Bulk Pharmaceutical API Sources for DEXTROSE 60% IN PLASTIC CONTAINER

Bulk Pharmaceutical API Sources for DEXTROSE 60% IN PLASTIC CONTAINER

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		66370
IS Chemical Technology		I14-6963
ABI Chem		AC1L2586

Bulk Active Pharmaceutical Ingredient (API) Sources for: DEXTROSE 60% IN PLASTIC CONTAINER

Last updated: August 6, 2025

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Introduction

Dextrose, also known as glucose, is a monosaccharide vital in clinical, nutritional, and pharmaceutical applications. Its 60% formulation, packaged in plastic containers for ease of use and preservation, is widely utilized across hospitals, nutraceuticals, and drug manufacturing. The procurement and supply chain of bulk API—particularly dextrose—must meet stringent regulatory, quality, and safety standards to ensure product efficacy and patient safety. This article explores the key sources and considerations in sourcing bulk dextrose 60% in plastic containers, emphasizing global manufacturing landscapes, quality assurance practices, and strategic procurement insights.

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Global Manufacturing Landscape for Pharmaceutical Dextrose

Major Producers of Pharmaceutical Dextrose

The global supply of pharmaceutical-grade dextrose APIs is concentrated among a handful of reputable manufacturers primarily located in Asia, North America, and Europe:

1. China

   • Leading Manufacturers: Jiujiang Lihua Biological Co., Ltd., Shandong First Grain Co., Ltd.
   • Capabilities: These producers supply high-purity dextrose, adhering to Pharmacopeial standards (USP, EP, BP). They benefit from economies of scale, competitive pricing, and extensive export networks.

2. India

   • Notable Companies: Roquette India Pvt Ltd., International Glucose Ltd.
   • Strengths: India’s pharmaceutical-grade dextrose APIs often meet international standards, supported by strict GMP compliance, making them a popular choice for global buyers.

3. United States and North America

   • Key Suppliers: Ingredion (Vintage Brands), Archer Daniels Midland (ADM)
   • Distinctive Features: These companies emphasize quality assurance, Good Manufacturing Practices (GMP), and regulatory compliance, providing high-quality APIs and ensuring consistent supply.

4. Europe

   • Main Suppliers: Cargill, Roquette (Europe branch)
   • Advantages: European suppliers often emphasize organic certification, non-GMO status, and sustainable sourcing.

Specialty and Contract Manufacturers

Beyond large-scale producers, several specialty and contract manufacturers provide customized formulations, including 60% dextrose solutions in plastic containers, tailored for pharmaceutical and clinical needs.

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Sources of Bulk Dextrose API

1. Primary API Suppliers

For pharmaceutical-grade dextrose, sourcing from certified API manufacturers ensures regulatory compliance and product consistency:

• Jiujiang Lihua Biological Co., Ltd.
  Certifications: GMP, ISO 9001, HACCP.
  Strength: Reliable supply chain with strict quality standards suitable for injection and infusion applications.

• Roquette (India, Europe, North America)
  Certifications: USP, EP, BP, GMP.
  Features: High-purity, food-grade dextrose suitable for medical formulations.

• Shandong First Grain Co., Ltd.
  Standards: Meets international pharmacopeial standards with extensive export experience.

• Ingredion Incorporated
  Product Offerings: Pharmaceutical-grade dextrose solutions distributed globally, emphasizing compliance and safety.

2. Contract Manufacturing and Private Label Suppliers

Numerous firms specialize in producing customized 60% dextrose solutions in pre-filled, sterile plastic containers. Such suppliers often partner with large API manufacturers to ensure quality:

• Baxter International / Hospira
  Application: Exclusive focus on sterile, Ready-to-Use (RTU) formulations, including dextrose 60% solutions.

• Fresenius Kabi
  Strength: Supplies high-quality parenteral solutions, including bulk dextrose preparations.

• Local regional manufacturers
  Smaller contract manufacturers, especially in India and China, often offer tailored formulations with competitive pricing but require due diligence on certifications.

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Regulatory and Quality Assurance Considerations

Reliable sourcing of dextrose API mandates adherence to robust quality standards:

• Pharmacopoeial Standards:
  Products must comply with USP, EP, or BP monographs. These stipulate purity (>99%), absence of microbial contamination, arsenic, lead, and other heavy metals.

