Bulk Pharmaceutical API Sources for LIDOCAINE HYDROCHLORIDE 0.8% IN DEXTROSE 5% IN PLASTIC CONTAINER

Bulk Pharmaceutical API Sources for LIDOCAINE HYDROCHLORIDE 0.8% IN 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
ABI Chem		AC1Q5LY0

Bulk Active Pharmaceutical Ingredient (API) Sources for: Lidocaine Hydrochloride 0.8% in Dextrose 5% in Plastic Container

Last updated: July 29, 2025

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Introduction

Lidocaine hydrochloride 0.8% in dextrose 5% is a widely used local anesthetic and antiarrhythmic agent supplied predominantly in intravenous formulations for clinical use. The API, lidocaine hydrochloride, is a stabilized, water-soluble compound critical for pharmaceutical manufacturers aiming to produce ready-to-administer solutions. Ensuring reliable, high-quality API sourcing is essential for maintaining product safety, efficacy, and regulatory compliance. This report explores key global suppliers of lidocaine hydrochloride suitable for formulation in sterile intravenous preparations, focusing on the bulk API sources that meet pharmaceutical industry standards.

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Market Overview of Lidocaine Hydrochloride API

Lidocaine hydrochloride is among the most commonly used local anesthetics, with extensive applications ranging from dental procedures to intravenous arrhythmia management. The global API market for lidocaine is mature, with multiple manufacturers demonstrating advanced synthesis capabilities, rigorous quality control, and ability to produce high-purity API compliant with pharmacopeias such as USP, Ph. Eur., and JP.

The demand for API in sterile formulations, especially ready-to-use infusions, requires suppliers to adhere to Good Manufacturing Practices (GMP), establish stable supply chains, and obtain regulatory clearances in key markets such as the U.S., Europe, and Asia.

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Leading Global Suppliers of Lidocaine Hydrochloride API

1. SIGMA-ALDRICH / MERCK KGaA

Overview: Sigma-Aldrich, now part of Merck KGaA, remains a premier supplier of pharmaceutical-grade APIs, including lidocaine hydrochloride. Their products are renowned for high purity, batch-to-batch consistency, and comprehensive documentation.

Capabilities:

• GMP-certified manufacturing facilities
• USP, EP, JP grade API
• Supply scale suited for large-volume pharmaceutical manufacturing
• Extensive technical support and quality assurance documentation

Certifications: GMP, ISO, and regulatory approvals for global markets.

Application Suitability: API suitable for sterile injectable formulations, provided proper sterilization validation during manufacturing.

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

Overview: A leading Chinese pharmaceutical manufacturer specializing in local anesthetics, including lidocaine hydrochloride API. Zhejiang Xianju offers competitive pricing and reliable supply.

Capabilities:

• Multiple ISO-certified manufacturing plants
• Grade certifications aligned with USP and other pharmacopeias
• Large-scale production capacities

Regulatory Notes: While primarily serving Asian markets, their API has achieved registration in some Western jurisdictions through regulatory pathways.

3. Tocris Bioscience (UK)

Overview: Tocris supplies research-grade lidocaine hydrochloride API primarily for development and preclinical use; however, their products meet high purity standards.

Capabilities:

• High-purity API, suitable for pharmaceutical-grade research
• Documentation and quality data consistent with GMP requirements (for investigational use)

Application Suitability: For bulk pharmaceutical manufacturing of sterile products, sourcing from Tocris may necessitate further validation and certification.

4. Jiangsu Hengrui Medicine Co., Ltd. (China)

Overview: A prominent Chinese pharmaceutical company with a broad portfolio including lidocaine hydrochloride API.

Capabilities:

• GMP-certified facilities
• Focused on both bulk APIs and finished formulations
• Ability to supply large quantities for global markets

Regulatory Status: API approved for use in various regulatory jurisdictions; detailed validation needed for sterile injectable applications.

5. Akorn, Inc. (USA)

Overview: Akorn manufactures and supplies pharmaceutical APIs, including lidocaine hydrochloride, with keen emphasis on quality and regulatory adherence.

