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Suppliers and packagers for DEXTROSE 50% IN PLASTIC CONTAINER
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DEXTROSE 50% 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 |
|---|---|---|---|---|---|---|---|---|---|
| Baxter Hlthcare | DEXTROSE 50% IN PLASTIC CONTAINER | dextrose | INJECTABLE;INJECTION | 020047 | NDA | Baxter Healthcare Corporation | 0338-0719-06 | 2000 mL in 1 BAG (0338-0719-06) | 1991-07-02 |
| Otsuka Icu Medcl | DEXTROSE 50% IN PLASTIC CONTAINER | dextrose | INJECTABLE;INJECTION | 018563 | NDA | ICU Medical Inc. | 0990-7936-19 | 12 POUCH in 1 CASE (0990-7936-19) / 1 BAG in 1 POUCH / 500 mL in 1 BAG | 2019-10-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: DEXTROSE 50% IN PLASTIC CONTAINER
Introduction
Dextrose 50% in plastic containers is a widely used intravenous (IV) fluid in clinical settings, primarily for rapid infusion and correction of hypoglycemia. Its demand has surged across hospitals, clinics, and pharmaceutical distributors globally. Identifying reliable suppliers is essential for healthcare providers to ensure a consistent, high-quality supply chain, regulatory compliance, and cost-effectiveness. This article provides an in-depth overview of key manufacturers and distributors specializing in Dextrose 50% solutions in plastic containers, analyzing their market presence, quality standards, and sourcing strategies.
Market Overview
The global parenteral nutrition solutions market is projected to grow at a compound annual growth rate (CAGR) of approximately 4-5% over the next five years, driven by increasing incidences of diabetes, malnutrition, and emergency care needs [1]. Within this landscape, Dextrose 50% in plastic containers represents a critical segment, with a rising shift toward pre-filled, ready-to-use solutions that enhance safety and convenience.
The procurement of Dextrose 50% involves considerations such as pharmaceutical-grade purity, aseptic manufacturing, clear labeling, shelf stability, and compliance with regulatory frameworks like the U.S. FDA, EMA, and other regional agencies.
Leading Suppliers and Manufacturers
1. Baxter International Inc.
Overview: Baxter is a global leader in healthcare solutions, producing a comprehensive portfolio of IV fluids, including Dextrose solutions. Their proprietary line, Baxter IV Solutions, is renowned for high purity, stringent quality control, and global distribution capabilities.
Product Details: Baxter manufactures Dextrose 50% in sterile, ready-to-use plastic containers, designed for hospital and clinical use. The products adhere to USP and EP standards, with rigorous sterility testing.
Market Reach: Extensive distribution across North America, Europe, Asia-Pacific, with well-established supply chains supporting hospital, emergency, and home care sectors.
Regulatory Compliance: GMP-certification, FDA registration, and CE marking ensure compliance with major regulatory bodies.
2. Hospira (a Pfizer company)
Overview: Hospira is a key global supplier specializing in injectable medications and infusion solutions. Their Dextrose 50% in plastic bottles conforms to pharmaceutical standards and is widely adopted in various healthcare settings.
Product Details: The solution is supplied in tamper-evident, aseptically sealed plastic containers, highlighted for stability and ease of handling.
Market Reach: Strong presence in North America, with expanding operations in emerging markets through regional partners.
Regulatory Compliance: FIFO-accredited manufacturing facilities, adherence to USP, and DMF submissions bolster quality assurances.
3. B. Braun Melsungen AG
Overview: B. Braun is a German-based leader recognized for parenteral nutrition solutions, including Dextrose formulations. Their offerings focus on safety, stability, and compatibility with infusion systems.
Product Details: B. Braun supplies Dextrose 50% in sterile, polyvinyl chloride (PVC) or alternative plastic containers, complying with international pharmacopeias.
Market Reach: Wide distribution network across Europe, Asia, Middle East, and Africa, emphasizing high-production standards and customized solutions.
Regulatory Compliance: Certified under ISO standards, with robust pharmacovigilance systems.
