Suppliers and packagers for generic pharmaceutical drug: HYDROXYZINE PAMOATE

HYDROXYZINE PAMOATE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Barr	HYDROXYZINE PAMOATE	hydroxyzine pamoate	CAPSULE;ORAL	088496	ANDA	Teva Pharmaceuticals USA, Inc.	0555-0323-02	100 CAPSULE in 1 BOTTLE (0555-0323-02)	1984-07-01
Barr	HYDROXYZINE PAMOATE	hydroxyzine pamoate	CAPSULE;ORAL	088496	ANDA	Teva Pharmaceuticals USA, Inc.	0555-0323-04	500 CAPSULE in 1 BOTTLE (0555-0323-04)	1984-07-01
Barr	HYDROXYZINE PAMOATE	hydroxyzine pamoate	CAPSULE;ORAL	088496	ANDA	American Health Packaging	60687-696-01	100 BLISTER PACK in 1 CARTON (60687-696-01) / 1 CAPSULE in 1 BLISTER PACK (60687-696-11)	2023-11-28
Barr	HYDROXYZINE PAMOATE	hydroxyzine pamoate	CAPSULE;ORAL	088496	ANDA	Proficient Rx LP	71205-483-30	30 CAPSULE in 1 BOTTLE (71205-483-30)	1984-07-01

Hydroxyzine Pamoate Drug Suppliers

Last updated: February 19, 2026

This report analyzes key suppliers of Hydroxyzine Pamoate, a pharmaceutical ingredient. It identifies leading manufacturers, their production capacities, regulatory standing, and market positioning to inform R&D and investment decisions.

Who are the Primary Manufacturers of Hydroxyzine Pamoate?

Multiple manufacturers globally produce Hydroxyzine Pamoate. Key players include both established pharmaceutical ingredient suppliers and specialized chemical manufacturers.

Table 1: Leading Hydroxyzine Pamoate Manufacturers

Manufacturer Name	Country of Origin	Primary Production Location(s)	Noteworthy Certifications
Zhejiang Langhua Pharmaceutical Co., Ltd.	China	Zhejiang, China	FDA, EDQM, PMDA
Jiangsu Shengkai Pharmaceutical Co., Ltd.	China	Jiangsu, China	FDA, EDQM
Mylan Laboratories Ltd. (Viatris)	India	Multiple sites, India	FDA, EDQM, WHO-GMP
Anqiu Jianfeng Pharmaceutical Co., Ltd.	China	Shandong, China	N/A
SICHUAN LUDE PHARMACEUTICAL CO., LTD.	China	Sichuan, China	N/A

Source: Company websites, industry databases, regulatory filings.

What is the Regulatory Landscape for Hydroxyzine Pamoate Production?

Regulatory compliance is critical for pharmaceutical ingredient suppliers. Key regulatory bodies whose approvals are sought by manufacturers include the U.S. Food and Drug Administration (FDA), the European Directorate for the Quality of Medicines & HealthCare (EDQM), and Japan's Pharmaceuticals and Medical Devices Agency (PMDA). Compliance with Good Manufacturing Practices (GMP) is a baseline requirement.

• FDA: United States Food and Drug Administration. Grants approval for Active Pharmaceutical Ingredients (APIs) to be used in drugs marketed in the U.S. Inspections are conducted to ensure compliance with current Good Manufacturing Practices (cGMP).
• EDQM: European Directorate for the Quality of Medicines & HealthCare. Issues Certificates of Suitability (CEP) which demonstrate that an API complies with the requirements of the European Pharmacopoeia. This facilitates the marketing of drugs in European Union member states.
• PMDA: Pharmaceuticals and Medical Devices Agency. The Japanese regulatory authority responsible for approving pharmaceuticals and medical devices.

Manufacturers often possess multiple certifications to access diverse global markets. Zhejiang Langhua Pharmaceutical, for example, holds FDA, EDQM, and PMDA certifications, indicating broad market access. Mylan Laboratories (now Viatris) also demonstrates significant international regulatory compliance.

What are the Production Capacities and Market Share of Key Suppliers?

Precise, publicly disclosed production capacities for Hydroxyzine Pamoate are often proprietary. However, market analysis suggests that Chinese manufacturers hold a significant share of global API production due to cost efficiencies and large-scale facilities.

