Bulk Pharmaceutical API Sources for CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINER

Bulk Pharmaceutical API Sources for CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINER

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		C7912_SIGMA
Sigma-Aldrich		C7039_SIGMA
NovoSeek		10695961
TCI (Tokyo Chemical Industry)		C2224
MolPort		MolPort-003-928-040
ABBLIS Chemicals		AB1009356
ChemMol		49424132

Bulk Active Pharmaceutical Ingredient (API) Sources for Cefotaxime and Dextrose 2.4% in Plastic Container

Last updated: August 2, 2025

Introduction

The generic pharmaceutical market's evolution has heightened the importance of sourcing high-quality Active Pharmaceutical Ingredients (APIs) for manufacturing injectable formulations. Cefotaxime, a third-generation cephalosporin antibiotic, and dextrose 2.4%, a 2.4% glucose solution used for hydration, are frequently combined for clinical administration. Ensuring reliable global sources of these APIs in bulk form, particularly for formulations in plastic containers, is critical for manufacturers aiming for consistent quality, regulatory compliance, and cost-effectiveness.

This report examines key global API suppliers for cefotaxime and dextrose 2.4%, focusing on their capabilities, quality assurance standards, and market positioning, to assist pharmaceutical companies in strategic sourcing.

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Cefotaxime API: Global Supply Landscape

Manufacturers and Suppliers

Cefotaxime API production is predominantly concentrated among established international and regional manufacturers. Notable sources include:

• Synthesis Chemistry International Manufacturers: Large-scale producers in China, India, and Europe supply cefotaxime API with high purity standards compliant with USP, EP, and JP pharmacopoeias. Major Chinese companies such as North China Pharmaceutical Group (NCPC) and Hunan Jinjing Pharmaceutical Co. are significant suppliers, offering cost-competitive APIs with documented regulatory compliance for export.

• Indian API Manufacturers: Companies like Biophore India Pharmaceuticals, Aurobindo Pharma, and Hetero Drugs have developed cefotaxime API detailing extensive cGMP compliance, batch validation, and stability data. These suppliers are recognized by international regulatory bodies, meeting stringent standards necessary for critical injectable APIs.

• European and US Suppliers: While fewer in number, high-quality cefotaxime APIs are provided by pharmaceutical contract manufacturing organizations (CMOs) such as Cambridge Major Laboratories and Fresenius Kabi, focusing on premium quality APIs suitable for markets with strict regulatory oversight.

Quality Assurance and Regulatory Status

Top-tier cefotaxime API suppliers adhere to current Good Manufacturing Practices (cGMP), with quality control laboratories conducting comprehensive analyses, including high-performance liquid chromatography (HPLC), residual solvent testing, and microbiological assessments. Certificates of Analysis (CoA), batch validation data, and stability reports are routinely supplied, facilitating regulatory submissions globally.

Many suppliers hold approvals or inspections from regulatory agencies like the US FDA, European Medicines Agency (EMA), and local authorities, ensuring API compliance for parenteral formulations in plastic containers.

Supply Chain and Packaging Considerations

While APIs are usually supplied in bulk powder form, some suppliers offer pre-packaged sterile API vials or lyophilized forms suitable for reconstitution, but for large-volume liquid formulations, APIs are shipped in bulk, then processed downstream.

Supply chain robustness is supported via multiple manufacturing sites, with some suppliers providing direct shipping in primary or secondary packaging specific for enhanced stability during transit.

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Dextrose 2.4% API: Global Supply Landscape

Manufacturers and Suppliers

The dextrose API used in injectable formulations is primarily manufactured in facilities in India, China, and Europe, with prominent suppliers including:

• Fujian Union New Material Co., Ltd. (China): Specializes in high-grade dextrose monohydrate, with certification for pharmaceutical use, offering bulk APIs for production in plastic container-compatible formulations.

• SinoFresh (China): Provides pharmaceutical-graded dextrose API in large quantities, adhering to pharmacopeial standards (USP, EP). Their APIs are used globally in injectable products, including in plastic containers.

• Indian Suppliers: Companies like Shivam Dextro-Cure Pvt Ltd and Gist Brocades (now part of DSM) supply USP-grade dextrose APIs. These manufacturers have established cGMP compliance, extensive quality control systems, and reliable supply chains.

• European and US Providers: Smaller but highly regulated entities, such as Fresenius Kabi and Baxter International, supply sterile dextrose API with proven regulatory acceptance for parenteral use, often in pre-sterilized, ready-to-use formats suitable for plastic containers.

