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Suppliers and packagers for PROCHLORPERAZINE
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PROCHLORPERAZINE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Cosette | PROCHLORPERAZINE | prochlorperazine | SUPPOSITORY;RECTAL | 040058 | ANDA | Cosette Pharmaceuticals, Inc. | 0713-0135-10 | 1000 BLISTER PACK in 1 CARTON (0713-0135-10) / 1 SUPPOSITORY in 1 BLISTER PACK | 1993-11-30 |
| Cosette | PROCHLORPERAZINE | prochlorperazine | SUPPOSITORY;RECTAL | 040058 | ANDA | Cosette Pharmaceuticals, Inc. | 0713-0135-12 | 12 BLISTER PACK in 1 CARTON (0713-0135-12) / 1 SUPPOSITORY in 1 BLISTER PACK | 1993-11-30 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
ppliers for the Pharmaceutical Drug: PROCHLORPERAZINE
Introduction
Prochlorperazine is a potent antipsychotic and antiemetic medication widely utilized in the treatment of nausea, vomiting, schizophrenia, and severe agitation. As with many pharmaceutical agents, the availability of prochlorperazine depends on a network of reliable suppliers, including manufacturers, wholesalers, and authorized distributors. This article examines the landscape of prochlorperazine suppliers, analyzing key players, manufacturing sources, distribution channels, and implications for healthcare providers and pharmaceutical procurement strategies.
Manufacturers of Prochlorperazine
Prochlorperazine is primarily produced by several reputable pharmaceutical companies operating across multiple regions. These manufacturers adhere to stringent quality standards set by regulatory agencies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and others.
Major Pharmaceutical Manufacturers
1. Teva Pharmaceuticals
Teva is one of the leading generic drug manufacturers globally, offering prochlorperazine in various forms, including tablets, suppositories, and injections. Known for its vast production capacity and global distribution network, Teva supplies healthcare institutions, pharmacies, and wholesalers worldwide.
2. Hikma Pharmaceuticals
Hikma manufactures and markets prochlorperazine as part of its extensive portfolio of generic medicines. Its manufacturing facilities in the Middle East and Europe comply with international quality standards, enabling consistent supply to markets in Europe, the Middle East, and North America.
3. Mylan (now part of Viatris)
Viatris, the successor of Mylan following its merger, supplies prochlorperazine in both tablet and injectable formulations. Their strategic manufacturing facilities ensure regulatory compliance and broad distribution reach.
4. Sandoz (Novartis division)
Sandoz produces semi-synthetic pharmaceuticals, including prochlorperazine, emphasizing quality manufacturing under GMP (Good Manufacturing Practice) conditions, primarily serving North American and European markets.
5. Local and Regional Manufacturers
In addition to global players, several regional producers in countries such as India, China, and Southeast Asia manufacture prochlorperazine, often serving local markets or export corridors. These manufacturers may vary in quality assurance standards but generally adhere to national regulatory frameworks.
Distribution Channels and Wholesalers
Prochlorperazine reaches end-users predominantly through established distribution channels. These include wholesale distributors, hospital pharmacy depots, and retail pharmacies.
Key Wholesaler Networks
1. McKesson Corporation
As one of North America’s largest pharmaceutical distributors, McKesson supplies prochlorperazine to hospitals, clinics, and pharmacies with a reliable supply chain backbone.
2. Cardinal Health
Another major American distributor, Cardinal Health, offers prochlorperazine in various formulations, serving as a critical link between manufacturers and healthcare providers.
3. AmerisourceBergen
AmerisourceBergen maintains a vast inventory of generic medications, including prochlorperazine, ensuring prompt delivery in the U.S. and international markets.
4. International Distributors
In regions like Europe, Asia, and the Middle East, distributors such as Sanofi Genzyme, MEAS Pharmaceuticals, and local entity networks facilitate the supply of prochlorperazine.
Online and Contract Manufacturing
- Online Pharmaceutical Suppliers: Certain certified pharmaceutical stockists operate online platforms, offering prochlorperazine to licensed healthcare entities. These sources often provide bulk purchasing options for hospitals and clinics.
- Contract Manufacturing Organizations (CMOs): Some pharmaceutical companies outsource the manufacturing of prochlorperazine to CMOs, which specialize in large-scale production while maintaining regulatory compliance.