4. Fresenius Kabi
Overview: Fresenius Kabi produces a comprehensive range of sterile infusion solutions, including Dextrose 50%. Their focus on innovation ensures high-quality products suitable for diverse clinical environments.
Product Details: Packages include ready-to-use plastic bottles, with emphasis on thermal stability, sterility, and patient safety.
Market Reach: Extensive presence in Europe, North America, and Asia-Pacific, along with a dedicated supply chain network.
Regulatory Compliance: Strict compliance with cGMP, US FDA approvals, and the European Medicines Agency (EMA) standards.
5. Jagotec GmbH (a part of the Fresenius Group)
Overview: Specializes in sterile bulk solutions, including Dextrose formulations for hospital and industrial use. Known for customization options and regional market penetration.
Product Details: Provides Dextrose 50% in plastic containers designed for rapid IV infusion with validation for clinical safety.
Market Reach: Emerging presence in Asia and Middle East, with a focus on standardization and compliance.
Regional Distributors and Contract Manufacturing
In addition to the above manufacturers, regional distributors often procure from these giants and repack or distribute Dextrose 50% in plastic containers, catering to localized demand and regulatory requirements. Contract manufacturers (CMOs) are also instrumental, especially for custom formulations, bulk supplies, or private-label products aligned with specific client standards.
Sources and Regulatory Considerations
Procurement strategies should prioritize suppliers holding valid FDA registrations, EU GMP certifications, and compliance with pharmacopeial standards like USP, EP, or JP. Quality assurance mechanisms, including batch testing, stability data, and Certificates of Analysis (CoA), are critical for procurement approval.
Emerging Trends and Future Outlook
- Enhanced Safety and Packaging: Transition toward pre-filled, closed-system containers with tamper-evident caps, reducing infection risk.
- Sustainability Initiatives: Incorporation of eco-friendly plastics and recyclable packaging aligns with global green protocols.
- Digital Integration: Use of serialization, QR codes, and blockchain for traceability in supply chains.
- Regional Manufacturing Growth: Increasing local manufacturing capacity in emerging markets to reduce costs and mitigate logistical disruptions.
Key Takeaways
- Major global suppliers like Baxter, Pfizer-Hospira, B. Braun, and Fresenius dominate the Dextrose 50% market in plastic containers, offering high-quality, regulatory-compliant products.
- Stability, sterility, and regulatory compliance are critical parameters for sourcing Dextrose 50% solutions, especially in hospital and critical care contexts.
- Regional distributors and contract manufacturers play vital roles in customized solutions, catering to local regulatory landscapes and market needs.
- Trends favor safer packaging, sustainability, and integrated supply chain solutions, impacting procurement strategies.
- Due diligence in supplier qualification, including validation of GMP compliance and traceability, ensures uninterrupted clinical operations.
FAQs
1. What are the primary international standards governing Dextrose 50% in plastic containers?
The main standards include the United States Pharmacopeia (USP), European Pharmacopoeia (EP), and Japanese Pharmacopoeia (JP), which specify purity, sterility, stability, and packaging requirements.
2. How do I verify the quality of Dextrose 50% from suppliers?
Request Certificates of Analysis (CoA), GMP certification, and detailed stability and sterility testing reports. Cross-verify supplier registration with regulatory authorities like FDA or EMA to confirm compliance.
3. Are there sustainable packaging alternatives for Dextrose 50% solutions?
Yes. Manufacturers are developing recyclable plastics, biodegradable containers, and reusable infusion systems to reduce environmental impact while maintaining safety standards.
4. Which regions have the fastest-growing markets for Dextrose 50% solutions?
Emerging markets in Asia-Pacific, Middle East, and Latin America are experiencing rapid growth due to expanding healthcare infrastructure and increased demand for parenteral nutrition.
5. Can Dextrose 50% in plastic containers be compounded locally?
While technically possible, local compounding often faces regulatory hurdles. Procuring ready-to-use, GMP-certified products from established suppliers ensures quality, compliance, and safety in clinical settings.
References
[1] MarketWatch. “Parenteral Nutrition Market Size, Share & Trends Analysis Report.” 2022.
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