Bulk Pharmaceutical API Sources for hydroxyzine

Bulk Pharmaceutical API Sources for hydroxyzine

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
Vitas-M Laboratory		STL417960

HYDROXYZINE BULK ACTIVE PHARMACEUTICAL INGREDIENT (API) SOURCING ANALYSIS

Last updated: February 19, 2026

This report details key manufacturers, regulatory approvals, and market trends for bulk Hydroxyzine API. Understanding these factors is critical for pharmaceutical companies managing R&D pipelines and supply chain stability.

WHO ARE THE PRIMARY GLOBAL MANUFACTURERS OF HYDROXYZINE API?

Global production of Hydroxyzine API is concentrated among a limited number of manufacturers, primarily located in Asia. These suppliers vary in their regulatory compliance and production scale.

Manufacturer	Country of Origin	Key Certifications	Notable Products
Zhejiang Hisun Pharmaceutical Co., Ltd.	China	US FDA, EDQM	Hydroxyzine HCl API
Jiangsu Nhwa Pharmaceutical Co., Ltd.	China	US FDA, EDQM	Hydroxyzine HCl API
Aurobindo Pharma Ltd.	India	US FDA, EDQM	Hydroxyzine HCl API
Dr. Reddy's Laboratories Ltd.	India	US FDA, EDQM	Hydroxyzine HCl API
Teva Pharmaceutical Industries Ltd.	Israel	US FDA, EDQM	Hydroxyzine HCl API

Source: Company reports, regulatory filings.

Additional Manufacturers identified include:

• S.A. Pharma Group (India): Known for various generic APIs, including antihistamines.
• Cadila Healthcare Ltd. (India): A major Indian pharmaceutical company with API manufacturing capabilities.
• Divi's Laboratories Limited (India): Specializes in custom synthesis and generic API production.

These manufacturers operate under Good Manufacturing Practices (GMP) and are subject to inspections by global regulatory bodies. The choice of manufacturer can impact product quality, regulatory pathways, and cost of goods.

WHAT ARE THE KEY REGULATORY CONSIDERATIONS FOR HYDROXYZINE API IMPORT AND USE?

Regulatory approval is a prerequisite for any pharmaceutical product containing Hydroxyzine API entering regulated markets. Key considerations include Drug Master Files (DMFs) and national drug agency inspections.

• United States Food and Drug Administration (US FDA): Manufacturers must file Type II DMFs for Hydroxyzine API. These filings contain detailed information about the manufacturing process, facilities, quality control, and stability of the API. The FDA reviews these DMFs as part of Abbreviated New Drug Application (ANDA) submissions for generic Hydroxyzine products. Facilities are subject to FDA pre-approval inspections.
• European Directorate for the Quality of Medicines & HealthCare (EDQM): Manufacturers can obtain a Certificate of Suitability (CEP) from EDQM for Hydroxyzine API. A CEP demonstrates that the API complies with the requirements of the European Pharmacopoeia. This simplifies the regulatory process for marketing authorization applications in European Union member states.
• Other National Regulatory Authorities: Agencies such as Health Canada, Australia's Therapeutic Goods Administration (TGA), and Japan's Pharmaceuticals and Medical Devices Agency (PMDA) have their own requirements for API sourcing and approval, often referencing US FDA or EDQM standards.

Recent Trends in Regulatory Scrutiny:

• Increased focus on impurity profiles: Regulatory bodies are demanding more comprehensive data on API impurities, including potential genotoxic impurities.
• Supply chain transparency: Greater emphasis is placed on understanding and documenting the entire API supply chain, from raw material sourcing to final API production.
• Facility inspections: Ongoing, unannounced inspections of API manufacturing sites are becoming more frequent, particularly for facilities supplying the US and EU markets.

WHAT ARE THE PRIMARY ACTIVE PHARMACEUTICAL INGREDIENTS (APIs) RELATED TO HYDROXYZINE?

Hydroxyzine is typically available as Hydroxyzine Hydrochloride. Other related forms or salts are not commonly manufactured or used for commercial pharmaceutical production.

• Hydroxyzine Hydrochloride (CAS No. 2192-20-3): This is the most prevalent salt form of Hydroxyzine used in pharmaceutical formulations. It is a white, crystalline powder, soluble in water.

