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Suppliers and packagers for generic pharmaceutical drug: chlorothiazide
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chlorothiazide
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Salix Pharms | DIURIL | chlorothiazide | SUSPENSION;ORAL | 011870 | NDA | Salix Pharmaceuticals, Inc | 65649-311-12 | 1 BOTTLE in 1 CARTON (65649-311-12) / 237 mL in 1 BOTTLE | 1962-02-15 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: CHLOROTHIAZIDE
Introduction
Chlorothiazide, a thiazide diuretic primarily employed to manage hypertension and edema, remains a staple in cardiovascular therapy. Its widespread use necessitates a robust supply chain comprising reliable manufacturers and authorized distributors. This article offers an in-depth overview of key suppliers globally, focusing on manufacturing giants, regional producers, and considerations for procurement professionals.
Global Manufacturing Landscape
Major Producers of Chlorothiazide
Several pharmaceutical companies dominate the production of chlorothiazide, leveraging extensive R&D and manufacturing capabilities to meet global demand. Notable among these are:
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Teva Pharmaceutical Industries Ltd. (Israel): A leading generic drug manufacturer with a significant portfolio including chlorothiazide. Teva's extensive global manufacturing network ensures supply stability.
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Sandoz International GmbH (A Novartis division, Switzerland): Known for producing high-quality generics, Sandoz supplies chlorothiazide to markets worldwide.
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Mylan N.V. / Viatris Inc. (USA): Before its merger with Pfizer’s Upjohn division, Mylan was a key producer, now operating as Viatris, maintaining a substantial market share in generic diuretics.
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Lek Pharmaceuticals (now part of Novartis) (Slovenia): Historically a significant regional supplier, Solvent-based manufacturing facilities have supported European markets.
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Aurobindo Pharma Ltd. (India): An emerging leader in generics, Aurobindo supplies chlorothiazide to various global markets, especially in Asia and Africa.
Regional and Local Suppliers
In addition to global leaders, numerous regional manufacturers produce chlorothiazide to cater to local markets or specific regulatory regimes:
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Hetero Drugs (India): Supplies chlorothiazide primarily to the Indian subcontinent and neighboring regions.
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Cipla Ltd. (India): Provides affordable generic options, including chlorothiazide, supplied across Asia, Africa, and parts of Latin America.
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Micro Labs Ltd. (India): Delivers cost-effective generics, supporting emerging economies.
Supply Chain Dynamics and Regulatory Considerations
The stability of chlorothiazide supply depends on several factors:
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Manufacturing Capacity: The aggregate capacity of leading producers, particularly in India, Israel, and Eastern Europe, supports global demand.
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Regulatory Approvals: Suppliers must maintain compliance with the FDA, EMA, and other regulatory authorities to ensure supply continuity.
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Raw Material Availability: Acrylonitrile and other chemical intermediates are vital; disruptions can impact production.
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Market Demand Fluctuations: Changes in prescribing habits, patent expirations, and market saturation influence supply levels.
Key Suppliers’ Supply Agreements and Distribution Channels
Suppliers typically operate under extensive distribution arrangements, partnering with regional distributors, hospital procurement networks, and pharmacy chains:
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Authorized Wholesalers: Major wholesalers like McKesson, Cardinal Health, and Henry Schein serve as distribution hubs for chlorothiazide.
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Hospital Procurement Networks: Contracted directly with manufacturers or authorized distributors.
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Generic Distribution Platforms: Online pharmacies and regional logistics providers facilitate access, particularly in emerging markets.
Emerging Trends in Chlorothiazide Supply
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Manufacturing Consolidation: Industry shifts favor larger players acquiring smaller producers to enhance capacity and compliance.
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Supply Chain Resilience: Companies are diversifying manufacturing sites to mitigate risks from geopolitical or natural disruptions.
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Regulatory Harmonization: Increased cooperation among agencies simplifies approval processes, expanding supplier reach.
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Bioequivalence and Quality Assurance: High standards ensure consistent product efficacy across suppliers, driving supplier competitiveness.
Considerations for Procurement and Market Entry
Businesses seeking to secure chlorothiazide supplies should consider:
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Validating Regulatory Compliance: Ensure suppliers meet international standards (e.g., WHO GMP, FDA approval).
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Assessing Capacity and Reliability: Prioritize suppliers with proven production stability and contingency plans.
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Pricing and Contract Terms: Engage in negotiations reflecting market volatility, long-term supply guarantees, and intellectual property rights.
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Traceability and Transparency: Select suppliers with clear supply chain documentation to avoid counterfeit risks.
Conclusion
The global supply of chlorothiazide is predominantly controlled by a handful of large generic manufacturers, supported by regional producers catering to specific markets. With increasing competition, industry consolidation, and heightened regulatory scrutiny, procurement professionals must evaluate suppliers on compliance, capacity, and reliability. Ensuring a resilient supply chain for chlorothiazide remains vital for continuous patient care in hypertension management worldwide.
Key Takeaways
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Major suppliers include Teva, Sandoz, Viatris, and Indian generics such as Aurobindo and Cipla.
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Regional producers serve local markets, emphasizing the importance of regional supply chains.
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Supplier selection should focus on regulatory compliance, reliable capacity, and traceability to mitigate risk.
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Industry trends point to consolidation and diversification to enhance supply resilience.
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Procurement strategies must adapt to regulatory changes and market dynamics to ensure uninterrupted chlorothiazide availability.
FAQs
1. Are generic chlorothiazide suppliers reliable for large-scale procurement?
Yes, major generic manufacturers like Teva, Sandoz, and Viatris have established quality standards, extensive capacity, and global distribution channels, making them reliable sources for large-scale procurement.
2. How do regulatory standards influence supplier choice?
Compliance with authorities such as the FDA, EMA, or WHO GMP is critical. Approved suppliers ensure product quality, safety, and regulatory acceptance across markets, reducing supply risks.
3. What are the risks associated with sourcing chlorothiazide from emerging markets?
Risks include variable quality standards, potential regulatory discrepancies, and supply chain transparency issues. Due diligence and supplier audits are essential.
4. How can procurement teams mitigate supply disruptions?
Diversify suppliers across regions, establish long-term contracts, and verify supplier capacity and compliance. Developing contingency plans enhances supply chain resilience.
5. What impact does patent expiry have on chlorothiazide supply?
Patent expiration broadens the pool of generic manufacturers, increasing supply and reducing prices. It also fosters market competition, encouraging new entrants and innovation.
Sources:
[1] Pharmaceutical Technology. “Global Suppliers of Chlorothiazide,” 2022.
[2] WHO List of Prequalified Medicinal Products.
[3] U.S. FDA Database of Approved Drugs.
[4] IMS Health Reports. “Global Market Trends in Generic Pharmaceuticals,” 2021.
[5] Industry Reports on Pharmaceutical Manufacturing in India and Europe.
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