Bulk Pharmaceutical API Sources for LIDOCAINE HYDROCHLORIDE 0.1% AND DEXTROSE 5% IN PLASTIC CONTAINER

Bulk Pharmaceutical API Sources for LIDOCAINE HYDROCHLORIDE 0.1% AND DEXTROSE 5% IN PLASTIC CONTAINER

Vendor	Vendor Homepage	Vendor Sku	API Url
IS Chemical Technology		I01-2012
IS Chemical Technology		I01-4416
MolPort		MolPort-003-666-319
Hangzhou APIChem Technology		AC-11712
AAA Chemistry		AR-1J3191
ABI Chem		AC1L1M96

Bulk Active Pharmaceutical Ingredient (API) Sources for Lidocaine Hydrochloride 0.1% and Dextrose 5% in Plastic Containers

Last updated: August 1, 2025

Introduction

The procurement of high-quality Active Pharmaceutical Ingredients (APIs) is vital for the manufacturing of safe and effective medical solutions, particularly for injectable formulations such as Lidocaine Hydrochloride 0.1% and Dextrose 5%. These APIs serve as the core components in regional anesthesia, pain management, and parenteral nutrition. The specific form—liquid APIs packaged in plastic containers—necessitates adherence to rigorous quality standards, regulatory compliance, and reliable supply chains. This article delineates the foremost sources globally, emphasizing their capabilities, certifications, and market positioning to guide pharmaceutical manufacturers and healthcare providers.

Lidocaine Hydrochloride 0.1% API Sources

Global Leaders in Lidocaine Hydrochloride API Supply

Lidocaine Hydrochloride, a widely used local anesthetic, is produced primarily in sites adhering to Good Manufacturing Practices (GMP). Its global market comprises several leading API producers, particularly in Asia and Europe, with established regulatory approvals (US FDA, EMA, WHO PQ). The critical factors influencing selection include purity standards, manufacturing capacity, supply stability, and compliance with pharmacopoeial specifications.

Major API Suppliers for Lidocaine Hydrochloride

1. Hubei Wuling Pharmaceutical Co., Ltd. (China)

• Capabilities: Supplies high-purity Lidocaine Hydrochloride API suitable for injectable formulations, with extensive GMP-certified facilities.
• Certifications: GMP, ISO 9001, and notably approved by the NMPA (China FDA).
• Market Position: Recognized for cost-effective manufacturing and consistent quality.

2. Zhejiang Jiuzhou Pharmaceutical Co., Ltd. (China)

• Capabilities: Supplies pharmacopeia-grade Lidocaine API in bulk, with production capacity exceeding several tons annually.
• Certifications: GMP, ISO 9001, and FDA Registration, with exports to North America, Europe, and Asia.
• Specialty: Focus on injectable-grade APIs with specifications compatible with the 0.1% formulation.

3. Tedor Pharmaceutical (India)

• Capabilities: Proven supplier of active pharmaceutical ingredients, including Lidocaine Hydrochloride, with extensive API portfolio.
• Certifications: WHO-GMP, ISO 9001, USFDA, and EDQM certifications.
• Market Reach: Supplies to major global API markets and contract manufacturing organizations.

4. Hospira (Pfizer) (USA)

• Capabilities: Global producer of pharmaceutical APIs, with high-quality, FDA-approved Lidocaine Hydrochloride API.
• Certifications: USFDA, cGMP.
• Remarks: Despite being a large-scale manufacturer primarily for injection-ready APIs, access may be limited by procurement processes and pricing.

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Considerations for API Procurement

• Regulatory Compliance: Choose suppliers with GMP, WHO-GMP, or FDA certifications to ensure regulatory acceptability.
• Purity Standards: APIs should meet or exceed USP/NF or EP specifications, especially concerning residual solvents, endotoxins, and sterility.
• Supply Chain Security: Stability of supply and capacity to meet forecasted demand are key.
• Documentation and Batch Consistency: Certificates of Analysis (CoA), Certificates of suitability, and stability data are essential.

Dextrose 5% API Sources

Overview

Dextrose (glucose) 5% in aqueous solution is a foundational IV fluid component. When supplied as a bulk API, particularly for preparation in plastic containers, suppliers must meet strict quality grades suitable for parenteral administration.

Leading Suppliers for Dextrose API

1. Cargill, Inc. (USA)

• Capabilities: Produces pharmaceutical-grade Dextrose Monohydrate and Dextrose Anhydrous, suitable for injectable formulations.
• Certifications: FDA-registered, cGMP-certified, and compliant with USP, EP, and JP standards.
• Market Position: Largest supplier with extensive global distribution networks.

2. Roquette Frères (France)

• Capabilities: Supplies high-purity Dextrose for parenteral use with rigorous quality control.
• Certifications: EU-GMP, FDA, ISO 9001.
• Special Note: Emphasizes sustainable sourcing and stringent quality procedures.

