Last updated: July 31, 2025
Introduction
Lidocaine hydrochloride viscous is a topical anesthetic extensively utilized in dental procedures, oral surgeries, and pain management applications. Due to its widespread clinical use, a robust supply chain comprising reputable manufacturers and suppliers is critical to ensure consistent availability and quality. This article provides a comprehensive overview of leading suppliers globally, their product specifications, regulatory compliance, and strategic considerations for procurement professionals seeking reliable Lidocaine Hydrochloride Viscous sources.
Overview of Lidocaine Hydrochloride Viscous
Lidocaine hydrochloride viscous typically features a concentration ranging from 2% to 5%, designed for topical application in the oral cavity. Its formulation includes stabilizers and viscosity agents to optimize adhesion and efficacy. As a regulated pharmaceutical product, manufacturers must adhere to stringent quality standards, such as those stipulated by the FDA, EMA, and other regulatory bodies.
Major Global Suppliers
1. Ajinomoto Co., Inc. (Japan)
Ajinomoto is a leading supplier of pharmaceutical-grade active pharmaceutical ingredients (APIs), including lidocaine hydrochloride. Their offerings include high-purity APIs used in compounded formulations and commercial drugs. They have extensive GMP-certified manufacturing facilities across Asia, ensuring product quality and supply capacity.
Product Highlights:
- Pharmaceutical-grade lidocaine hydrochloride APIs.
- Compatibility with viscous formulations for compounded preparations.
- Strong compliance with international pharmacopoeias (USP, EP).
2. Molar Chemicals (India)
Molar Chemicals is a prominent Indian manufacturer specializing in APIs and intermediates for the pharmaceutical industry. They manufacture lidocaine hydrochloride with approved quality standards, catering to both domestic and export markets, including formulations like viscous lidocaine for oral applications.
Product Highlights:
- Certified GMP production facilities.
- Competitive pricing for bulk quantities.
- Reliable supply chain with global export capabilities.
3. Piramal Enterprises Ltd. (India)
Piramal is a global pharmaceutical enterprise with a comprehensive API portfolio, including lidocaine hydrochloride. They emphasize high purity and advanced manufacturing processes, ensuring consistent product performance.
Product Highlights:
- USP, EP, and BP grade APIs.
- Focus on quality control and validation.
- Dedicated facilities for sterile and non-sterile APIs.
4. Jiangsu Nhwa Pharmaceutical Co., Ltd. (China)
Specializing in anesthetic agents, Jiangsu Nhwa produces both APIs and finished formulations of lidocaine hydrochloride. They have a proven track record in delivering high-quality products compatible with viscous formulations.
Product Highlights:
- Multiple certifications, including ISO and GMP.
- Large-scale manufacturing capacity.
- Focused on innovation in gel and viscous formulations.
5. Pfizer Inc. (USA)
Pfizer, a major multinational, manufactures a broad range of APIs, including lidocaine hydrochloride. They supply pharmaceutical companies directly or via authorized distributors, ensuring adherence to strict quality standards and regulatory requirements.
Product Highlights:
- High purity API supply.
- Extensive regulatory filings.
- Established distribution network.
6. Teva Pharmaceutical Industries Ltd. (Israel)
Teva is renowned for its robust API manufacturing and generic product offerings, including lidocaine hydrochloride. Their products conform to international standards, suitable for formulation into viscous topical agents.
Product Highlights:
- Quality assured APIs.
- Global distribution capabilities.
- Focus on affordable healthcare solutions.
Key Suppliers of Finished Lidocaine Hydrochloride Viscous Formulations
While many companies distribute APIs, sourcing ready-to-use viscous formulations ensures convenience and immediate availability. Notable suppliers include:
- Hercon Lab, India: Specializes in compounded anesthetic gels containing lidocaine hydrochloride viscous.
- Eli Lilly and Company (via licensing partners): Offers finished formulations in select markets.
- Afi Pharma (India): Provides compounded anesthetic gels for dental and oral practices.
Regulatory and Quality Considerations
Procurement of lidocaine hydrochloride viscous necessitates rigorous assessment of supplier compliance with regulatory standards. Key aspects include:
- GMP Certification: Ensures manufacturing adherence to Good Manufacturing Practices.
