Bulk Pharmaceutical API Sources for DEXTROSE 10% IN PLASTIC CONTAINER

Bulk Pharmaceutical API Sources for DEXTROSE 10% 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
Finetech Industry Limited		FT-0645133
Finetech Industry Limited		FT-0624560

Bulk Active Pharmaceutical Ingredient (API) Sources for Dextrose 10% in Plastic Container

Last updated: August 8, 2025

---

Introduction

Dextrose 10% in plastic containers, also known as 10% glucose injection, is a widely used intravenous fluid for fluid replacement and nutritional support in clinical settings. The active pharmaceutical ingredient (API), dextrose monohydrate (commonly), is fundamental to manufacturing this parenteral solution. A reliable supply chain for high-quality API is crucial for pharmaceutical companies to ensure consistent product quality, regulatory compliance, and timely delivery.

This article examines the global landscape of API sourcing for dextrose 10%, focusing on key manufacturing regions, suppliers’ profiles, quality certifications, and market trends influencing procurement decisions.

---

Overview of Dextrose Monohydrate as API

Dextrose monohydrate (C₆H₁₂O₆·H₂O) is a monosaccharide derived predominantly through the enzymatic hydrolysis of starch, typically originating from maize, wheat, or tapioca. Its pharmaceutical grade must comply with pharmacopeial standards such as USP, EP, or JP, reflecting stringent purity and safety specifications.

The API’s primary role in 10% glucose injections centers on its isotonic properties, safety profile, and bioavailability, making the quality of the API pivotal for pharmaceutical manufacturing.

---

Regional Sources of Dextrose API

1. Asia-Pacific Region

a. China

China is the dominant manufacturer and exporter of dextrose API globally, accounting for over 50% of the world’s supply [1]. Major companies such as Jianfeng Group and Shandong Wonderful Industrial Group produce high-purity dextrose monohydrate meeting international standards.

• Strengths: Large production capacity, cost competitiveness, extensive export infrastructure.
• Certifications: GMP, ISO 9001, and certification aligned with pharmacopeial standards.

b. India

India’s dextrose API industry is growing rapidly, driven by massive agro-based raw material availability and cost efficiencies [2].

• Key players: ACG Associated Capsules, Shree Food & Chemicals.
• Quality: Many facilities possess WHO-GMP certifications, with some approved for export to regulated markets like the US and Europe.

2. North America

a. United States & Canada

While less dominant in raw API production, North American suppliers like Cargill and Archer Daniels Midland (ADM) provide pharmaceutical-grade dextrose API sourced mainly from domestically produced or imported raw materials.

• Focus: High purity, compliance with FDA regulations, and strict quality adherence.

3. Europe

European manufacturers mainly source dextrose API through imports, as most production occurs in Asia. However, some companies in Germany and France produce specialty grades and supply API conforming to EU standards [3].

---

Leading API Suppliers and Manufacturers

Top Suppliers

Supplier	Location	Certification & Quality Features	Capacity & Supply	Market Focus
Jianfeng Group	China	GMP, ISO 9001, pharmacopeial standards	Large-scale, export-oriented	Global
Shandong Wonderful Industrial Group	China	GMP, ISO, pharmacopoeial compliance	Major exporter	Global
Cargill	USA	cGMP, FDA-approved	High-volume, reliable supply	North America, global markets
Archer Daniels Midland (ADM)	USA	GMP, FDA compliance	Extensive capacity	North America, international
Roquette	France	EU GMP, pharmacopeial standards	Niche and bulk supply	Europe, regulated markets

Emerging Suppliers

Regional manufacturers in Southeast Asia and Eastern Europe are expanding their API production capabilities, emphasizing quality standard upgrades to meet global market requirements.

---

Quality Standards and Regulatory Compliance

API sourcing mandates stringent adherence to pharmacopoeial standards: USP, EP, JP, and others. Supply chain validation includes raw material traceability, process validation, and comprehensive quality control (QC) testing for identity, purity (>99%), endotoxin levels, and microbial contamination.

