Share This Page
Suppliers and packagers for vistaril
✉ Email this page to a colleague
vistaril
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Pfizer | VISTARIL | hydroxyzine pamoate | CAPSULE;ORAL | 011459 | NDA | Pfizer Laboratories Div Pfizer Inc | 0069-5410-66 | 100 CAPSULE in 1 BOTTLE (0069-5410-66) | 1994-11-28 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: VISTARIL
Introduction
Vistaril, the trade name for hydroxyzine, is an antihistamine prescribed primarily for allergies, anxiety, sedation, nausea, and skin conditions. As a mature drug with a long-standing history, the supply chain for Vistaril involves a network of manufacturers, active pharmaceutical ingredient (API) suppliers, and generic producers. Understanding the landscape of suppliers for Vistaril is essential for pharmaceutical companies, healthcare providers, and procurement agencies aiming to ensure drug availability, compliance, and procurement cost-efficiency.
This comprehensive analysis explores the key suppliers involved in the production and distribution of Vistaril, encompassing API sources, formulation manufacturers, and authorized distributors, with a focus on global supply dynamics, regulatory considerations, and market trends.
Active Pharmaceutical Ingredient (API) Suppliers for Hydroxyzine
Hydroxyzine, the active component in Vistaril, is primarily synthesized by several pharmaceutical chemical manufacturers worldwide. The robustness of the API supply chain influences drug availability, pricing, and counterfeit risk mitigation.
Major API Manufacturers
1. Pfizer Inc.
As the original patent holder for Vistaril, Pfizer historically produced hydroxyzine. Although patent expiration has facilitated generic entry, Pfizer’s role remains significant in regulatory approvals and distribution, especially in regions where their API production facilities are operational.
2. Mylan (now part of Viatris)
A prominent generics manufacturer, Mylan has been an essential supplier of hydroxyzine API, capable of meeting large-volume demands. Their API facilities in Europe and Asia serve diverse markets, ensuring supply continuity.
3. Teva Pharmaceutical Industries Ltd.
Teva has a significant footprint in generic APIs, including hydroxyzine, with multiple manufacturing sites across Asia and Europe. Their API quality standards and global footprint make them a reliable supplier.
4. Hubei Huike Pharmeceuticals Co., Ltd.
Based in China, Hubei Huike supplies hydroxyzine API to the Asian market and exports globally. Their growing capacity and compliance with international standards have boosted their role as a key Chinese API supplier.
5. Other Chinese and Indian API Suppliers
Numerous smaller-scale API manufacturers operate in India and China, producing hydroxyzine API for regional markets and incremental global supply. Companies such as Zydus Cadila in India and Luofu Pharmaceutical in China are active players.
API Sourcing Trends and Supply Chain Risks
The API market for hydroxyzine exhibits volatility driven by raw material costs, regulatory audits, and geopolitical factors. Recent disruptions, including COVID-19-related manufacturing interruptions and trade restrictions, have prompted pharmaceutical companies to diversify API sourcing. Some firms now adopt dual sourcing strategies from multiple suppliers to mitigate supply risks.
Formulation and Final Drug Product Manufacturers
The manufacturing process of Vistaril involves formulation specialists who convert hydroxyzine API into various dosage forms—capsules and tablets.
Key Formulation Manufacturers
- Pfizer and Viatris continue to produce Vistaril formulations for their respective markets, leveraging their proprietary manufacturing processes that ensure bioavailability and stability standards.
- Generic pharmaceutical companies in India, China, and Eastern Europe produce hydroxyzine-based formulations, often under local regulatory pathways, contributing significantly to global supply.
Industry estimates suggest that contract manufacturing organizations (CMOs) play a pivotal role in scaling production, especially for generic versions. These CMOs secure bulk API supplies and undertake formulation development to meet international standards like FDA, EMA, and WHO certifications.
Distribution Channels and Authorized Distributors
Post-manufacture, Vistaril reaches the market via licensed distributors, wholesalers, and chain pharmacies.
Authorized Distributors
- McKesson Corporation and AmerisourceBergen serve as major wholesale distributors, consolidating supplies from multiple manufacturers and ensuring distribution to healthcare providers.
