Bulk Pharmaceutical API Sources for DEXTROSE 30% IN PLASTIC CONTAINER

Bulk Pharmaceutical API Sources for DEXTROSE 30% IN PLASTIC CONTAINER

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		66370
IS Chemical Technology		I14-6963
ABI Chem		AC1L2586
AKos Consulting & Solutions		AKOS015915125
Chembase.cn		106156
ChemMol		99098420
1717 CheMall Corporation		CA001510

Bulk Active Pharmaceutical Ingredient (API) Sources for Dextrose 30% in Plastic Container

Last updated: August 17, 2025

Introduction

Dextrose, a monosaccharide second only to glucose in clinical utility, is extensively employed in the pharmaceutical sector, especially as an injectable carbohydrate source for parenteral nutrition. Comprising approximately 30% dextrose solution in a plastic container, this formulation is critical for hydration and metabolic support in hospitals and clinics. Sourcing high-quality bulk dextrose API is paramount to meet regulatory standards and ensure patient safety. This report examines the leading API suppliers capable of providing pharmaceutical-grade dextrose suitable for formulation into 30% solutions stored in plastic containers.

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Regulatory Considerations in API Sourcing

For pharmaceutical applications, API procurement mandates strict adherence to Good Manufacturing Practices (GMP) mandated by agencies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and World Health Organization (WHO). Suppliers must provide Certificates of Analysis (CoA), stability data, and compliance with pharmacopeial standards such as the USP, EP, BP or JP.

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Global Key Suppliers of Dextrose API

1. Archer Daniels Midland Company (ADM)

Overview:
ADM is a global leader in the production of high-quality glucose and dextrose API, operating extensive manufacturing facilities in North America and Europe.

Capabilities:

• GMP-compliant production of pharmaceutical-grade dextrose monohydrate and anhydrous forms.
• Strict adherence to pharmacopeial standards, ensuring suitability for injectables and solutions in plastic containers.
• Proven track record in supplying to pharmaceutical OEMs and intermediaries.

Certifications:

• GMP and ISO certifications.
• Certificates of Analysis and stability data available per customer request.

Supply Focus:
Supply of bulk dextrose APIs in various grades, with capabilities to tailor specifications aligned with pharmaceutical formulation needs.

2. Roquette Frères

Overview:
Based in France, Roquette specializes in plant-based ingredients, including pharmaceutical-grade dextrose.

Capabilities:

• Production of pharmaceutical and food-grade glucose and dextrose APIs.
• Focus on high purity, low color, and low endotoxin levels to meet injectable standards.
• Extensive R&D to support custom specifications.

Certifications:

• GMP, ISO 9001, and applicable pharmacopeial certifications.
• Strong validation and stability data in line with regulatory needs.

Supply Focus:
Large-scale availability of dextrose monohydrate powder, with flexibility for bulk API supply for direct formulation into solutions.

3. Cargill, Inc.

Overview:
Cargill provides a comprehensive portfolio of glucose and dextrose APIs, mainly serving pharmaceutical and nutritional markets globally.

Capabilities:

• Utilizes GMP manufacturing processes for pharmaceutical APIs.
• Offers high-purity dextrose monohydrate suitable for injectable solutions stored in plastic containers.
• Commitment to sustainable sourcing and supply chain integrity.

Certifications:

• GMP and ISO certifications.
• Detailed batch certification and stability data available.

Supply Focus:
Bulk API production focusing on large volume needs for hospital and industrial customers.

4. Ingredion Incorporated

Overview:
Ingredion is a major global supplier of carbohydrates, including pharmaceutical-grade dextrose.

Capabilities:

• Produces high purity dextrose monohydrate APIs with strict quality controls.
• Compatible with sterile formulations in plastic containers.
• Emphasis on raw material transparency and consistency.

Certifications:

• GMP, ISO 9001, and pharmacopeial compliance.

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Regional and Specialty Suppliers

Beyond the major global players, several regional entities and specialty manufacturers cater to niche markets with high-quality dextrose API:

• Sigma-Aldrich (Merck KGaA): Provides laboratory-grade and pharmaceutical-grade dextrose for R&D and small-scale manufacturing, including custom API options.
• Vinson Ingredients: A supplier specializing in customized carbohydrate APIs, with a focus on high purity and regulatory compliance.
• Tate & Lyle: Known for food-grade and pharmaceutical-grade glucose supplies, with facilities in North America and Europe.

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Selection Criteria for API Suppliers

When considering API sources for pharmaceutical-grade dextrose intended for preparation of 30% solutions in plastic containers, stakeholders should evaluate:

• Regulatory compliance: Ensure GMP adherence, pharmacopeial standards, and certifications.
• Quality parameters: Purity (>99%), low endotoxin levels, and compatibility with intravenous applications.
• Supply reliability: Consistent volume capacity and supply chain robustness.
• Documentation and support: Certificates of analysis, stability data, and technical support.
• Cost and logistics: Competitive pricing, shipping capabilities, and minimum order quantities.

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Emerging Trends in API Sourcing

• Sustainable manufacturing: Increasing preference for suppliers utilizing environmentally friendly processes.
• Traceability: Demand for full supply chain transparency to satisfy global regulatory audits.
• Customized API specifications: Evolving formulations may require suppliers adaptable to specific purity, endotoxin, or residual moisture parameters.
• Regulatory harmonization: Suppliers aligning certifications across regions to facilitate global distribution.

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Conclusion

Securing bulk active pharmaceutical ingredient (API) dextrose for formulating 30% solutions in plastic containers requires a meticulous selection process centered on quality, compliance, and supply chain integrity. Established providers like ADM, Roquette, Cargill, and Ingredion dominate the market with robust GMP practices, extensive certifications, and reliable supply chains. Regional and specialty suppliers further augment options for tailored requirements. Companies should prioritize suppliers offering comprehensive documentation, consistent product quality, and logistical flexibility to ensure compliance and operational efficiency.

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Key Takeaways

• Major global suppliers such as ADM, Roquette, Cargill, and Ingredion are primary sources for pharmaceutical-grade dextrose API suitable for 30% solution formulation.
• Rigorously verify GMP compliance, pharmacopeial adherence, and certification documentation before engaging suppliers.
• Consider supply reliability, sustainability practices, and ability to meet specific formulation specifications.
• Emerging trends emphasize transparency, customization, and sustainability in API sourcing.
• Due diligence in supplier qualification accelerates regulatory approval processes and minimizes manufacturing disruptions.

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FAQs

1. Can I source dextrose API globally for pharmaceutical use?
Yes, major multinational suppliers provide globally compliant dextrose APIs, but regional regulations and import restrictions should be reviewed.

2. What quality standards should API suppliers meet for injectable solutions?
Suppliers must provide GMP certification, low endotoxin levels, high purity (>99%), and documentation aligned with USP, EP, or other pharmacopeias.

3. How do I evaluate if a supplier’s API is suitable for 30% dextrose solutions?
Assess purity, compatibility with plastic containers, stability data, endotoxin levels, and compliance certificates.

4. Are regional suppliers a viable alternative to global providers?
Yes. Regional suppliers can offer faster delivery and lower logistics costs, provided they meet international quality standards.

5. How can I ensure consistent API quality across batches?
Establish supplier qualification protocols, conduct regular audits, and require detailed Certificates of Analysis and batch validation data.

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References

1. U.S. Pharmacopeia (USP) Monograph on Dextrose.
2. European Pharmacopoeia (EP) standards for Dextrose.
3. Archer Daniels Midland Company Product Catalog.
4. Roquette Frères API specifications documentation.
5. Cargill Nutritional Ingredients Product Data Sheets.