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Suppliers and packagers for TPN ELECTROLYTES IN PLASTIC CONTAINER
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TPN ELECTROLYTES 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 |
|---|---|---|---|---|---|---|---|---|---|
| Hospira | TPN ELECTROLYTES IN PLASTIC CONTAINER | calcium chloride; magnesium chloride; potassium chloride; sodium acetate; sodium chloride | INJECTABLE;INJECTION | 018895 | NDA | Hospira, Inc. | 0409-5779-01 | 25 VIAL, SINGLE-DOSE in 1 CARTON (0409-5779-01) / 20 mL in 1 VIAL, SINGLE-DOSE (0409-5779-11) | 2005-02-28 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: TPN ELECTROLYTES IN PLASTIC CONTAINER
Introduction
Total Parenteral Nutrition (TPN) electrolytes in plastic containers represent a critical component in clinical nutrition management, especially for patients unable to take oral or enteral routes. The procurement process for these specialized formulations demands precise sourcing from reputable suppliers who adhere to stringent regulatory, safety, and quality standards. This report provides a comprehensive overview of leading suppliers globally providing TPN electrolytes in plastic containers, emphasizing their product portfolios, regulatory compliance, market presence, and strategic advantages.
Market Landscape for TPN Electrolytes in Plastic Containers
The global market for TPN electrolytes is expanding, driven by increasing prevalence of gastrointestinal disorders, oncology treatments, and critically ill patient care. The demand for pre-mixed, ready-to-use solutions, such as TPN electrolytes in plastic containers, is rising owing to their extended shelf life, reduced contamination risk, and convenience.
Major manufacturers focus on high-quality, sterile, and stable formulations delivered in polyethylene (PE) or polypropylene (PP) containers. Suppliers vary from multinational pharmaceutical giants to specialized niche manufacturers, often regulated by agencies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and other national authorities.
Leading Suppliers for TPN Electrolytes in Plastic Containers
1. Baxter International Inc.
Overview: Baxter is a global leader in medical products, including nutritional solutions. It offers a broad portfolio of TPN solutions with electrolytes designed for stability and compatibility in plastic containers.
Product Highlights:
- Baxter's PREVAIL series includes TPN electrolytes in clear, ready-to-use plastic containers.
- Solutions formulated with precise concentrations of sodium, potassium, magnesium, calcium, and chloride.
- Containers made primarily of polyethylene or polyolefin blends for optimal safety and stability.
Regulatory & Quality Standards: Baxter’s products comply with FDA cGMP standards, USP monographs, and ISO certifications.
Market Presence: North America, Europe, Asia-Pacific.
2. ICU Medical (Smiths Medical)
Overview: ICU Medical specializes in healthcare innovations, including electrolyte solutions for TPN.
Product Highlights:
- Offers a range of electrolytes in ready-to-use plastic container formats.
- Emphasizes contamination control and extended shelf life.
- Solutions tailored for pediatric, adult, and critical care applications.
Regulatory & Quality Standards: Meets FDA and CE requirements, adherence to USP standards.
Market Presence: North America, Europe, emerging markets in Asia and Middle East.
3. Fresenius Kabi
Overview: Renowned for infusion therapy, Fresenius Kabi produces customizable electrolyte solutions and TPN components.
Product Highlights:
- Supplies electrolyte mixes in sterile, low-particulate plastic containers.
- Focuses on high-purity, additive-free formulations suitable for TPN.
Regulatory & Quality Standards: GMP compliance, ISO certified manufacturing facilities, CE marking in Europe.
Market Presence: Global footprint, with strong foothold in Europe, Asia, and the Americas.
4. Nutricia (Danone)
Overview: Nutricia, part of Danone, specializes in clinical nutrition, including electrolyte formulations for TPN.
Product Highlights:
- TPN solutions with electrolytes preloaded into plastic containers.
- Focus on pediatric and adult nutritional therapy with formulations ensuring osmolarity stability.
Regulatory & Quality Standards: Secures approvals across major health authorities with GMP adherence.
Market Presence: Europe, Middle East, Asia-Pacific.