• GMP Certification:
  Ensures manufacturing processes meet Good Manufacturing Practices, vital for APIs used in injectable and nutritional applications.

• Certifications & Documentation:
  Certificates of Analysis (CoA), Material Safety Data Sheets (MSDS), and regulatory filings are requisite for importation and use.

• Traceability and Supply Chain Integrity:
  Selecting suppliers with transparent sourcing, batch documentation, and quality management systems reduces regulatory risk.

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Procurement Strategies and Risks

Key Strategies:

• Supplier Qualification:
  Conduct thorough audits, verify certifications, and assess production capacity to ensure reliable supply.

• Sample Testing:
  Prior to large-scale procurement, batch testing for microbiological purity, pH, osmolarity, and residual contaminants is critical.

• Long-term Contracts:
  Engage in multi-year agreements with reputable suppliers to stabilize pricing and mitigate shortages.

• Diversification:
  Sourcing from multiple suppliers reduces dependency and supply disruption risks.

Risks:

• Regulatory Non-Compliance:
  Import restrictions or product rejection due to quality issues can disrupt supply.

• Price Fluctuations:
  Raw material costs, feedstock availability, and geopolitical factors influence pricing.

• Supply Chain Disruptions:
  Global events, such as COVID-19, can cause shipment delays or shortages.

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Packaging and Logistics

Plastic Container Specifications:
Pharmaceutical dextrose solutions, especially at 60%, are supplied in sterile, medical-grade plastic containers—typically single-dose or multidose bottles made from high-density polyethylene (HDPE) or polypropylene.

Quality Features:

• Bacteriostatic properties or sterile filtration to prevent microbial contamination.
• Compatibility with storage conditions, usually stable at room temperature.
• Labeling that complies with regulatory standards with batch number, expiry date, storage conditions.

Logistics Considerations:

• Cold chain management if required.
• Documentation for customs clearance.
• Arrangements with logistic providers experienced in pharmaceutical transport.

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Conclusion

Global sourcing of bulk dextrose 60% in plastic containers hinges on strategic selection of reputable API manufacturers and contract producers aligning with stringent quality and regulatory standards. North American, European, and Asian suppliers dominate the landscape, offering diverse options suited for pharmaceutical, nutritional, and clinical applications. Ensuring compliance, establishing reliable supply chains, and rigorous quality validation are imperative for procurers aiming for consistent product integrity and regulatory adherence.

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Key Takeaways

• Prioritize suppliers with ISO, GMP, and pharmacopeial certifications to mitigate regulatory risks.
• Diversify sources to avoid supply disruptions and achieve competitive pricing.
• Conduct thorough batch testing and supplier audits before long-term procurement.
• Negotiate contractual terms that include quality guarantees, documentation, and support.
• Maintain traceability and compliance with shipping, storage, and labeling standards.

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FAQs

1. What are the primary regulatory standards for pharmaceutical-grade dextrose API?
Pharmaceutical-grade dextrose must comply with pharmacopoeial standards such as USP, EP, or BP, which specify purity, sterility, and contaminant limits. Additionally, GMP certification of manufacturing facilities is essential.

2. How do I verify the quality of dextrose supplied in plastic containers?
Conduct independent testing of batches, including assessments of microbial content, osmolarity, pH, residual metals, and visually inspect packaging for integrity. Request detailed Certificates of Analysis (CoA) from suppliers.

3. What are common packaging formats for bulk dextrose 60% solutions?
They are typically supplied in sterile, pre-filled plastic bottles or containers made from medical-grade HDPE or polypropylene, designed for stability and easy use in clinical settings.

4. Which regions are most reliable for sourcing pharmaceutical dextrose APIs?
North America and Europe are considered highly reliable due to stringent quality standards, but China and India also provide cost-effective options with appropriate validation and certifications.

5. How can supply chain risks be minimized when sourcing dextrose APIs?
Engage multiple qualified suppliers, establish long-term contracts, conduct regular quality audits, and maintain safety stocks to buffer against disruptions.

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References

[1] U.S. Pharmacopeia. USP Monographs for Dextrose.
[2] European Pharmacopoeia. Dextrose Monograph.
[3] FDA. Guidance for Industry - Good Manufacturing Practices.
[4] World Health Organization. Guidelines on Good Pharmacy Practice.
[5] Market research reports on pharmaceutical excipient suppliers and manufacturing trends.