Bulk Pharmaceutical API Sources for ACTAHIST

Bulk Pharmaceutical API Sources for ACTAHIST

Vendor	Vendor Homepage	Vendor Sku	API Url
BenchChem		B1236461
THE BioTek		bt-1570029
J&H Chemical Co.,ltd		JH487488

Bulk Active Pharmaceutical Ingredient (API) Sources for ACTAHIST (Hydroxyzine Hydrochloride)

Last updated: July 29, 2025

Introduction

Hydroxyzine hydrochloride, marketed under the brand name ACTAHIST, is an antihistamine widely used in the treatment of allergy symptoms, anxiety, nausea, and sleep disorders. As a critical component in pharmaceutical formulations, the procurement of high-quality bulk Active Pharmaceutical Ingredient (API) is essential for manufacturers to ensure product efficacy, safety, and regulatory compliance. This article provides an in-depth analysis of the global sources of Hydroxyzine Hydrochloride API, key manufacturers, sourcing considerations, and industry trends.

Overview of Hydroxyzine Hydrochloride

Hydroxyzine hydrochloride (C21H27ClN2O2) is a first-generation H1 antihistamine with sedative and anxiolytic properties. It is synthesized via multi-step chemical processes requiring strict quality control parameters. API sourcing strategies are crucial for pharmaceutical companies to maintain supply chains, minimize costs, and meet regulatory standards.

Global API Manufacturers and Suppliers

1. Major API Producers

The primary sources of Hydroxyzine Hydrochloride API are established pharmaceutical ingredient manufacturers with extensive production capacities and stringent quality management systems (QMS). Leading suppliers include:

• CordenPharma: A prominent global API manufacturer offering high-quality Hydroxyzine Hydrochloride. Known for its robust manufacturing facilities in Europe and the U.S., CordenPharma emphasizes cGMP compliance and comprehensive analytical testing protocols [1].

• LGM Pharma: Specializes in bulk APIs, including Hydroxyzine Hydrochloride, with a wide distribution network. LGM Pharma emphasizes sourcing from reputable manufacturers and offers flexible procurement options [2].

• Shandong Yudow Pharmaceutical Co., Ltd. (China): A well-known Chinese API producer with a significant market share, offering cost-effective Hydroxyzine Hydrochloride APIs that meet international standards [3].

• Taj Pharmaceuticals Ltd. (India): An established Indian manufacturer providing Hydroxyzine Hydrochloride, certified with WHO-GMP, ISO, and other regulatory accreditations [4].

• Famar مصنع الأدوية (Greece): European manufacturer known for high-quality active ingredients, including Hydroxyzine Hydrochloride, serving regulated markets in Europe and North America [5].

2. Emerging and Regional Suppliers

In addition to established players, several regional manufacturers supply Hydroxyzine Hydrochloride, often serving specific markets:

• Hunan Huiying Pharmaceutical Co., Ltd. (China): Focused on generic APIs, with ISO-certified production facilities.

• Sun Pharmaceutical Industries Ltd. (India): Offers a range of APIs, including Hydroxyzine, with a focus on cost-effective sourcing.

• Zhejiang Kangsheng Pharmaceutical Co., Ltd. (China): Provides API solutions compliant with global standards at lower costs, suitable for generic formulations.

Sourcing Considerations for Hydroxyzine Hydrochloride API

Quality and Regulatory Compliance

Given the therapeutic applications of Hydroxyzine Hydrochloride, API quality assurance is paramount. Suppliers should comply with cGMP standards and possess necessary certifications such as EDQM CEP, USFDA registration, or equivalent approvals. Strict analytical testing for potency, purity, residual solvents, heavy metals, and microbial contamination ensures compliance with pharmacopeial standards (USP, EP, Ph. Eur.).

Cost and Supply Chain Stability

Price competitiveness remains critical; however, price should not compromise quality. Sourcing from regions with stable political and economic climates reduces supply chain disruptions. Companies often diversify suppliers across geographies to mitigate risks associated with manufacturing interruptions, quality issues, or regulatory changes.

Lead Times and Capacity

Manufacturers should evaluate supplier capacity and lead times, especially amid global supply chain disruptions witnessed during the COVID-19 pandemic. Strategic inventory management and long-term contracts can ensure uninterrupted supply.

