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Suppliers and packagers for POTASSIUM CHLORIDE 20MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
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POTASSIUM CHLORIDE 20MEQ IN SODIUM CHLORIDE 0.9% 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 |
|---|---|---|---|---|---|---|---|---|---|
| Otsuka Icu Medcl | POTASSIUM CHLORIDE 20MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | potassium chloride; sodium chloride | INJECTABLE;INJECTION | 019686 | NDA | ICU Medical Inc. | 0990-7115-09 | 12 POUCH in 1 CASE (0990-7115-09) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG | 2019-11-01 |
| Otsuka Icu Medcl | POTASSIUM CHLORIDE 20MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | potassium chloride; sodium chloride | INJECTABLE;INJECTION | 019686 | NDA | ICU Medical Inc. | 0990-7116-09 | 12 POUCH in 1 CASE (0990-7116-09) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG | 2019-12-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for Potassium Chloride 20mEq in Sodium Chloride 0.9% in Plastic Container
Introduction
The pharmaceutical market for electrolytes is indispensable in clinical, hospital, and emergency settings, given the critical role of maintaining electrolyte balance. Among these, Potassium Chloride (KCl) at a concentration of 20mEq in a 0.9% sodium chloride (NaCl) solution, packaged in plastic containers, is a standard intravenous (IV) electrolyte replenisher. Identifying reliable suppliers for this formulation is crucial for healthcare providers demanding high-quality, regulatory-compliant products. This article offers an exhaustive overview of current key suppliers, focusing on global and regional manufacturers known for manufacturing this specific formulation.
Market Overview of Potassium Chloride in Sodium Chloride 0.9% Solutions
Potassium Chloride in 0.9% Sodium Chloride solution, also referred to as normal saline with added potassium, is a routine product used to correct hypokalemia, maintain electrolyte balance, and support various clinical interventions. The global demand for such formulations has surged over recent years, driven by expanding healthcare infrastructure, increased prevalence of electrolyte disturbances, and the growing use of IV therapies.
Manufacturers typically produce these solutions under strict regulatory standards, such as GMP (Good Manufacturing Practice), to ensure safety and efficacy.
Leading Suppliers of Potassium Chloride 20mEq in Sodium Chloride 0.9% in Plastic Containers
1. Baxter International Inc.
Overview:
Baxter is a leading global provider of sterile IV solutions, including electrolyte products. Their portfolio features pre-filled and large-volume IV solutions, including potassium chloride solutions in sodium chloride.
Product Details:
- Packaging Options: Plastic bottles (typically 250 mL, 500 mL, or 1000 mL).
- Compliance: FDA-approved, CE-marked, and compliant with international standards.
- Distribution: Worldwide, with extensive supply chains in North America, Europe, and Asia.
Reputation & Capacity:
Baxter’s manufacturing prowess and quality controls position it as a preferred supplier for hospitals and pharmaceutical companies seeking reliable electrolyte solutions.
2. B. Braun Melsungen AG
Overview:
B. Braun offers a broad spectrum of IV fluids, including potassium chloride in sodium chloride 0.9%, produced under stringent regulatory environments.
Product Details:
- Packaging: Plastic containers (250 mL to 1000 mL).
- Features: Compatible with standard IV infusion sets, assured stability, and shelf life.
- Certifications: ISO, GMP, and compliant with both European and US regulatory standards.
Global Reach:
B. Braun’s large manufacturing network supports consistent supply across multiple regions, emphasizing product purity and batch-to-batch uniformity.
3. Fresenius Kabi AG
Overview:
Fresenius Kabi is a prominent manufacturer of IV drug solutions, including electrolyte replenishment products.
Product Details:
- Packaging: Plastic containers suitable for IV infusion.
- Quality Standards: Adheres to USFDA, EUGMP, and other regulatory standards.
- Availability: Sold extensively in North America, Europe, and Asia-Pacific markets.
Key Strengths:
Fresenius is noted for its technological advances in aseptic manufacturing processes, ensuring high product safety.
4. Hospira (a Pfizer company)
Overview:
Hospira specializes in sterile injectable drugs and infusion solutions, with extensive lines of electrolyte products.
Product Details:
- Packaging: Various volumes in plastic containers, including prefilled and flexible bottles.
- Regulatory Compliance: USFDA-approved with international certifications.
