DEXTROSE 60% IN PLASTIC CONTAINER: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Baxter Hlthcare	DEXTROSE 60% 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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 5, 2025

Introduction

Dextrose 60% solution packaged in plastic containers is a critical component in medical settings, primarily used for nutritional support, fluid replacement, and as a diluent for various medications. The global demand for such solutions has seen consistent growth driven by expanding healthcare infrastructure, rising prevalence of metabolic disorders, and advancements in intravenous therapy. Selecting reliable suppliers for Dextrose 60% ensures pharmaceutical companies, hospitals, and distributors maintain supply chain integrity, comply with regulatory standards, and meet patient needs efficiently.

Market Overview of Dextrose 60% Solutions

Dextrose, chemically identical to glucose, is supplied in various concentrations, with 60% being a standard for parenteral nutrition and dilution purposes. The packaging in plastic containers—typically polyethylene or polypropylene bottles—offers advantages such as ease of handling, reduced breakage risk, and compatibility with medical-grade standards. The global market features a mix of large multinational pharmaceutical ingredient suppliers and regional manufacturers, each adhering to strict compliance and quality standards.

Major Suppliers of Dextrose 60% in Plastic Containers

1. Archer Daniels Midland Company (ADM)

Overview: ADM is a leader in ingredient manufacturing for food, beverage, and pharmaceutical industries. Its pharmaceutical-grade dextrose solutions meet rigorous standards such as USP, EP, and JP.

Product Range: Offers Dextrose 60% solutions in various pack sizes, including plastic bottles suitable for hospital and pharmaceutical applications.

Certifications: ISO 9001/ISO 13485, GMP-compliant manufacturing.

Global Reach: Supplies across North America, Europe, and Asia.

Key Advantages:

Robust supply chain infrastructure.
Consistency in quality and compliance.
Customizable packaging options.

2. Farbwerke Hoechst AG (Celanese Corporation)

Overview: A historic manufacturer with a strong presence in carbohydrate derivatives, Celanese produces high-purity dextrose solutions.

Product Range: Provides sterile Dextrose 60% solutions, compatible with plastic containers in pharmaceutical-grade quality.

Certifications: GMP, USP, EP.

Regional Presence: Europe, North America, Asia-Pacific.

Strengths:

Long-standing experience.
Reliable supply for large-volume industrial requirements.

3. Roquette Frères

Overview: A global leader in plant-based ingredients, Roquette supplies medical nutrition-grade dextrose solutions.

Product Range: Offers USP-grade Dextrose 60% solutions in pre-sterilized plastic containers suitable for clinical settings.

Certifications: ISO 13485, GMP.

Regional Presence: Europe, Americas, Asia-Pacific.

Key Strengths:

Focus on pharmaceutical and medical-grade products.
Expertise in sterility and container compatibility.

4. Tate & Lyle PLC

Overview: Known for specialty food ingredients, Tate & Lyle also offers pharmaceutical-grade dextrose solutions meeting appropriate standards.

Product Range: Provides Dextrose 60% formulations in plastic bottles, tailored for IV use and dilution.

Certifications: GMP, pharmacopoeial standards.

Regional Presence: United Kingdom, North America, Asia-Pacific.

Strengths:

High-quality product standards.
Capacity for large-scale supply.

5. Shandong Yuwang Chemical (Yuwang Group)

Overview: A key regional manufacturer in China offering cost-effective dextrose solutions.

Product Range: Supplies USP-grade Dextrose 60% in plastic containers, including sterile options for medical use.

Certifications: ISO 9001, GMP.

Regional Presence: China, Southeast Asia, global export markets.

Strengths:

Competitive pricing.
Growing reputation for pharmaceutical excipients.

Key Selection Criteria for Suppliers

Regulatory Compliance: Ensure suppliers hold necessary certifications like USP, EP, JP, and GMP approvals.
Quality Assurance: Verify product specifications, sterility, and batch-to-batch consistency.
Supply Capacity: Confirm manufacturing scale aligns with procurement volume.
Packaging Standards: Plastic containers must be medical-grade, leak-proof, and compatible with IV administration protocols.
Delivery Turnaround: Evaluate logistics, lead times, and regional distribution networks.
Cost Effectiveness: Balance quality with competitive pricing, considering freight and import tariffs.

