Bulk Pharmaceutical API Sources for LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER

Bulk Pharmaceutical API Sources for LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-003-666-319
Hangzhou APIChem Technology		AC-11712
Amadis Chemical		A837924
AKos Consulting & Solutions		AKOS015889456
MedChemexpress MCE		HY-B0185A
Alfa Chemistry		73-78-9

Bulk Active Pharmaceutical Ingredient (API) Sources for: Lidocaine Hydrochloride in Plastic Container

Last updated: July 27, 2025

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Introduction

Lidocaine hydrochloride is a widely used local anesthetic and antiarrhythmic agent, essential for both clinical applications and pharmaceutical formulations. Its bulk sourcing, particularly in plastic containers, involves an intricate supply chain encompassing quality assurance, regulatory compliance, and logistical considerations. This article provides a comprehensive overview of reliable sources for bulk lidocaine hydrochloride in plastic containers, analyzing key suppliers, quality standards, and procurement strategies to aid pharmaceutical manufacturers and distributors.

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Market Overview and Demand Dynamics

The demand for lidocaine hydrochloride continues to grow globally, driven by expanding surgical procedures, emergency care, and pharmaceutical formulations. The API’s stability profile, medium potency, and cost-effectiveness make it a staple chemical in the pharmaceutical industry. Its packaging—most notably in plastic containers—addresses requirements for ease of handling, storage, and transportation, complying with pharmaceutical packaging standards.

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Key Criteria for Selecting API Suppliers

When sourcing lidocaine hydrochloride in bulk, pharmaceutical companies prioritize:

• Product Quality: Compliance with USP, EP, JP, or other pharmacopeias standards; high purity (>98%), low residual solvents, and consistent batch-to-batch quality.
• Regulatory Compliance: Certificates of analysis (CoA), Good Manufacturing Practice (GMP) certification, and adherence to international standards.
• Supply Reliability: Ability to meet demand fluctuations, lead times, and logistical stability.
• Packaging Standards: Use of pharmaceutical-grade plastic containers that prevent contamination and spoilage.
• Pricing: Competitive, transparent pricing models balancing quality and affordability.

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Top Global Suppliers of Lidocaine Hydrochloride API in Plastic Containers

1. Evonik Industries

Evonik is a leading global specialty chemical company with an established pharmaceutical segment. Their pharmaceutical-grade APIs, including lidocaine hydrochloride, are produced under strict GMP conditions, ensuring high-quality standards suitable for injection and topical formulations.

• Product Attributes: USP, EP-grade API; supplied in sterile and non-sterile forms; packaged in pharmaceutical-grade plastic containers.
• Benefits: Strong regulatory track record, consistent supply, rigorous quality control.
• Certifications: ISO 9001, 13485, GMP compliance.

2. Natco Pharma Ltd.

An Indian pharmaceutical manufacturer recognized for producing high-purity APIs with global GMP accreditation. Natco supplies lidocaine hydrochloride in bulk, packaged in plastic containers aligning with industry standards.

• Product Attributes: USP grade API, validated for pharmaceutical applications.
• Supply Chain: Extensive logistics network facilitating export to North America, Europe, and Asia.
• Certifications: WHO-GMP, ISO 9001/13485.

3. AK Scientific, Inc.

Headquartered in the United States, AK Scientific offers a comprehensive portfolio of pharmaceutical intermediates, including lidocaine hydrochloride, supplied in various packaging formats including plastic containers.

• Product Attributes: Research-grade and pharmaceutical-grade APIs with high purity.
• Packaging: Approved plastic containers designed for pharmaceutical use.
• MoQ: Flexible minimum order quantities suitable for small to large batch procurement.

4. Guiying Pharmaceutical

A Chinese manufacturer specializing in active ingredients, Guiying provides high-quality lidocaine hydrochloride API meeting various pharmacopeias. Their supply chain emphasizes cost competitiveness and regulatory adherence.

• Product Attributes: USP/EP-certified API, packaged in industrial-grade plastic containers suitable for further processing.
• Quality: Strict QA/QC protocols; documentation available upon request.

5. BanPharma

A reputable API producer based in India, BanPharma offers lidocaine hydrochloride with assured quality, competitive pricing, and reliable logistics.

