Bulk Pharmaceutical API Sources for DEXTROSE 5% IN PLASTIC CONTAINER

Bulk Pharmaceutical API Sources for DEXTROSE 5% 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

Bulk Active Pharmaceutical Ingredient (API) Sources for: Dextrose 5% in Plastic Container

Last updated: August 1, 2025

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Introduction

Dextrose 5% in plastic containers, also known as 5% dextrose (D5W), is a widely used intravenous (IV) fluid for hydration, medication delivery, and metabolic support. Its API—dextrose (glucose)—is a vital pharmaceutical ingredient, produced globally by numerous manufacturers. Ensuring a reliable, high-quality supply chain of dextrose API is crucial for pharmaceutical companies, compounding pharmacies, and healthcare providers. This article examines key bulk API sources for dextrose 5% solutions, emphasizing manufacturing countries, quality standards, supplier profiles, and market dynamics influencing procurement decisions.

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Understanding Dextrose API for Parenteral Use

Dextrose API intended for injectable formulations must adhere to strict pharmaceutical grade standards—primarily, the United States Pharmacopeia (USP), European Pharmacopoeia (EP), or other relevant pharmacopeial standards. The API’s purity, absence of microbial contamination, sterility, and correct physicochemical properties are central to regulatory approval and patient safety.

Manufacturers generally produce dextrose monohydrate or anhydrous dextrose, which are then used to prepare IV solutions in sterile, single-use plastic containers. The API’s sourcing involves considerations of quality, cost, supply stability, and compliance with Good Manufacturing Practices (GMP).

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Major Global API Suppliers for Dextrose

1. United States

The United States hosts several prominent API producers specializing in carbohydrate manufacturing, primarily serving North American and global markets.

• Archer Daniels Midland Company (ADM): A leading global producer of dextrose API, ADM manufactures high-purity dextrose monohydrate compliant with USP standards. Their facilities in Decatur, Illinois, are ISO 9001 and GMP certified, with extensive quality control processes.

• Roquette Frères: A French multinational with manufacturing plants in the U.S., Roquette supplies pharmaceutical-grade dextrose API with consistent quality, certified under GMP, and compliant with pharmacopeial standards. Their North American operations focus on supplying both ingredient and bulk API markets.

2. Europe

Europe remains a dominant hub for pharmaceutical ingredient production, with stringent quality standards and regulatory oversight.

• Roquette Frères (France): As noted, Roquette offers a comprehensive range of dextrose APIs meeting international standards, with advanced manufacturing practices ensuring high purity profiles.

• Cargill Inc.: Based in Belgium, Cargill supplies dextrose API for parenteral use, adhering to global pharmacopeial standards with GMP compliance. Their facilities focus on precision and contaminant control.

• Harles & Jentzsch GmbH (Germany): A niche player specializing in carbohydrate API production, including pharmaceutical-grade dextrose with regulatory approvals, serving European and global markets.

3. Asia-Pacific

Asia-Pacific, especially China and India, accounts for a significant share of global carbohydrate API production due to cost advantages, scale, and rapidly expanding pharmaceutical manufacturing sectors.

• Jilin Yuming Biological Technology Co., Ltd. (China): Produces pharmaceutical-grade dextrose monohydrate, complying with USP/EP standards. Their facility emphasizes GMP certification and quality assurance.

• Shandong Manxin Bio-Tech Co., Ltd. (China): Offers pharmaceutical-grade dextrose APIs, with production adhering to GMP and other regulatory requirements, serving both domestic and export markets.

• Meghmani Organics Ltd. (India): A key Indian manufacturer with ISO and GMP certifications, supplying pharmaceutical-grade dextrose API, catering to global needs.

• Vinci Biochem (India): Has developed capabilities for high-quality dextrose API production, targeting both local and international clients.

4. Latin America & Other Regions

While less prominent, regional manufacturers focus on supplying local markets with generic APIs.

• Groupe Solvay / Solvay Pharma (Mexico): Supplies pharmaceutical-grade dextrose API compliant with international standards.

