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

Bulk Pharmaceutical API Sources for LIDOCAINE HYDROCHLORIDE 0.4% 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 0.4% in Dextrose 5% in Plastic Container

Last updated: August 13, 2025

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Introduction

Lidocaine hydrochloride, a widely used local anesthetic and antiarrhythmic agent, is integral to various medical formulations, including injectable solutions. One such formulation, comprising 0.4% Lidocaine Hydrochloride in Dextrose 5% in a plastic container, is utilized for local anesthesia during minor procedures, as well as for systemic antiarrhythmic therapy in specific clinical settings. The procurement of high-quality API, specifically lidocaine hydrochloride, is critical to ensure product efficacy, safety, and regulatory compliance.

This document delineates the global sources for bulk lidocaine hydrochloride suitable for formulating the specified concentration and vehicle, emphasizing manufacturing standards, regulatory approvals, and supply reliability.

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Overview of Lidocaine Hydrochloride API

Lidocaine hydrochloride is a well-established amide-type local anesthetic. Its pharmaceutical-grade API must meet strict criteria, including purity (>99%), low residual solvents, and compliance with pharmacopeial standards such as USP, EP, or JP.

The API's sourcing landscape comprises reputable manufacturers primarily located in Asia, Europe, and North America, with increasing scrutiny on quality assurance and regulatory registration. Variability in manufacturing processes, quality control, and documentation emphasizes the importance of selecting verified suppliers.

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Key Criteria for Selecting API Suppliers

• Regulatory Compliance: Suppliers should possess valid GMP certifications (e.g., EMA, FDA, WHO) and have their API comply with pharmacopeial standards.
• Quality Assurance: Certificates of Analysis (CoA), batch history, and stability data are essential.
• Supply Reliability: Consistent production capacity, logistics capabilities, and adherence to delivery timelines.
• Pricing and Lead Time: Competitive pricing aligned with quality standards; responsive lead times to meet demand fluctuations.
• Traceability: Transparent supply chain management and documentation for regulatory audits.

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Major Global API Manufacturers for Lidocaine Hydrochloride

1. China-based Manufacturers

a) Zheijang Huadong Pharmaceutical Co., Ltd.
A leading producer with extensive expertise in anesthetic APIs, including lidocaine hydrochloride. It adheres to GMP standards verified by Chinese regulatory authorities and holds export licenses approved by the relevant authorities.
Certifications: GMP, ISO 9001, CE marking for some products.

b) Zhejiang Tianyu Pharmaceutical Co., Ltd.
Known for producing injectable-grade APIs, with rigorous quality systems aligned with international standards. Their lidocaine hydrochloride APIs meet USP and BP specifications.

c) Hebei Kailin Pharmaceutical Co., Ltd.
Specializes in local anesthetics, offering bulk API with consistent quality and competitive pricing.

2. Indian Manufacturers

a) Sun Pharmaceutical Industries Ltd.
One of India's largest pharmaceutical companies with a significant API production portfolio. Their lidocaine hydrochloride complies with USP and other pharmacopeial standards, supported by robust QA systems.

b) Ipca Laboratories Ltd.
A WHO-GMP certified manufacturer known for reliable bulk APIs, including lidocaine hydrochloride, with extensive export markets.

c) Hetero Labs Ltd.
Offers high-quality lidocaine hydrochloride API, integrated into their sterile and non-sterile product portfolio, with certifications aligned with international standards.

3. European Manufacturers

a) BASF (Germany)
Offers pharmaceutical-grade APIs, including lidocaine hydrochloride, with stringent regulatory compliance and quality management systems aligned with EMA standards.

b) Bayer (Germany)
Produces APIs with established quality and regulatory certifications; their API sourcing supports global pharma manufacturers.

c) Evonik Industries (Germany)
Supplies specialty chemicals and APIs, including lidocaine salts, with high purity standards suitable for injectable formulations.

