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Suppliers and packagers for POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINER
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POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% 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 |
|---|---|---|---|---|---|---|---|---|---|
| B Braun | POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINER | dextrose; potassium chloride | INJECTABLE;INJECTION | 019699 | NDA | B. Braun Medical Inc. | 0264-7625-00 | 12 CONTAINER in 1 CASE (0264-7625-00) / 1000 mL in 1 CONTAINER | 1989-09-29 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Potassium Chloride 0.3% in Dextrose 5% in Plastic Container
Overview of Potassium Chloride 0.3% in Dextrose 5% in Plastic Container
Potassium chloride (KCl) at a concentration of 0.3% in dextrose 5% solution is a commonly used intravenous fluid, predominantly for replenishing potassium levels and maintaining electrolyte balance in clinical settings. The formulation’s sterile, stable nature requires manufacturers and supply chains that meet stringent pharmaceutical standards. The solution’s primary packaging involves plastic containers, usually IV bags, designed for safe administration.
Key Requirements for Suppliers
Suppliers must adhere to Good Manufacturing Practices (GMP), have FDA or equivalent regulatory approval, and maintain robust quality assurance protocols. Packaging must comply with regulatory standards like USP, EP, or JP monographs, depending on the region.
Global Suppliers and Manufacturers
1. Baxter International Inc.
- Overview: A leading manufacturer of sterile infusion solutions, Baxter supplies a broad portfolio, including potassium chloride in dextrose solutions.
- Product Specifications: Offers 0.3% potassium chloride in 5% dextrose in multi-dose and single-dose plastic IV bags.
- Certifications: FDA-approved, ISO-certified manufacturing facilities.
- Markets: Global, with strong presence in North America, Europe, and Asia.
2. B. Braun Melsungen AG
- Overview: German-based healthcare company with a comprehensive portfolio of infusion solutions.
- Product Specifications: Provides potassium chloride 0.3% in 5% dextrose, packaged in polyethylene or polyvinyl chloride (PVC) IV bags.
- Certifications: CE mark, GMP compliance, and FDA registration.
- Markets: Europe, North America, Asia, and Africa.
3. ICU Medical (Smiths Medical)
- Overview: Specializes in IV therapy, including large-volume infusion solutions.
- Product Specifications: Supplies potassium chloride 0.3% in dextrose solutions, primarily for institutional use.
- Certifications: FDA 510(k), ISO 13485, and other international standards.
- Markets: North America, Europe, and Asia-Pacific.
4. Hospira, a Pfizer Company
- Overview: Known for its extensive portfolio, Hospira offers potassium chloride infusion solutions.
- Product Specifications: 0.3% potassium chloride in 5% dextrose, packaged in sterile, flexible IV bags.
- Certifications: FDA registration, ISO standards compliance.
- Markets: Global.
5. Fresenius Kabi
- Overview: A leading provider of infusion therapies and IV solutions with a broad distribution network.
- Product Specifications: Supplies potassium chloride in dextrose 5% solutions, packaged in prefilled plastic containers.
- Certifications: ISO, GMP, and FDA.
- Markets: Worldwide, especially in Europe and Asia.
Regional and Local Suppliers
Certain regions maintain local or regional manufacturers to meet specific market demands and regulatory requirements.
India
- Micro Labs Ltd.
- Venkateshwara Hatcheries Ltd.
- Cipla Ltd.
These companies produce sterile infusion solutions, including potassium chloride 0.3% in dextrose, for domestic and export markets, often meeting WHO GMP standards.
China
- Shanghai Xinyi Pharmaceutical Co.
- North China Pharmaceutical Group Corp. (NCPC)
These firms supply IV solutions to Asia and other emerging markets, providing cost-competitive options.
Quality and Regulatory Considerations
Suppliers must supply products with validated sterility, stability, and compatibility, conforming to pharmacopoeial standards such as the USP, EP, or JP. Being registered with regulatory authorities (FDA, EMA, NMPA) ensures compliance with quality standards. Furthermore, suppliers should have documentation for batch traceability, stability data, and clear instructions for use.
Emerging Trends and Suppliers
The increasing demand for ready-to-use sterile infusion solutions has prompted new entrants, especially in emerging markets, to develop sterile, stable formulations packaged in high-quality plastic containers. Companies investing in advanced sterile manufacturing and quality control methodologies are better positioned for long-term partnerships.
Supply Chain Challenges
Supply chain risks include raw material shortages, regulatory delays, geopolitical tensions, and logistical disruptions. Due diligence on supplier quality assurance programs and regulatory standing is crucial.
Summary of Top Suppliers
| Supplier | Location | Certification | Market Focus | Packaging Types |
|---|---|---|---|---|
| Baxter International Inc. | USA | FDA, ISO | Global | IV bags (PVC, PE) |
| B. Braun Melsungen AG | Germany | CE, GMP, FDA | Europe, Asia | Polyethylene, PVC IV bags |
| ICU Medical | USA | FDA 510(k), ISO | North America, APAC | Plastic IV bags |
| Hospira (Pfizer) | USA | FDA, ISO | Worldwide | Sterile IV bags |
| Fresenius Kabi | Germany | ISO, GMP | Europe, Asia | Infusion bottles, bags |
Key Takeaways
- Leading multinational companies like Baxter, B. Braun, ICU Medical, Hospira, and Fresenius Kabi dominate the supply of potassium chloride 0.3% in dextrose 5% in plastic containers.
- Regulatory compliance, especially FDA approval and GMP adherence, remains essential for procurement and quality assurance.
- Emerging regional manufacturers provide cost-effective alternatives but require thorough due diligence regarding quality standards.
- Supply chain resilience involves diversifying suppliers and monitoring geopolitical and logistical risks.
- Packaging standards are critical to maintaining sterility and stability; IV bag quality directly impacts patient safety.
Frequently Asked Questions
1. What are the primary regulatory standards for suppliers of potassium chloride injections?
Suppliers must conform to pharmacopoeial standards such as USP, EP, or JP. Additionally, regulatory approval by agencies like the FDA, EMA, or NMPA ensures compliance with pharmaceutical manufacturing requirements and safety standards.
2. How does supplier quality impact patient safety?
High-quality suppliers guarantee product sterility, accurate concentration, stability, and proper packaging, all crucial in preventing adverse events and ensuring effective patient treatment.
3. Are regional suppliers suitable alternatives to global brands?
Regional manufacturers can offer cost-effective options, particularly in emerging markets. However, validating their quality assurance processes and regulatory compliance is imperative before procurement.
4. What are the typical packaging types for this formulation?
Potassium chloride 0.3% in dextrose 5% is usually packaged in sterile, prefilled plastic containers such as IV bags made from PVC or polyethylene, designed for safe intravenous administration.
5. How can supply chain risks be mitigated?
Diversify suppliers, establish long-term agreements, conduct regular quality audits, and maintain stock buffer levels to address potential disruptions caused by raw material shortages or logistical issues.
References
[1] FDA Drug Database. (2022). List of approved intravenous solutions.
[2] International Society for Pharmaceutical Engineering (ISPE). (2021). Good Manufacturing Practices for Injectable Drugs.
[3] European Pharmacopoeia (EP). (2022). Standards on infusion solutions.
[4] World Health Organization. (2020). Good manufacturing practices for sterile pharmaceutical products.
[5] GlobalData. (2022). Market analysis of intravenous solutions and supply chain dynamics.
This comprehensive overview provides business professionals with crucial insights into suppliers capable of providing high-quality potassium chloride 0.3% in dextrose 5% solutions in plastic containers, emphasizing regulatory compliance, quality assurance, and strategic procurement considerations.
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