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Suppliers and packagers for POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9%
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POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9%
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Fresenius Kabi Usa | POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% | dextrose; potassium chloride; sodium chloride | INJECTABLE;INJECTION | 213445 | ANDA | Fresenius Kabi USA, LLC | 65219-118-10 | 10 BAG in 1 CASE (65219-118-10) / 1000 mL in 1 BAG (65219-118-01) | 2022-08-31 |
| Fresenius Kabi Usa | POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% | dextrose; potassium chloride; sodium chloride | INJECTABLE;INJECTION | 213445 | ANDA | Fresenius Kabi USA, LLC | 65219-119-10 | 10 BAG in 1 CASE (65219-119-10) / 1000 mL in 1 BAG (65219-119-01) | 2022-08-31 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Potassium Chloride 40 mEq in Dextrose 5% and Sodium Chloride 0.9%
Introduction
The pharmaceutical market for intravenous (IV) electrolyte solutions, such as Potassium Chloride 40 mEq in Dextrose 5% and Sodium Chloride 0.9%, is highly regulated and characterized by a limited number of trusted suppliers due to stringent quality standards. These solutions are critical for various clinical indications, including electrolyte replenishment, hydration, and maintenance therapy. Securing reliable suppliers ensures compliance, quality assurance, and consistent product availability to meet global healthcare demands.
Market Overview
Potassium Chloride (KCl) in combination with Dextrose 5% (D5W) and Sodium Chloride 0.9% (normal saline) is a standard IV formulation used worldwide. Its manufacturing requires advanced sterile processing, rigorous quality control, and adherence to regulatory standards such as the U.S. FDA, EMA, and comparable authorities across Asia, Africa, and Latin America.
The global IV fluids market is projected to grow due to rising prevalence of chronic illnesses, increasing hospitalizations, and expanding healthcare infrastructure, particularly in emerging economies. As a result, key suppliers are expanding manufacturing capacity and diversifying their product portfolios.
Major Suppliers of Potassium Chloride in Dextrose 5% and 0.9% Sodium Chloride
1. Baxter International Inc.
Overview:
A leading global provider of IV fluids and electrolyte solutions, Baxter offers a comprehensive portfolio including Potassium Chloride in Dextrose 5% and Sodium Chloride 0.9%. Known for robust quality systems, Baxter supplies hospitals, clinics, and distribution networks worldwide.
Product Highlights:
- Commercially standardized formulations with FDA and EU compliance.
- Availability in multiple packaging sizes, including multi-dose vials and prefilled infusion bags.
Market Footprint:
Strong presence across North America, Europe, and Asia through direct manufacturing facilities and authorized distributors.
2. Fresenius Kabi
Overview:
A major player in generic and sterile injectable pharmaceuticals, Fresenius Kabi produces both potassium chloride and sodium chloride solutions, including combination products formulated with Dextrose 5%.
Product Highlights:
- Adheres to Good Manufacturing Practices (GMP).
- Offers ready-to-use infusion solutions compatible with various administration devices.
- Focuses on innovation in sterile production processes.
Market Footprint:
Extensive distribution network in Europe, Asia-Pacific, and Latin America.
3. B. Braun Melsungen AG
Overview:
A German-based multinational specializing in infusion therapy and clinical nutrition, B. Braun manufactures trustworthy electrolyte solutions, including IV potassium and sodium chloride combinations.
Product Highlights:
- High-quality ingredients with rigorous testing.
- Emphasis on safety features to minimize infusion errors.
- Wide portfolio spanning clinical and outpatient settings.
Market Footprint:
Presence in over 50 countries, especially strong in Europe, North America, and Asia.
4. Hospira (a Pfizer company)
Overview:
A renowned supplier of sterile injectables, Hospira offers a breadth of IV fluids, including potassium chloride and normal saline solutions in various formulations.
Product Highlights:
- Focus on cost-effective, high-quality products.
- Extensive supply chain network.
- Regulatory approvals across major markets.
Market Footprint:
Global reach with notable presence in North America, Europe, and Asia.