Capabilities:

• GMP-certified API production
• Compliant with U.S. Pharmacopeia standards
• Strong supply chain infrastructure

Application Suitability: Suitable for sterile injectable formulations due to their compliance with US standards.

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Key Considerations in Sourcing API for Injectable Formulations

• Regulatory Compliance: Ensure supplier GMP certification and ability to provide comprehensive documentation, including Certificates of Analysis (CoA) and stability data.

• API Grade: Confirm that API specifications meet USP, Ph. Eur., or JP standards suitable for intravenous use. For injectables, API purity must typically exceed 99%, with low endotoxin and microbial limits.

• Supply Reliability: Establish supplier capacity for large-volume, consistent supply, considering geopolitical stability and supply chain resilience.

• Validation and Certification: Request detailed process validation, impurity profiles, and stability data for API batches to facilitate regulatory registration.

• Sterilization Compatibility: Engage with suppliers to verify API quality after sterilization procedures, such as heat or filtration, to ensure product integrity for injectable use.

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Future Trends and Sourcing Strategies

• Vertical Integration: Manufacturers increasingly prefer API suppliers involved in the entire production chain, ensuring product control and traceability.

• Regional Sourcing: Companies are diversifying sources from China, India, and Western manufacturers to mitigate geopolitical risks, ensure supply continuity, and optimize costs.

• Quality Benchmarking: Increasing emphasis on analytical rigor, including advanced impurity profiling and bioequivalence testing, drives sourcing decisions.

• Regulatory Navigation: Suppliers capable of supporting registrations under global agencies (FDA, EMA) gain competitive advantage.

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Conclusion

Securing a reliable source of high-purity lidocaine hydrochloride API is fundamental for pharmaceutical companies manufacturing sterile solutions like 0.8% in dextrose 5% formulations. Leading suppliers such as Merck KGaA’s Sigma-Aldrich, Zhejiang Xianju Pharmaceutical, Jiangsu Hengrui, and Akorn offer robust options aligned with industry standards. Engaging with suppliers that demonstrate compliance, stability, and supply capacity ensures regulatory adherence, product quality, and uninterrupted supply for critical healthcare applications.

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Key Takeaways

• Leading global APIs suppliers for lidocaine hydrochloride include Merck KGaA, Zhejiang Xianju, Jiangsu Hengrui, and Akorn.
• Rigorous GMP compliance and documentation are non-negotiable for sterile injectable applications.
• Regional diversification minimizes supply chain risks amid geopolitical uncertainties.
• Suppliers should provide comprehensive validation, impurity profiles, and stability data.
• Early engagement and qualification of API suppliers streamline regulatory approval and production timelines.

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FAQs

1. What are the primary regulatory standards for lidocaine hydrochloride API used in injectables?
The API must meet pharmacopeial standards such as USP, Ph. Eur., or JP. Additionally, manufacturers must comply with GMP guidelines, ensure low endotoxin levels, microbial limits, and high purity (typically >99%).

2. How does API purity impact the safety and efficacy of injectable lidocaine formulations?
High API purity reduces the risk of adverse reactions, impurities, and endotoxins, ensuring patient safety. Impurities can compromise drug stability, potency, and regulatory approval.

3. Is regional sourcing advisable for lidocaine API?
Regional sourcing can mitigate supply disruptions, lower costs, and expedite regulatory approvals, but it requires rigorous due diligence concerning quality standards and supplier validation.

4. What are common challenges in sourcing API for sterile formulations?
Challenges include maintaining API stability post-sterilization, ensuring consistent quality, meeting stringent impurity profiles, and navigating complex regulatory pathways.

5. What emerging trends influence API sourcing for local anesthetics like lidocaine?
Trends include increased focus on supply chain resilience, adoption of advanced analytical techniques, and preference for suppliers with integrated quality management systems supporting global regulatory compliance.

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References

[1] USP, "United States Pharmacopeia," USP 44–NF 39, 2021.
[2] Merck KGaA, “API Portfolio,” (2023).
[3] Zhejiang Xianju Pharmaceutical Co., Ltd., “Product Certifications,” (2023).
[4] Jiangsu Hengrui Medicine Co., Ltd., “API Quality Standards,” (2023).
[5] Akorn, Inc., “API GMP Certification,” (2023).