While Hydroxyzine can exist as a free base, the hydrochloride salt offers improved stability and solubility, making it the preferred form for oral and injectable dosage forms.

WHAT IS THE CURRENT MARKET DYNAMICS FOR HYDROXYZINE API?

The Hydroxyzine API market is characterized by a stable demand driven by its established use in generic medications. Supply is generally consistent, though geopolitical factors and regulatory changes can influence availability and pricing.

Key Market Drivers:

• Established therapeutic use: Hydroxyzine is a widely prescribed antihistamine used for conditions such as allergic reactions, anxiety, and pruritus.
• Generic drug market growth: The continued expansion of the generic pharmaceutical sector supports demand for established APIs like Hydroxyzine.
• Aging global population: This demographic trend can lead to increased prevalence of conditions treated by Hydroxyzine.

Market Challenges:

• Price pressure: Competition among generic manufacturers and API suppliers can lead to downward pressure on API pricing.
• Regulatory compliance costs: Meeting evolving regulatory standards, such as enhanced impurity testing and facility upgrades, increases manufacturing costs.
• Supply chain disruptions: Global events, trade disputes, or localized manufacturing issues can impact API availability.

Pricing Trends:

Hydroxyzine HCl API pricing is subject to fluctuations based on raw material costs, manufacturing efficiency, and competitive landscape. Typical bulk pricing can range from $15 to $40 per kilogram, depending on purity, volume, and supplier. Long-term contracts with major manufacturers often secure more stable pricing.

Geographic Distribution of Demand:

North America and Europe represent the largest markets for Hydroxyzine API, driven by mature healthcare systems and high prescription volumes. Asia-Pacific is a growing market due to increasing healthcare access and pharmaceutical manufacturing capabilities.

WHAT ARE THE KEY QUALITY CONTROL PARAMETERS FOR HYDROXYZINE API?

Maintaining high quality for Hydroxyzine API is paramount to ensuring the safety and efficacy of finished pharmaceutical products. Regulatory bodies mandate strict adherence to pharmacopoeial standards and detailed impurity profiling.

Pharmacopoeial Standards:

• United States Pharmacopeia (USP): Hydroxyzine Hydrochloride monograph in the USP specifies tests for identification, assay, related substances, residual solvents, heavy metals, and loss on drying.
• European Pharmacopoeia (Ph. Eur.): Similar to the USP, the Ph. Eur. monograph details required quality attributes, including appearance, solubility, identification, assay, and limits for specific impurities.

Key Quality Parameters:

1. Assay: The quantitative determination of Hydroxyzine Hydrochloride content, typically required to be between 98.0% and 102.0% on the dried basis.
2. Related Substances (Impurities): Strict limits are placed on known and unknown impurities. This includes:
   • Specific identified impurities: e.g., 1-(4-chlorobenzhydryl)piperazine.
   • Unspecified impurities: Limits are set for any single unknown impurity and the total of all unknown impurities.
   • Genotoxic impurities: Particular attention is paid to identifying and controlling potentially genotoxic impurities that may arise from the manufacturing process.
3. Residual Solvents: Limits are defined for solvents used during the manufacturing process, adhering to ICH Q3C guidelines. Common solvents include ethanol, methanol, and isopropanol.
4. Loss on Drying: Measures the amount of volatile matter (primarily water) present in the API, with specific limits defined.
5. Heavy Metals: Limits are set for potentially toxic heavy metals, such as lead and mercury.
6. Particle Size Distribution: Important for formulation development, particularly for solid dosage forms. Manufacturers may offer specific particle size ranges upon request.
7. Microbial Enumeration Tests: Assesses the microbial load, ensuring the API meets specified limits for bacteria, yeast, and mold.

Manufacturers must provide Certificates of Analysis (CoAs) with each batch, detailing the results of these quality control tests against defined specifications.

HOW HAS THE REGULATORY LANDSCAPE FOR API MANUFACTURING EVOLVED?

The global regulatory landscape for Active Pharmaceutical Ingredient (API) manufacturing has undergone significant evolution, driven by a demand for enhanced patient safety and supply chain integrity.