• China: Major hubs for API manufacturing, including Shandong, Zhejiang, and Jiangsu provinces, are home to numerous producers. Companies like Zhejiang Langhua Pharmaceutical and Jiangsu Shengkai Pharmaceutical are recognized for their substantial output.
• India: Indian pharmaceutical companies, such as Mylan Laboratories (Viatris), are also significant players, leveraging their established API manufacturing infrastructure and regulatory expertise.

The market is competitive, with price and consistent quality being primary differentiating factors. Suppliers with strong regulatory dossiers and reliable supply chains tend to secure larger contracts from generic and branded drug manufacturers.

What are the Key Technical Specifications and Quality Standards for Hydroxyzine Pamoate API?

Hydroxyzine Pamoate is a synthetic API. Quality standards are dictated by pharmacopoeias and regulatory agencies.

• Chemical Name: 2-[2-[4-[(RS)-(4-chlorophenyl)phenylmethyl]piperazin-1-yl]ethoxy]ethanol pamoate.
• Molecular Formula: C₂₁H₂₇ClN₂O₂ · C₂₃H₁₆N₂O₆
• Molecular Weight: 734.98 g/mol
• Appearance: Typically an off-white to pale yellow powder.
• Solubility: Practically insoluble in water, soluble in methanol.
• Identification: Tested via infrared spectroscopy and HPLC (High-Performance Liquid Chromatography).
• Assay: Minimum 98.0% and maximum 102.0% on the dried basis (as per USP and EP).
• Related Substances: Limits are set for specific impurities, typically monitored by HPLC.
• Heavy Metals: Limit is usually ≤ 10 ppm.
• Loss on Drying: Typically not more than 0.5%.
• Residue on Ignition: Typically not more than 0.1%.
• Particle Size: May be specified for certain formulations to ensure dissolution and bioavailability.

These specifications are critical for drug formulation and therapeutic efficacy. Manufacturers must adhere to these pharmacopoeial standards, such as those found in the United States Pharmacopeia (USP) or the European Pharmacopoeia (EP).

What is the Supply Chain Risk Profile for Hydroxyzine Pamoate?

Supply chain risks for Hydroxyzine Pamoate can be categorized as follows:

• Geopolitical Risks: Concentration of manufacturing in specific regions, particularly China, can expose the supply chain to disruptions from trade disputes, environmental regulations, or political instability.
• Regulatory Changes: Shifts in regulatory requirements by major agencies (FDA, EMA, PMDA) can necessitate costly revalidation of manufacturing processes and facilities.
• Raw Material Sourcing: Fluctuations in the availability and cost of key starting materials used in the synthesis of Hydroxyzine Pamoate can impact production.
• Quality Control Failures: Any lapse in quality control by a supplier can lead to batch rejections, recalls, and significant financial and reputational damage.
• Logistics and Transportation: Global shipping disruptions, port congestion, or increased freight costs can affect delivery timelines and cost of goods.

Mitigation strategies include diversifying supplier bases, conducting thorough supplier audits, maintaining safety stock, and establishing long-term supply agreements.

How Do Suppliers Differentiate Themselves in the Market?

Suppliers differentiate themselves through several key strategies:

• Regulatory Approvals: Holding a broad range of international regulatory approvals (FDA, EDQM, PMDA, etc.) is a primary differentiator, granting access to major pharmaceutical markets.
• Quality and Compliance: Consistent adherence to cGMP, robust quality management systems, and a strong audit history build trust.
• Pricing: Competitive pricing, especially for high-volume generic drug manufacturers, is a crucial factor.
• Reliability and Lead Times: The ability to consistently meet delivery schedules and maintain short lead times is essential for pharmaceutical production planning.
• Technical Support: Offering comprehensive technical documentation, impurity profiling, and regulatory support can strengthen supplier-customer relationships.
• Capacity and Scalability: Demonstrating the capacity to meet increasing demand and scale up production as needed is attractive to large pharmaceutical companies.

Zhejiang Langhua Pharmaceutical's broad regulatory portfolio and established manufacturing base position it as a strong player. Similarly, Mylan Laboratories' global presence and integrated supply chain offer competitive advantages.

What are the Future Trends Impacting Hydroxyzine Pamoate Suppliers?

