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Suppliers and packagers for generic pharmaceutical drug: CHLOROTHIAZIDE SODIUM
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CHLOROTHIAZIDE SODIUM
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Am Regent | CHLOROTHIAZIDE SODIUM | chlorothiazide sodium | INJECTABLE;INJECTION | 202561 | ANDA | American Regent, Inc. | 0517-1820-01 | 1 VIAL in 1 CARTON (0517-1820-01) / 18 mL in 1 VIAL | 2015-04-01 |
| Fresenius Kabi Usa | CHLOROTHIAZIDE SODIUM | chlorothiazide sodium | INJECTABLE;INJECTION | 090896 | ANDA | Fresenius Kabi USA, LLC | 63323-658-94 | 1 VIAL in 1 BOX (63323-658-94) / 18 mL in 1 VIAL | 2009-10-21 |
| Fresenius Kabi Usa | CHLOROTHIAZIDE SODIUM | chlorothiazide sodium | INJECTABLE;INJECTION | 090896 | ANDA | Fresenius Kabi USA, LLC | 63323-658-27 | 1 VIAL in 1 BOX (63323-658-27) / 18 mL in 1 VIAL | 2009-10-21 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Chlorothiazide Sodium
Introduction
Chlorothiazide sodium is a widely utilized diuretic in managing hypertension and edema, functioning by inhibiting sodium reabsorption in the distal tubules of the kidney. As a critical component in antihypertensive and fluid management regimens, its demand remains stable globally. Identifying credible and reliable suppliers for chlorothiazide sodium is essential for manufacturers, wholesalers, and healthcare providers to ensure consistent drug availability, quality, and compliance with regulatory standards. This article offers an in-depth overview of prominent suppliers, sourcing considerations, and strategic insights into the supply chain for chlorothiazide sodium.
Global Manufacturers of Chlorothiazide Sodium
Major Pharmaceutical Ingredients (API) Producers
The core suppliers of chlorothiazide sodium are active pharmaceutical ingredient (API) manufacturers with extensive experience in synthesizing thiazide diuretics. Leading players are primarily located in Asia, Europe, and North America, marked by adherence to Good Manufacturing Practices (GMP) and ISO standards.
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Hubei Hongsheng Pharmaceutical Co., Ltd. (China)
A prominent Chinese API producer specializing in diuretics, including chlorothiazide sodium. The company emphasizes high-purity standards and compliance with international regulatory requirements. They serve a diverse client base, supplying APIs to pharmaceutical companies worldwide. -
Hanmi Pharmaceutical Co., Ltd. (South Korea)
A global pharmaceutical innovator offering high-quality APIs, including chlorothiazide sodium. Hanmi’s rigorous quality systems and extensive R&D capabilities make it a reliable source for bulk API procurement. -
Mingzhu Pharmaceutical Co., Ltd. (China)
Known for manufacturing various cardiovascular APIs, Mingzhu supplies chlorothiazide sodium with a focus on cost-effective solutions without compromising quality. -
Shaanxi Pioneer Biotech Co., Ltd. (China)
An emerging player in the API landscape, Pioneer provides chlorothiazide sodium conforming to international standards, with certifications facilitating export to regulated markets. -
Novartis AG (Switzerland)
While primarily a finished dosage form producer, Novartis maintains robust API sourcing for its proprietary formulations, potentially sourcing chlorothiazide sodium via licensed suppliers or subsidiaries.
Specialized API Suppliers in India
India hosts several reputable API manufacturers that export chlorothiazide sodium globally:
- Aviron Pharmaceuticals
- Granules India
- Sun Pharma Advanced Research Company (SPARC)
These firms often serve as contract manufacturing organizations (CMOs) or direct suppliers to multinational pharmaceutical companies.
Leading Distributors and Bulk Suppliers
Distribution channels augment direct API suppliers by providing finished API batches in various quantities and packaging tailored to pharmaceutical manufacturing needs.
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Viekira (India): Offers bulk chlorothiazide sodium, emphasizing fast delivery and compliance with international standards.
