Bulk Pharmaceutical API Sources for DEXTROSE 20% IN PLASTIC CONTAINER

Bulk Pharmaceutical API Sources for DEXTROSE 20% 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 20% in Plastic Container

Last updated: August 17, 2025

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Introduction

Dextrose 20% in plastic containers is a widely utilized intravenous (IV) fluid, serving as a vital source of free glucose for patients with metabolic needs, dehydration, or nutritional deficiencies. Its pharmaceutical-grade formulation in a sterile, aqueous solution demands stringent sourcing standards for active pharmaceutical ingredients (APIs). Ensuring access to high-quality APIs from reputable suppliers is crucial for manufacturers, regulators, and healthcare providers to guarantee safety, efficacy, and compliance.

This article reviews primary sources of bulk dextrose APIs suitable for manufacturing 20% dextrose solutions in plastic containers, highlighting global suppliers, quality standards, and regulatory considerations.

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Overview of Dextrose as an API

Dextrose, chemically known as D-glucose, is a simple sugar classified as a monosaccharide. In pharmaceutical applications, dextrose is produced via high-quality manufacturing processes, including enzymatic conversion of cornstarch, maize, or other carbohydrate sources. The API must meet pharmacopeial standards—namely, U.S. Pharmacopeia (USP), European Pharmacopoeia (EP), or Pharmacopoeia of the Chinese Pharmacopoeia (ChP)—which specify purity, crystallinity, and microbiological standards.

Manufacturers typically purchase bulk dextrose API in various grades, including pharmaceutical, food, or technical grades, though pharmaceutical-grade is mandated for injectable solutions.

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Major Global API Suppliers for Dextrose

1. Meggle Pharma (Germany)

Meggle Pharma offers high-quality pharmaceutical-grade dextrose monohydrate with USP and EP certifications. Their manufacturing processes adhere to strict GMP standards, ensuring isotonic, sterile-ready APIs suitable for IV solutions.

2. Roquette Frères (France)

A prominent supplier of pharmaceutical-grade glucose, Roquette provides dextrose monohydrate compatible with injectable formulations. Their APIs conform to global pharmacopeial standards and undergo rigorous quality control.

3. Cargill, Inc. (USA)

Cargill’s pharmaceutical-grade dextrose APIs are derived from non-GMO corn, produced under GMP conditions. They offer a range of dextrose monohydrate products with stability, purity, and microbiological compliance suitable for injectable solutions.

4. Tate & Lyle (UK)

Tate & Lyle supplies dextrose monohydrate APIs globally, compliant with pharmacopeial standards. Their product portfolio emphasizes high purity and consistent quality, making them a preferred choice for pharmaceutical applications.

5. Archer Daniels Midland Company (USA)

ADM provides pharmaceutical-grade dextrose APIs produced through enzymatic conversion of corn starch. Their APIs meet USP and EP standards and are suitable for sterile use in IV formulations.

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Regional Suppliers and Emerging Markets

In addition to established Western suppliers, emerging markets offer API sources due to competitive manufacturing costs and increasing local infrastructure:

• India: Major manufacturers like Rallies Fine Chemicals and Gujarat State Fertilizers & Chemicals (GSFC) supply dextrose monohydrate API meeting international standards. India’s pharmaceutical API sector has grown significantly, with exports to global markets.

• China: Large producers such as Bright Moon Bio-tech and Shandong Shuangmu Biological Technology are recognized for GMP-compliant APIs. These suppliers comply with WHO-GMP standards and are approved for export.

• Brazil & Middle East: Local producers are expanding API offerings, often targeting regional markets with manufacturing plants certified under WHO or local regulatory approvals.

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Quality and Regulatory Standards

API sourcing must prioritize quality assurance and compliance. Suppliers should demonstrate adherence to:

• GMP Certification: Ensures facility compliance with international quality standards.
• Pharmacopoeial Certification: Certificates that their dextrose API complies with USP, EP, or other relevant standards.
• Stability & Purity Tests: Confirm low levels of contaminants such as heavy metals, microbiological impurities, and residual solvents.
• Documentation & Batch Traceability: Critical for regulatory audits and pharmacovigilance.

Manufacturers must validate the API’s consistency, bio-compatibility, and suitability for IV use, often via rigorous testing and quality control protocols.

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Considerations for Sourcing Dextrose API

• Supply Chain Stability: Global geopolitical factors and manufacturing capacity influence availability.
• Cost & Lead Time: Balance between competitive pricing and quality assurance.
• Regulatory Acceptance: Ensure supplier approval by local authorities (e.g., FDA, EMA, TGA).
• Environmental & Sustainability Policies: Suppliers committed to environmentally responsible practices are increasingly preferred.

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Conclusion

The global landscape offers diverse sources for pharmaceutical-grade dextrose API suitable for manufacturing 20% dextrose solutions in plastic containers. Established European and North American corporations like Roquette, Cargill, Tate & Lyle, and ADM provide high-quality APIs certified for sterile, injectable formulations. Emerging producers in India and China are expanding supply options with competitive pricing and regulatory compliance.

Stringent supplier qualification, compliance verification, and ongoing quality audits are essential. Selecting reliable API sources ensures drug safety, regulatory adherence, and supply chain resilience for pharmaceutical companies and healthcare providers.

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Key Takeaways

• Major global API suppliers such as Roquette, Cargill, Tate & Lyle, and ADM offer high-grade dextrose monohydrate suitable for IV solutions.
• Emerging markets like India and China have become important sources, expanding global supply options.
• Regulatory standards, GMP compliance, and meticulous quality control are non-negotiable criteria for sourcing APIs for injectable formulations.
• Collaboration with reputable suppliers enhances supply chain security and product integrity.
• Continuous market monitoring and supplier audits are vital for maintaining high standards in API procurement.

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FAQs

1. What are the key quality standards to consider when sourcing dextrose API for IV solutions?
Manufacturers must ensure the API complies with pharmacopeial standards (USP, EP, ChP), adheres to GMP certifications, and passes microbiological and chemical purity testing.

2. Can dextrose APIs from emerging markets like India and China be reliably used for pharmaceutical applications?
Yes, provided they meet international regulatory requirements, possess valid GMP certifications, and are supported by thorough quality documentation and audits.

3. How does the choice of API supplier impact the safety of intravenous dextrose solutions?
High-quality, compliant APIs minimize the risk of contamination, impurities, and batch inconsistencies, directly impacting patient safety and regulatory approval.

4. Are there specific regulations governing the import and use of pharmaceutical APIs globally?
Yes. Importers must comply with local regulatory authorities such as the FDA (USA), EMA (Europe), TGA (Australia), and relevant national agencies, ensuring suppliers meet regional standards.

5. What are the main logistical considerations when sourcing bulk dextrose APIs?
Shipping logistics include ensuring stable temperature conditions, maintaining sterile conditions during transfer, and selecting suppliers with reliable supply chain infrastructure for timely delivery.

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Sources
[1] U.S. Pharmacopeia Convention. Dextrose Monohydrate monograph.
[2] European Pharmacopoeia. Dextrose monohydrate monograph.
[3] Global API manufacturers’ product datasheets and certifications.
[4] Industry reports on API manufacturing and supply chain dynamics.