Bulk Pharmaceutical API Sources for XYLOCAINE 5% W/ GLUCOSE 7.5%

Bulk Pharmaceutical API Sources for XYLOCAINE 5% W/ GLUCOSE 7.5%

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 XYLOCAINE 5% W/ GLUCOSE 7.5%

Last updated: August 26, 2025

Introduction

Xylocaine 5% with Glucose 7.5% is a combination formulation primarily utilized in local anesthesia and pain management, notably in dental, ophthalmic, and surgical procedures. The active pharmaceutical ingredient (API) in this formulation is lidocaine, a widely used amide-type local anesthetic. Securing a dependable and compliant API source is critical for pharmaceutical manufacturers engaged in producing Xylocaine formulations. This article reviews the global landscape of bulk API suppliers for lidocaine, focusing on quality standards, regulatory compliance, market positioning, and sourcing options suitable for producing Xylocaine 5% with Glucose 7.5%.

Lidocaine as the Primary API in Xylocaine 5% with Glucose

Lidocaine (C14H22N2O) is characterized by rapid onset, moderate duration, and high efficacy in nerve conduction blockade. Its API quality directly influences the safety, efficacy, and regulatory approval of the final product. Originating from the German chemist Nils Løfgren and first synthesized in 1943, lidocaine's widespread use has driven the global manufacturing of high-quality APIs compliant with pharmacopeial monographs, such as the USP, EP, and JP.

Global API Manufacturers and Suppliers

1. Major Multinational API Suppliers

a) Novartis AG

• Overview: Novartis is a leader in pharmaceutical manufacturing, including the production of high-purity lidocaine API. Their APIs are manufactured in compliance with GMP standards, with extensive cGMP-certified facilities in Switzerland, the United States, and other regions.

• Capabilities: Novartis supplies pharmaceutical-grade lidocaine suitable for injectable and topical formulations. Their APIs meet stringent quality specifications, including residual solvent limits, heavy metal content, and assay validations.

b) Hikma Pharmaceuticals

• Overview: Hikma is a global pharmaceutical company with a significant portfolio of generic APIs, including lidocaine. Their facilities adhere to international regulatory standards, particularly in the Middle East, Europe, and North America.

• Capabilities: They offer various grades of lidocaine API, including USP and EP specifications, with scalable manufacturing capabilities.

c) TEVA Pharmaceuticals

• Overview: As one of the world's largest generic drug producers, TEVA manufactures lidocaine API for global distribution.

• Standards: TEVA’s APIs comply with GMP and pharmacopeial standards, ensuring robust quality and consistent supply.

2. Regional and Contract Manufacturing Organizations (CMOs)

a) Mylan (Now part of Viatris)

• Known for reliable sourcing of pharmaceuticals, including lidocaine API, with facilities certified under international standards.

b) SINOPHARM (China)

• Overview: Chinese pharma manufacturers have become prominent sources of generic APIs including lidocaine. They offer cost-effective API manufacturing with increasing GMP compliance.

• Quality assurance: Many Chinese suppliers are achieving registration with regulatory bodies like the FDA and EMA, though due diligence is essential.

c) Jiangsu Hansoh Pharmaceutical

• China's leading manufacturer with GMP-certified facilities, providing high-quality lidocaine APIs aligned with international standards.

3. Fine Chemical and API Specialized Suppliers

Large chemical suppliers such as BASF, Sigma-Aldrich (Merck), and Silicycle provide pharmaceutical-grade intermediates and APIs, including potentially lidocaine, often utilized in research or as intermediates for bulk manufacturing.

Sourcing Considerations for Pharmaceutical Companies

Quality Standards and Regulatory Compliance

Manufacturers sourcing lidocaine APIs must prioritize products compliant with:

• Current Good Manufacturing Practices (cGMP): Ensures the API consistently meets quality specifications suitable for medicinal use.

• Pharmacopoeial Standards (USP, EP, JP): Confirm purity, potency, and safety profiles.

• Regulatory Approvals: Suppliers with FDA, EMA, orPMDA inspections and certifications offer additional assurance of quality.

Supply Chain and Scaleability

Ensure capacity to meet production demands, especially for large batches used in manufacturing Xylocaine 5% with Glucose 7.5%. Long-term agreements with suppliers providing reliable lead times and contingency options mitigate supply disruptions.

Cost and Lead Time

Cost-effective procurement balances API quality and supplier reliability. Chinese and Indian manufacturers often present competitive pricing but require rigorous validation and supplier audits to align with regulatory expectations.

Sustainability and Ethical Sourcing

Manufacturers should consider suppliers committed to sustainable practices, ethical sourcing, and environmental compliance, aligning with corporate social responsibility standards.

Emerging Trends in API Sourcing

The pharmaceutical industry is increasingly adopting digitalization, e-registries, and advanced supply chain management to ensure transparency and traceability. API counterfeit risks are mitigated through serialization, authentication, and supplier audits. Additionally, the trend toward regional manufacturing aims to reduce dependency and ensure faster response times during global disruptions, as observed during the COVID-19 pandemic.

Conclusion

Sourcing high-quality lidocaine API for formulations like Xylocaine 5% with Glucose 7.5% involves a strategic assessment of supplier credentials, regulatory compliance, and supply stability. Leading multinational pharmaceutical suppliers such as Novartis, Hikma, and TEVA offer reliable options, while Chinese and Indian manufacturers expand cost-effective sourcing avenues. Careful due diligence, including auditing and validation, ensures API integrity, compliance, and seamless integration into manufacturing processes.

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Key Takeaways

• Prioritize cGMP-compliant suppliers: Ensures API quality suitable for regulatory approval and patient safety.
• Assess supplier reputation and regulatory certifications: Especially for Chinese and Indian manufacturers, to mitigate quality risks.
• Leverage multiple sourcing channels: Mitigates supply chain disruptions for bulk API procurement.
• Keep abreast of industry trends: Digital verification and regional manufacturing enhance reliability.
• Conduct thorough validation: Before integrating new API sources into the production environment to ensure potency, purity, and compliance.

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FAQs

1. What are the key quality parameters to verify in lidocaine API?
   Residual solvents, heavy metals, assay purity, melting point, and microbial limits aligned with pharmacopeial standards are critical.

2. How do I select a reputable API supplier for lidocaine?
   Verify certifications such as cGMP, FDA approval, and compliance with USP or EP monographs. Conduct supplier audits when possible.

3. Are Chinese and Indian lidocaine APIs compliant with international standards?
   Increasingly, yes. Many suppliers hold certifications and have demonstrated compliance, but rigorous validation and inspection are recommended.

4. What are the common challenges in sourcing lidocaine APIs?
   Variability in quality, regulatory hurdles, supply chain disruptions, and counterfeit risks.

5. How can I ensure the stability of supply for large-volume production?
   Establish long-term partnerships, diversify suppliers, and maintain inventory buffers to offset disruptions.

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Sources:

[1] USP Monograph for Lidocaine HCl. United States Pharmacopeia.
[2] European Pharmacopoeia (EP) Monograph for Lidocaine. European Directorate for the Quality of Medicines & HealthCare.
[3] Global API Market Reports. IQVIA and other industry sources.
[4] Company websites and certificatory documents of Novartis, Hikma, TEVA, Jiangsu Hansoh.