Future trends will likely shape the Hydroxyzine Pamoate supply landscape:

• Increased Regulatory Scrutiny: Expect intensified scrutiny on API impurity profiles, particularly genotoxic impurities, and stricter enforcement of cGMP across global manufacturing sites.
• Supply Chain Resilience: Pharmaceutical companies will increasingly demand greater transparency and diversification in their API supply chains to mitigate risks. This may lead to a re-evaluation of single-source dependencies.
• Focus on Sustainability: Environmental, Social, and Governance (ESG) factors are becoming more important. Suppliers with demonstrable sustainable practices may gain a competitive edge.
• Technological Advancements: Adoption of advanced manufacturing technologies, such as continuous manufacturing, could improve efficiency and quality control, though implementation requires significant investment.
• Generic Competition: As patents for branded formulations expire, the demand for cost-effective generic APIs like Hydroxyzine Pamoate will continue, driving price competition among suppliers.

These trends necessitate strategic investment in quality systems, capacity expansion, and supply chain management by existing and potential suppliers.

Key Takeaways

• Key global manufacturers of Hydroxyzine Pamoate are concentrated in China and India, with Zhejiang Langhua Pharmaceutical, Jiangsu Shengkai Pharmaceutical, and Mylan Laboratories (Viatris) being prominent players.
• Regulatory compliance, particularly FDA and EDQM certifications, is paramount for market access and supplier credibility.
• Suppliers differentiate based on quality, regulatory standing, pricing, reliability, and technical support.
• Supply chain risks include geopolitical factors, regulatory changes, and raw material sourcing challenges.
• Future trends emphasize increased regulatory scrutiny, supply chain resilience, and sustainability.

Frequently Asked Questions

1. Which suppliers have FDA approval for Hydroxyzine Pamoate?

Zhejiang Langhua Pharmaceutical Co., Ltd. and Mylan Laboratories Ltd. (Viatris) are known to hold FDA approvals for Hydroxyzine Pamoate. Regulatory approvals are dynamic and subject to change; direct verification with the FDA or the suppliers is recommended.

2. What is the typical lead time for ordering Hydroxyzine Pamoate API?

Typical lead times can range from 4 to 12 weeks, depending on the supplier's inventory, current production schedules, and order volume. Large, established suppliers often provide more predictable delivery windows.

3. Are there any single-source risks associated with Hydroxyzine Pamoate production?

While multiple manufacturers exist, significant market concentration exists. Reliance on a single supplier for a critical API like Hydroxyzine Pamoate presents a risk due to potential disruptions from quality issues, geopolitical events, or capacity constraints. Diversification is advisable for robust supply chains.

4. What pharmacopoeial standards must Hydroxyzine Pamoate API meet?

Hydroxyzine Pamoate API must meet the specifications outlined in major pharmacopoeias, including the United States Pharmacopeia (USP) and the European Pharmacopoeia (EP). These standards cover identity, purity, assay, and impurity limits.

5. How can a company assess the quality of a Hydroxyzine Pamoate supplier?

Quality assessment involves reviewing supplier regulatory certifications (FDA, EDQM), conducting on-site audits of manufacturing facilities to verify cGMP compliance, examining Certificates of Analysis (CoA) for batch-to-batch consistency, and assessing their quality management systems and history of regulatory inspections.

Citations

[1] Zhejiang Langhua Pharmaceutical Co., Ltd. (n.d.). Product List. Retrieved from [Company Website] (Specific URL not provided as it changes; access via direct search for the company name). [2] Jiangsu Shengkai Pharmaceutical Co., Ltd. (n.d.). APIs. Retrieved from [Company Website] (Specific URL not provided as it changes; access via direct search for the company name). [3] Viatris Inc. (n.d.). API Products. Retrieved from [Company Website] (Specific URL not provided as it changes; access via direct search for Viatris and API products). [4] United States Pharmacopeia. (2023). Hydroxyzine Pamoate Monograph. In United States Pharmacopeia and The National Formulary (USP 46). [5] European Directorate for the Quality of Medicines & HealthCare. (n.d.). Certificates of Suitability (CEP). Retrieved from EDQM website. (General information, specific monograph for Hydroxyzine Pamoate not directly linked here).