Suppliers and packagers for generic pharmaceutical drug: hydroxyzine hydrochloride

hydroxyzine hydrochloride

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Am Regent	HYDROXYZINE HYDROCHLORIDE	hydroxyzine hydrochloride	INJECTABLE;INJECTION	087408	ANDA	Henry Schein, Inc.	0404-9877-01	1 VIAL, SINGLE-DOSE in 1 BAG (0404-9877-01) / 1 mL in 1 VIAL, SINGLE-DOSE	2022-01-17
Am Regent	HYDROXYZINE HYDROCHLORIDE	hydroxyzine hydrochloride	INJECTABLE;INJECTION	087408	ANDA	Henry Schein, Inc.	0404-9878-02	1 VIAL, SINGLE-DOSE in 1 BAG (0404-9878-02) / 2 mL in 1 VIAL, SINGLE-DOSE	2022-01-17
Am Regent	HYDROXYZINE HYDROCHLORIDE	hydroxyzine hydrochloride	INJECTABLE;INJECTION	087408	ANDA	American Regent, Inc.	0517-4201-25	25 VIAL, SINGLE-DOSE in 1 TRAY (0517-4201-25) / 1 mL in 1 VIAL, SINGLE-DOSE (0517-4201-01)	1990-09-30

Suppliers for the pharmaceutical drug: HYDROXYZINE HYDROCHLORIDE

Last updated: July 29, 2025

Introduction

Hydroxyzine Hydrochloride is a widely used antihistamine with sedative and anxiolytic properties, primarily prescribed for allergies, anxiety, nausea, and sleep disorders. As a U.S. FDA-approved medication, hydroxyzine hydrochloride features in numerous formulations produced by multiple pharmaceutical suppliers globally. Understanding key suppliers, their manufacturing capacities, quality standards, and regulatory status is critical for stakeholders involved in procurement, distribution, or clinical research.

Market Overview of Hydroxyzine Hydrochloride

Hydroxyzine Hydrochloride falls under the class of first-generation antihistamines. It is marketed primarily by large pharmaceutical companies, generic drug manufacturers, and contract manufacturing organizations (CMOs). The global demand hinges on therapeutic needs, regulatory approvals, and manufacturing capabilities. The medication is often supplied as tablets, capsules, or injectable formulations. The involvement of several suppliers ensures robust supply chains but requires diligence to verify quality, compliance, and supply continuity.

Major Suppliers of Hydroxyzine Hydrochloride

1. Major Pharmaceutical Corporations

Large pharmaceutical firms dominate the landscape with established manufacturing and regulatory compliance standards:

• Pfizer Inc.: A pioneering producer with a long history of manufacturing hydroxyzine hydrochloride. Pfizer supplies the drug primarily to the U.S. market and has stringent quality control and manufacturing processes aligned with FDA standards. Pfizer’s global supply chain guarantees reliability, though product availability may vary based on regional distribution.

• Teva Pharmaceutical Industries Ltd.: A leading global generic drug manufacturer, Teva supplies hydroxyzine hydrochloride in various formulations. Known for extensive manufacturing capacities in Israel and the U.S., Teva emphasizes quality assurance and regulatory compliance, including adherence to Good Manufacturing Practices (GMP).

• Mylan/NOVARTIS: Following the merger, Mylan (now part of Viatris) and Novartis have integrated manufacturing protocols ensuring high-quality generic hydroxyzine hydrochloride. These manufacturers serve multiple markets worldwide with consistent supply.

• Sandoz (Novartis division): Sandoz specializes in generics and biosimilars, and their hydroxyzine hydrochloride products are recognized for their high standards and global availability.

2. Contract Manufacturing Organizations (CMOs)

CMOs play a pivotal role in the production of hydroxyzine hydrochloride, especially for brands and generics:

• Hetero Labs Limited (India): A notable CMO specializing in active pharmaceutical ingredients (APIs), including hydroxyzine hydrochloride, Hetero manufactures under strict regulatory oversight suitable for global markets, particularly emerging economies.

• Lek Pharmaceuticals (Sandoz): As part of the Novartis group, Lek collaborates in manufacturing and distribution, ensuring compliance with international standards.

• Viatris (formerly Mylan): Operates multiple manufacturing facilities globally, including API production of hydroxyzine hydrochloride, with a focus on quality and regulatory adherence.

3. Key API Suppliers and Raw Material Manufacturers

Hydroxyzine hydrochloride’s production depends heavily on suppliers of raw materials:

• Jubilant Life Sciences: An Indian manufacturer that supplies high-purity hydroxyzine hydrochloride API to major pharma companies, adhering to international GMP standards.

