Suppliers and packagers for POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER

POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Baxter Hlthcare	POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER	potassium chloride	INJECTABLE;INJECTION	019904	NDA	Baxter Healthcare Corporation	0338-0703-41	24 BAG in 1 CARTON (0338-0703-41) / 50 mL in 1 BAG	1989-12-26
Baxter Hlthcare	POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER	potassium chloride	INJECTABLE;INJECTION	019904	NDA	Baxter Healthcare Corporation	0338-0703-48	24 BAG in 1 CARTON (0338-0703-48) / 100 mL in 1 BAG	1989-12-26
Baxter Hlthcare	POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER	potassium chloride	INJECTABLE;INJECTION	019904	NDA	Baxter Healthcare Corporation	0338-0705-41	24 BAG in 1 CARTON (0338-0705-41) / 50 mL in 1 BAG	1989-12-26

Suppliers for the Pharmaceutical Drug: Potassium Chloride 20 mEq in Plastic Container

Last updated: August 7, 2025

Introduction

Potassium chloride (KCl) 20 mEq in plastic containers is a critical pharmaceutical product used extensively in clinical settings for treating hypokalemia and as an electrolyte replenisher. The global demand for this medication is driven by the increasing prevalence of cardiovascular diseases, kidney disorders, and electrolyte imbalances. Ensuring a reliable supply chain involves identifying reputable manufacturers and suppliers capable of meeting quality standards and regulatory requirements. This report delineates the leading suppliers globally, their manufacturing capabilities, and considerations for procurement.

Overview of Potassium Chloride 20 mEq in Plastic Containers

Potassium chloride is commonly supplied in various formulations, with the 20 mEq strength (equivalent to 20 milliequivalents per 10 mL or as specified) being among the most used in infusion therapy. Packaging in plastic containers, such as infusion bags or bottles, facilitates sterile administration. Suppliers must comply with stringent quality controls, including Good Manufacturing Practices (GMP), and obtain necessary approvals from health authorities like the FDA, EMA, or other relevant regulatory bodies.

Global Leading Suppliers and Manufacturers

1. B. Braun Melsungen AG

Overview: B. Braun is a German multinational renowned for manufacturing infusion therapy solutions, including potassium chloride. Their portfolio includes sterile solutions in plastic containers designed for intravenous administration.

Capabilities & Compliance: B. Braun adheres to strict GMP standards, and their products are widely approved in multiple markets. They have an extensive distribution network worldwide, supplying hospitals and healthcare providers with reliable infusion solutions.

Product Range: B. Braun offers potassium chloride 20 mEq solutions in plastic infusion bags and bottles, with certifications including FDA approvals and CE marking, ensuring compliance with global standards.

2. Baxter International Inc.

Overview: Baxter is an American healthcare company with a significant presence in intravenous solutions, including potassium chloride formulations. Their products are known for high purity and stability.

Manufacturing & Quality Control: Baxter’s manufacturing facilities follow cGMP guidelines, and the company invests heavily in quality assurance processes. Their potassium chloride infusions are available in various plastic container formats suitable for clinical use.

Global Reach: Baxter’s products are available in North America, Europe, and Asia, with regulatory approvals from agencies like the FDA and EMA.

3. Fresenius Kabi AG

Overview: Based in Germany, Fresenius Kabi specializes in infusion solutions and injectable drugs, including potassium chloride in plastic containers. Their focus is on clinical efficacy and safety.

Supply and Compliance: They manufacture under strict GMP conditions, with products approved by numerous health authorities. Their globally distributed potassium chloride solutions are used in hospitals and clinics alike.

4. ICU Medical

Overview: ICU Medical manufactures infusion therapy solutions with a focus on aseptic production. They produce potassium chloride in plastic containers suited for intravenous administration.

Regulatory Standing: Their products meet global regulatory standards, including US FDA and EU CE certifications, ensuring safety and quality.

5. Pfizer Inc.

Overview: Pfizer offers a range of injectable solutions, including potassium chloride in plastic containers, mainly for hospital use.

Product Characteristics: Pfizer’s formulations adhere to high-quality standards, with widespread availability in various markets.

6. Hikma Pharmaceuticals

Overview: Hikma produces generic injectable drugs, including potassium chloride solutions in plastic containers, serving both emerging and developed markets.

Regulatory & Quality: Compliant with cGMP protocols, Hikma’s products undergo rigorous testing and validation.

7. Sagent Pharmaceuticals

Overview: Sagent specializes in sterile injectable pharmaceuticals, including potassium chloride solutions designed for IV infusion, supplied in plastic containers.