Key Evolutions:

• Increased Harmonization Efforts: Initiatives like the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) have led to greater global alignment on quality standards, particularly ICH Q7 (Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients) [1]. This provides a unified framework for API manufacturing quality.
• Enhanced Focus on Data Integrity: Regulatory agencies worldwide have intensified scrutiny of data integrity. This includes ensuring that all data generated during API manufacturing is accurate, complete, and attributable. Deficiencies in data integrity are a frequent cause of regulatory warning letters and import alerts.
• Stringent Impurity Control: Regulatory expectations for identifying, quantifying, and controlling impurities, especially potentially genotoxic impurities (PGIs), have become more rigorous. ICH M7 guidance [2] provides a framework for assessing and controlling PGIs.
• Supply Chain Security and Transparency: There is an increased emphasis on understanding and securing the entire API supply chain. This includes detailed knowledge of starting material suppliers and intermediate manufacturers, as well as measures to prevent counterfeiting and diversion.
• Risk-Based Approaches to Inspections and Approvals: Regulatory bodies are increasingly adopting risk-based approaches to prioritize inspections and review processes. Facilities with a history of non-compliance or those manufacturing critical APIs are subject to higher scrutiny.
• Post-Approval Changes: The process for managing post-approval changes to API manufacturing processes has become more complex, requiring thorough justification and often pre-approval from regulatory authorities.

These evolutions necessitate continuous investment in quality systems, advanced analytical capabilities, and robust documentation practices by API manufacturers.

KEY TAKEAWAYS

• Concentrated Supply: Hydroxyzine API production is dominated by a few key manufacturers, primarily in China and India, holding US FDA and EDQM certifications.
• Regulatory Prerequisites: US FDA DMFs and EDQM CEPs are critical for market access in major regulated markets.
• Quality is Paramount: Adherence to pharmacopoeial standards (USP, Ph. Eur.) and stringent control of impurities, residual solvents, and other quality attributes are non-negotiable.
• Market Stability: The Hydroxyzine API market is stable, driven by consistent demand for its generic applications, though price pressures and regulatory compliance costs are present.
• Evolving Compliance: Manufacturers must adapt to increasingly stringent global regulatory expectations regarding data integrity, impurity control, and supply chain transparency.

FREQUENTLY ASKED QUESTIONS

1. What is the primary difference between Hydroxyzine Hydrochloride API and Hydroxyzine Pamoate API? Hydroxyzine Hydrochloride is the more common and soluble salt form, typically used for oral and injectable formulations. Hydroxyzine Pamoate is a less soluble salt, primarily used in specific oral suspension formulations to provide a longer duration of action due to its slower dissolution rate.
2. How does the particle size of Hydroxyzine API affect its use in formulations? Particle size distribution is a critical attribute for solid oral dosage forms. Finer particles generally exhibit faster dissolution rates, which can impact bioavailability. Manufacturers may offer controlled particle sizes to meet specific formulation requirements for tablet compression or dissolution profiles.
3. What are the implications of a US FDA warning letter issued to a Hydroxyzine API manufacturer? A US FDA warning letter signals significant regulatory non-compliance. It can lead to import alerts, blocking the API from entering the U.S. market. This necessitates immediate corrective actions by the manufacturer and can cause supply chain disruptions for pharmaceutical companies relying on that API source.
4. Are there any known environmental concerns associated with Hydroxyzine API manufacturing? As with the synthesis of many complex organic molecules, Hydroxyzine API manufacturing can involve the use of various solvents and reagents. Manufacturers are expected to comply with local and international environmental regulations concerning waste management, solvent recovery, and emissions control.
5. What is the typical shelf life of bulk Hydroxyzine Hydrochloride API? Properly stored Hydroxyzine Hydrochloride API typically has a shelf life of 2 to 5 years. This is determined through stability studies conducted according to ICH guidelines, monitoring key quality attributes over time under specified storage conditions.

CITATIONS

[1] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (2009). ICH Harmonised Tripartite Guideline Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients. Retrieved from https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q7/Step4/Q7_Guideline.pdf

[2] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (2017). ICH Harmonised Guideline M7(R2) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk. Retrieved from https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/M7/M7_R2_Step_4_20170830.pdf