Bulk Pharmaceutical API Sources for LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5% IN PLASTIC CONTAINER

Bulk Pharmaceutical API Sources for LIDOCAINE HYDROCHLORIDE 0.2% 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

Bulk Active Pharmaceutical Ingredient (API) Sources for: Lidocaine Hydrochloride 0.2% in Dextrose 5% in Plastic Container

Last updated: August 1, 2025

Introduction

The global demand for local anesthetics, especially lidocaine hydrochloride, remains robust across healthcare sectors, including hospitals, clinics, and pharmaceutical manufacturing. Lidocaine Hydrochloride 0.2% in Dextrose 5% solutions in plastic containers is a widely utilized formulation, primarily for infiltration anesthesia, nerve blocks, and other regional anesthesia procedures. Securing reliable sources of high-quality API is critical for pharmaceutical companies to ensure safety, efficacy, and regulatory compliance. This report reviews primary API suppliers for Lidocaine Hydrochloride suitable for producing this specific injectable formulation.

Regulatory Landscape and Quality Standards

API suppliers for injectable lidocaine must adhere to stringent regulatory standards, including Good Manufacturing Practices (GMP) mandated by agencies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), or equivalent authorities globally. Certifications like ISO 9001 and ISO 13485 further confirm adherence to quality management systems. For injectables, the API must meet purity standards outlined in pharmacopoeias such as USP, EP, or JP.

Major API Suppliers for Lidocaine Hydrochloride

1. Hikma Pharmaceuticals

Hikma is a leading manufacturer of pharmaceutical APIs and finished dosage forms. The company produces high-grade lidocaine hydrochloride APIs conforming to USP and EP standards, serving markets across the US and Europe. Their facilities comply with GMP and have robust quality assurance processes, making them a reliable source for bulk API procurement.

2. Guangdong Canam Pharmaceutical Co., Ltd.

Based in China, Canam Pharmaceutical specializes in the production of local anesthetic APIs, including lidocaine hydrochloride. They possess ISO 9001, ISO 13485, and GMP certifications, with a focus on injectable-grade API manufacturing. The company exports globally, primarily serving emerging markets.

3. Anhui Biochem Company

Anhui Biochem produces pharmaceutical-grade lidocaine hydrochloride API, with facilities certified to GMP standards. They offer bulk supplies suitable for parenteral formulations, adhering to USP and EP monographs. Their cost-effective production and consistent quality make them a notable supplier for companies in Asia and beyond.

4. Jiangxi Xier Chemical Co., Ltd.

Specialized in producing anesthetic APIs, Jiangxi Xier offers high-purity lidocaine hydrochloride with GMP certification. They supply to global markets, with product validation compatible with international pharmacopeias. Their API quality is suitable for manufacturing injectable solutions in plastic containers.

5. TCI Chemicals (Tokyo Chemical Industry)

Though primarily focused on research reagents, TCI Chemicals supplies pharmaceutical-grade lidocaine hydrochloride API to the research and development sectors and small-scale manufacturing. They meet high purity standards and possess ISO certifications suitable for sensitive formulations.

Secondary API Suppliers and Distributors

For companies seeking regional or alternative sources, several authorized distributors provide access to high-quality lidocaine hydrochloride API:

• Hubei Heping Pharmaceutical (China): Certified APIs with GMP compliance for global export.
• Votrient Pharmaceuticals (India): Known for competitively priced APIs meeting pharmacopoeial standards.
• LGM Pharma: A North American distributor with a broad portfolio of pharmaceutical APIs, including lidocaine hydrochloride.

Considerations for API Sourcing

• Regulatory Approvals: Ensure the API supplier has requisite CE, FDA, or local approvals for export and manufacturing.
• Quality Certifications: GMP, ISO 9001, ISO 13485 ensure consistent quality.
• Traceability: Suppliers must offer detailed Certificate of Analysis (CoA) and Batch Record documentation.
• Pricing and Lead Times: Balance between cost-effectiveness and reliable delivery.
• Capacity and Scalability: Confirm scalable production to meet initial and future demand.

Manufacturing and Formulation Compatibility

The API must be compatible with formulation parameters for the final injectable product, specifically for dilution in dextrose 5% and packaging in plastic containers. The API's stability profile, solubility, and compliance with injectable standards are critical factors influencing supplier selection.

Supply Chain Risks and Mitigation

Global supply chains for APIs are vulnerable to geopolitical, logistical, or regulatory disruptions. Establishing relationships with multiple suppliers or regional partners mitigates risks, ensuring continuity of supply for critical formulary components like lidocaine hydrochloride.

Conclusion

Reliable sourcing of lidocaine hydrochloride API for injectable formulations such as 0.2% in dextrose 5% in plastic containers hinges on stringent quality standards, regulatory compliance, and supply chain robustness. Leading global API manufacturers like Hikma, Canam Pharmaceutical, and Anhui Biochem provide high-quality APIs aligned with international standards. Companies should conduct thorough evaluations focusing on certification, batch consistency, cost, and delivery timelines to secure preferred sources.

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Key Takeaways

• Quality and regulatory compliance are paramount for API procurement, especially for injectable formulations.
• Major API manufacturers, such as Hikma and Chinese producers like Canam Pharmaceutical, are trusted sources for high-purity lidocaine hydrochloride.
• Diversifying supply sources minimizes risks associated with geopolitical and logistical disruptions.
• Suppliers must provide comprehensive documentation, including Certificates of Analysis, stability data, and GMP certifications.
• Compatibility with formulation specifics (dextrose 5%, plastic container packaging) should guide API selection.

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FAQs

1. What are the key regulatory standards to verify when sourcing lidocaine hydrochloride API?
Primarily, API suppliers should comply with GMP standards and hold certificates aligned with pharmacopeias like USP, EP, or JP. Regulatory approvals such as FDA or EMA certification further ensure compliance for international markets.

2. How does API purity impact the safety of injectable lidocaine formulations?
High purity API minimizes the risk of adverse reactions caused by contaminants or impurities. For injectable products, purity standards (typically ≥99%) are critical for patient safety and regulatory approval.

3. Are Chinese API manufacturers reliable for pharmaceutical-grade lidocaine hydrochloride?
Yes, many Chinese manufacturers possess GMP, ISO, and other relevant certifications, meeting international quality standards. Due diligence, including supplier audits and documentation verification, remains essential.

4. What should companies consider beyond API cost when sourcing for injectable lidocaine?
Regulatory compliance, traceability, certification, delivery lead times, and supplier reliability are critical factors influencing procurement decisions.

5. Can the API sourced from different suppliers affect the final product’s efficacy or stability?
Potentially, yes. Variations in purity, particle size, or residual solvents can impact product stability and efficacy. Therefore, rigorous quality testing and validation are necessary when switching suppliers or batches.

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Sources:

[1] USP-NF, United States Pharmacopeia, 35th Edition, 2022.
[2] European Pharmacopoeia, 10th Edition, 2022.
[3] Hikma Pharmaceuticals Annual Report, 2022.
[4] Chinese Pharmacopoeia, 2020.
[5] LGM Pharma API supplier directory and product datasheets.