Bulk Pharmaceutical API Sources for LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5%

Bulk Pharmaceutical API Sources for LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5%

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

Bulk Active Pharmaceutical Ingredient (API) Sources for: Lidocaine Hydrochloride 0.4% in Dextrose 5%

Last updated: July 28, 2025

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Introduction

Lidocaine hydrochloride, a widely used local anesthetic and antiarrhythmic agent, finds extensive application across medical, pharmaceutical, and compounded formulations. Its injectable form, particularly at low concentrations such as 0.4% in dextrose 5%, demands high-purity Active Pharmaceutical Ingredients (APIs) supplied by credible manufacturers. Ensuring the quality, procurement reliability, regulatory compliance, and cost-efficiency of APIs is critical for pharmaceutical companies and compounded pharmacy sectors. This report explores global API sourcing options specifically for Lidocaine Hydrochloride suitable for compounding in dextrose solutions.

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Understanding API Requirements for Lidocaine Hydrochloride

The API—Lidocaine Hydrochloride—must meet strict pharmaceutical standards, including the United States Pharmacopeia (USP), European Pharmacopoeia (EP), or other recognized pharmacopeias. For injectable formulations like 0.4% Lidocaine in Dextrose 5%, key specifications include:

• Purity: Typically ≥99%
• Residual solvents: Limits per pharmacopeial standards
• Impurities and degradation products: Compliant with ICH guidelines
• Particle size and solubility: Consistent with injection-grade standards
• Certificates of Analysis (CoA): Availability from suppliers

The APIs should be supplied in bulk, sterile or non-sterile forms depending on intended manufacturing processes.

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Major API Manufacturers and Suppliers

1. Fermion Group (Cadila Pharmaceuticals)
An established global supplier with extensive experience in API production. Fermion offers pharmaceutical-grade Lidocaine hydrochloride with consistent quality compliant with pharmacopeial standards. Their manufacturing facilities are GMP-certified, ensuring regulatory compliance across regions such as the US, EU, and ROW.

2. Banbier Healthcare
Based in China, Banbier provides APIs including Lidocaine Hydrochloride with detailed CoA, stability data, and regulatory documentation. They support large-scale and clinical batch production, with adherence to GMP and ISO certifications.

3. Siegfried AG
A Swiss-based contract manufacturer with an extensive portfolio of APIs, including Lidocaine. They provide high-purity, pharmacopeial-grade APIs suitable for injectable use, with rigorous quality control and documentation.

4. Zhejiang Kangle Pharmaceutical Co., Ltd.
This Chinese manufacturer supplies high-quality Lidocaine Hydrochloride APIs, focusing on compliance with international standards like USP and EP, with export to global markets.

5. Roquette Frères
Primarily a specialty ingredient provider, Roquette offers pharmaceutical-grade APIs, including Lidocaine, with a focus on stability and consistency in formulations for injectable applications.

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Alternative and Emerging API Sources

• A.A. Pharma (India): Offers pharmaceutical-grade Lidocaine, compliant with US and EU standards, with availability of bulk packages suitable for compounding and manufacturing.
• MedChemExpress (Global): Provides APIs, including Lidocaine Hydrochloride, with detailed safety and quality reports, suitable for sourcing from multiple regions.
• Certara and Capsugel: Contract manufacturing organizations supplying APIs and excipients for customized formulations.

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Regional API Sourcing Considerations

North America:
U.S.-based suppliers such as Pfizer, Hospira (now part of Pfizer), and other GMP-certified manufacturers are primary sources. They provide high-quality APIs with robust regulatory documentation, easing compliance for pharmaceutical firms operating in the US.

Europe:
Companies like Siegfried and Boehringer Ingelheim supply EU-GMP-compliant APIs. European suppliers often offer strict adherence to the EMA standards, facilitating import and registration.

Asia:
China and India represent significant API manufacturing hubs offering cost-effective options. Suppliers such as Zhejiang Kangle and A.A. Pharma stand out with proven quality and competitive pricing. However, regulatory verification and documented compliance are vital.

Global Exporters and Distributors:
API aggregators and distributors such as Alfa Aesar, Thermo Fisher Scientific, and Spectrum Chemical supply multiple sources with diverse sourcing options, including certificates of analysis and regulatory dossiers.

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Regulatory and Quality Assurance

For APIs used in injectable formulations, strict compliance with pharmacopeial standards is mandatory. Procurement should include thorough validation of supplier GMP certification, batch consistency, and detailed documentation. Many reputable API suppliers offer comprehensive stability data, impurity profiles, and regulatory documentation to facilitate registration in different jurisdictions.

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Cost Considerations and Supply Chain Stability

While Asia-based API sources tend to be more economical, procurement involves due diligence in confirming manufacturing quality and regulatory compliance. North American and European suppliers often command premium pricing but provide ease of regulatory navigation. Supply chain stability, lead times, and geopolitical factors also influence sourcing decisions.

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Conclusion

Selecting a reliable API supplier for Lidocaine Hydrochloride suitable for 0.4% in Dextrose 5% formulations requires balancing quality, cost, regulatory compliance, and supply chain reliability. Major global suppliers provide high-quality APIs with diverse sourcing options. Compounding pharmacies and pharmaceutical manufacturers should prioritize GMP compliance, detailed documentation, and supplier reputation to mitigate risks associated with API quality and regulatory approval.

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Key Takeaways

• The highest priority should be sourcing GMP-certified, pharmacopeia-compliant Lidocaine Hydrochloride APIs.
• Global suppliers such as Fermion, Siegfried, and major Chinese manufacturers like Zhejiang Kangle offer reliable sources.
• Consider regional regulatory landscapes, cost, and supply chain stability in sourcing decisions.
• Detailed documentation, Certificates of Analysis, and stability data are critical for regulatory acceptance.
• Diversifying suppliers and establishing supplier quality audit protocols minimize supply disruptions.

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FAQs

1. What are the critical quality attributes of Lidocaine Hydrochloride API for injectable formulations?
Purity (≥99%), low residual solvents, compliant impurity profiles, particle size suited for injections, and thorough documentation are essential.

2. Which regions are best for sourcing Cost-effective Lidocaine APIs?
Asia, particularly China and India, offers competitive pricing. North American and European suppliers provide high compliance standards with higher costs.

3. How can I verify the quality of an API supplier?
Check GMP certification, request detailed Certificates of Analysis, conduct supplier audits, review stability and impurity data, and seek references from other clients.

4. Are there any regulatory issues associated with sourcing Chinese APIs?
While many Chinese manufacturers produce high-quality APIs, due diligence regarding GMP status and regulatory compliance is necessary to ensure acceptance in target markets.

5. What should be included in a supplier’s documentation package for API procurement?
Certificates of Analysis, stability data, process validation reports, regulatory compliance documentation, batch records, and safety data sheets.

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Sources

[1] U.S. Pharmacopeia (USP). Lidocaine Hydrochloride Monograph.
[2] European Pharmacopoeia (EP). Lidocaine Hydrochloride Monograph.
[3] Global API Suppliers’ websites and product catalogs, including Fermion Group, Siegfried AG, Zhejiang Kangle Pharmaceutical.
[4] WHO Good Manufacturing Practices Guidance.
[5] Industry reports on API manufacturing and sourcing trends, 2022–2023.

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(Note: This document has been prepared based on publicly available data and typical industry practices. For specific procurement, consult directly with suppliers and regulatory authorities.)