Regulatory and Quality Considerations
The procurement of prochlorperazine demands rigorous compliance with regional regulatory standards. Suppliers must hold appropriate approvals, such as FDA approval for U.S. distribution, EMA approval for Europe, or local regulatory licenses elsewhere.
- Quality Standard Certifications: Suppliers should demonstrate certifications including GMP compliance, ISO certifications, and Good Distribution Practice (GDP).
- Brand vs. Generic: While brand-name formulations of prochlorperazine are available in some markets, most supply is generic, supplied extensively by multiple manufacturers, affecting procurement strategy and pricing dynamics.
Emerging Trends in Supply Chain Dynamics
- Supply Chain Consolidation: Mergers among generic manufacturers (e.g., Pfizer’s divestiture of certain assets, Viatris’ formation) influence the availability and pricing of prochlorperazine.
- Regional Manufacturing Hubs: Increased manufacturing in India and China aims to meet rising demand, though geopolitical factors and intellectual property considerations may impact supply stability.
- Supply Chain Disruptions: Pandemic-related disruptions have underscored the importance of diversified supplier bases to mitigate shortages of vital medicines like prochlorperazine.
Implications for Healthcare and Business Professionals
Procurement professionals should evaluate supplier reliability based on compliance credentials, production capacity, and geographic diversification. Establishing long-term agreements with multiple suppliers can mitigate risks of shortages. Additionally, monitoring regulatory changes and regional manufacturing trends will support strategic purchasing decisions, ensuring continued access to this critical medication.
Key Takeaways
- Global Manufacturers: Major players include Teva, Hikma, Viatris (Mylan), and Sandoz, each with extensive distribution networks.
- Regional Suppliers: Emerging manufacturing hubs in India, China, and Southeast Asia enhance supply diversity but require quality due diligence.
- Distribution Networks: Wholesalers like McKesson, Cardinal Health, and AmerisourceBergen are primary channels for prochlorperazine distribution.
- Regulatory Compliance: Suppliers must adhere to regional GMP and licensing standards to guarantee drug quality and safety.
- Supply Chain Resilience: Ongoing industry consolidation and geopolitical factors necessitate diversified procurement strategies for consistent supply.
FAQs
1. What are the primary manufacturing regions for prochlorperazine?
Major manufacturing regions include North America (e.g., Teva, Mylan/Viatris), Europe (e.g., Sandoz), and Asia (India, China). Regional manufacturers focus on local markets and export, with increasing production in India and China to meet global demand.
2. How can healthcare providers verify the supplier’s quality standards?
Providers should request documentation confirming GMP certification, regulatory approvals (FDA, EMA), and compliance with Good Distribution Practices. Verifying the supplier’s track record and conducting audits, where feasible, also enhances quality assurance.
3. Are generic prochlorperazine formulations interchangeable with brand-name products?
Yes, regulatory authorities approve generics based on bioequivalence and manufacturing standards, making them therapeutically equivalent. However, formulation differences may influence patient tolerability, requiring clinician oversight.
4. How has COVID-19 impacted the supply of prochlorperazine?
The pandemic has disrupted supply chains, causing shortages in some regions. Diversifying supplier sources and maintaining sufficient stockpiles have become critical measures to ensure uninterrupted access to prochlorperazine.
5. What strategies can procurement teams adopt to ensure a stable supply of prochlorperazine?
Procurement teams should establish multi-supplier agreements, monitor supply chain risks, verify supplier compliance, and anticipate regulatory changes. Building relationships with regional manufacturers can bolster supply resilience during global disruptions.
Conclusion
Prochlorperazine remains an essential medication with a broad supply chain network spanning global manufacturers and regional producers. Ensuring consistent access requires an informed approach to supplier validation, regulatory compliance, and strategic sourcing. As industry dynamics evolve, healthcare providers and procurement professionals must remain vigilant, leveraging diversified sources and maintaining quality standards to support patient care.
Sources:
- [1] FDA Drug Approvals and Manufacturing Data.
- [2] EMA Marketing Authorization for Generic Drugs.
- [3] Global Pharmaceutical Supply Chain Insights.
- [4] Industry Reports on Generic Drug Manufacturing Trends.
- [5] World Health Organization (WHO) Guidelines on Medicine Quality Assurance.
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