- Distribution Footprint: Major markets in North America, Latin America, and emerging economies.
5. MacoPharma (part of the Macau Pharmaceutical Group)
Overview:
MacoPharma manufactures and supplies electrolyte solutions and infusion fluids, catering to regional markets with high compliance standards.
Product Details:
- Packaging: Plastic bottles, compatible with infusion pumps.
- Regulatory Certificates: WHO-GMP, ISO compliance, and regional approvals.
6. Local and Regional Manufacturers
In addition to multinational corporations, various regional manufacturers in Asia-Pacific, Latin America, and Eastern Europe produce Potassium Chloride in Sodium Chloride solutions, often at competitive prices:
- Fresenius Kabi India
- HIS Pharmaceuticals (India)
- China-based manufacturers like Jiangsu Hengrui Medicine
These manufacturers often cater to local hospitals and distributors, adhering to local GMP standards but may vary in global regulatory compliance.
Key Considerations When Selecting Suppliers
- Regulatory Compliance: Ensure products meet local and international standards, such as USFDA, EMA, or WHO-GMP certifications.
- Product Stability & Packaging: Confirm the suitability of plastic containers for IV administration, stability data, and expiry.
- Supply Chain Reliability: Choose suppliers with robust logistics, especially in the context of global disruptions.
- Pricing & Contract Terms: Evaluate cost-effectiveness, volume discounts, and contractual flexibility.
- Reputation & Quality Track Record: Prioritize companies with proven safety profiles and consistent quality certifications.
Emerging Trends & Future Outlook
The electrolytes market is witnessing innovations like pre-filled syringes, ready-to-use formulations, and closed-system containers to reduce contamination risks. Manufacturers investing in process automation and sterilization enhancements are likely to strengthen their market position.
Furthermore, increasing demand in emerging markets and the expansion of hospital infrastructure promises continued growth for suppliers capable of scaling up production while maintaining quality.
Conclusion
Securing reliable suppliers for Potassium Chloride 20mEq in Sodium Chloride 0.9% in plastic containers requires thorough vetting of quality standards, regulatory compliance, and supply chain robustness. Leading global providers like Baxter, B. Braun, Fresenius Kabi, and Hospira remain prominent choices, backed by extensive regulatory approvals and manufacturing capacity. Regional manufacturers can also serve local needs efficiently, provided they meet necessary standards.
Healthcare organizations should prioritize suppliers with a proven track record for safety, consistency, and logistical reliability to ensure uninterrupted, high-quality electrolyte therapy.
Key Takeaways
- Major global suppliers include Baxter, B. Braun, Fresenius Kabi, and Hospira, all recognized for compliance and manufacturing excellence.
- Regional manufacturers can offer competitive pricing but require careful validation of regulatory adherence.
- Packaging quality and compatibility with infusion systems are critical for safety.
- Maintaining diversified supplier relationships minimizes supply risks amid global disruptions.
- Staying informed about emerging formulations and technology advances enhances supply chain resilience.
FAQs
1. Are there specific licensing requirements for importing potassium chloride solutions?
Yes. Importers must comply with local regulatory agencies such as the FDA (USA), EMA (Europe), or respective national authorities, ensuring the products are approved and labeled appropriately.
2. What are the key safety features to consider in plastic containers for IV solutions?
Containers should be sterile, tamper-evident, made from inert, medical-grade plastics, and compatible with infusion systems to prevent contamination, degradation, or leaching.
3. How does the quality of regional manufacturers compare to global suppliers?
While many regional manufacturers meet local standards, global suppliers typically adhere to more rigorous international quality standards, but regional players can be suitable if certified accordingly.
4. Can these electrolyte solutions be used beyond hospital settings?
Yes. They are also used in clinics, emergency services, and in certain controlled outpatient care settings where sterile IV administration is required.
5. How should healthcare providers verify the authenticity of supplied potassium chloride solutions?
Verify certificates of analysis, batch records, and certification labels. Prefer suppliers that provide traceability and have transparent quality assurance processes.
Sources:
[1] Baxter International Inc. – Product information and regulatory compliance statements.
[2] B. Braun Melsungen AG – Official product catalog.
[3] Fresenius Kabi – Corporate website and product datasheets.
[4] Hospira (Pfizer) – USFDA approval documents.
[5] WHO-GMP guidelines and regional manufacturing standards.
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