Suppliers and packagers for POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% IN PLASTIC CONTAINER
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POTASSIUM CHLORIDE 0.15% 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 0.15% 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 0.15% in Dextrose 5% in Plastic Container
Introduction
The demand for potassium chloride (KCl) in dextrose solutions is significant within hospital and clinical settings for electrolyte replenishment and parenteral nutrition. This specific formulation—potassium chloride 0.15% in dextrose 5% in plastic containers—addresses the need for safe, sterile, and stable intravenous (IV) electrolytes. Given the complex regulatory landscape and the importance of reliable supply chains, understanding the key suppliers is essential for procurement, manufacturing, and distribution stakeholders. This article systematically examines the global landscape of suppliers for this specific drug formulation, considering manufacturing capacities, regulatory compliance, and market presence.
Global Market Overview and Demand
Potassium chloride in dextrose solutions is a standard IV therapy component, with enormous demand across North America, Europe, Asia-Pacific, and emerging markets. Hospitals rely on high-quality sterile preparations, often sourced from companies holding Good Manufacturing Practice (GMP) certifications and robust supply chains.
The formulation's particular concentration—0.15% potassium chloride in 5% dextrose—in plastic containers, requires specialized sterile compounding and packaging capabilities, typically provided by multinational pharmaceutical manufacturers and contract manufacturers (CMOs).
Major Suppliers and Manufacturers
1. Baxter International Inc.
Baxter is a leading provider of IV solutions globally. Their portfolio includes sterile, pre-packaged electrolyte solutions, including potassium chloride in dextrose formulations. Baxter’s manufacturing facilities in the U.S., Europe, and Asia ensure compliance with international standards such as FDA, EMA, and WHO cGMP regulations. Its supply chain boasts high-volume production capability, ensuring ongoing availability for hospitals and distributors.
2. B. Braun Melsungen AG
This German-based company manufactures a broad spectrum of IV fluids, including potassium chloride solutions. B. Braun emphasizes quality, safety, and innovates in container technologies—including plastic bags and bottles—that meet global regulatory standards. Their market reach extends worldwide, particularly strong in Europe and North America.
3. Fresenius Kabi AG
Fresenius is renowned for its extensive portfolio of sterile infusion solutions, including potassium chloride 0.15% in 5% dextrose in plastic containers. Their manufacturing facilities in Germany, the United States, and India enable large-scale production aligned with international regulatory frameworks. Fresenius’ products are widely used in hospital settings across multiple continents.
4. Hospira, A Pfizer Company
Though now part of Pfizer, Hospira specializes in the manufacture of sterile injectable drugs, including electrolyte formulations. Their global manufacturing network ensures reliable supply chains with an emphasis on sterile processing and compliance with GMP standards.
5. Harrods Pharmaceuticals (India)
A significant regional manufacturer, Harrods supplies sterile electrolyte solutions to Asia and Africa. Their facilities adhere to WHO-GMP standards, and their products often serve as cost-effective alternatives for hospitals in developing regions.
6. Local and Contract Manufacturers
Numerous regional and contract manufacturing organizations supply potassium chloride dextrose solutions, especially in markets with logistical restrictions or specific regulatory requirements. Notable contract manufacturers include Vifor Pharma, Seqirus, and Baxter’s contract manufacturing units.
Regulatory and Quality Standards
More… ↓
