Bulk Pharmaceutical API Sources for DEXTROSE 70% IN PLASTIC CONTAINER

Bulk Pharmaceutical API Sources for DEXTROSE 70% IN PLASTIC CONTAINER

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		66370
IS Chemical Technology		I14-6963
ABI Chem		AC1L2586
AKos Consulting & Solutions		AKOS015915125

Bulk Active Pharmaceutical Ingredient (API) Sources for Dextrose 70% in Plastic Container

Last updated: July 30, 2025

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Introduction

Dextrose 70% in plastic containers is a widely used intravenous (IV) carbohydrate solution, primarily serving as a quick source of glucose for patients requiring caloric supplementation or rapid blood sugar elevation. The demand for high-quality APIs like Dextrose Monohydrate, which forms the basis for this solution, necessitates a reliable supply chain with quality, consistency, and regulatory compliance. Identifying reputable bulk API suppliers is crucial for pharmaceutical manufacturers to ensure product efficacy, safety, and regulatory adherence.

This article provides an in-depth overview of the primary global suppliers and sources for Dextrose API suitable for filling into plastic containers, emphasizing the importance of quality standards and market dynamics.

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Global API Markets for Dextrose Monohydrate

Dextrose API is predominantly produced through grain processing, chiefly cornstarch hydrolysis. The leading API suppliers operate across North America, Europe, and Asia, where large-scale pharmaceutical ingredient manufacturing facilities adhere to Good Manufacturing Practices (GMP) and other strict quality standards.

Major API Suppliers for Dextrose Monohydrate

1. Archer Daniels Midland Company (ADM)

• Overview: ADM is a North American agricultural processing giant with extensive API production capabilities.
• Strengths: Certified GMP facilities, robust supply chain, consistent product quality.
• API Offerings: Dextrose Monohydrate, a pharmaceutical-grade product suitable for injectable and IV solutions.
• Market Presence: Particularly dominant in North America and expanding into global markets.

2. Roquette Frères

• Overview: French-based global leader specializing in plant-based ingredients, including pharmaceutical-grade dextrose.
• Strengths: Extensive R&D, adherence to Pharmacopeial standards, reliable supply.
• API Offerings: Pharmaceutical Dextrose Monohydrate with high purity required for injectable applications.
• Market Reach: Europe, North America, and Asia.

3. Cargill Inc.

• Overview: A major US-based agribusiness with substantial production of dextrose APIs.
• Strengths: GMP-certified facilities, broad product portfolio, global distribution.
• API Offerings: USP/FCC-grade Dextrose Monohydrate suitable for pharmaceutical use.
• Global Footprint: North America, Europe, Asia.

4. J.I. Baker (A Division of Ingredion Incorporated)

• Overview: US-based provider of specialty ingredients, including pharmaceutical-grade dextrose.
• Strengths: Expertise in high-grade nutrition and pharmaceutical ingredients.
• API Offerings: Pharmaceutical Dextrose Monohydrate, compliant with USP/EP standards.
• Market Focus: North America, expansion into global markets.

5. Jiangsu Fuyi Pharmaceutical Co., Ltd.

• Overview: Chinese manufacturer with considerable API production, including dextrose.
• Strengths: Competitive pricing, growing GMP compliance.
• API Offerings: Pharmaceutical Dextrose Monohydrate, with certifications aligning with international standards.
• Market Reach: Asia, intermediates exported globally.

6. Shandong Jinye Pharmaceutical Co., Ltd.

• Overview: Chinese pharmaceutical API producer with GMP accreditation.
• Strengths: Cost competitiveness; increasing quality standards.
• API Offerings: Dextrose Monohydrate for pharmaceutical applications.

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Selection Criteria for API Suppliers

When sourcing Dextrose API for manufacturing 70% solutions in plastic containers, several criteria are critical:

• Regulatory Compliance: Suppliers should possess GMP certification, and API should conform to USP, EP, or JP standards.
• Purity and Quality Standards: API purity levels typically exceed 99.5% for pharmaceutical-grade Dextrose Monohydrate.
• Supply Reliability: Consistent delivery schedules and large-scale production capacity are essential.
• Traceability and Documentation: Comprehensive Certificates of Analysis (CoA), Certificates of Compliance (CoC), and manufacturing documentation.
• Cost-effectiveness: Competitive pricing without compromising quality.

