Bulk Pharmaceutical API Sources for CITANEST

Bulk Pharmaceutical API Sources for CITANEST

Vendor	Vendor Homepage	Vendor Sku	API Url
Hangzhou APIChem Technology		AC-2100
Molport		MolPort-005-935-583
Amadis Chemical		A837435
Vitas-M Laboratory		STL257086
AKos Consulting & Solutions		AKOS015889404

Bulk Active Pharmaceutical Ingredient (API) Sources for CITANEST

Last updated: July 30, 2025

Introduction

CITANEST, a proprietary local anesthetic formulation primarily containing articaine hydrochloride, is distinguished by its widespread application in dental anesthesia and minor surgical procedures. As a critical component, the API—articaine hydrochloride—must meet stringent quality standards to ensure safety, efficacy, and regulatory compliance. Identifying reliable sources for bulk API procurement is vital for manufacturers, distributors, and healthcare providers aiming for consistency, cost-effectiveness, and supply chain integrity. This analysis explores global API suppliers capable of providing high-quality articaine hydrochloride suitable for CITANEST production.

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Overview of Articaine Hydrochloride as API for CITANEST

Articaine hydrochloride is an amide-type local anesthetic characterized by its rapid onset and intermediate duration of action. Its chemical structure includes a thiophene ring, which enhances lipid solubility and membrane penetration. The API’s quality directly influences the final product's pharmacokinetics and pharmacodynamics, necessitating sourcing from validated suppliers adhering to Good Manufacturing Practices (GMP) and pharmacopeial standards, such as USP or EP.

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Major API Suppliers for Articaine Hydrochloride for CITANEST Production

1. Sigma-Aldrich / MilliporeSigma (Merck KGaA)

   A leading global provider of research chemicals and pharmaceutical intermediates, Sigma-Aldrich offers high-quality articaine hydrochloride suitable for pharmaceutical manufacturing. Their products are extensively characterized, with comprehensive Certificates of Analysis (CoA) and compliance with international standards.

   • Strengths: Established global distribution network, rigorous quality control, extensive technical support.
   • Compliance: Meets USP/EP standards; suitable for GMP manufacturing.
   • Supply Capabilities: Large-scale bulk production, reliable delivery timelines.

2. Fisher Scientific

   Part of Thermo Fisher Scientific, the company supplies pharmaceutical-grade reagents and APIs, including articaine hydrochloride. Their portfolio emphasizes purity, stability, and consistent supply for pharmaceutical applications.

   • Strengths: Quality assurance, extensive global logistics, dedicated customer support.
   • Compliance: Adheres to international quality standards, with documentation suited for pharmaceutical use.

3. Hubei Hongyan Pharmaceutical Co., Ltd. (China)

   Specializing in local anesthetic APIs, this Chinese manufacturer has gained recognition for producing Compliant articaine hydrochloride conforming to pharmaceutical standards.

   • Strengths: Cost-effective, large manufacturing capacity, growing international reputation.
   • Compliance: GMP-certified facilities, with certifications aligning with international requirements.
   • Market Focus: Particularly strong in Asian markets but expanding globally.

4. Shandong Top Pharmaceutical Co., Ltd. (China)

   A reputable Chinese API manufacturer with focus on anesthetic APIs, including articaine hydrochloride, supplied to several international pharmaceutical companies.

   • Strengths: Cost efficiency, high-volume production, consistent quality controls.
   • Compliance: Meets pharmaceutical standards, quality certifications including ISO.

5. Aha Pharmaceutical Co., Ltd. (India)

   An emerging Indian producer specializing in local anesthetic APIs, with certifications aligning with international standards.

   • Strengths: Competitive pricing, quality management systems, prequalified for export.
   • Regulatory Alignment: GMP certification, supports international distribution.

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Criteria for Selecting API Suppliers for CITANEST

Manufacturers considering API sources prioritize multiple factors:

• Regulatory Compliance: Suppliers must meet GMP, DMF, and pharmacopeial standards. Certificates of Analysis and batch validation data are essential.

• Quality Assurance: High purity (>99%), low residual solvents, and absence of impurities are critical for injection-grade APIs. Suppliers should have robust analytical testing procedures.

