Last updated: August 6, 2025
Introduction
In the pharmaceutical industry, sourcing reliable suppliers for injectable electrolytes like Delflex W/ Dextrose 4.25% in Plastic Container is critical for healthcare providers and distributors. This fluid combination, primarily utilized for rehydration and electrolyte replenishment, requires strict compliance with regulatory standards, manufacturer reliability, and consistent quality control. This report delineates the leading suppliers globally specializing in this product, highlighting their manufacturing capabilities, regulatory compliance, and market presence.
Product Overview
Delflex W/ Dextrose 4.25% is an intravenous infusion solution combining electrolytes with dextrose, formulated for hydration therapy, diabetes management, or as a vehicle for medication delivery. Packaged typically in sterile, single-use plastic containers, the product demands high-quality manufacturing processes to ensure safety and efficacy.
Key Suppliers of Delflex W/ Dextrose 4.25% in Plastic Containers
1. B. Braun Melsungen AG
Overview:
A global leader in medical devices and pharmaceuticals, B. Braun supplies a comprehensive portfolio of infusion solutions, including electrolyte and dextrose-containing products. Their manufacturing facilities are certified under ISO standards and comply with regulatory agencies such as the FDA and EMA.
Capabilities:
- Extensive manufacturing infrastructure for sterile solutions.
- Wide distribution network across North America, Europe, and Asia.
- Product variants in plastic containers meeting USP, EP, and JP standards.
Regulatory & Quality Assurance:
- Certified under ISO 13485.
- Compliant with FDA’s cGMP regulations.
- Used extensively in hospitals and clinics worldwide.
2. Baxter International Inc.
Overview:
Baxter produces a broad spectrum of intravenous fluids, including electrolyte solutions with dextrose, catering to hospitals, clinics, and emergency services internationally.
Capabilities:
- Large-scale manufacturing in North America, Europe, and Asia-Pacific.
- Focus on single-dose polyethylene and PVC containers with tight sterility controls.
- Developed multiple formulations for electrolyte repletion.
Regulatory & Quality Assurance:
- FDA-approved, with CE marking in Europe.
- Complies with global pharmacopoeias and cGMP standards.
3. Fresenius Kabi
Overview:
Specializing in infusion therapies, Fresenius Kabi offers electrolyte-dextrose solutions suited for various clinical applications. Their capacity includes production in flexible and rigid plastic containers.
Capabilities:
- State-of-the-art aseptic filling facilities.
- Focus on stability and preservative-free formulations for patient safety.
- Supplies globally, particularly in Europe, Asia, and Latin America.
Regulatory & Quality Assurance:
- ISO 13485 and cGMP certified.
- Meets WHO prequalification standards, facilitating use in resource-limited settings.
4. Hospira (a Pfizer company)
Overview:
Known for producing sterile injectable drugs and infusion solutions, Hospira’s portfolio includes electrolyte solutions with dextrose, packaged predominantly in plastic containers.
Capabilities:
- Integrated manufacturing plants adhering to strict quality standards.
- Convenience in supply chain, with commitment to availability in critical markets.
Regulatory & Quality Assurance:
- FDA-approved facilities and products.
- Compliant with European directives and other international standards.
5. Fanavaran Pharmaceutical (Iran)
Overview:
A leading regional supplier of intravenous solutions, including electrolyte-dextrose formulations, catering primarily to the Middle East and North Africa markets.
Capabilities:
- Local manufacturing in compliance with Iranian regulations.
- Competitive pricing, with product availability for regional healthcare providers.
Regulatory & Quality Assurance:
- Certified by Iran’s Ministry of Health.
- Works towards achieving GMP certification aligned with international standards.
Emerging and Regional Players
While the above companies are among the largest global suppliers, regional manufacturers and lesser-known companies also provide comparable electrolyte solutions. These include:
- Shandong Weigao Group (China)
- Sarepta Pharmaceuticals (India)
- YaoPharma (Turkey)
Regulatory acceptance, distribution reach, and quality assurance remain the primary considerations when evaluating these sources.
Selection Criteria for Suppliers
When selecting suppliers for Delflex W/ Dextrose 4.25%, stakeholders must evaluate:
- Regulatory Compliance: Certification under local and international standards (FDA, EMA, WHO PQ).
- Manufacturing Quality: Good Manufacturing Practice (GMP) adherence, aseptic processing capabilities.
- Product Consistency: Batch-to-batch uniformity, stability data, and expiration shelf life.
- Supply Chain Reliability: Delivery timelines, capacity, and contingency planning amid disruptions.
- Pricing and Contractual Terms: Competitive pricing, minimum order quantities, and post-market support.
Conclusion
Reliable procurement of Delflex W/ Dextrose 4.25% in Plastic Containers necessitates partnering with established manufacturers adhering to stringent quality and regulatory standards. Leading global suppliers like B. Braun, Baxter, Fresenius Kabi, and Hospira dominate the market due to their compliance, capacity, and widespread distribution networks. Emerging regional manufacturers also serve specific markets, emphasizing the importance of comprehensive due diligence during supplier selection.
Key Takeaways
- Top-tier global suppliers such as B. Braun, Baxter, and Fresenius Kabi dominate the electrolyte Dextrose infusion market, providing high-quality products in sterile plastic containers.
- Regulatory compliance with agencies like the FDA, EMA, and WHO prequalification is crucial to ensure product safety and marketability.
- Manufacturing capacity, quality control processes, and supply chain robustness are key decision factors.
- Regional manufacturers can be considered for cost-effective solutions, provided they meet requisite standards.
- Strategic supplier partnerships should be grounded in transparency, compliance, and performance guarantees.
FAQs
1. Are all suppliers of Delflex W/ Dextrose 4.25% in plastic containers compliant with international standards?
Most reputable manufacturers comply with standards like ISO 13485, cGMP, and regional regulatory requirements such as the FDA or EMA. However, verifying individual supplier certifications is essential.
2. How does quality control differ among suppliers?
Leading suppliers employ rigorous quality assurance processes, including aseptic manufacturing, batch testing, and stability studies. Regional or smaller suppliers may vary in their quality systems; due diligence is warranted.
3. What factors influence the cost of Delflex W/ Dextrose 4.25% in plastic containers?
Factors include manufacturing scale, regulatory compliance costs, branding, distribution networks, and market demand. Competitive bidding often yields better pricing.
4. Can regional suppliers meet the same regulatory standards as global companies?
Some regional manufacturers attain similar standards through accreditation and certification processes, but verification is necessary to ensure compliance for international markets.
5. What is the typical lead time for procurement from these suppliers?
Lead times range from 4 to 12 weeks, influenced by manufacturing capacity, regulatory approvals, and logistics. Emergency procurement may require supplier pre-qualification.
Sources
[1] B. Braun Melsungen AG. Corporate Website.
[2] Baxter International Inc. Product Catalog.
[3] Fresenius Kabi. Global Product Portfolio.
[4] Hospira (Pfizer). Product Specifications.
[5] World Health Organization. WHO Prequalification of Essential Medicines.