Quality and Regulatory Compliance

The API suppliers of dextrose emphasize high purity, moisture content control, and absence of endotoxins, crucial for injectable applications. Certificates of analysis demonstrate compliance with stringent pharmacopeial standards, with many suppliers securing ISO 9001, ISO 13485, and cGMP certifications.

Importantly, suppliers provide stability data and appropriate packaging solutions to prevent contamination or moisture ingress during transit and storage.

Packaging and Logistics

Bulk dextrose API is primarily supplied in large drums or tankers, with downstream processing enabling formulation into solutions in plastic containers. Certain suppliers offer pre-sterilized, ready-to-use API solutions in polypropylene or polyethylene containers designed to ensure compatibility and stability in medical settings.

Efficient logistics and regulatory documentation streamline supply continuity essential for formulations requiring consistent API availability.

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Market Trends and Sourcing Strategies

Increased Quality and Regulatory Demands

Evolving regulatory landscapes, including US FDA and EMA standards, necessitate sourcing APIs from certified manufacturers with comprehensive cGMP practices. Ongoing pharmacovigilance and quality audits are integral to maintaining supply chain integrity.

Cost Optimization vs. Quality Security

While Chinese and Indian suppliers offer competitive pricing for cefotaxime and dextrose APIs, pharmaceutical companies must balance cost with regulatory compliance, purity, and batch-to-batch consistency—particularly for APIs intended for injectable formulations in plastic containers.

Emerging Suppliers and Regional Shifts

Supply diversification is increasingly observed, with some manufacturers investing in second sourcing and regional manufacturing footprints to mitigate risks linked to geopolitical or pandemic-related disruptions.

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Conclusion

Securing reliable bulk APIs for cefotaxime and dextrose 2.4% involves navigating a broad supplier landscape characterized by geographical diversity, quality standards, and supply chain stability. Top-tier suppliers from China, India, and Europe—such as NCPC, Biophore, and Fresenius Kabi—offer high-quality APIs compatible with pharmaceutical manufacturing and regulatory requirements.

Firms must conduct comprehensive supplier due diligence, emphasizing cGMP compliance, documentation, and stability data, to ensure API integrity in formulations packaged in plastic containers. Strategic sourcing rooted in quality assurance and supply resilience remains a fundamental component for the successful production of injectable cefotaxime-Dextrose 2.4% solutions.

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Key Takeaways

• Diverse Supplier Base: Key sources include China, India, and Europe, with each offering varying cost and compliance benefits.
• Regulatory Alignment: Priority on suppliers with cGMP certification, regulatory approvals, and comprehensive documentation.
• Quality Assurance: Strict quality control, stability testing, and certification support API suitability for injectable formulations.
• Supply Chain Resilience: Multi-sourcing and regional manufacturing hubs mitigate risks associated with geopolitical and logistical disruptions.
• Packaging Compatibility: APIs are available in bulk powder or pre-sterilized forms optimized for formulation in plastic containers, emphasizing stability and contamination prevention.

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FAQs

1. What are the primary factors to consider when sourcing cefotaxime API?
Quality compliance (cGMP, regulatory approvals), purity levels, batch consistency, supply reliability, and packaging compatibility are vital considerations.

2. Are Chinese and Indian cefotaxime APIs suitable for parenteral products?
Yes, many Chinese and Indian manufacturers produce cefotaxime APIs meeting international pharmacopeial standards and regulatory requirements suitable for injectable formulations.

3. How do I ensure dextrose API quality for infusion solutions?
Verify supplier certifications (USP, EP), conduct independent testing for purity, moisture, and endotoxin levels, and review stability and sterility documentation.

4. What are the key differences between API suppliers from different regions?
European suppliers often have more stringent regulatory oversight, higher costs, but proven quality; Chinese and Indian suppliers offer cost-effectiveness with compliant quality levels, depending on the manufacturer.

5. Is pre-sterilized API available for cefotaxime and dextrose?
Pre-sterilized APIs are less common and typically more expensive. Most APIs are supplied as bulk powders, with sterilization implemented during downstream processing.

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Sources

[1] United States Pharmacopeia (USP), 2022.
[2] European Pharmacopoeia (EP), 2022.
[3] Chinese Pharmacopoeia, 2020.
[4] Indian Pharmacopoeia, 2019.
[5] Market analysis reports on API suppliers, 2022.