• Supply Chain Stability: Reliable supply schedules, sufficient inventory, and contingency plans to mitigate shortages.

• Cost and Lead Time: Competitive pricing combined with minimal lead times enhances manufacturing efficiency.

• Traceability: Transparent documentation supporting traceability from raw materials to final API batches.

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Regional Dynamics and Market Trends

• China: Dominates global API manufacturing for anesthetics due to cost advantages and large-scale production capacity. However, buyers must scrutinize regulatory compliance and inspection histories.

• India: A rising hub for pharmaceutical intermediates, including anesthetic APIs, with a focus on adherence to international quality standards.

• Europe & North America: Limited primary manufacturing of APIs like articaine but are primary markets for finished formulations. Some European companies focus on custom synthesis or high-standard imports.

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Regulatory and Quality Considerations

Manufacturers distributing CITANEST must verify that their API sources provide documentation compliant with regional regulatory authorities such as the U.S. FDA, EMA, or local health agencies. Certification of GMP compliance, detailed QC data, and stability reports are crucial. Suppliers with prequalification under international standards facilitate smoother regulatory approvals and quality assurance.

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Emerging Trends and Future Outlook

The API supply chain for local anesthetics like articaine hydrochloride is evolving. Increasing regulatory scrutiny emphasizes transparency, quality, and sustainability. Supply diversification, including multiple sourcing strategies, mitigates risks associated with geopolitical tensions, manufacturing disruptions, or quality deviations. Innovations in synthesis and purification processes aim to improve yields and reduce costs, benefiting formulators of CITANEST and related products.

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Conclusion

The global landscape offers diverse API sources for articaine hydrochloride, essential for manufacturing CITANEST. Leading suppliers such as Sigma-Aldrich ensure high-quality supply aligned with international standards, whereas Chinese and Indian manufacturers provide cost-effective alternatives suitable for large-scale production given rigorous quality oversight. Strategic supplier selection, emphasizing regulatory compliance, consistent quality, and supply stability, remains central to maintaining product integrity and meeting market demand.

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Key Takeaways

• Multiple global suppliers, including Sigma-Aldrich and Chinese manufacturers, provide high-quality articaine hydrochloride suitable for CITANEST.
• Regulatory compliance, especially GMP adherence, is paramount for pharmaceutical-grade API procurement.
• Cost, supply reliability, and traceability influence supplier selection; diversification reduces supply chain risks.
• Emerging trends favor increased transparency, sustainability, and quality assurance in API sourcing.
• Strategic procurement aligned with regulatory requirements supports continuous and compliant CITANEST manufacturing.

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FAQs

1. What are the key regulatory considerations when sourcing API for CITANEST?
   Ensuring APIs meet GMP standards, possess comprehensive Certificates of Analysis, and adhere to pharmacopeial specifications such as USP or EP is critical for regulatory approval and product safety.

2. Can Chinese API manufacturers supply quality articaine hydrochloride suitable for pharmaceutical use?
   Yes, several Chinese manufacturers operate GMP-certified facilities capable of producing pharmaceutical-grade articaine hydrochloride, provided buyers conduct thorough audits and verify certifications.

3. How does API purity influence the final CITANEST product?
   High API purity (>99%) minimizes impurities and contaminants, reducing adverse reactions and ensuring consistent anesthetic efficacy.

4. What are the benefits of sourcing from multiple API suppliers?
   Diversification mitigates supply disruptions, enhances bargaining power, and ensures consistent material availability for continuous production.

5. What trends are shaping the future of API sourcing for local anesthetics?
   Increasing regulatory standards, focus on quality transparency, and supply chain sustainability are shaping the API market, with advancements in synthesis technology reducing costs and environmental impact.

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References

[1] U.S. Pharmacopeia (USP). Monograph: Articaine Hydrochloride.
[2] European Pharmacopoeia (EP). Monograph: Articaine.
[3] Sigma-Aldrich. Product information: Articaine Hydrochloride.
[4] Chinese Pharmacopoeia. Standards for anesthetic APIs.
[5] Indian Pharmacopoeia Commission. Guidelines for pharmaceutical APIs.

(Note: The references are representative; actual sourcing should involve verification of supplier documentation and pharmacopeial standards.)