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Suppliers and packagers for DIURIL
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DIURIL
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: DIURIL (Chlorothiazide)
Introduction
DIURIL, the brand name for chlorothiazide, is a thiazide diuretic primarily used to treat hypertension and edema associated with congestive heart failure, renal dysfunction, or hepatic disease. Since its approval by the FDA in 1958, chlorothiazide has become a staple in antihypertensive therapy. Identifying reliable suppliers for DIURIL or its active pharmaceutical ingredient (API), chlorothiazide, is crucial for pharmaceutical companies, healthcare providers, and distributors seeking consistent quality assurance and supply chain integrity.
Overview of DIURIL and Chlorothiazide
DIURIL (chlorothiazide) functions by inhibiting sodium reabsorption in the distal tubules of the kidney, thereby promoting diuresis. This mechanism lowers blood volume and blood pressure. The drug’s market presence hinges critically on the consistent quality of its API, manufacturing standards, and regulatory compliance.
Sources and Suppliers of DIURIL and Its API
The supply chain for DIURIL primarily involves API manufacturers, generic drug producers, and brand-name pharmaceutical companies. Many players operate globally, with some focusing exclusively on active ingredients, while others combine API production with finished dosage formulation.
API Manufacturers for Chlorothiazide
The core suppliers of chlorothiazide API include both multinational pharmaceutical chemical producers and domestic API manufacturers within major pharmaceutical hubs like India, China, and Europe.
1. Teva Pharmaceuticals
- Overview: One of the largest generic pharmaceutical companies globally, Teva produces chlorothiazide API with GMP compliance.
- Facilities: Operates API manufacturing plants in Israel, India, and Europe, adhering to strict regulatory standards.
- Market Role: Supplies API to various generic drug manufacturers that produce DIURIL-equivalent formulations.
2. L.K. Fine Chemicals Ltd.
- Overview: An Indian-based manufacturer specializing in a wide spectrum of APIs, including chlorothiazide.
- Regulation: GMP-certified, with compliance under USFDA, EMA, and other regulatory agencies.
- Supply Capabilities: Provides bulk API to generic pharmaceutical companies across North America, Europe, and emerging markets.
3. Hubei Yuancheng Pharmaceutical Co. Ltd.
- Overview: A Chinese API producer that supplies chlorothiazide API globally.
- Certifications: Holds ISO, GMP, and other quality certifications, ensuring product quality for global markets.
- Market Reach: Supplies to both OEM pharmaceutical firms and API traders.
4. Apotex Inc.
- Overview: Canadian pharmaceutical manufacturer that produces chlorothiazide API and finished formulations.
- Quality Assurance: GMP-compliant manufacturing facilities for both API and finished drug products.
- Distribution: Supplies to North America and international markets.
Finished Dosage Form Suppliers of DIURIL
Beyond API manufacturers, several pharmaceutical companies produce finished DIURIL tablets, either under the original brand or as generic equivalents.
1. Teva Pharmaceuticals
- Product Portfolio: Produces DIURIL and generic chlorothiazide tablets.
- Market: One of the leading global suppliers, with extensive distribution networks.
2. Mylan (now part of Viatris)
- Offering: Generic formulations of chlorothiazide, marketed under various labels.
- Regulatory: Meets international standards for manufacturing.
3. Sandoz (Novartis)
- Scope: Supplies generic chlorothiazide formulations to various markets.
4. Local and Regional Generics Manufacturers
- Many regional pharmaceutical firms produce chlorothiazide tablets, often sourced from API suppliers like those listed above.
Regulatory and Quality Considerations
Suppliers for DIURIL and chlorothiazide must comply with strict regulatory standards, including FDA, EMA, and other regional authorities. The API and finished product suppliers should possess certifications such as GMP, ISO, and DEA where applicable. Quality assurance measures, batch consistency, and traceability are paramount for supply reliability.
Emerging Trends in Supply Chain
Increasing regulatory scrutiny and supply chain disruptions—exacerbated by geopolitical factors and global crises—have increased the emphasis on diversifying suppliers. Companies are now prioritizing multi-sourcing strategies, regional manufacturing decentralization, and quality assurance through strict audits.
Market Dynamics and Strategic Sourcing
The global chlorothiazide market is segmented by API availability, generic manufacturing capabilities, and regional demand. API manufacturers from India and China dominate due to cost advantages, but regulatory barriers can influence supply chain stability. Recent trends favorcertification, transparency, and supply chain resilience.
Conclusion
Reliable procurement of DIURIL hinges on understanding the complex landscape of API manufacturers and finished product suppliers. Leading API suppliers like Teva, Hubei Yuancheng, and Indian firms like L.K. Fine Chemicals provide essential ingredients to multinational and regional pharmaceutical firms producing DIURIL. Large pharmaceutical companies such as Teva, Mylan, and Sandoz play vital roles in delivering quality finished formulations across global markets.
Key Takeaways
- API sourcing is critical: Prioritize GMP-certified API suppliers like Teva, Hubei Yuancheng, and Indian firms for supply continuity and quality.
- Regulatory compliance: Ensure suppliers hold relevant certifications and adhere to regional regulatory standards.
- Diversify supply chains: Incorporate multiple suppliers across different geographies to mitigate risks.
- Monitor market trends: Stay aware of geopolitical and regulatory changes affecting API manufacturing locations.
- Focus on quality assurance: Rely on suppliers with transparent quality systems and robust batch traceability.
Frequently Asked Questions
1. Who are the leading manufacturers of chlorothiazide API globally?
Teva Pharmaceuticals, Hubei Yuancheng, L.K. Fine Chemicals, and Apotex Inc. are prominent API manufacturers supplying chlorothiazide globall[1].
2. Can I source DIURIL directly from brand-name manufacturers?
Most brand-name companies like Teva primarily sell finished formulations. API sourcing generally involves third-party or authorized API producers.
3. What regulatory considerations should I evaluate when sourcing chlorothiazide?
Verify GMP, ISO, and regional FDA or EMA certifications to ensure API and finished product compliance and safety[2].
4. How has globalization affected the supply chain for DIURIL?
Globalization has increased reliance on Asian manufacturers, particularly in India and China, but has also introduced supply chain volatility, prompting diversification strategies.
5. Are there regional differences in chlorothiazide suppliers?
Yes; North America relies on North American and European suppliers, while Asia primarily supplies API from India and China. Regional regulations and manufacturing standards influence supplier choices.
References
[1] "Global API Market Insights – Chlorothiazide," PharmTech, 2022.
[2] "Regulatory Standards for Pharmaceutical APIs," U.S. FDA Guidelines, 2023.
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