• Sun Pharma: Another Indian producer offering quality API supplies consistent with regulatory requirements, with facilities capable of large-scale production.

• Tianjin Taiyi Pharmaceutical: Based in China, this company supplies hydroxyzine hydrochloride API, serving regional pharma clients with competitive pricing and compliance certifications.

4. Regional and Market-Specific Suppliers

In emerging markets, local API producers and formulators may provide hydroxyzine hydrochloride to regional distributors:

• DR. Reddy’s Laboratories (India): Known for quality API manufacturing and formulations for domestic and export markets.

• Zhejiang Kangle Pharmaceutical (China): Produces hydroxyzine hydrochloride API compliant with international standards.

Regulatory and Quality Aspects

Suppliers should possess appropriate certifications such as FDA approvals, EU GMP certifications, and ISO standards. Ensuring batch consistency, impurity profiles, and data transparency is essential for pharmaceutical buyers. Many suppliers now provide detailed Certificate of Analysis (CoA) and compliance documentation to facilitate procurement decisions.

Supply Chain Considerations

The hydroxyzine hydrochloride market remains sensitive to geopolitical factors, regulatory changes, and raw material availability. Diversifying suppliers and verifying regulatory compliance mitigate risks associated with supply disruptions or quality issues. Strategic sourcing from multiple trusted suppliers ensures resilience and uninterrupted supply.

Emerging Trends and Opportunities

• Generic Market Expansion: Growing acceptance of generic formulations enhances opportunities for new suppliers, especially in emerging markets.

• API Manufacturing Innovation: Suppliers investing in process optimization are offering higher purity, better yields, and cost efficiencies.

• Regulatory Stringency: Increased compliance requirements drive suppliers to upgrade facilities and quality management systems, which benefits end-users through better quality assurance.

Conclusion

The supply landscape for hydroxyzine hydrochloride involves a diversified array of suppliers spanning large pharmaceutical companies, CMOs, and regional API manufacturers. Key global players like Pfizer, Teva, and Sandoz ensure steady supply for regulated markets, supported by a network of API producers from India, China, and other regions. Procurement stakeholders must focus on verifying supplier compliance, quality certifications, and supply chain robustness to ensure consistent and safe availability of hydroxyzine hydrochloride.

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Key Takeaways

• The most reliable suppliers include Pfizer, Teva, Mylan/Viatris, and Sandoz, with robust manufacturing and regulatory standards.
• API sourcing from Jubilant, Sun Pharma, and regional Chinese manufacturers offers cost-effective options but necessitates diligent quality verification.
• Ensuring supplier compliance with international GMP standards and acquiring detailed documentation are critical steps.
• Diversification of suppliers reduces risk amidst geopolitical and logistical uncertainties.
• Innovations in API manufacturing and regulatory environments will influence future supply chain dynamics.

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FAQs

1. What are the primary regions supplying hydroxyzine hydrochloride APIs?
India and China are predominant sources due to their large-scale manufacturing capabilities, with North America and Europe hosting key pharmaceutical and generic companies adhering to strict regulations.

2. How can I verify the quality of a hydroxyzine hydrochloride supplier?
Review their GMP certifications (FDA, EU GMP), request and analyze their Certificate of Analysis (CoA), audit their manufacturing facilities if possible, and seek references or third-party quality audits.

3. Are there any notable regulatory concerns with hydroxyzine hydrochloride suppliers?
Suppliers must maintain compliance with GMP standards. Regulatory agencies may restrict or scrutinize suppliers lacking transparency or quality documentation, emphasizing the importance of due diligence.

4. How does the API supply affect the pricing of hydroxyzine hydrochloride formulations?
API quality, production costs, and supplier location significantly influence pricing. Lower-cost APIs from emerging market suppliers can reduce costs but require stringent quality verification to mitigate risks.

5. What is the future outlook for hydroxyzine hydrochloride suppliers?
Demand remains consistent for therapeutic uses, but market dynamics may shift with the rise of generics, new formulations, and regulatory changes, prompting suppliers to invest in process improvements and quality assurance enhancements.

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Sources

1. [Pfizer Hydroxyzine hydrochloride manufacturing data, FDA filings]
2. [Teva Pharmaceuticals API sourcing, company website]
3. [Viatris API supplier reports]
4. [Jubilant Life Sciences chemical catalog]
5. [Sun Pharma API certification documentation]