4. North American Suppliers

a) DAIICHI SANKYO (USA)
While primarily a pharmaceutical company, DAIICHI SANKYO supplies pharmaceutical-grade APIs globally, including lidocaine hydrochloride, with requisite quality controls.

b) Allergan (USA)
Produces medical and pharmaceutical-grade APIs with stringent quality standards aligned with FDA regulations.

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Emerging and Niche API Suppliers

• VivaChem (India): Focuses on high-quality anesthetic APIs, with a reputation for customization and flexible supply.
• Amercian Bio Medicals (India): Provides GMP-compliant lidocaine hydrochloride for clinical and commercial use.
• Jubilant Chemical (India): Offers competitively priced APIs adhering to international pharmacopeial standards.

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Regulatory Considerations and Validation

For APIs procured internationally, validation of supplier compliance with regulatory standards such as the FDA's cGMP, EMA directives, or WHO PQ standards is paramount. Due diligence includes requesting audit reports, recent batch stability data, and CoA documentation. Additionally, manufacturers with approved API Master Files (MAFs) or Drug Master Files (DMFs) facilitate smoother registration processes for finished products.

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Quality Control and Storage

Ensuring API quality involves rigorous in-house testing, including:

• Assaying potency (e.g., HPLC analysis for purity ≥99%).
• Residual solvent analysis.
• Impurity profiling.
• Moisture content and sterility testing where applicable.

APIs should be stored under controlled conditions, typically in a cool, dry environment away from light to preserve stability.

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Supply Chain and Logistics

Efficient supply chain logistics are vital, especially considering the global demand for injectable formulations. Factors include:

• Packaging suitable for storage and transport (airtight, tamper-evident containers).
• Cold chain capabilities if required.
• Lead times adjustment based on regional manufacturing and customs clearance.

Engagement with suppliers that maintain proactive communication and transparent documentation expedites inventory management and regulatory submissions.

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Conclusion

Securing a reliable source of high-quality lidocaine hydrochloride API is essential for manufacturing the specified 0.4% in Dextrose 5% in plastic container formulation. Leading suppliers span across China, India, Europe, and North America, each with distinct advantages concerning compliance, quality, and capacity.

A comprehensive supplier evaluation—covering certifications, quality assurance, regulatory alignment, and logistics—is advised. Ensuring close collaboration with reputable manufacturers minimizes risk, guarantees regulatory compliance, and supports consistent product quality.

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Key Takeaways

• Top API suppliers include Chinese manufacturers like Zhejiang Tianyu, Indian firms such as Sun Pharma, and European companies like BASF.
• Validation of GMP compliance and quality documentation is critical to mitigate regulatory risks.
• Consider supply reliability, logistics, and price competitiveness when selecting a supplier.
• Maintain rigorous QC procedures to verify API purity and stability upon arrival.
• Engaging with suppliers holding validated API Master Files expedites regulatory registration.

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FAQs

1. What are the primary factors influencing the choice of a lidocaine hydrochloride API supplier?
Regulatory compliance, quality assurance, supply reliability, cost, and traceability are key factors. Suppliers with GMP certification, strict QC protocols, and proven track records are preferable.

2. How does API purity impact the final product's safety and efficacy?
High-purity API (typically ≥99%) minimizes impurities and ensures consistency, directly affecting the safety profile and therapeutic effectiveness of injectable formulations.

3. Are there specific regulatory considerations for importing lidocaine hydrochloride APIs globally?
Yes. Importers must ensure the API complies with local pharmacopeial standards, possess appropriate certifications, and meet customs and import regulations, including registration with relevant health authorities.

4. Can regional manufacturing differences affect API performance?
Yes. Variations in production processes and quality control can influence purity, impurity profiles, and stability, underscoring the importance of sourcing from reputable, globally certified suppliers.

5. What documentation should be requested from API suppliers prior to procurement?
Certificates of Analysis, Quality Compliance Certificates, stability data, manufacturing licenses, GMP/ISO certificates, and API Master Files or DMFs if available.