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Suppliers and packagers for POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% IN PLASTIC CONTAINER
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POTASSIUM CHLORIDE 0.075% 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 0.075% 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 Potassium Chloride 0.075% in Dextrose 5% in Plastic Container
Overview of Potassium Chloride in Dextrose Solutions
Potassium chloride (KCl) in Dextrose 5% solution—commonly known as Dextrose 5% with potassium chloride—is a vital parenteral electrolyte replenishment therapy used in medical settings. Its primary role is correcting hypokalemia, maintaining electrolyte balance, and providing nutritional support, especially in IV formulations. The drug is packaged in sterile, single-use plastic containers, typically polyethylene or polypropylene bottles, to ensure stability and ease of administration.
Given its widespread clinical use, the global supply chain features numerous reputable manufacturers and distributors. This article explores key suppliers supplying Potassium Chloride 0.075% in Dextrose 5% solutions in plastic containers, focusing on large-scale, validated, and quality-assured providers.
Major Pharmaceutical Manufacturers and Suppliers
1. Baxter International Inc.
Overview: Baxter is a leading global provider of IV solutions, including electrolyte replenishments. Their product line includes Dextrose and potassium chloride formulations in sterile plastic containers. Baxter’s manufacturing facilities adhere to stringent GMP standards, ensuring high-quality products.
Product Details: Baxter offers customized formulations of potassium chloride in Dextrose 5% solutions, available in various container sizes suitable for hospital settings.
Distribution: They operate through a widespread network, especially in North America and Europe, with select suppliers globally.
2. B. Braun Melsungen AG
Overview: B. Braun specializes in infusion therapies and is a prominent provider of intravenous electrolytes. Their products meet international pharmaceutical standards and are widely used in clinical environments.
Product Details: B. Braun supplies potassium chloride in Dextrose 5%, packaged in ready-to-use plastic containers with precise concentration specifications, including the 0.075% strength.
Distribution: Their global distribution network ensures broad availability, including markets in Europe, North America, and Asia.
3. Fresenius Kabi
Overview: A key player in hospital and infusion therapies, Fresenius Kabi produces a comprehensive portfolio of electrolyte solutions, including potassium chloride in Dextrose solutions.
Product Details: Their products are known for compliance with rigorous international quality standards and are available in various container sizes, optimized for clinical use.
Distribution: The company maintains a robust global distribution network, ensuring consistent availability in emerging and developed markets.
4. Hospira (A Pfizer Company)
Overview: Hospira, now part of Pfizer, is renowned for its sterile injectable drugs and infusion solutions.
Product Details: They supply potassium chloride in dextrose solutions, packaged in pre-filled, sterile plastic containers, with strict adherence to pharmacopoeial requirements.
Distribution: Extensive global reach with a focus on North American and European markets.
5. West-Ward Pharmaceuticals (Part of Hikma Pharmaceuticals)
Overview: West-Ward specializes in sterile injectable products, including electrolyte solutions.
Product Details: Offers potassium chloride in dextrose solutions, in various container sizes, with a focus on quality assurance and regulatory compliance.
Distribution: Strong presence in North America, Middle East, and other regions.
Regional and Generic Suppliers
In addition to these global giants, several regional and generic manufacturers supply Potassium Chloride 0.075% in Dextrose 5% plastic containers:
- Sagent Pharmaceuticals: An American manufacturer with a focus on hospital-use IV solutions.
- Viatris (Formerly Mylan): Supplies a range of sterile solutions, including electrolytes, with widespread distribution.
- DFL (Dompe Farmaceutici): Italian-based manufacturer providing IV solutions to European markets.
- Uni-Pharma Inc.: Regional supplier operating primarily within Southeast Asia.
Key Considerations When Selecting Suppliers
- Regulatory Compliance: Ensure product approval per local regulatory agencies (FDA, EMA, PMDA, etc.).
- Quality Assurance: Verify manufacturing certifications (GMP, ISO 13485).
- Product Stability & Packaging: Confirm compatibility of plastic container material with potassium chloride solutions.
- Supply Chain Reliability: Evaluate the supplier’s capacity for consistent delivery, especially amidst global supply chain disruptions.
- Pricing and Contract Terms: Negotiate bulk purchase discounts and flexible supply agreements.
Emerging Trends and Alternative Suppliers
Recent shifts toward regional manufacturing and increased demand due to global health crises have led to the emergence of new suppliers and shorter supply chains. Alternative sources include:
- Indian and Chinese pharmaceutical companies: such as Cipla, Aurobindo Pharma, and Shanghai Fosun Pharmaceutical, which have expanded their sterile injectable product lines.
- Contract Manufacturing Organizations (CMOs): Offering customization, scale, and rapid deployment.
Supply Chain Challenges and Solutions
The supply of IV solutions like potassium chloride in Dextrose solutions often faces challenges due to:
- Global shortages: Fluctuations in raw material availability.
- Regulatory hurdles: Variances across regions.
- Logistical delays: Especially during pandemics or geopolitical disturbances.
Mitigation strategies include diversifying supplier base, establishing long-term contracts, and prioritizing suppliers with validated cold chain and logistics networks.
Conclusion
Multiple reputable suppliers vertically integrated with high regulatory standards supply Potassium Chloride 0.075% in Dextrose 5% solutions in plastic containers. Key players like Baxter, B. Braun, Fresenius Kabi, Hospira, and Hikma lead the global market, supported by regional manufacturers and generic producers. Choosing the right supplier hinges on regulatory compliance, supply reliability, product quality, and cost considerations. Staying aligned with evolving supply chain dynamics and regulatory standards ensures continuous access for healthcare providers and mitigates potential shortages.
Key Takeaways
- Global Leaders: Baxter, B. Braun, Fresenius Kabi, Hospira, and Hikma dominate the supply landscape.
- Regulatory & Quality Standards: Essential for ensuring safety and efficacy—verify certifications before procurement.
- Supply Chain Resilience: Engage multiple suppliers, especially regional ones, to mitigate shortages.
- Market Trends: Regional manufacturing and emerging suppliers are expanding options but require due diligence.
- Procurement Strategy: Prioritize quality, reliability, and compliance over cost alone to ensure patient safety.
FAQs
1. Are generic suppliers as reliable as global pharmaceutical companies for Potassium Chloride solutions?
Yes. Many regional and generic manufacturers meet international GMP standards, providing quality-equivalent products. Nevertheless, it’s essential to verify certifications, regulatory approvals, and supplier audits before procurement.
2. What regulatory bodies should approve Potassium Chloride in Dextrose solutions?
Regulatory approvals should come from agencies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), or equivalent national authorities, ensuring compliance with safety and quality standards.
3. How can supply chain disruptions be minimized when sourcing IV electrolyte solutions?
Diversify suppliers across regions, establish long-term relationships, monitor global market trends, and maintain buffer stocks to handle sudden shortages or delays.
4. What are the main packaging materials used for these solutions, and do they affect stability?
Sterile plastic containers, typically polyethylene or polypropylene, are standard. They provide inert, stable environments for solutions, with packaging materials validated to prevent leaching or container-solution interactions.
5. Is it possible to customize formulations or container sizes for Potassium Chloride 0.075% in Dextrose 5%?
Yes. Many manufacturers offer customization options, including concentration adjustments, volume capacities, and specialized packaging, especially for hospital or institutional needs.
Sources:
- [FDA Drug Approvals and Guidelines]
- [European Medicines Agency Database]
- [Company Websites and Product Catalogs of Baxter, B. Braun, Fresenius Kabi, Hospira, Hikma]
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