Bulk Pharmaceutical API Sources for HYZYD

Bulk Pharmaceutical API Sources for HYZYD

Vendor	Vendor Homepage	Vendor Sku	API Url
Vitas-M Laboratory		STK086288
TCI (Tokyo Chemical Industry)		I0138
Molport		MolPort-000-141-557
AKos Consulting & Solutions		AKOS000119062
TimTec		ST078858
Vitas-M Laboratory		BBL008409
Amadis Chemical		A830384

Bulk Active Pharmaceutical Ingredient (API) Sources for HYZYD

Last updated: August 7, 2025

Introduction

Hydroxyzine, marketed under the brand name HYZYD among others, is a first-generation antihistamine widely used for its anxiolytic, sedative, antihistaminic, and antiemetic properties. Its active pharmaceutical ingredient (API) is hydroxyzine hydrochloride, a compound initially synthesized in the mid-20th century. The API's sourcing is a vital component for pharmaceutical companies involved in generic or branded formulations of HYZYD, influencing supply chain stability, cost-efficiency, and compliance with regulatory standards.

This article provides a comprehensive overview of bulk API sources for hydroxyzine hydrochloride, examining the global landscape, key manufacturers, and factors influencing supplier selection.

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Global Market Overview for Hydroxyzine Hydrochloride API

The hydroxyzine hydrochloride API market remains relatively niche, with concentrated manufacturing hubs primarily located in Asia. Major suppliers tend to be established pharmaceutical ingredient producers with a track record of compliance with Good Manufacturing Practices (GMP).

The API market has shown steady growth in line with demand for allergy, anxiety, and sleep disorder medications involving hydroxyzine. The global pharmaceutical industry’s regulatory environment demands that API suppliers demonstrate stringent quality control, good manufacturing practices, and reliable supply chains.

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Major API Manufacturers and Suppliers

1. Indian Pharmaceutical API Producers

India boasts a robust API manufacturing sector, with numerous companies supplying hydroxyzine hydrochloride. Notable among them are:

• Glenmark Pharmaceuticals: Known for high-quality APIs, with GMP-certified facilities capable of large-scale production.
• Hetero Labs: Offers a range of active ingredients, including hydroxyzine hydrochloride, with ISO and WHO-GMP certifications.
• Lark Laboratories: Specializes in various antihistamines and sedatives, including hydroxyzine.

These Indian suppliers are often favored for competitive pricing, consistent quality, and extensive supply capacity, making them popular choice for global markets.

2. Chinese API Manufacturers

China remains a dominant player in pharmaceutical intermediates and APIs, including hydroxyzine hydrochloride. Leading Chinese API manufacturers include:

• Jiangsu Hualan Bio-Tech: Known for rigorous quality standards, large-scale production, and export capabilities.
• Zhejiang Hongle Pharmaceutical: Offers GMP-compliant APIs with a focus on cost competitiveness.

Chinese suppliers have expanded their footprint due to technological advancements and increased regulatory compliance, attracting international buyers seeking reliable supplies.

3. European and North American Suppliers

While comparatively limited in numbers, some European and North American companies supply high-purity hydroxyzine hydrochloride APIs, often targeting regulatory-compliant markets such as the US and EU.

• Siegfried AG (Switzerland): Recognized for high-quality APIs, adhering to stringent GMP standards suitable for regulated markets.
• ASM Biotechnology (UK): Offers custom API synthesis, including hydroxyzine hydrochloride, with a focus on quality and regulatory compliance.

Such suppliers are typically chosen by manufacturers requiring APIs for high-value, regulated markets requiring complex compliance attestations.

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Selecting API Suppliers: Critical Factors

Quality and Regulatory Compliance

GMP certification remains the primary criterion. Suppliers must provide comprehensive documentation, including Certificates of Analysis (CoA), stability data, and compliance with pharmacopoeia standards (USP, EP, BP).

Supply Chain Reliability

Given hydroxyzine hydrochloride's demand stability, suppliers with proven logistics, inventory management, and contingency plans are preferred.

Pricing and Lead Times

Cost competitiveness influences sourcing decisions, especially for generic formulations. Long-term contracts facilitate favorable pricing and assured supply.

Manufacturing Capacity and Scalability

Suppliers capable of scaling production to meet forecasted demand are vital, particularly during global supply chain disruptions.

Geopolitical and Regulatory Considerations

Due diligence on export restrictions, trade tariffs, and country-specific regulatory requirements help safeguard supply continuity.

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Emerging Trends and Future Outlook

Shift Toward Verified Global Suppliers

Regulatory scrutiny prompts manufacturers to prefer suppliers with established GMP compliance and traceability. Certification from agencies like the US FDA or EMA enhances supplier credibility.

Growth in Chinese API Exports

Chinese API manufacturers continue to expand their footprint due to investments in manufacturing technology and quality systems, providing competitive options to global buyers.

Sustainability and Quality Initiatives

Increasing focus on sustainable manufacturing practices influences sourcing—suppliers investing in environmentally friendly processes gain a competitive edge.

Impact of Patent Laws and Generics

Although hydroxyzine is generic, patent expiration and patent challenges influence market dynamics, expanding the pool of API suppliers.

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Conclusion

The global supply landscape for hydroxyzine hydrochloride API features a diverse array of reputable manufacturers primarily based in India, China, and select developed regions. Pharmaceutical companies must prioritize quality, regulatory compliance, and supply reliability when selecting API sources for HYZYD. Continued monitoring of geopolitical, regulatory, and technological developments will be essential in maintaining a resilient and cost-effective supply chain.

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Key Takeaways

• The majority of hydroxyzine hydrochloride APIs are sourced from India and China, offering cost-effective and scalable manufacturing options.
• Regulatory compliance, GMP certification, and supply chain reliability are critical factors for API selection.
• High-quality suppliers from Europe and North America fulfill needs for regulated markets like the US and EU.
• Emerging trends favor suppliers with certifications, technological investments, and sustainable manufacturing practices.
• Strategic partnerships and long-term contracts allow for better pricing and assurance of supply amidst global supply chain challenges.

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FAQs

1. What are the main criteria for choosing an API supplier for HYZYD?
Key criteria include GMP certification, consistent quality, regulatory compliance, supply capacity, competitive pricing, and reliable logistics.

2. How does jurisdiction affect API sourcing for hydroxyzine hydrochloride?
Suppliers in regulated regions like the US, EU, or Japan are preferred for high-purity applications, while Indian and Chinese manufacturers often provide cost advantages for global markets.

3. Are there any emerging markets for hydroxyzine hydrochloride API?
Yes, growth is observed in Southeast Asia, Latin America, and certain African countries, driven by expanding pharmaceutical industries and increasing access to generic medications.

4. What risks are associated with sourcing API from China or India?
Potential risks include regulatory discrepancies, quality variability, intellectual property concerns, and geopolitical trade tensions, necessitating thorough due diligence.

5. How can manufacturers ensure API quality from overseas suppliers?
By requesting comprehensive documentation, audits, GMP certificates, and conducting periodic quality assessments, manufacturers can mitigate quality risks.

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Sources:

1. [1] "Global API Market Report," Pharmaceutical Technology, 2022.
2. [2] "Indian API Manufacturers Maintain Competitive Advantage," Pharma Business Today, 2021.
3. [3] "Chinese API Industry Outlook," China Pharmaceutical Industry Report, 2022.
4. [4] US FDA Data on GMP certifications and APIs, FDA website, 2023.
5. [5] "Ensuring Supply Chain Security for APIs," International Journal of Pharmaceutical Quality, 2022.