- Pharmacopoeia Compliance: Compatibility with USP, EP, BP standards.
- Validation and Testing: Certificates of Analysis (CoA), stability data, and microbiological testing.
- Regulatory Approvals: FDA registration or EMA approval for both APIs and finished formulations.
Strategic Sourcing Insights
- Reliability: Engage suppliers with proven track records and sufficient production capacity to prevent shortages.
- Cost-Effectiveness: Balance quality with cost, considering long-term supply agreements.
- Geographical Diversification: Avoid reliance on single-source suppliers to mitigate risks.
- Regulatory Track Record: Prefer suppliers with consistent compliance to international standards to facilitate faster regulatory approvals.
Emerging Trends in Suppliers and Supply Chain Resilience
The COVID-19 pandemic underscored vulnerabilities in pharmaceutical supply chains. Suppliers with diversified manufacturing sites and robust quality systems are now prioritized. Additionally, increasing demand for compounded and customized formulations bolsters the need for reliable APIs and finished products.
Advancements in continuous manufacturing and sourcing from multiple regulatory-compliant regions are strategic considerations for pharmaceutical companies aiming for supply security and cost efficiency.
Conclusion
Securing reliable suppliers for lidocaine hydrochloride viscous demands a comprehensive evaluation of quality standards, regulatory compliance, production capacity, and geographic diversification. Major industry players such as Ajinomoto, Piramal, Jiangsu Nhwa, and pharmaceutical giants like Pfizer and Teva offer high-quality products. Simultaneously, specialized compounded gel manufacturers serve niche markets requiring ready-to-use formulations. Strategic sourcing aligned with global regulations ensures continuous availability of this essential anesthetic agent.
Key Takeaways
- Prioritize GMP-certified suppliers with proven regulatory compliance for consistent, high-quality lidocaine hydrochloride viscous.
- Evaluate supplier capacity, reliability, and geographical diversity to mitigate supply chain disruptions.
- Combine procurement of high-purity APIs with finished formulations where applicable to meet specific clinical needs.
- Keep abreast of regulatory trends and standards internationally to streamline approval processes.
- Consider emerging manufacturing innovations and supply chain resilience strategies for long-term procurement effectiveness.
FAQs
1. What are the critical quality considerations when sourcing lidocaine hydrochloride viscous?
Ensuring GMP compliance, USP/EP standards adherence, and detailed Certificates of Analysis are essential to confirm purity, stability, and safety for pharmaceutical applications.
2. Which regions dominate the production and supply of lidocaine hydrochloride APIs?
Asia-Pacific (India, China, Japan) leads in API manufacturing, while North America and Europe focus on finished formulations and regulatory integration.
3. Can I source ready-to-use viscous lidocaine formulations directly from suppliers?
Yes, specialized pharmaceutical compounding companies and finished product manufacturers supply ready-to-use viscous gels, suitable for immediate clinical deployment.
4. How does supplier diversity impact supply chain security for lidocaine-based products?
Diversification reduces dependency on single sources, minimizes risks of shortages, and enhances negotiation leverage.
5. What regulatory hurdles should procurement teams consider?
Complying with importing country standards, validating supplier certifications, and maintaining thorough documentation facilitate smooth regulatory approvals and market access.
References
- U.S. Pharmacopeia. USP General Notices and Regulations. United States Pharmacopeial Convention; 2022.
- European Pharmacopoeia. European Pharmacopoeia 10.0. European Directorate for the Quality of Medicines & HealthCare; 2022.
- Ajinomoto Co., Inc. Official Website. Pharmaceutical APIs. https://www.ajinomoto.com/products/pharmaceuticals
- Piramal Pharma Solutions. API Portfolio. https://www.piramalpharma.com/api-portfolio
- Jiangsu Nhwa Pharmaceutical Co., Ltd. Official Website. Product Details. http://en.nhwapharma.com
Note: The selection of suppliers and product data reflects publicly available information as of early 2023; ongoing due diligence is essential for procurement decisions.