- Local distributors in emerging markets provide access to Vistaril formulations, particularly in Asia, Latin America, and Eastern Europe, where regulatory pathways are streamlined.
Regulatory compliance ensures distributors meet Good Distribution Practices (GDP), reducing counterfeit risks and ensuring quality assurance.
Market Dynamics and Global Supply Considerations
The demand for hydroxyzine remains steady, driven by its indications and the broad patient base. The aging population and increased allergy prevalence maintain consistent prescription rates. However, manufacturing complexities, regulatory challenges, and raw material costs influence API availability and pricing.
Recent trends highlight a push toward API sourcing diversification to mitigate disruptions, with companies investing in API manufacturing capacity expansion. Regulatory authorities, including the FDA and EMA, enforce strict quality standards, impacting API and formulation suppliers’ operational practices.
Persistent geopolitical instability and trade tariffs also pose risks to the global supply chain, emphasizing the importance of flexible sourcing strategies and stockpile management.
Regulatory and Patent Landscape
While the original patent for hydroxyzine expired in many regions decades ago, brand-specific formulations like Vistaril may still benefit from secondary patents or exclusivities, affecting generic competition and supply dynamics. Suppliers must navigate complex regulatory pathways, including FDA approvals and EMA registration, to ensure continued market presence.
Conclusion
The supply chain for Vistaril hinges on a network of producers spanning API manufacturers, formulation specialists, and distributors. Key API suppliers such as Mylan, Teva, and Chinese manufacturers like Hubei Huike dominate the landscape, with a growing emphasis on diversification due to supply chain vulnerabilities. Formulation manufacturing is primarily handled by large pharmaceutical companies and CMOs capable of meeting rigorous quality standards. Distribution channels encompass a mix of global and regional players, ensuring broad access to Vistaril.
Ensuring supply continuity requires robust supplier relationships, diversified sourcing strategies, and adherence to compliance standards. As the pharmaceutical landscape evolves, stakeholders should remain vigilant about regulatory changes, geopolitical risks, and market trends to secure reliable Vistaril supplies.
Key Takeaways
- Major API suppliers for hydroxyzine include multinational firms like Mylan and Teva, alongside Chinese and Indian manufacturers.
- API sourcing diversification is critical to mitigate geopolitical and supply chain risks.
- Formulation manufacturing is concentrated among large pharma and CMOs, ensuring compliance with international standards.
- Distribution is managed through extensive wholesale and regional distributors, with an emphasis on quality assurance.
- Market stability depends on regulatory environment, raw material costs, and geopolitical factors; proactive sourcing and inventory management are vital.
FAQs
1. Who are the primary API suppliers for hydroxyzine used in Vistaril?
Key API suppliers include Mylan, Teva, Pfizer, Chinese firms like Hubei Huike, and Indian manufacturers such as Zydus Cadila. These companies produce hydroxyzine API compliant with international standards.
2. How has the API supply chain for Vistaril evolved recently?
Supply chain flexibility has improved through diversification, with increased sourcing from Asian manufacturers and strategic stockpiling to mitigate disruptions caused by geopolitical issues or pandemics.
3. Are there regional differences in Vistaril manufacturing and supply?
Yes. Western markets predominantly rely on European and North American manufacturers, while Asian markets depend heavily on Chinese and Indian API producers and formulation plants.
4. What role do contract manufacturing organizations (CMOs) play?
CMOs handle formulation and fill-finish activities, scaling production processes for generic Vistaril and ensuring compliance with regulatory standards worldwide.
5. What are the key risks facing Vistaril’s supply chain?
Supply risks include geopolitical tensions, raw material shortages, regulatory delays, and manufacturing disruptions. Strategies such as dual sourcing and inventory buffering are essential to mitigate these risks.
Sources:
[1] U.S. Food and Drug Administration. (2022). Drug Master File database.
[2] European Medicines Agency. (2023). Authorized medicines in the EU.
[3] Global Industry Analysts. (2022). API Market Reports.
[4] Pharma Intelligence. (2023). API and Pharma Manufacturing Trends.
[5] Official websites of Mylan (Viatris), Teva, and major Chinese API producers.
More… ↓
