Last updated: July 30, 2025
Introduction
The pharmaceutical product Delflex with Dextrose 1.5%, Low Magnesium in Plastic Container is a specialized intravenous (IV) formulation used predominantly in clinical settings, primarily for fluid and electrolyte replenishment. This formulation necessitates sourcing from reliable manufacturers that adhere to stringent quality standards, including Good Manufacturing Practices (GMP), regulatory approvals, and supply consistency.
In this analysis, we identify key suppliers capable of manufacturing or distributing Delflex with specified composition and packaging, focusing on global pharmaceutical companies, contract manufacturing organizations (CMOs), and suppliers with proven expertise in sterile injectable solutions.
Product Overview
Delflex W/ Dextrose 1.5% Low Magnesium is a sterile, parenteral fluid designed for intravenous administration. Its formulation typically consists of dextrose (glucose) as a carbohydrate source, with minimal magnesium content tailored to patient needs, presented in durable, light-protective plastic containers suitable for hospital and clinical use.
Manufacturers must meet regulatory standards such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), or equivalents, and operate under strict sterile manufacturing environments.
Key Supplier Categories
- Original Equipment Manufacturers (OEMs) & Brand Owners
- Contract Manufacturing Organizations (CMOs)
- Authorized Distributors & Importers
- Regional/National Suppliers
Leading Suppliers & Manufacturers
1. Baxter International Inc.
Profile: Baxter is a global leader in sterile injectable products, including IV fluids infused with dextrose solutions. Known for its rigorous quality standards and extensive distribution network, Baxter manufactures various dextrose-containing IV fluids under brand names like Dextrose 5% in Water (D5W) and similar formulations.
Relevance: Baxter’s portfolio includes low-magnesium dextrose solutions in plastic containers. Their manufacturing standards comply with FDA, EMA, and other regulatory bodies, making them a primary supplier for hospitals worldwide.
Supply Capabilities: Multiple manufacturing facilities globally, ensuring supply chain robustness, including in North America, Europe, and Asia.
2. B. Braun Melsungen AG
Profile: B. Braun produces a broad portfolio of IV solutions, including dextrose and electrolyte-balanced fluids tailored for various clinical needs.
Relevance: Their Dextrose solutions, often available in prefilled plastic containers, meet international GMP standards, with formulations that can be adapted to low magnesium content as per custom specifications.
Supply Capabilities: Extensive global distribution, with regional manufacturing units ensuring timely supply.
3. Pfizer Inc.
Profile: Pfizer, a leading pharmaceutical entity, manufactures and distributes parenteral solutions, including dextrose-based IV fluids, often used in hospital settings worldwide.
Relevance: Their sterile solutions adhere to strict regulatory requirements, with high-quality manufacturing standards capable of producing customized formulations.
Supply Capabilities: Large-scale global manufacturing network capable of fulfilling high-volume demands.
4. Hospira (a Pfizer company)
Profile: Specializes in injectable drugs and infusion solutions, including dextrose in plastic containers.
Relevance: Known for high compliance with GMP, Hospira’s offerings include custom formulations and container types suited for hospital use.
Supply Capabilities: Broad distribution channels across North America and internationally.
5. Fresenius Kabi
Profile: A significant player in sterile hospital products, offering IV solutions such as dextrose with electrolyte compositions.
Relevance: Capable of providing low-magnesium formulations in plastic containers, with a focus on hospital-grade supplies.
Supply Capabilities: Global manufacturing infrastructure ensuring supply security.
Contract Manufacturing Organizations (CMOs)
For formulators or distributors seeking tailored or private-label solutions, CMOs offer manufacturing excellence:
- Lonza Group
- Catalent Pharma Solutions
- Recipharm
- Famar
- BIO-TECHNE
These CMOs can produce Delflex W/ Dextrose 1.5% Low Magnesium to specific specifications, including specialized container materials and dosing.
Regional & Specialty Suppliers
In addition to global giants, regional pharmaceutical suppliers and distributors, like Sun Pharmaceutical, Hubei Bostar Pharmaceutical, or Local distributors in Asia, Europe, and North America, may have formulations meeting the specifications or can source via international supply chains.
Regulatory & Quality Considerations
Suppliers must demonstrate compliance with pharmacopeial standards (USP, EP, JP), possess current GMP certifications, and verify stability and sterility data for containers used. Importantly, plastic container compatibility, preservative-free formulations, and aseptic filling are non-negotiable for injectable solutions.
Industry certifications like ISO 9001 and ISO 13485, along with regulatory approvals from relevant authorities, are indicators of supplier reliability.
Supply Chain & Distribution Dynamics
Global supply chains for sterile injectable solutions are sensitive to geopolitical, logistical, and regulatory factors. Ensuring uninterrupted supply for Delflex formulations requires establishing relationships with suppliers demonstrating:
- Proven quality and compliance history
- Adequate manufacturing capacity
- Robust logistics networks
- Ability to adapt to regional regulatory variations
Conclusion
The primary suppliers for Delflex W/ Dextrose 1.5% Low Magnesium in plastic containers include industry giants like Baxter, B. Braun, Hospira (Pfizer), and Fresenius Kabi, complemented by reputable CMOs such as Catalent and Lonza. Regional suppliers can serve specific markets, often with customizable formulations.
Stakeholders should prioritize suppliers with proven regulatory compliance, extensive distribution networks, and capacity for customization and supply continuity.
Key Takeaways
- Global leaders such as Baxter and B. Braun are primary sources for sterile dextrose solutions in plastic containers, meeting rigorous regulatory standards.
- CMOs offer customization around low magnesium formulations and container types, providing flexibility for specific clinical needs.
- Establishing supply chains with suppliers holding current GMP certifications and robust logistics is crucial to ensure consistent product availability.
- Regional and local suppliers should be evaluated for compliance, capacity, and regulatory approvals pertinent to their markets.
- Regular audits and supplier qualification processes are vital to mitigate supply chain disruptions and ensure product quality.
FAQs
1. Can I source Delflex W/ Dextrose 1.5%, Low Magnesium directly from major pharmaceutical companies?
Yes. Major pharmaceutical companies like Baxter, B. Braun, and Fresenius supply sterile IV solutions directly to hospitals and authorized distributors, often via regional distribution networks.
2. Are there regional restrictions or considerations in sourcing this product?
Yes. Regulatory approvals, import/export regulations, and local GMP standards influence availability. Regional suppliers may offer formulations compliant with local pharmacopeial standards.
3. Can CMOs produce customized formulations of Delflex with specific magnesium concentrations?
Yes. CMOs like Catalent and Lonza can develop tailored formulations to meet specific dose and container specifications, subject to regulatory approval.
4. What should be considered when selecting a supplier for this product?
Regulatory compliance, GMP certification, manufacturing capacity, supply chain reliability, and quality control processes.
5. Is there a difference between branded and generic sources for this formulation?
Branded products tend to guarantee consistent quality and supply, whereas generics or private-label manufacturers may vary but can be viable options if GMP and regulatory standards are met.
References
[1] Baxter International Inc., Product Catalog.
[2] B. Braun Melsungen AG, Institutional Product Portfolio.
[3] Pfizer Inc., IV Solutions Overview.
[4] Hospira, Product Information.
[5] Fresenius Kabi, IV Fluids Portfolio.
