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

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

Last updated: July 28, 2025

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Introduction

In pharmaceutical manufacturing, sourcing high-quality Active Pharmaceutical Ingredients (APIs) is critical to ensure drug safety, efficacy, and regulatory compliance. This report examines key global suppliers of Lidocaine Hydrochloride 0.4% and Dextrose 5% in plastic containers, focusing on their manufacturing capabilities, quality standards, regulatory compliance, and supply reliability.

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Lidocaine Hydrochloride 0.4% API Sources

Overview

Lidocaine Hydrochloride, a widely used local anesthetic and antiarrhythmic, is supplied globally by a spectrum of contract manufacturing organizations (CMOs) and chemical producers. The 0.4% formulation indicates a low-concentration API primarily intended for compounded formulations and specific dosage forms, often requiring APIs of pharmaceutical-grade purity compliant with pharmacopeial standards such as USP, EP, or JP.

Major Global Suppliers

1. Himalaya Drug Company (India)

• Overview: Himalaya is a reputable pharmaceutical manufacturer with extensive API production capabilities, including local anesthetics. The company adheres to cGMP standards, with ISO certifications, and supplies APIs to domestic and international markets.
• Strengths: Strong regulatory compliance, competitive pricing, and robust quality management.
• Certifications: ISO 9001, GMP compliant.

2. Boehringer Ingelheim (Germany)

• Overview: Boehringer is a leading global pharmaceutical company with a significant API manufacturing division. They produce high-purity lidocaine APIs for formulations used worldwide.
• Strengths: Strict quality control, proven reliability, and advanced manufacturing processes.
• Certifications: EMA-approved facilities, cGMP compliant.

3. Hanlim Pharm (South Korea)

• Overview: Specializes in local anesthetic APIs, including lidocaine hydrochloride, with facilities certified under stringent quality standards.
• Strengths: Proven scalability, competitive pricing, and dedicated API manufacturing segments.
• Certifications: GMP, ISO.

4. Sonarome Private Limited (India)

• Overview: Focused on bulk pharmaceutical chemicals, including lidocaine hydrochloride, with a commitment to meeting international quality standards.
• Strengths: High-quality API production, flexibility in order quantities, and global export experience.
• Certifications: ISO, cGMP.

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

• Overview: Manufacturer of various local anesthetics, with a focus on API quality and cost-effectiveness for global supply.
• Strengths: Cost competitiveness, large-scale production, regulatory filings.
• Certifications: GMP, Chinese State Food and Drug Administration approvals.

Supply Considerations for 0.4% Lidocaine API

• Quality Standards: Suppliers predominantly provide APIs conforming to USP or EP pharmacopoeial standards, with some offering additional stability and bioavailability optimization.
• Regulatory Status: Many suppliers hold certifications for international markets, including USFDA, EMA, and TGA approvals, ensuring regulatory acceptance.
• Pricing & Logistics: Cost competitiveness varies, with Indian and Chinese manufacturers typically offering lower prices. Supply chain stability is critical, especially amidst global disruptions.

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Dextrose 5% API Sources

Overview

Dextrose (glucose) 5% solutions are widely used in parenteral nutrition and fluid therapy. APIs for Dextrose are derived primarily from corn, wheat, or other carbohydrate sources, processed through enzymatic or chemical methods. The focus for API suppliers centers on high purity, low endotoxin levels, and regulatory compliance for parenteral use.

Major Global Suppliers

1. Archer Daniels Midland Company (USA)

• Overview: One of the most prominent producers of dextrose monohydrate and anhydrous dextrose, with extensive infrastructure for clean, pharmaceutical-quality API production.
• Strengths: High scale, consistent quality, global supply chain, and rigorous quality control.
• Certifications: ISO, GMP, USDA Organic.

2. Cargill Inc. (USA)

• Overview: Supplies pharmaceutical-grade dextrose derived from corn, with multiple GRAS and pharmacopeial grades available.
• Strengths: Large production capacity, strict quality standards, supply reliability.
• Certifications: GMP, ISO.

3. Roquette Frères (France)

• Overview: Manufactures pharmaceutical and food-grade dextrose from plant sources, with extensive API-grade offerings for injectables.
• Strengths: Expertise in sterile processing, high purity, cGMP accreditation.
• Certifications: ISO, GMP.