Intellectual Property and Licensing

Although Hydroxyzine Hydrochloride is a generic API, licensing agreements or patents in specific markets may influence sourcing options. Ensuring compliance with local patent laws and licensing requirements is essential.

Industry Trends and Future Outlook

• Shift Towards Asian Suppliers: Increasing capacity in China and India continues to drive down costs, with these regions dominating API manufacturing for Hydroxyzine Hydrochloride.

• Enhanced Quality Standards: Regulatory authorities are intensifying oversight, compelling suppliers to improve compliance and documentation rigor.

• Sustainable Manufacturing: Growing emphasis on environmentally friendly processes influences supplier selection, promoting greener manufacturing practices.

• Supply Chain Diversification: Companies increasingly diversify sources to mitigate geopolitical and logistical risks, ensuring reliable supply of Hydroxyzine Hydrochloride API.

Regulatory Landscape and International Standards

Manufacturers and suppliers must adhere to strict regulatory frameworks, including:

• United States Pharmacopeia (USP): Specifications for Purity, Potency, and Impurities.

• European Pharmacopoeia (EP): Monographs that specify manufacturing and testing standards.

• FDA and EMA Registration: Ensuring suppliers are approved or registered under relevant agencies.

Adherence to these standards facilitates market access and maintains product integrity.

Procurement Strategies

• Single vs. Multiple Sourcing: Balancing cost, quality, and risk by establishing relationships with multiple suppliers.

• Vertical Integration: Engaging manufacturers that control entire production processes from raw material to final API.

• Quality Agreements: Formalizing quality responsibilities to ensure compliance and consistent product quality.

Key Challenges in API Sourcing

• Quality Variability: Variations in raw material quality and manufacturing processes can impact API purity and efficacy.

• Regulatory Barriers: Different regional requirements may complicate international sourcing.

• Pricing Fluctuations: Market dynamics influence API prices, impacting overall manufacturing costs.

• Supply Disruptions: Geopolitical tensions, pandemics, or natural disasters can affect API availability.

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Key Takeaways

• Diverse Global Suppliers: Major API manufacturers for Hydroxyzine Hydrochloride include CordenPharma, LGM Pharma, and regional producers in China and India.

• Regulatory Compliance Critical: Suppliers must meet cGMP standards and possess appropriate certifications to ensure high-quality API supply.

• Quality Over Cost: While cost-saving is important, maintaining quality and regulatory compliance should be prioritized.

• Supply Chain Resilience: Diversification and strategic procurement minimize risks associated with supply disruptions.

• Evolving Industry Landscape: Asian suppliers' increasing capacity and emphasis on sustainability shape future sourcing strategies.

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FAQs

1. What are the primary regions supplying Hydroxyzine Hydrochloride API?
The leading regions are Europe, North America, China, and India, with China and India being dominant due to cost efficiencies and large-scale manufacturing capacity [3][4].

2. How can pharmaceutical companies validate the quality of API suppliers?
They should review certifications such as cGMP, EDQM CEP, USFDA registration, conduct audits, and request batch testing documentation to ensure compliance with pharmacopeial standards.

3. Are there regional regulatory challenges in sourcing Hydroxyzine from certain countries?
Yes. Variations in approval processes and documentation requirements across regions may pose challenges, requiring careful regulatory due diligence and approval management.

4. What is the impact of supply chain disruptions on API sourcing?
Disruptions can lead to shortages, increased costs, and delays in manufacturing, emphasizing the importance of diversified sourcing and inventory management.

5. How is industry trend affecting the future sourcing of Hydroxyzine Hydrochloride API?
The trend towards Asian manufacturing expansion and stricter regulatory standards necessitate vigilant supplier qualification, with an increasing focus on sustainability and supply chain resilience.

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References

[1] CordenPharma. (2023). Active Pharmaceutical Ingredients. CordenPharma Corporate Website.
[2] LGM Pharma. (2023). API Sourcing and Distribution. LGM Pharma Overview.
[3] Shandong Yudow Pharmaceutical Co., Ltd. (2022). Product Quality Certificates.
[4] Taj Pharmaceuticals Ltd. (2022). WHO-GMP Certificate.
[5] Famar. (2023). European API Manufacturing Standards.

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