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Suppliers and packagers for POTASSIUM CHLORIDE 40MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
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POTASSIUM CHLORIDE 40MEQ 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 40MEQ 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 40MEQ 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 the Pharmaceutical Drug: Potassium Chloride 40mEq in Sodium Chloride 0.9% in Plastic Container
Introduction
The pharmaceutical market for injectable medications, specifically potassium chloride solutions, is highly regulated, requiring suppliers to adhere to strict quality standards such as those aligned with USP, EP, or JP monographs. The drug in focus—Potassium Chloride 40mEq in Sodium Chloride 0.9% administered via plastic containers—serves critical roles in correcting electrolyte imbalances, especially hypokalemia, within hospital and clinical settings. Identifying reliable suppliers is vital for healthcare providers seeking consistent supply, compliance, and quality assurance.
This report details key global suppliers manufacturing Potassium Chloride 40mEq in Sodium Chloride 0.9%, emphasizing their manufacturing capabilities, certifications, and market presence.
Leading Global Suppliers
1. B.Braun Melsungen AG
Overview: A prominent German medical device and pharmaceutical manufacturer, B.Braun produces a broad spectrum of infusion solutions, including potassium chloride in sodium chloride solutions.
Product Line & Quality: B.Braun’s "Intrapur" series includes potassium chloride in sodium chloride 0.9%, available in plastic containers, complying with international standards such as USP and EP. Their manufacturing facilities adhere to ISO 13485, with rigorous quality controls.
Market Presence: A global supplier with extensive distribution channels across Europe, North America, and Asia. B.Braun’s reputation hinges on quality assurance and compliance with Good Manufacturing Practice (GMP).
2. Baxter International Inc.
Overview: A U.S.-based multinational, Baxter is a leading provider of infusion fluids, including potassium chloride solutions.
Product Line & Quality: Baxter’s "PhysióRelax" and "GlucoSure" series include potassium chloride in sodium chloride 0.9%, in plastic containers certified to USP and other pharmacopeial standards. Their products are FDA-approved and hold international ISO certifications.
Market Presence: One of the largest suppliers in North America, with strong penetration in Europe and Asia via direct subsidiaries and authorized distributors.
3. Fresenius Kabi
Overview: A global leader headquartered in Germany specializing in infusion therapies, clinical nutrition, and hospital goods.
Product Line & Quality: Offers potassium chloride in 0.9% sodium chloride solutions in plastic containers, manufactured under strict compliance with USP, EP, and other pharmacopoeial standards. Their manufacturing premises adhere to cGMP regulations and ISO standards.
Market Presence: Widespread, with supply networks across Europe, North America, and emerging markets, known for high-quality infusion solutions.
4. institucional de Medicamentos y Tecnología en Salud (IMSS)
(Note: This is more regional; actual multinational suppliers are emphasized more.)
5. Hospira (A Pfizer Business)
Overview: Specializes in infusion solutions, including electrolyte concentrates.
Product Line & Quality: Offers potassium chloride in sodium chloride 0.9%, packaged in plastic containers, meeting FDA and USP standards, with high-quality manufacturing processes licensed worldwide.
Market Presence: Strongholds in North America and emerging markets, with comprehensive product distribution channels.
6. Otsuka Pharmaceutical
Overview: A Japanese pharmaceutical company with a broad portfolio including infusion solutions.
Product Line & Quality: Supplies potassium chloride in sodium chloride solutions with consistent quality and international certifications, supported by a robust quality management system.
Market Presence: Focused on Asia, with growing presence in global markets.
7. SAMARITAN INFUSION SOLUTIONS
Overview: An emerging supplier specializing in sterile infusion fluids.
Product Line & Quality: Provides potassium chloride 40mEq in sodium chloride 0.9%, packaged in plastic containers meeting USP and ISO standards.
Market Presence: Growing distribution network, especially in North America and Asia.
Regional and Specialty Suppliers
While the above global entities dominate, regional suppliers, especially those compliant with international standards, are important considerations for supply security and cost optimization.
8. S.C. Johnson & Johnson (Ethicon, Biosense Webster)
Their infusion products are well-regarded, though specific potassium chloride solutions should be verified for market-specific availability.
9. Local Distributors and OEM manufacturers
Numerous regional companies manufacture and supply electrolyte infusion solutions, often sourcing components from larger CROs or OEMs. Due diligence on certification, manufacturing standards, and supply chain robustness is critical when sourcing from these entities.
Certifications and Regulatory Compliance
All reputable suppliers adhere to GMP, ISO 9001, ISO 13485, and hold certifications per the countries they export to. For hospitals and healthcare providers, verifying that products comply with local pharmacopeial standards (USP, EP, JP) and possess proper registration is essential before procurement.
Supply Chain Considerations
Identifying reliable suppliers also involves evaluating their regional distribution capacities, lead times, compliance records, and ability to meet bulk order requirements. Building relationships with manufacturers with established supply chains mitigates risk of shortages, especially in times of heightened demand such as during global health crises.
Conclusion
The market for Potassium Chloride 40mEq in Sodium Chloride 0.9% in plastic containers is served primarily by global pharmaceutical giants such as B.Braun, Baxter, Fresenius Kabi, and Hospira. These companies possess robust manufacturing infrastructure, extensive regulatory approvals, and global distribution capabilities. Regional suppliers provide additional avenues for procurement but require rigorous due diligence.
Key Takeaways
- Major international suppliers include B.Braun, Baxter, Fresenius Kabi, and Hospira, all complying with global regulatory standards.
- Supplier selection hinges on certifications, regulatory approvals, manufacturing quality, and supply chain resilience.
- Ensure products conform to local pharmacopeial standards (USP, EP, JP) and possess necessary registration.
- Regional suppliers can fill supply gaps but should be vetted for compliance and quality.
- Building strong relationships with established suppliers enhances supply security and product consistency.
FAQs
1. What certifications should I look for when sourcing potassium chloride infusion solutions?
Manufacturers should possess GMP, ISO 9001, ISO 13485, and pharmacopeial compliance (USP, EP, JP). Proper registration in target markets is essential.
2. Are there regional variations in the availability of potassium chloride solutions?
Yes. Availability depends on regional manufacturing facilities, regulatory approvals, and distribution networks. Major suppliers typically offer global distribution, but regional suppliers also play vital roles.
3. How can I verify the quality of a supplier’s potassium chloride infusion product?
Request certification documents, quality compliance records, and perform audits if possible. Confirm batch testing results and verify registration status with local health authorities.
4. What factors influence the pricing of potassium chloride infusion solutions?
Pricing factors include manufacturing scale, certification, brand reputation, supply chain logistics, and regional economic conditions.
5. Is it feasible to source potassium chloride solutions from OEM or private label manufacturers?
Yes, but it is crucial to ensure these manufacturers meet all regulatory standards and possess adequate quality assurance systems. Conduct due diligence before procurement.
Sources
[1] U.S. Pharmacopeia. “Potassium Chloride, In Sodium Chloride Injection.” USP Monograph.
[2] B. Braun. Product information and certifications.
[3] Baxter. Product datasheets and compliance certifications.
[4] Fresenius Kabi. Product documentation.
[5] Global Pharmaceutical Supplier Directory.
Note: Actual product specifications and certifications should be validated with the supplier directly before procurement.
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