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Suppliers and packagers for POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% IN PLASTIC CONTAINER
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POTASSIUM CHLORIDE 0.037% 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 0.037% 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 0.037% in Dextrose 5% in Plastic Container
Introduction
Potassium chloride (KCl) 0.037% in dextrose 5% offers critical electrolyte replacement in intravenous therapy, particularly within hospital, clinic, and pharmaceuticals manufacturing settings. The demand for this formulation hinges on pharmaceutical quality, safety standards, and reliable supply chains. Identifying key suppliers capable of providing high-quality, regulatory-compliant potassium chloride injections in plastic containers is essential for stakeholders aiming to ensure drug availability and compliance.
Market Overview
The global intravenous (IV) electrolyte solutions market is projected to reach USD 4.3 billion by 2027, with a compounded annual growth rate (CAGR) of approximately 6.4%[1]. The segment for potassium-containing solutions constitutes a significant portion due to escalating hospitalizations and chronic disease management. Suppliers must comply with rigorous regulatory standards such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and other regional agencies that enforce Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP).
Leading Suppliers of Potassium Chloride 0.037% in Dextrose 5% in Plastic Containers
1. Baxter International Inc.
Overview:
Baxter is a global leader in IV solutions, including potassium chloride in dextrose formulations. Their products are known for high quality, rigorous safety standards, and extensive distribution networks. They manufacture potassium chloride solutions in various container types, including plastic bag and bottle formats.
Capabilities:
- Registration in multiple regions, including U.S., Europe, and Asia.
- Manufacturing facilities compliant with GMP standards.
- Extensive supply chain infrastructure ensuring large-scale distribution.
Product Features:
- Available in sterile, ready-to-use plastic containers.
- Meets pharmacopoeial standards (Pharmacopeia monographs).
- Compliant with USP, EP, and JP standards.
Market Presence:
Baxter's reputation for reliability makes them a preferred supplier for hospitals and pharmaceutical companies globally.
2. Fresenius Kabi
Overview:
Fresenius Kabi specializes in infusion therapies, including potassium chloride solutions. The German-based company maintains an expansive product portfolio with a focus on sterile, ready-to-use solutions in plastic containers.
Capabilities:
- Extensive manufacturing footprint adhering to international GMP.
- Focused on sterile, pyrogen-free IV solutions.
- Products available globally through direct and distributor channels.
Product Features:
- Potassium chloride in dextrose 5% solution supplied in color-coded, transparent plastic bottles.
- Consistent quality control aligned with EU and US pharmacopoeial standards.
Market Presence:
Highly ranked within hospital, clinic, and pharmaceutical supply chains across Europe, Asia, and the Americas.
3. Hikma Pharmaceuticals
Overview:
Hikma produces a range of injectable pharmaceuticals, including potassium chloride-in-dextrose formulations, targeting both regional and international markets.
Capabilities:
- Manufacturing compliant with US, EU, and Middle Eastern standards.
- Focus on sterile, pyrogen-free solutions.
- Strong regional distribution in the Middle East, Africa, and parts of Europe and North America.
Product Features:
- Potassium chloride in Dextrose 5% in plastic vials.
- Suitable for hospital and clinical use with strict quality assurance processes.
Market Presence:
Hikma’s strategic manufacturing and distribution networks bolster their role in supply continuity.
4. Sagent Pharmaceuticals (Now part of Hikma Pharmaceuticals)
Overview:
Specializes in sterile injectable drugs, including electrolyte solutions, with a focus on the North American market.
Capabilities:
- US FDA-approved manufacturing facilities.
- Compliance with cGMP and USP requirements.
- Wide distribution across hospitals and clinics.
Product Features:
- Readily available potassium chloride in dextrose formulations in plastic containers.
- Emphasis on quality, stability, and safety profiles.
Market Presence:
Sagent’s presence in North America makes it a reliable supplier for US-based procurement needs.
5. Sun Pharmaceutical Industries Ltd.
Overview:
As one of India’s largest pharmaceutical companies, Sun Pharma offers injectable electrolyte solutions, including potassium chloride in dextrose solutions suitable for export.
Capabilities:
- Manufacturing facilities compliant with US, EU, and Indian regulations.
- Competitive pricing due to scale advantages.
- Growing global distribution network, especially across Asia and Africa.
Product Features:
- Potassium chloride in 5% dextrose solutions in plastic containers tailored to regional needs.
Emerging and Regional Suppliers
In addition to global leaders, regional manufacturers often cater to local markets with high compliance and competitive pricing, particularly in Asia and Eastern Europe. Such suppliers can serve as cost-effective alternatives, especially in regions with developed GMP-certified manufacturing capabilities.
Regulatory Considerations
Suppliers must adhere to regional regulatory standards such as:
- United States: FDA’s cGMP regulations, USP<797> standards.
- European Union: EMA, Eudralex guidelines, and GMP compliance.
- Asia: Compliance varies by country but increasingly aligns with WHO Good Manufacturing Practices.
Selection of suppliers also necessitates verifying Certificate of Pharmaceutical Product (CPP), stability data, lot-to-lot consistency, and compliance history.
Conclusion: Strategic Supplier Selection
For stakeholders seeking reliable sources of potassium chloride 0.037% in dextrose 5% in plastic containers, globally recognized suppliers such as Baxter, Fresenius Kabi, Hikma, Sagent, and Sun Pharma represent the top-tier options. Their extensive manufacturing capacity, adherence to international standards, and proven distribution network ensure supply security for hospitals, clinics, and pharmaceutical manufacturers.
Key Takeaways
- Global pharmaceutical leaders dominate the supply chain, with Baxter and Fresenius Kabi as prominent options.
- Regional manufacturers provide cost-effective, compliant alternatives, particularly in emerging markets.
- Regulatory compliance, quality assurance, and supply chain robustness are critical when selecting suppliers.
- Ensuring supplier certifications such as GMP, FDA approval, and standard monographs mitigates risks related to safety and efficacy.
- Early engagement with suppliers regarding certification, stability data, and logistical capabilities streamlines procurement.
FAQs
1. What are the primary criteria for selecting a supplier of potassium chloride in IV solutions?
Regulatory compliance (GMP certification, regional approvals), product quality and consistency, supply stability, and pricing are paramount. Suppliers must also provide stability data, Certificates of Analysis, and adhere to pharmacopoeial standards.
2. Are regional suppliers as reliable as global leaders for high-demand pharmaceutical ingredients?
Yes, provided they meet stringent GMP and quality standards. Many regional suppliers maintain international certifications such as ISO and comply with regional regulatory agencies, ensuring comparable reliability.
3. What regulatory certifications should a reliable supplier possess?
Major certifications include FDA approval (USA), EMA certification (EU), WHO GMP, ISO certifications, and country-specific licenses.
4. How does the choice of container material impact drug stability?
Plastic containers (like polyethylene or polypropylene bottles) are widely used due to their chemical inertness, durability, and ease of use. Suppliers ensure container compatibility with KCl and dextrose to maintain stability and prevent leaching or contamination.
5. What are the logistical considerations in sourcing potassium chloride solutions internationally?
Lead times, shipping regulations, import tariffs, cold chain requirements, and local distribution networks impact procurement. Ensuring supplier adherence to GDP and efficient logistics partnerships mitigates supply disruptions.
Sources:
[1] MarketsandMarkets, "Intravenous (IV) Fluid and Electrolyte Solutions Market," 2021.
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