Suppliers typically possess certifications including:

• Good Manufacturing Practices (GMP)
• ISO 9001/ISO 14001
• Drug Master Files (DMFs) filed with regulatory agencies in major markets

Implication: Procurement from certified suppliers minimizes regulatory risks and ensures compatibility with pharmaceutical standards for injectable formulations.

---

Market Trends Influencing API Sourcing

• Cost pressures: Asian suppliers offer lower costs due to labor and raw material advantages, influencing purchasing decisions for large-volume buyers.
• Regulatory dynamics: Growing scrutiny in European and North American markets necessitate sourcing from certified, compliant suppliers.
• Supply chain resilience: Recent global disruptions have led to diversification strategies, engaging multiple suppliers across regions.
• Environmental and sustainability considerations: Increasing emphasis on eco-friendly manufacturing processes amplifies demand for suppliers adhering to environmental standards.

---

Strategic Considerations for Pharmaceutical Companies

• Supplier qualification: Conduct in-depth audits and assessments for capacity, quality, and compliance.
• Long-term contracts: Secure supply continuity amidst volatile markets.
• Regional diversification: Mitigate risks by sourcing from multiple regions.
• Regulatory alignment: Ensure suppliers’ certifications match target markets’ regulatory expectations.

---

Conclusion

Reliable procurement of dextrose monohydrate API for manufacturing 10% glucose injections hinges on discerning high-quality sources primarily located in China, India, and North America. The key to supply stability, regulatory compliance, and cost efficiency lies in partnering with suppliers holding robust certification credentials (GMP, ISO) and demonstrating capacity to meet pharmaceutical standards.

As the global pharmaceutical market evolves, supply chains must adapt through diversification, rigorous qualification, and adherence to evolving quality standards. Strategic sourcing ensures consistent production quality and continuous patient care.

---

Key Takeaways

• China remains the top global API supplier of dextrose monohydrate, offering large capacities and cost advantages.
• Indian manufacturers are rapidly scaling up, emphasizing quality and GMP compliance to access regulated markets.
• North American and European suppliers focus on high-purity API with strict regulatory adherence, suitable for high-standard markets.
• Quality certifications such as GMP, ISO, and compliance with pharmacopeial standards are non-negotiable for API procurement.
• Market adaptability depends on diversification, environmental compliance, and supplier reliability aligning with regulatory expectations.

---

FAQs

1. What are the primary regions supplying dextrose monohydrate API for injectable use?
   The main regions are China, India, North America (USA and Canada), and parts of Europe, with China dominating global exports.

2. How can pharmaceutical companies ensure the quality of their dextrose API sources?
   By verifying supplier certifications (GMP, ISO), reviewing regulatory filings (DMFs), conducting audits, and testing API batches for purity and contaminants.

3. Are there specific regulatory considerations when sourcing dextrose API?
   Yes, suppliers must meet pharmacopeial standards (USP, EP, JP), possess valid manufacturing licenses, and have quality certifications compatible with the target market's regulatory framework.

4. What factors influence pricing of dextrose monohydrate API globally?
   Major factors include raw material costs, manufacturing scale, currency fluctuations, regulatory costs, transportation, and certification compliance standards.

5. What are future trends impacting API sourcing for dextrose in pharmaceuticals?
   Increasing regulatory rigor, supply chain diversification, eco-friendly manufacturing practices, and technological innovations in manufacturing processes will significantly shape sourcing strategies.

---

References

[1] MarketsandMarkets. "Pharmaceutical Dextrose Monohydrate Market." 2022.
[2] Indian Department of Chemicals and Petrochemicals. "Growth of API Industry in India," 2021.
[3] European Directorate for the Quality of Medicines & HealthCare (EDQM). "Pharmacopoeial Standards for Dextrose," 2022.