4. Shandong Yuwang Chemical Industrial Co., Ltd. (China)

• Overview: Offers a variety of carbohydrate-based APIs, including pharmaceutical-grade dextrose suitable for injectable products.
• Strengths: Cost competitive, scalable manufacturing, international certification efforts ongoing.
• Certifications: GMP, ISO.

5. Merck KGaA (Germany)

• Overview: Provides high-purity dextrose APIs for parenteral and other uses, with rigorous quality controls aligned with pharmaceutical standards.
• Strengths: Strong regulatory compliance, consistent supply, and advanced quality assurance.
• Certifications: GMP, ISO.

Supply Considerations for Dextrose 5% API

• Quality Standards: Pharmaceutical Dextrose APIs must meet strict sterility, endotoxin levels, and particulate specifications for parenteral use.
• Regulatory Certifications: Suppliers typically hold certifications enabling approval in markets like North America, Europe, and Asia, such as FDA and EMA registrations.
• Supply Chain: Demand for Dextrose APIs remains steady, with supply chain resilience crucial amid geopolitical and pandemic-related disruptions.

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Integration of API Suppliers into Pharmaceutical Manufacturing

Sourcing APIs for formulations such as Lidocaine Hydrochloride 0.4% and Dextrose 5% injection requires rigorous validation of supplier compliance with pharmacopeial standards, cGMP regulations, and environmental controls. Manufacturers should prioritize suppliers with:

• Certifications: GMP, ISO, and market-specific approvals.
• Quality Control: Robust analytical testing, batch traceability, and documentation.
• Supply Reliability: Long-term capacity, contingency planning, and transparent logistics.
• Cost-Effectiveness: Balancing affordable pricing with quality and compliance.

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Conclusion

Securing reliable sources for Lidocaine Hydrochloride 0.4% and Dextrose 5% APIs necessitates a comprehensive evaluation process emphasizing quality standards, regulatory compliance, and supply chain resilience. Leading global suppliers such as Himalaya, Boehringer Ingelheim, Archer Daniels Midland, and Cargill stand out for their extensive capabilities and regulatory adherence. Engaging with these partners enables pharmaceutical developers to maintain high-quality product standards while mitigating production risks.

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Key Takeaways

• Select API suppliers with proven regulatory compliance (GMP, ISO, pharmacopeial standards) to ensure seamless market approval and product safety.
• Prioritize suppliers with global certifications and capacity for large-scale, consistent production to meet demand fluctuations.
• Ensure comprehensive analytical and quality control measures are in place, tracking batch-to-batch consistency.
• Monitor geopolitical and supply chain dynamics that could impact API availability, developing contingency sourcing strategies.
• Balance cost and quality considerations carefully, avoiding compromises that could jeopardize regulatory compliance or patient safety.

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FAQs

Q1: Are APIs for Lidocaine Hydrochloride 0.4% and Dextrose 5% widely available from multiple suppliers?
Yes, numerous global manufacturers supply these APIs, including reputable Indian, Chinese, European, and American companies, ensuring competitive options.

Q2: What are critical quality attributes for pharmaceutical-grade Dextrose API?
Key attributes include high purity (≥99%), sterility, low endotoxin levels, particulate control, and consistency with pharmacopeial specifications.

Q3: How can manufacturers verify API suppliers' regulatory compliance?
Request comprehensive certifications (GMP, ISO), batch documentation, audit reports, and verify registration status with relevant health authorities (FDA, EMA, PMDA, etc.).

Q4: What role does supply chain resilience play in sourcing APIs?
It is vital; manufacturers must assess supplier capacity, geographic diversification, and contingency plans to mitigate risks of shortages.

Q5: Are there specific considerations for low-concentration APIs like Lidocaine 0.4%?
Yes, ensuring the API's stability in low concentrations, compatibility with formulation excipients, and regulatory approval for this specific dosage are essential.

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Sources

1. [1] FDA, "API Manufacturing Standards," U.S. Food and Drug Administration.
2. [2] European Pharmacopoeia, Monographs on Local Anesthetics and Dextrose Solutions.
3. [3] Cargill, "Pharmaceutical Dextrose Specifications," Cargill Corporate Website.
4. [4] Boehringer Ingelheim, "API Production and Quality Assurance," Official Publications.
5. [5] Asian Pallet Industry Report, "Global API Market Value and Trends," 2022.

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