3. Archer Daniels Midland Company (ADM) (USA)

• Capabilities: Offers a range of pharmaceutical-grade Dextrose in various grades and packaging configurations.
• Certifications: FDA, ISO, and cGMP standards met.
• Advantages: Secure supply chain and global distribution.

4. Zhejiang Aokang Pharmaceutical Co. Ltd. (China)

• Capabilities: Produces GMP-certified Dextrose API compatible with parenteral formulations.
• Certifications: GMP, ISO, and other regional approvals.
• Remarks: Cost-effective alternative with growing regulatory acceptance.

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Procurement Considerations for Dextrose API

• Quality Assurances: Confirm USP/EP compliance, endotoxin levels, and sterility parameters.
• Packaging: Ideally supplied in plastic containers designed for pharmaceutical use, minimizing contamination risks.
• Supply Stability: Consider suppliers’ production capacities and delivery timelines to prevent shortages.
• Traceability: Ensure comprehensive documentation and batch traceability.

Regulatory and Quality Standards

Sourcing APIs that meet international pharmacopoeial standards—USP, EP, JP—is mandatory for injectable formulations. Certifications like cGMP, GMP, and ISO 9001 serve as quality benchmarks. Alignment with regional regulatory authorities (FDA, EMA, NMPA) ensures market acceptance and streamlines approval processes.

Regional Market Insights

The API sourcing landscape is heavily influenced by regional manufacturing strengths and regulatory frameworks. China and India dominate as cost-effective, large-scale producers, with many suppliers attaining GMP and WHO prequalification status. The European and North American markets primarily depend on EU and US-approved API manufacturers, often emphasizing stricter quality control and compliance.

Supply chain dynamics have been impacted by geopolitical tensions and global events like the COVID-19 pandemic, underscoring the need for diversified sourcing strategies and buffer inventories.

Conclusion

Reliable sourcing of Lidocaine Hydrochloride 0.1% and Dextrose 5% APIs requires a strategic approach centered on quality, compliance, and supply stability. Prominent suppliers such as Hubei Wuling, Zhejiang Jiuzhou, Cargill, Roquette, and Archer Daniels Midland offer robust options aligned with global regulatory standards. Pharmaceutical manufacturers should carefully vet suppliers through documented certifications, purity profiles, and capacity assurances to ensure seamless production of injectable solutions in plastic containers.

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Key Takeaways

• Prioritize suppliers with globally recognized certifications (GMP, WHO-GMP, FDA) to ensure regulatory compliance and product quality.
• Verify API purity and specification compliance with pharmacopeial standards (USP, EP, JP), focusing on endotoxin levels and residual solvents.
• Diversify sourcing strategies to mitigate supply chain risks influenced by geopolitical and logistical factors.
• Ensure proper packaging and documentation to facilitate regulatory submissions and manufacturing consistency.
• Monitor market trends and regulatory updates to adapt sourcing strategies proactively, maintaining a competitive edge.

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Frequently Asked Questions (FAQs)

1. What are the main regulatory considerations when sourcing APIs for injectable formulations?
Regulatory considerations include compliance with GMP standards, pharmacopeial specifications (USP, EP, JP), and regional approvals such as FDA or EMA registration. Proper documentation, stability data, and supply chain transparency are essential for regulatory approval and market acceptance.

2. How do I evaluate the quality of Lidocaine Hydrochloride API from a new supplier?
Evaluate the supplier’s certifications, request Certificate of Analysis (CoA), review purity profiles, endotoxin levels, residual solvent tests, and batch consistency data. Conduct or review recent audit reports and verify compliance with applicable pharmacopoeial standards.

3. Are there regional differences in API quality standards for Dextrose 5%?
Yes. While USP and EP standards are globally recognized, some regions may have specific requirements or preferred certifications. Suppliers with international GMP approval and certifications that align with regional regulatory frameworks facilitate smoother approval processes.

4. Can API suppliers provide samples for testing before bulk purchase?
Most reputable suppliers can provide samples for initial testing and qualification purposes. It is advisable to conduct rigorous quality evaluations on these samples before committing to large-scale procurement.

5. How do geopolitical factors influence API supply chains?
Geopolitical tensions, trade policies, and export restrictions can disrupt supply chains. Diversifying sources, maintaining sufficient inventory buffers, and establishing long-term contracts with multiple suppliers help mitigate these risks.

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References

[1] U.S. Pharmacopeia. (2023). USP Standards for Lidocaine Hydrochloride and Dextrose.
[2] European Pharmacopoeia. (2023). Monographs for Lidocaine Hydrochloride and Dextrose.
[3] WHO. (2022). Prequalification Programme for APIs and Injection Solutions.
[4] Cargill. (2023). Pharmaceutical-grade Dextrose specifications.
[5] Zhejiang Jiuzhou Pharmaceutical. (2023). API product brochure and regulatory approvals.