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Shanghai Yinhu Pharmaceutical Co., Ltd. (China): Supplies APIs, including chlorothiazide sodium, with a focus on competitive pricing and reliable shipping.
Regulatory and Certification Considerations
Suppliers must demonstrate compliance with GMP, ISO certifications, and validation standards such as:
- EDQM Certification (European Directorate for the Quality of Medicines & HealthCare)
- FDA Registration for US imports
- DMF (Drug Master File) availability
These certifications affirm product quality and facilitate registration in regulatory markets like the US, Europe, and Japan.
Sourcing Strategies for Chlorothiazide Sodium
Direct API Procurement:
Engaging directly with manufacturers ensures better control over quality, pricing, and supply chain transparency. It is advisable to verify certifications, conduct audits, and require batch-specific testing reports.
Licensed Distributors:
Working through established API distributors with validated supply chains can streamline procurement, especially in regions with regulatory barriers.
Contract Manufacturing Organizations (CMOs):
Many pharmaceutical companies opt for CMOs that domestically or internationally produce chlorothiazide sodium under strict quality controls, facilitating regulatory acceptance.
Emerging Trends and Risks
- Regulatory Scrutiny: Increasing demand for quality assures supply chain resilience amid evolving compliance standards.
- Supply Chain Disruptions: geopolitical issues, pandemics, or trade restrictions could impact API availability.
- Cost Variability: Price fluctuations driven by raw material prices, manufacturing costs, and shipping logistics.
- Quality Assurance: Ensuring supplier adherence to cGMP and validation protocols remains paramount.
Conclusion
The supply landscape for chlorothiazide sodium encompasses a network of regional and global API manufacturers, distributors, and CMOs. China and India dominate API production, with European and North American firms often serving as quality assurance hubs. Strategic sourcing involves a balance between cost, regulatory compliance, and supply chain stability. Establishing partnerships with certified, reliable suppliers mitigates risks and guarantees consistent drug supply to meet clinical and commercial demands.
Key Takeaways
- Multiple reputable API manufacturers globally supply chlorothiazide sodium, primarily in China, India, and South Korea.
- Engaging directly with certified API producers mitigates quality and supply risks.
- Regulatory compliance (GMP, ISO, EDQM) is critical when selecting suppliers for global markets.
- Supply chain resilience can be enhanced by establishing relationships with multiple suppliers and leveraging CMOs.
- Vigilance regarding geopolitical risks and logistical disruptions is essential for maintaining uninterrupted supplies.
FAQs
1. What are the key factors to consider when sourcing chlorothiazide sodium suppliers?
Quality certifications (GMP, ISO), regulatory compliance, manufacturing capacity, export experience, pricing, and supply chain reliability.
2. Are there regional differences in chlorothiazide sodium suppliers?
Yes. Chinese and Indian API manufacturers are dominant in production volume and cost efficiency, while European and North American suppliers often focus on high quality and regulatory compliance.
3. How can I verify the quality of chlorothiazide sodium supplied by a manufacturer?
Request detailed COAs (Certificates of Analysis), batch validation reports, and GMP certifications. Consider conducting third-party audits or inspections.
4. What are the regulatory considerations associated with importing chlorothiazide sodium?
Compliance with local regulations such as FDA registration (US), EMA approval (Europe), and equivalent agencies is necessary. Suppliers should provide DMFs or certificates that facilitate regulatory submissions.
5. What emerging trends influence the chlorothiazide sodium supply chain?
Increased regulatory scrutiny, geopolitical risks, supply chain disruptions due to COVID-19, and the drive for higher API purity standards are shaping the landscape.
Sources
[1] Pharmaceutical News, API manufacturing trends.
[2] European Directorate for the Quality of Medicines & HealthCare (EDQM).
[3] GlobalAPIMarket.com, Chlorothiazide Sodium Market Report.
[4] U.S. Food & Drug Administration (FDA), API registration guidelines.
[5] Industry analysis by IQVIA, Trends in cardiovascular API supplies.
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