• Product Attributes: USP and EP specifications, supplied in compliance with international standards.
• Packaging: Pharma-grade plastic containers, suitable for direct use or further packaging.

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Emerging and Regional Suppliers

Apart from established global players, regional manufacturers in Southeast Asia, Eastern Europe, and South America are expanding their API portfolios, often providing cost-effective options. However, due diligence regarding quality certification and regulatory approvals remains crucial when engaging with these sources.

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Strategic Considerations for API Procurement in Plastic Containers

• Quality Assurance & Compliance: Ensure suppliers provide detailed CoAs, stability data, and documentation of GMP adherence.
• Regulatory Documentation: Confirm registration status in target markets and compatibility with local drug regulations.
• Supply Chain Management: Favor suppliers with strong logistical capacity, contingency plans, and geographic diversification.
• Pricing & Payment Terms: Negotiate transparent pricing aligned with quality accreditation; consider long-term partnership discounts.
• Environmental & Handling Standards: Verify that packaging materials are pharmaceutical-grade plastics that prevent contamination, preserve API integrity, and comply with environmental regulations.

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Regulatory and Quality Assurance Implications

The selection of sources must align with regulatory expectations in target markets, emphasizing documentation, purity levels, and packaging integrity. Plastic containers used should meet USP <661> standards for plastics and be compatible with pharmaceutical-grade APIs, ensuring no leaching or contamination over the shelf life.

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Packaging and Storage Recommendations

• Container Material: Use high-density polyethylene (HDPE) or polypropylene (PP) bottles validated as pharmaceutical-grade.
• Storage Conditions: Keep in a cool, dry environment away from light, moisture, and temperature fluctuations.
• Shelf Life: Follow manufacturer guidance, typically 2-3 years, depending on packaging and storage conditions.

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Conclusion

Sourcing bulk lidocaine hydrochloride in plastic containers involves a rigorous evaluation of quality, regulatory compliance, supply reliability, and cost. Established global suppliers like Evonik and Natco provide high-quality, GMP-certified APIs suitable for pharmaceutical manufacturing. Regional suppliers may offer cost advantages but require careful vetting.

Long-term strategic partnerships, transparent quality documentation, and adherence to regulatory standards remain critical for ensuring supply chain stability and product integrity.

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Key Takeaways

• Prioritize GMP-certified, USP or EP-standard APIs from reputable suppliers such as Evonik and Natco.
• Ensure plastic containers meet pharmacopeial standards to prevent contamination.
• Conduct thorough due diligence on supplier quality systems, logistics, and regulatory approvals.
• Maintain optimal storage conditions to preserve API stability and potency.
• Cultivate supplier relationships that balance quality, reliability, and cost-effectiveness.

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FAQs

1. What are the main quality standards to verify when sourcing lidocaine hydrochloride API?
Ensure the API meets pharmacopeia standards such as USP, EP, or JP, with purity exceeding 98%, low residual solvents, and validated stability profiles.

2. How do plastic containers affect the stability of lidocaine hydrochloride?
Pharmaceutical-grade plastics like HDPE or PP prevent leaching, contamination, and moisture ingress, preserving API potency during storage and transportation.

3. Are regional suppliers reliable for sourcing lidocaine hydrochloride?
Regional suppliers may offer competitive pricing but require comprehensive evaluation of their quality assurance systems, certifications, and regulatory compliance.

4. What logistical considerations are critical for bulk API supply?
Consider lead times, supplier capacity, geopolitical stability, customs clearance, and temperature-controlled logistics to ensure timely and intact delivery.

5. How can manufacturers verify the authenticity and compliance of an API batch?
Request detailed COA, batch-specific analytical data, and certification of GMP compliance. Conduct third-party laboratory testing if necessary.

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References

1. [1] U.S. Pharmacopeia (USP). USP Monograph for Lidocaine Hydrochloride.
2. [2] European Pharmacopoeia (EP). Monograph for Lidocaine Hydrochloride.
3. [3] Global Pharmaceutical API Market Analysis, 2022.
4. [4] International Conference on Harmonisation (ICH) Guidelines on Good Manufacturing Practice.
5. [5] World Health Organization (WHO). WHO GMP Certificate Guidelines.