5. Otsuka Pharmaceutical
Overview:
Otsuka produces IV electrolyte solutions, contributing to markets in Asia and expanding globally, with a focus on sterile injectable formulations.
Product Highlights:
- Complies with international standards.
- Known for consistent quality and innovation.
- Supplies both hospitals and pharmaceutical distributors.
Market Footprint:
Strong in Asian countries such as Japan, China, and Southeast Asia.
Emerging and Regional Suppliers
While the aforementioned companies dominate the global market, regional manufacturers in India, China, and Latin America are increasingly important due to cost advantages and local regulatory compliance. These include:
- Vifor Pharma (Global player, with regional manufacturing facilities).
- Shandong Weigao Group (China).
- Gland Pharma (India).
- Hikma Pharmaceuticals (Middle East and North Africa).
These regional suppliers often serve as alternative sources, especially for bulk procurement and localized distribution.
Considerations for Supplier Selection
- Regulatory Compliance: Confirm adherence to local and international standards (FDA, EMA, WHO GMP).
- Quality Assurance: Product sterility, stability, and consistency are non-negotiable.
- Supply Chain Reliability: Evaluate manufacturing capacity, lead times, and regional logistics.
- Pricing and Contract Terms: Competitive pricing balanced with quality assurance.
- Certification and Accreditation: ISO 13485, WHO-GMP certification, and others are critical indicators.
Challenges and Risks
- Regulatory Variability: Differing requirements across markets can delay procurement.
- Supply Disruptions: Political instability, manufacturing issues, or raw material shortages can impact supply.
- Counterfeit and Substandard Products: Vigilance is necessary, especially in emerging markets with less stringent regulations.
- Pricing Fluctuations: Market dynamics and raw material costs can influence pricing structures.
Conclusion
Securing reliable suppliers for Potassium Chloride 40 mEq in Dextrose 5% and Sodium Chloride 0.9% involves navigating a landscape of globally recognized manufacturers and regional producers. Top-tier companies such as Baxter, Fresenius Kabi, B. Braun, and Hospira lead the market with high standards of quality, regulatory compliance, and extensive distribution networks. Companies seeking procurement partnerships should prioritize compliance, product integrity, and supply chain resilience to ensure uninterrupted access to these critical IV solutions.
Key Takeaways
- The global market is led by Baxter, Fresenius Kabi, B. Braun, and Hospira, offering high-quality, regulatory-compliant potassium chloride and sodium chloride solutions.
- Regional suppliers in Asia, India, and Latin America provide cost-effective alternatives but require thorough vetting for quality assurance.
- Supply chain resilience, regulatory compliance, and product safety are paramount considerations in supplier selection.
- Emerging geopolitical or economic factors can influence raw material availability and manufacturing stability.
- Diversification of suppliers minimizes risk and enhances procurement flexibility.
FAQs
1. What regulatory certifications should I verify for suppliers of IV electrolyte solutions?
Manufacturers should have GMP compliance from recognized authorities like the FDA or EMA, ISO 13485 certification, and adherence to WHO-GMP standards for global markets.
2. Are regional suppliers suitable alternatives for international procurement?
Yes, regional suppliers in India, China, and Latin America often offer cost advantages and can meet quality standards if appropriately certified and vetted.
3. How does supply chain disruption impact procurement of IV solutions?
Disruptions can lead to shortages, delays, and increased costs. Establishing multiple supplier relationships and maintaining safety stocks mitigate these risks.
4. What should healthcare providers look for beyond price when selecting suppliers?
Product quality, regulatory compliance, supply reliability, and after-sales support are critical factors. Certifications and audit histories also provide insight into supplier credibility.
5. How do geopolitical factors influence supplier availability?
Trade policies, tariffs, export bans, and regional conflicts can restrict or delay supplies, emphasizing the importance of diversified sourcing strategies.
References:
[1] Market analysis reports on global IV fluids and electrolyte solutions.
[2] Company websites and official product datasheets of Baxter, Fresenius Kabi, B. Braun, and Hospira.
[3] World Health Organization (WHO) guidelines for pharmaceutical manufacturing.
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