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Regional Considerations

• North America & Europe: High-quality API supplies from ADM, Roquette, and Cargill dominate the market. These suppliers adhere strictly to international quality standards and are preferred for regulatory submissions.
• Asia-Pacific: Competitive pricing from Chinese manufacturers like Jiangsu Fuyi and Shandong Jinye offers viable options, especially for bulk procurement, provided that quality certifications are verified.

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Regulatory and Quality Standards

In pharmaceutical manufacturing, API quality is governed by strict standards, including:

• United States Pharmacopeia (USP)
• European Pharmacopoeia (EP)
• Japanese Pharmacopoeia (JP)

Suppliers must provide detailed documentation attesting to API compliance with these standards, along with data on container integrity, batch consistency, and microbiological safety.

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Emerging Trends and Market Dynamics

• GMP Expansion in China: Growing capacity of Chinese APIs with increasing quality standards due to stricter regulations.
• Vertical Integration: Some pharmaceutical manufacturers prefer suppliers capable of integrated manufacturing, ensuring supply chain security.
• Sustainability Initiatives: Suppliers investing in environmentally sustainable processes are increasingly favored.

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Conclusion

Securing a reliable, high-quality bulk API source for Dextrose 70% in plastic containers involves evaluating supplier credentials, regulatory compliance, and supply chain robustness. Leading global suppliers such as ADM, Roquette, and Cargill deliver pharmaceutical-grade Dextrose Monohydrate suitable for manufacturing injectable solutions. For regions with cost pressures, Chinese suppliers like Jiangsu Fuyi are emerging as capable alternatives, provided rigorous quality audits are conducted.

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Key Takeaways

• Supplier Selection: Prioritize GMP-certified API suppliers with proven track records and adherence to international pharmacopoeial standards.
• Quality Assurance: Ensure comprehensive documentation—including CoA, CoC, and stability data—to verify API purity and compliance.
• Regional Preferences: North American and European suppliers offer premium quality suitable for highly regulated markets; Chinese suppliers may provide cost-effective options, contingent upon quality validation.
• Supply Chain Security: Opt for suppliers with scalable manufacturing and reliable distribution networks to prevent shortages.
• Regulatory Readiness: Maintain up-to-date knowledge of regional regulatory requirements for API importation and validation.

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FAQs

1. What are the primary quality standards for pharmaceutical-grade Dextrose API?
Pharmaceutical-grade Dextrose API generally complies with USP, EP, or JP standards, emphasizing high purity (>99.5%), microbiological safety, and consistent batch quality.

2. How do regional regulations impact API sourcing?
Different regions mandate specific standards (e.g., FDA approval in the US, EMA in Europe). Suppliers must possess relevant certifications, and imported API must meet regional regulatory dossiers.

3. What factors influence the decision to source from Chinese API manufacturers?
Cost advantages and increasing quality standards are primary factors, but thorough due diligence, including audits and validation, are critical to ensure compliance and quality.

4. How can manufacturers verify the quality of API suppliers?
Request third-party audit reports, Certificates of Analysis, GMP certificates, and conduct physical inspections when possible. Certification from recognized authorities enhances credibility.

5. What are the key logistical considerations for sourcing Dextrose API?
Ensure suppliers can meet delivery schedules, adhere to quality specifications in transit, and comply with import/export regulations to prevent supply disruptions.

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Sources

[1] U.S. Pharmacopeia. Dextrose Monohydrate standards.
[2] European Pharmacopoeia. Dextrose specifications.
[3] Market research reports on pharmaceutical excipient suppliers.
[4] Company websites: ADM, Roquette, Cargill, Ingredion.
[5] Industry analyses on API sourcing and manufacturing trends.