Compliance & Distribution: Their products meet US FDA standards, with an expanding presence in the global market.

Regional and Specialty Suppliers

• Sun Pharma (India): Known for cost-effective injectable solutions, including potassium chloride.
• Hengrui Medicine (China): Growing presence in injectable pharmaceuticals with a focus on Asia.
• West-Ward Pharmaceuticals (USA): Offers injectable electrolytes, including potassium chloride.

Key Selection Factors for Suppliers

Regulatory Compliance

Suppliers must have approvals from designated regulatory authorities (e.g., FDA, EMA). Product documentation should include stability data, Certificate of Analysis (CoA), and compliance with pharmacopeial standards (USP, EP, BP).

Manufacturing Capabilities

Facilities need to adhere to GMP, maintain sterile environments, and demonstrate consistent product quality. Large-scale manufacturers typically have better capacity for supply continuity.

Quality Assurance and Certifications

Certifications such as ISO 9001, ISO 13485, and adherence to pharmacopeia standards are crucial for quality assurance.

Pricing and Supply Chain Reliability

Given the critical nature of the medication, suppliers with proven logistics, timely delivery, and competitive pricing are preferred.

Market Presence and Customer Support

Established suppliers with robust customer service and technical support facilitate smooth procurement and issue resolution.

Regional Market Considerations

• North America: Dominated by Baxter, ICU Medical, and Pfizer. Stringent regulatory environment emphasizes product safety and compliance.
• Europe: Fresenius Kabi, B. Braun, and Hikma hold significant market shares, with high regulatory standards.
• Asia-Pacific: Growing supply chain with suppliers like Sun Pharma and Hengrui providing cost-effective options.
• Emerging Markets: Focus on establishing partnerships with regional distributors and generic manufacturers to ensure affordable access.

Supply Chain Challenges and Risk Mitigation

• Regulatory Delays: Ongoing compliance updates may delay approvals; maintaining quality documentation is essential.
• Quality Variability: Sourcing from manufacturers with established GMP compliance reduces risk.
• Supply Disruption: Diversification of suppliers minimizes dependency on single entities.
• Price Fluctuations: Long-term contracts and volume-based negotiations can ensure stability.

Conclusion

The procurement of potassium chloride 20 mEq in plastic containers necessitates partnering with suppliers possessing robust regulatory compliance, consistent quality, and reliable supply chains. Leading manufacturers such as B. Braun, Baxter, and Fresenius Kabi dominate the global market, offering high-quality products supported by extensive certifications. Emerging suppliers from Asia provide cost-effective alternatives but require rigorous validation. Strategic sourcing, considering regulatory standards and supply chain resilience, is critical to maintaining uninterrupted availability in clinical settings.

Key Takeaways

• Prioritize suppliers with FDA, EMA, or equivalent approvals, and GMP-certified manufacturing facilities.
• Establish diversified supplier relationships to mitigate supply chain disruptions.
• Evaluate product documentation, including stability data and pharmacopeial compliance.
• Consider logistical capabilities and after-sales support in supplier selection.
• Monitor regional regulatory developments to ensure continued compliance and supply.

FAQs

Q1: What regulatory approvals should a supplier of potassium chloride in plastic containers possess?
A1: Suppliers should hold approvals from key agencies such as the US FDA, European EMA, or other relevant health authorities, with certifications confirming GMP compliance and product registration.

Q2: Are domestic or regional manufacturers viable sources for potassium chloride?
A2: Yes, especially in emerging markets, regional manufacturers can provide cost-effective options. However, verifying their regulatory compliance and quality standards is essential.

Q3: How does packaging impact the quality and stability of potassium chloride solutions?
A3: Proper sterile, sealed plastic containers prevent contamination, maintain stability, and ensure safe infusion. The packaging must meet pharmacopeial and regulatory standards.

Q4: What considerations are essential when selecting a supplier for large-scale procurement?
A4: Consistency of quality, regulatory compliance, supply capacity, logistical support, and pricing are key considerations for large-scale procurement.

Q5: How do geopolitical factors influence the supply chain of pharmaceutical electrolytes?
A5: Trade restrictions, tariffs, and geopolitical tensions can affect availability and pricing. Establishing diversified and strategic supplier partnerships can mitigate these risks.

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Sources

[1] B. Braun. (2022). Infusion Solutions Overview.
[2] Baxter International. (2022). Injectable Solutions Portfolio.
[3] Fresenius Kabi. (2022). Infusion Therapy Products.
[4] ICU Medical. (2022). Aseptic Infusion Solutions.
[5] Pfizer Inc. (2022). Injectable Pharmaceuticals.