Bulk Pharmaceutical API Sources for ATARAX

Bulk Pharmaceutical API Sources for ATARAX

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-002-506-318
AKos Consulting & Solutions		AKOS003334349
TimTec		ST059726
AbaChemScene		CS-2650
MedChemexpress MCE		HY-B0548
AKos Consulting & Solutions		AKOS016843978

Bulk Active Pharmaceutical Ingredient (API) Sources for ATARAX (Hydroxyzine)

Last updated: August 1, 2025

Introduction

Hydroxyzine, marketed under the brand name ATARAX, is a first-generation antihistamine with anxiolytic, sedative, and antiemetic properties. It is primarily utilized for relief from allergy symptoms, preoperative sedation, and anxiety. As a crucial pharmaceutical ingredient, the quality, sourcing, and regulatory compliance of Hydroxyzine API influence manufacturing efficacy, product safety, and market access. This report provides a comprehensive overview of bulk API sources for Hydroxyzine, analyzing global suppliers, quality standards, regulatory considerations, and market trends.

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Understanding Hydroxyzine API and Market Dynamics

Hydroxyzine is chemically identified as a piperazine derivative with the molecular formula C₂₁H₂₃ClN₂O₂. Its synthesis involves complex multi-step chemical reactions, often paralleling the production of other piperazine-based antihistamines. The API's demand is primarily driven by the pharmaceutical manufacturing of generics, hospital formulary needs, and compounding pharmacies.

The global API market for Hydroxyzine is concentrated in regions with robust pharmaceutical manufacturing capabilities—predominantly India, China, and Western markets like the United States and Europe. The rising demand for safer, high-quality APIs necessitates suppliers adhering to strict Good Manufacturing Practice (GMP) standards and international regulatory requirements such as those from the FDA, EMA, and other health authorities.

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Key API Manufacturers for Hydroxyzine (ATARAX)

1. Indian API Manufacturers

India remains a dominant player in API manufacturing due to cost efficiencies, technological expertise, and existing GMP infrastructure.

• Sun Pharma
  A major global pharmaceutical player, Sun Pharma produces Hydroxyzine API compliant with WHO GMP standards. Their facilities are certified, and they supply to multiple international markets. Their product undergoes rigorous QC testing, ensuring batch-to-batch consistency.

• Lupin Limited
  Lupin's API plant facilities are FDA-approved, providing high-quality Hydroxyzine APIs that meet stringent quality standards. They focus on global demand, including North American and European markets.

• Aarti Industries
  Specializing in specialty chemicals and APIs, Aarti Industries produces Hydroxyzine API under GMP conditions, exporting largely to North America and Europe. Their manufacturing facilities are certified by international agencies.

• Micro Labs
  A prominent generic pharmaceutical manufacturer, Micro Labs produces Hydroxyzine API, emphasizing adherence to cGMP and regulatory compliance in their manufacturing processes.

2. Chinese API Manufacturers

China hosts numerous API producers, often offering competitive pricing while maintaining international standards.

• Hubei Biocause Pharmaceutical
  Certified with GMP and capable of large-scale Hydroxyzine API production. Their products comply with international regulatory standards and are widely distributed globally.

• Shandong Hongjitang Pharmaceutical Group
  Produces Hydroxyzine API meeting international specifications, targeting global markets with a focus on timely delivery and compliance.

• Zhejiang NHU Co., Ltd.
  As a leading Chinese API and intermediate producer, NHU manufactures Hydroxyzine with compliance to GMP and possesses multiple international certifications.

3. European and US API Suppliers

While less prevalent, some European and US-based companies produce Hydroxyzine API or contract manufacturing services for international clients.

• BASF
  Not a traditional API producer for Hydroxyzine but known for custom synthesis and contract manufacturing—with capabilities that could extend to Hydroxyzine GMP APIs for clients.

• Bulk Pharmaceutical Services (BPS)
  US-based contract manufacturer with extensive experience in producing APIs, potentially offering Hydroxyzine under contract manufacturing arrangements.

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Quality Standards and Regulatory Considerations

For pharmaceutical companies sourcing Hydroxyzine API, compliance with quality and regulatory standards is paramount:

• GMP Certification
  Ensures API production adheres to manufacturing practices that guarantee safety, efficacy, and consistent quality.