• Other emerging markets: Several local producers in Brazil, Argentina, and Southeast Asia are increasingly investing in GMP-compliant facilities to serve local pharmaceutical manufacturers.

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Criteria for Selecting API Suppliers

• Regulatory Compliance: Suppliers must meet GMP standards, hold certifications such as ISO, FDA, EMA, or equivalent.
• Purity and Quality: High-purity dextrose (USP/EP grade), with low microbial load, endotoxins, and heavy metals.
• Supply Stability: Reliable production capacity, contingency plans, and consistent delivery performance.
• Traceability: Clear documentation, batch records, and transparency for regulatory audits.
• Cost Effectiveness: Competitive pricing without compromising quality.
• Environmental and Ethical Standards: Suppliers adhering to sustainability and ethical manufacturing practices.

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Market Trends and Supply Chain Considerations

The global demand for dextrose API continues to grow, driven by increasing usage in intravenous therapies, nutrition, and immunotherapy. Supply chain resilience is paramount given recent disruptions from geopolitical tensions, pandemics, and raw-material shortages. Geo-specific production capacities have been underscored, emphasizing the importance of diversified sourcing strategies.

Consolidation within the API manufacturing sector has led to a smaller pool of high-quality suppliers capable of meeting the rigorous standards for injectable APIs. Regulatory scrutiny is intensifying, necessitating rigorous qualification processes for suppliers.

Furthermore, the trend toward sustainable manufacturing and green chemistry is influencing selection criteria, with buyers increasingly favoring suppliers with environmentally friendly practices.

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Conclusion

Securing a reliable source of pharmaceutical-grade dextrose API is critical for producing safe, effective dextrose 5% solutions in plastic containers. The primary sources span North America, Europe, and Asia-Pacific, with key industry players like ADM, Roquette, Cargill, and regional manufacturers in China and India dominating the market.

Decision-makers must evaluate suppliers based on quality standards, regulatory compliance, supply stability, and cost efficiency. Maintaining diversified sourcing and rigorous qualification processes will mitigate risks associated with supply disruptions.

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Key Takeaways

• Top Suppliers: Recognize global leaders such as ADM (USA), Roquette (France), Cargill (Belgium), and major Asian manufactures in China and India.
• Quality Over Cost: Prioritize GMP compliance, purity, and regulatory certifications over solely cost considerations.
• Supply Stability: Diversify sourcing to manage geopolitical and logistical risks amidst growing global demand.
• Regulatory Vigilance: Ensure supplier adherence to USP, EP, and other standards, including validation and documentation that facilitate regulatory approval.
• Sustainability: Include environmental practices as part of supply qualification criteria to align with modern corporate responsibility standards.

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FAQs

1. What specifications should I ensure for pharmaceutical-grade dextrose API?
   The API must meet pharmacopoeial standards such as USP or EP, with high purity (typically >99%), low microbial contaminants, endotoxins, and heavy metals, validated for injectable applications.

2. Are Chinese and Indian manufacturers reliable sources for dextrose API?
   Yes, several Chinese and Indian firms now hold GMP certifications and comply with international regulatory standards, providing high-quality APIs suitable for pharmaceutical use.

3. How do geopolitical issues influence API supplier choice?
   Political tensions and trade restrictions can disrupt supply chains; thus, sourcing from diversified regions reduces dependency on a single source.

4. What role does regulatory compliance play in API sourcing?
   It ensures the API's safety, efficacy, and quality, facilitating smooth approval processes in target markets and reducing compliance risks.

5. Is sustainability a factor in choosing API suppliers?
   Increasingly, yes. Many companies prefer suppliers with environmentally friendly practices, sustainable sourcing, and compliance with green chemistry principles.

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References

[1] U.S. Pharmacopeia. (2023). Dextrose monohydrate monograph.
[2] European Pharmacopoeia. (2023). Dextrose monohydrate monograph.
[3] ADM. (2023). Corporate sustainability report.
[4] Roquette. (2023). Product quality specifications for pharmaceutical-grade dextrose.
[5] Cargill. (2023). Annual report on pharmaceutical excipients.
[6] Global API Market Report. (2022). Carbohydrate API segment analysis.