Regional Suppliers and Emerging Markets

While large multinational companies dominate the market, regional suppliers are increasingly prominent in emerging markets:

India: Companies such as Jubilant Lifesciences and Sun Pharma offer pharmaceutical-grade dextrose solutions.
Brazil and Latin America: Several local manufacturers comply with regulatory standards, providing accessible supply options.
Asia-Pacific: Suppliers like Yuwang Group and others serve growing demand, often at lower costs.

Emerging suppliers are often preferred for regional procurement but require rigorous validation due to variable quality standards.

Regulatory and Quality Considerations

Global pharmaceutical supply chains mandate compliance with strict regulatory standards:

USP (United States Pharmacopoeia): Ensures high purity and sterility.
EP (European Pharmacopoeia): Sets standards for pharmaceutical ingredients in Europe.
JP (Japanese Pharmacopoeia): Ensures quality in Asian markets.
GMP (Good Manufacturing Practices): Validates production quality, safety, and efficacy.

Procurement must include supplier audits, quality agreements, and validation of their manufacturing processes to mitigate risks associated with contamination, substandard quality, or regulatory non-compliance.

Supply Chain Challenges and Risk Mitigation

Global Disruptions: Pandemics, geopolitical tensions, or natural disasters can impact supply.
Container Compatibility: Plastic containers must meet pharmacy standards for extractability and compatibility.
Traceability: Establish traceability mechanisms for batch records for regulatory audits.
Pricing Volatility: Fluctuations in raw material costs can influence pricing; long-term contracts mitigate risks.

Establishing relationships with multiple suppliers and maintaining safety stock levels enhances resilience against disruptions.

Conclusion

The procurement of Dextrose 60% in plastic containers demands meticulous supplier selection based on quality, compliance, capacity, and geographical considerations. Major global manufacturers like ADM, Celanese, Roquette, and Tate & Lyle offer reliable options, supported by rigorous regulatory standards. Regional suppliers may provide competitive alternatives, particularly in emerging markets, subject to strict validation.

Strategic sourcing aligned with regulatory requirements and supply chain resilience is essential for pharmaceutical companies and healthcare providers ensuring uninterrupted delivery of critical nutritional and medical solutions.

Key Takeaways

Prioritize Regulatory Compliance: Only partner with suppliers holding recognized GMP and pharmacopoeial certifications.
Assess Quality and Sterility: Verify product specifications, sterilization methods, and batch consistency.
Consider Regional and Global Options: Balance cost-effectiveness with supply reliability.
Evaluate Packaging Standards: Confirm containers meet medical-grade, compatibility, and safety standards.
Implement Robust Supply Chain Strategies: Diversify sources, maintain safety stock, and enforce strict validation and traceability measures.

FAQs

1. What are the primary considerations when sourcing Dextrose 60% in plastic containers?
Quality, regulatory compliance, sterility, container compatibility, supply capacity, and cost are paramount.

2. Which certifications should suppliers of pharmaceutical-grade dextrose hold?
Certifications such as USP, EP, JP, GMP, ISO 9001, and ISO 13485 ensure product quality and safety.

3. Can regional suppliers meet the same standards as multinational corporations?
Yes, but they require thorough validation, audits, and compliance verification to ensure standards match global requirements.

4. What are the main challenges in the global supply of Dextrose solutions?
Disruptions due to geopolitical issues, natural disasters, raw material shortages, and logistical complexities.

5. How does container choice impact the safety and efficacy of Dextrose solutions?
Plastic containers must be medical-grade, sterilizable, leak-proof, and chemically compatible to maintain stability and prevent contamination.

Sources

[1] "Global Dextrose Market Analysis," MarketsandMarkets, 2022.
[2] "Pharmaceutical Excipients Market Overview," Grand View Research, 2023.
[3] "GMP Standards and Guidelines," U.S. FDA, 2022.
[4] "European Pharmacopoeia Standards," European Directorate for the Quality of Medicines & HealthCare (EDQM), 2023.
[5] "Regional Manufacturing Capabilities," Company Websites and Regulatory Approvals, 2023.

Suppliers and packagers for DEXTROSE 60% IN PLASTIC CONTAINER