5. B. Braun Melsungen AG
Overview: B. Braun offers comprehensive infusion therapy solutions, including electrolyte products in plastic containers.
Product Highlights:
- Pre-mixed electrolyte solutions designed for TPN administration.
- Compatibility with various infusion devices and line systems.
Regulatory & Quality Standards: Compliant with FDA, EMA, and other relevant agencies.
Market Presence: Europe, North America, Asia.
Emerging & Niche Suppliers
Beyond the giants, several specialty manufacturers serve regional markets with tailored TPN electrolyte solutions:
- Fresenius Kabi India and MACOPHARMA (France) offer regional supply options with customizable electrolyte formulations.
- Vifor Pharma emphasizes mineral-based electrolyte solutions aligned with nephrology and pediatric needs.
- BTG International supplies specialized electrolyte additive kits for compounded TPNs, focusing on aseptic handling.
Key Factors Influencing Supplier Selection
- Regulatory Compliance: Certification adherence is paramount; suppliers must meet local and international standards.
- Product Compatibility: Packaging materials should prevent leaching, pyrogenicity, and microbial contamination.
- Supply Chain Robustness: Reliable logistics, shelf life, and inventory management are essential to avoid shortages.
- Customization & Formulation Flexibility: Ability to tailor electrolyte concentrations per clinical protocols.
- Cost & Contract Terms: Competitive pricing, volume discounts, and procurement terms influence supplier decisions.
Regulatory and Quality Considerations
Ensuring product safety involves verifying suppliers' compliance with Good Manufacturing Practices (GMP), purification standards, and sterility requirements. Notably, suppliers should provide stability data supporting shelf life and container compatibility, aligned with pharmacopeial standards such as the USP, EP, or JP monographs.
Furthermore, for products intended for regulated markets, suppliers must hold appropriate manufacturing licenses, undergo periodic audits, and operate in validated facilities.
Conclusion
The procurement of TPN electrolytes in plastic containers necessitates a strategic approach grounded in product quality, regulatory adherence, and supply chain resilience. Leading global manufacturers such as Baxter International, ICU Medical, Fresenius Kabi, Nutricia, and B. Braun offer reliable, high-quality solutions tailored to diverse clinical needs. Emerging regional suppliers provide additional options, especially in markets with localized regulatory requirements or specific formulation preferences.
Key Takeaways
- Prioritize regulatory compliance: Ensure suppliers meet the relevant standards (FDA, EMA, ISO, GMP) to mitigate risks.
- Assess product compatibility: Confirm that plastic containers are chemically inert and stable under storage conditions.
- Evaluate supply chain stability: Choose suppliers with a proven track record for timely delivery and adequate inventory levels.
- Leverage customization options: Select suppliers capable of tailoring electrolyte concentrations to patient-specific protocols.
- Consider regional manufacturing: For cost efficiency and quicker turnaround, regional suppliers can be advantageous.
FAQs
1. What are the primary factors to consider when sourcing TPN electrolytes in plastic containers?
Key factors include regulatory compliance, product stability, container compatibility, supply chain reliability, and the ability to customize formulations.
2. Are all TPN electrolyte solutions in plastic containers suitable for all patient populations?
Not necessarily. Formulations should be tailored to specific patient needs, considering age, clinical condition, and electrolyte imbalances, and suppliers must provide appropriate formulations.
3. How do I verify the quality of TPN electrolyte products from different suppliers?
Verify certification documents, batch testing reports, stability data, and compliance with pharmacopeial standards during supplier qualification.
4. What role does container material play in the safety of TPN electrolytes?
Container materials such as polyethylene or polypropylene are selected for inertness; they must prevent leaching and contamination, maintaining electrolyte stability during storage.
5. How can procurement professionals mitigate risks associated with supply shortages?
Developing relationships with multiple approved suppliers, maintaining adequate inventory levels, and signing long-term contracts can help ensure continuous supply.
Sources
- Baxter International Inc. Product datasheets and regulatory filings.
- ICU Medical product catalogs and FDA approvals.
- Fresenius Kabi official product information.
- Danone Nutricia Clinical Nutrition documentation.
- B. Braun Melsungen AG manufacturing standards and certifications.
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