• API Validation and Testing
  Must conform to pharmacopeial standards such as USP, EP, or JP. Testing includes assay, residual solvents, impurities, and stability.

• Regulatory Approvals
  API suppliers with approvals from agencies like the US FDA, EMA, or TGA can streamline the registration process and reduce time-to-market.

• Documentation & Traceability
  Detailed batch records, Certificates of Analysis (CoA), and compliance certificates facilitate regulatory inspections and quality assurance.

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Market Trends & Sourcing Strategies

Global Supply Chain Challenges

The COVID-19 pandemic accelerated awareness around the vulnerabilities of over-reliance on specific regions for APIs. Diversifying suppliers across geographies minimizes risks related to geopolitical issues, supply disruptions, or regulatory changes.

Cost versus Quality Considerations

While Indian and Chinese manufacturers often provide cost-competitive options, pharmaceutical companies must balance cost savings with strict adherence to regulatory and quality standards, especially for APIs intended for markets with high compliance thresholds like the US and Europe.

Emerging Contract Manufacturing Models

Contract manufacturing organizations (CMOs) increasingly offer bespoke API synthesis, allowing brand owners to secure supply while maintaining control over quality and regulatory documentation.

Vertical Integration and Strategic Alliances

Major pharmaceutical firms are pursuing vertical integration strategies, either through acquiring API producers or developing in-house capabilities, reducing dependency and enhancing control of the supply chain for Hydroxyzine API.

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Supply Chain Considerations for Pharmaceuticals

• Long-term Contracts: Establishing long-term agreements with certified suppliers ensures price stability and assured quality.
• Inventory Management: Maintaining strategic inventory levels mitigates risks associated with supply interruptions.
• Regulatory Due Diligence: Continuous compliance monitoring and supplier audits are essential for maintaining regulatory approvals.
• Sustainability & Ethics: Ethical sourcing and environmental compliance from API suppliers reinforce corporate responsibility and regulatory standing.

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Conclusion

Hydroxyzine API sourcing options span globally, primarily from India, China, and select Western suppliers. The key to successful procurement lies in balancing cost-effectiveness with rigorous quality and regulatory compliance. Strategic partnership with GMP-certified manufacturers, coupled with supply chain diversification, enhances operational resilience. As demand for high-quality Hydroxyzine APIs persists, keeping abreast of emerging suppliers, technological innovations, and regulatory shifts remains critical for pharmaceutical stakeholders.

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Key Takeaways

• Indian and Chinese manufacturers dominate Hydroxyzine API supply due to cost and capacity advantages, with multiple GMP-certified facilities.
• Quality standards, including compliance with WHO, USP, and other pharmacopeias, are vital for global market approval.
• Diversification and establishing long-term contractual relationships mitigate supply chain risks.
• Regulatory compliance, meticulous documentation, and supplier audits are essential for ensuring API quality and streamlining approvals.
• Market trends favor dynamic sourcing strategies, including contract manufacturing and vertical integration, to stay ahead of supply disruptions and regulatory challenges.

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FAQs

1. What are the main concerns when sourcing Hydroxyzine API internationally?
   Ensuring GMP compliance, regulatory approvals, consistent quality, and reliable supply chain management are critical concerns.

2. Which countries are the leading suppliers of Hydroxyzine API?
   India and China are the primary producers, with additional suppliers from Europe and the US providing specialized manufacturing services.

3. How can pharmaceutical companies verify API supplier quality?
   Through audits, certification verification (GMP, ISO), review of Certificates of Analysis, and compliance with recognized pharmacopeial standards.

4. What regulatory hurdles are associated with importing Hydroxyzine API?
   Importers must ensure the API meets local regulatory standards, provide necessary documentation, and obtain approvals from authorities such as the FDA or EMA.

5. Is vertical integration a viable strategy for Hydroxyzine API procurement?
   Yes; it offers increased control over quality, cost, and supply stability but requires significant investment and strategic planning.

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References

[1] WHO Pharmaceuticals: Good Manufacturing Practices (GMP) guidelines.
[2] U.S. Food and Drug Administration (FDA). API Registration and Compliance.
[3] European Medicines Agency (EMA). Regulatory Standards for Active Substances.
[4] Global API Market Report 2022. Pharma Intelligence.
[5] Contract Manufacturing in APIs. Pharmaceutical Technology Magazine.