Bulk Pharmaceutical API Sources for CETIRIZINE HYDROCHLORIDE HIVES RELIEF

Bulk Pharmaceutical API Sources for CETIRIZINE HYDROCHLORIDE HIVES RELIEF

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		89126_SIGMA
TCI (Tokyo Chemical Industry)		C2316
Molport		MolPort-000-832-941
Hangzhou APIChem Technology		AC-1600
AKos Consulting & Solutions		AKOS000280979
TimTec		ST077146

Bulk Active Pharmaceutical Ingredient (API) Sources for: Cetirizine Hydrochloride for Hives Relief

Last updated: July 29, 2025

Introduction

Cetirizine hydrochloride, a second-generation antihistamine, remains a frontline treatment for allergic conditions such as urticaria (hives). As demand surges globally, pharmaceutical companies prioritize sourcing reliable, high-quality bulk APIs to ensure effective and consistent product formulations. This report evaluates the global API manufacturing landscape, focusing on suppliers of cetirizine hydrochloride suitable for hives relief, examining their manufacturing capabilities, regulatory compliance, pricing strategies, and geopolitical considerations.

Overview of Cetirizine Hydrochloride as an API

Cetirizine hydrochloride (C₂₂H₂₆ClN₂O₃) selectively antagonizes peripheral H₁ histamine receptors, reducing allergy symptoms without significant sedative effects typical of first-generation antihistamines. The API's efficacy and safety profile demand stringent quality control during manufacturing, encompassing purity standards (generally >99%), stability, and bioavailability.

Global API Manufacturing Landscape for Cetirizine Hydrochloride

The supply of cetirizine hydrochloride hinges on a network of established API producers predominantly located in Asia, Europe, and North America. The key players are large-scale pharmaceutical manufacturers, comprising both integrative companies with in-house synthesis capabilities and third-party API producers catering to generic formulations.

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Major API Suppliers for Cetirizine Hydrochloride

1. Zhejiang Huahai Pharmaceutical Co., Ltd. (China)

Overview: One of China’s leading API manufacturers, Zhejiang Huahai specializes in antihistamines, including cetirizine hydrochloride. The company sustains a robust R&D pipeline and adheres to international Good Manufacturing Practices (GMP).

Strengths:

• High-volume production capacity.
• Competitive pricing and reliable supply.
• Proven quality with multiple certifications recognized globally.

Regulatory Status: Active registration in major markets; however, some regulatory scrutiny due to manufacturing compliance issues in the past [1].

2. Jiangsu Hegang Pharmaceutical Co., Ltd. (China)

Overview: Hegang is recognized for producing high-grade APIs for antihistamines, including cetirizine hydrochloride, with a focus on quality control and cost efficiency.

Strengths:

• ISO-certified manufacturing facilities.
• WHO-GMP compliance.
• Competitive export pricing targeting Asian and international markets.

Regulatory Status: Approved by several regulatory authorities; ongoing efforts to strengthen GMP credentials for Western markets.

3. Dr. Reddy’s Laboratories (India)

Overview: Dr. Reddy’s produces cetirizine hydrochloride API, serving the North American and European markets. The company emphasizes quality assurance and regulatory compliance.

Strengths:

• Extensive R&D capabilities.
• Stringent quality control.
• Compliance with US FDA, EMA, and other standards.

Regulatory Status: Approved and inspected by major regulators; adheres to strict manufacturing standards.

4. Synthesis and Contract Manufacturing Firms in India and China

Other notable suppliers include Hunan Qisen Pharmaceutical (China), Teva Pharmaceuticals (Israel), and Mylan (USA), which produce cetirizine hydrochloride API either in-house or via contract manufacturing.

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Emerging Suppliers and Regional Considerations

New entrants from Southeast Asia and Eastern Europe are increasingly capable of producing cetirizine hydrochloride. For instance, Vietnam-based APIs are gaining recognition for quality and cost advantages, though regulatory validations are ongoing (e.g., DMF filings).

Regional geopolitical factors influence sourcing decisions; reliance on China and India remains predominant due to cost efficiency and manufacturing capacity. However, regulatory pressures from Western nations are prompting diversification to ensure supply chain resilience.

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Regulatory and Quality Considerations

For APIs used in Hives relief medications, regulatory compliance is non-negotiable. Suppliers must demonstrate:

• GMP Certification: Ensuring consistency, purity, and safety.
• DMF Submissions: Detailed dossiers complying with FDA, EMA standards.
• Analytical Method Validations: To confirm API potency and purity.

Large-scale manufacturers often possess extensive regulatory documentation, simplifying approval pathways for pharmaceutical companies.

Pricing Dynamics and Supply Chain Stability

Pricing for cetirizine hydrochloride API varies widely based on scale, purity, and regulatory approval. Chinese manufacturers typically offer the most competitive prices, often below USD 50 per kilogram, while Indian producers may command slightly higher premiums due to stringent quality controls. Supply chain stability is essential, especially during global disruptions like pandemics or geopolitical tensions, influencing inventory management and sourcing strategies.

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Quality Certifications and Compliance

Preferred suppliers hold certifications such as:

• WHO-GMP
• US FDA DMF
• European GMP Certification
• ISO Certifications

Contract manufacturers often facilitate ongoing regulatory audits to maintain compliance, which is crucial for generic drug manufacturing, especially for markets with strict pharmacovigilance standards.

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Conclusion

Sourcing cetirizine hydrochloride API involves balancing cost, quality, regulatory compliance, and supply stability. Leading Chinese manufacturers like Zhejiang Huahai and Jiangsu Hegang remain dominant, offering competitive prices and proven quality. Indian firms such as Dr. Reddy’s further bolster options for regulatory-compliant APIs. Diversification and rigorous supplier due diligence are vital to mitigate supply chain risks.

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Key Takeaways

• Global API suppliers primarily originate from China and India, with established reputations for cost-effective, high-quality cetirizine hydrochloride production.
• Regulatory compliance remains the key procurement criterion; certifications like WHO-GMP and DMF are vital.
• Supply chain resilience requires strategic diversification, especially given geopolitical and logistical challenges.
• Pricing disparities reflect manufacturing scale, regulatory compliance, and regional factors, influencing procurement negotiations.
• Emerging suppliers from Southeast Asia show potential, but thorough validation and certification are essential before integrating into supply chains.

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FAQs

1. What are the primary factors influencing the choice of cetirizine hydrochloride API suppliers?
Quality certifications, regulatory compliance, manufacturing capacity, pricing, and supply chain reliability are critical factors.

2. Are Chinese manufacturers compliant with international regulatory standards?
Many are, particularly those with WHO-GMP certification. However, due diligence is necessary due to past regulatory scrutiny.

3. How does geopolitical tension impact API sourcing for cetirizine hydrochloride?
It prompts diversification away from reliance on single regions, with companies seeking alternative sources to secure supply continuity.

4. What role do third-party contract manufacturers play in cetirizine hydrochloride supply?
They enable pharmaceutical companies to scale production without significant capital investment, offering flexibility and regulatory support.

5. Can smaller or emerging suppliers meet international quality standards?
Yes, but they must obtain necessary certifications, undergo regulatory audits, and demonstrate consistent product quality.

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References

[1] U.S. FDA Warning Letter, Zhejiang Huahai Pharmaceutical, 2019.