pharmaceutical-grade containers, including plastics designed for stability

Reputation & Certification:

• GMP certifications and stringent quality assurance protocols
• Supplying large volumes to global markets

Notes:
Sanofi’s extensive distribution network ensures consistent supply and compliance.

5. Jiangxi Hengrui Medicine Co., Ltd. (China)

Profile:
Specializing in electrolyte APIs, Jiangxi Hengrui maintains robust manufacturing capabilities with certifications aligned with international standards.

Product Offerings:

• Various formulations of potassium chloride, including 40mEq strength
• Packaged in sterile plastic containers suitable for pharmaceutical operations

Reputation & Certification:

• GMP compliant
• Export licenses and adherence to pharmacopeial standards

Notes:
Hengrui’s competitive pricing and quality control systems make it a preferred supplier for bulk procurement.

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Key Factors in Selecting API Suppliers for Potassium Chloride (40mEq)

• Regulatory Compliance: Ensure suppliers are GMP-certified, with documented compliance to USP, EP, or equivalent pharmacopeias.
• Quality Assurance: Check for comprehensive testing, including assay, impurity profile, microbiological tests, and stability data.
• Packaging Standards: Confirm the API is offered in pharmaceutical-grade plastic containers designed to preserve stability, prevent contamination, and facilitate handling.
• Supply Chain Reliability: Evaluate the supplier’s production capacity, delivery timelines, and track record of consistent supply.
• Pricing & Contract Terms: Compare costs considering quality, certifications, and shipping terms, especially for large-volume orders.

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Regulatory Considerations & Quality Standards

Pharmaceutical APIs like potassium chloride must adhere to strict manufacturing and quality standards. Regulatory agencies such as the U.S. FDA, EMA, and China NMPA (National Medical Products Administration) mandate rigorous testing, documentation, and facility audits.

Manufacturers and purchasers should verify that the supplier holds valid GMP certifications, and the API batch documentation aligns with the intended pharmacopoeia specifications. Proper validation of the source and batch-to-batch consistency reduces risks associated with contamination, impurities, and efficacy failure.

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Emerging Trends and Future Outlook

The API supply landscape is increasingly influenced by evolving regulation, quality expectations, and geopolitical factors. Chinese and Indian API producers continue to dominate due to cost-effectiveness, but Western markets are emphasizing stricter quality governance, favoring suppliers with stringent certifications and validated quality standards.

Additionally, innovations in packaging—such as sterile, tamper-evident plastic containers—are improving stability and safety during transport and storage. The trend toward sustainable manufacturing and environmentally friendly packaging also influences supplier selection.

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Key Takeaways

• Major global suppliers such as Sichuan Kelina, Anhui Biochem, Sigma-Aldrich, and Sanofi dominate the potassium chloride API market, offering products suitable for pharmaceutical formulation in plastic containers.
• Certification and compliance with GMP, USP, and pharmacopeial standards are critical when selecting a supplier, ensuring safety, efficacy, and regulatory approval.
• Bulk procurement requires assessing supply chain reliability, pricing, and quality assurance processes; partnering with established, certified suppliers mitigates risks.
• Packaging in pharmaceutical-grade plastics ensures stability and compliance, vital for maintaining API integrity during storage and transportation.
• Regulatory vigilance and ongoing quality validation safeguard the manufacturing process and final medicinal product efficacy.

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FAQs

1. What quality standards should I verify when sourcing potassium chloride API?
Ensure the supplier complies with GMP standards and provides certification-based conformity with pharmacopoeial specifications such as USP, EP, or BP. Confirm relevant testing reports, impurity profiles, and stability data.

2. Are Chinese suppliers reliable for pharmaceutical-grade potassium chloride?
Yes. Numerous Chinese manufacturers possess GMP certification, export licenses, and adhere to international pharmacopeial standards, making them reliable sources when properly vetted.

3. What packaging considerations are essential for potassium chloride API in bulk?
API should be packaged in sterile, pharmaceutical-grade plastic containers that prevent contamination, oxidation, and moisture ingress, ensuring stability over the product’s shelf-life.

4. How does geopolitics influence API sourcing for potassium chloride?
Trade policies, tariffs, and geopolitical tensions can impact supply chain stability. Diversifying suppliers across different regions mitigates risks associated with disruptions.

5. What are the cost implications of sourcing from global suppliers?
Chinese and Indian suppliers typically offer competitive prices, but additional costs may arise from shipping, certification documentation, and quality testing. Balancing cost with quality assurance is essential.

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References

[1] PharmSource, "Global Pharmaceutical API Market Overview," 2022.
[2] U.S. Pharmacopeia, "USP Standards for Potassium Chloride," 2022.
[3] China Food and Drug Administration, "GMP Certification Requirements," 2022.
[4] European Medicines Agency, "Guidelines on Good Manufacturing Practice," 2022.
[5] MarketWatch, "Potassium Chloride Market Trends," 2023.