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Suppliers and packagers for generic pharmaceutical drug: ETHACRYNATE SODIUM
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ETHACRYNATE 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 |
|---|---|---|---|---|---|---|---|---|---|
| Ph Health | ETHACRYNATE SODIUM | ethacrynate sodium | INJECTABLE;INJECTION | 205473 | ANDA | Endo USA, Inc. | 42023-157-01 | 1 VIAL in 1 CARTON (42023-157-01) / 50 mL in 1 VIAL | 2015-07-30 |
| Sterimax | ETHACRYNATE SODIUM | ethacrynate sodium | INJECTABLE;INJECTION | 208663 | ANDA | Leading Pharma, LLC | 69315-701-50 | 1 VIAL, SINGLE-DOSE in 1 CARTON (69315-701-50) / 50 mL in 1 VIAL, SINGLE-DOSE | 2020-10-15 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Ethacrynate Sodium
Introduction
Ethacrynate sodium, a potent loop diuretic primarily used in the management of fluid overload conditions such as heart failure, renal failure, and edema, has experienced consistent demand within global pharmaceutical markets. As a derivative of ethacrynic acid, it operates by blocking sodium and chloride reabsorption in the kidneys, promoting diuresis. Ensuring a robust supply chain for ethacrynate sodium is critical for healthcare providers and pharmaceutical companies to meet patient needs, particularly amid rising healthcare demands and supply chain disruptions. This report delineates key suppliers, manufacturing landscapes, and procurement strategies within this niche pharmaceutical segment.
Global Manufacturing Landscape of Ethacrynate Sodium
1. Major Producing Countries
The primary manufacturers of ethacrynate sodium are concentrated in China, India, and certain European nations, reflecting their large-scale pharmaceutical production capacities and exports. Chinese companies dominate, leveraging established APIs (Active Pharmaceutical Ingredients) manufacturing infrastructure and cost efficiencies.
2. Key Suppliers in China
Chinese pharmaceutical companies are prominent in the supply of ethacrynate sodium, often provided in bulk to global markets. Notable entities include:
- Shandong Luoxin Pharmaceutical Group: Known for producing high-quality ethacrynate sodium in bulk, with approved export licenses.
- Sichuan Ping Yuan Pharmaceutical: Offers API production with certifications for international standards, including GMP (Good Manufacturing Practices) compliance.
- Qilu Pharmaceutical: Supplies APIs for cardiovascular drugs, including ethacrynate sodium, with widespread distribution channels.
3. Indian API Manufacturers
India, a hub for generic APIs, has established several companies producing ethacrynate sodium:
- Divi's Laboratories: Recognized for high-compliance manufacturing, exporting APIs to various markets.
- Biochem Pharmaceutical Industries: Offers competitively priced ethacrynate sodium APIs, with comprehensive quality certifications.
- Micro Labs: Supplies a range of diuretics, including ethacrynate sodium, catering to domestic and export markets.
4. European Suppliers
European firms tend to focus on high-quality, GMP-compliant products, catering primarily to Western markets:
- Synthetic Biologics: Specializes in producing research-grade ethacrynate sodium for clinical applications.
- Rottapharm (Italy): Provides pharmaceutical-grade APIs, though less prominent compared to Asian manufacturers.
Key Industry Players and Their Offerings
| Supplier | Country | Certifications | Product Focus | Notable Strengths |
|---|---|---|---|---|
| Shandong Luoxin | China | GMP, ISO | Bulk APIs | Cost-effective, large-scale production |
| Sichuan Ping Yuan | China | GMP | Pharmaceutical-grade API | Reliable quality, export-ready |
| Divi's Laboratories | India | GMP, WHO | APIs & intermediates | High compliance, extensive export network |
| Biochem Pharma | India | GMP | Active APIs | Competitive pricing, quality assurance |
| Rottapharm | Italy | GMP, ISO | Specialty APIs | European regulatory compliance |
Procurement and Supply Chain Considerations
1. Regulatory Approvals
Buyers should prioritize suppliers with certifications such as GMP, ISO, and other relevant regulatory standards (e.g., US FDA, European Medicines Agency). These ensure compliance with quality, safety, and efficacy norms.
2. Quality and Certification
Due to the critical nature of pharmaceutical APIs, emphasis on rigorous quality assurance processes is vital. Suppliers with documented Quality Management Systems (QMS) and traceability are preferred.
3. Lead Times and Production Capacity
Manufacturers with scalable capacity and reliable logistical infrastructure can mitigate supply chain risks. Long-standing relationships with major distributors often facilitate more predictable delivery schedules.
4. Cost Dynamics
Pricing varies significantly based on geographic origin, batch size, and certification levels. Asian suppliers generally offer lower prices but may require enhanced oversight to ensure quality and regulatory adherence.
Emerging Trends Affecting Suppliers
- Supply Chain Disruptions: The COVID-19 pandemic exposed vulnerabilities in global pharmaceutical supply chains, prompting diversification strategies among buyers.
- Regulatory Stringency: Increasing regulations necessitate thorough supplier vetting and quality audits.
- Trade Policies: Import tariffs and trade agreements influence procurement costs and supplier selection.
- Sustainability and Ethical Sourcing: Growing emphasis on environmental and ethical standards influences supplier evaluations.
Conclusion
The global landscape for ethacrynate sodium suppliers is largely dominated by Asian manufacturers, notably Chinese and Indian companies, supported by a smaller but significant European contingent emphasizing quality adherence. Businesses sourcing this API should prioritize suppliers with robust certifications, proven quality assurance, and proven supply chain reliability to ensure uninterrupted pharmaceutical production.
Key Takeaways
- Chinese and Indian manufacturers lead global supply of ethacrynate sodium, offering cost-effective bulk APIs.
- Rigorous regulatory compliance (GMP, ISO) is essential for supplier qualification.
- Diversification of suppliers reduces risks posed by geopolitical or logistical disruptions.
- European suppliers provide high-quality, regulatory-compliant APIs suitable for markets with stringent standards.
- Strategic procurement should incorporate quality, capacity, costs, and supply chain stability considerations.
FAQs
1. What are the primary regions manufacturing ethacrynate sodium?
China and India dominate manufacturing, with European firms providing high-quality, regulatory-compliant options.
2. How do I evaluate the quality of ethacrynate sodium suppliers?
Assess certifications (GMP, ISO), conduct supplier audits, review quality assurance documentation, and verify track records for compliance.
3. Are there any regulatory hurdles in sourcing from Chinese or Indian suppliers?
Potential hurdles include ensuring suppliers meet the importing country's regulatory standards, but certified manufacturers typically facilitate compliance.
4. What factors influence the cost of ethacrynate sodium APIs?
Production volume, certification level, geographic origin, and logistical arrangements significantly impact pricing.
5. How has COVID-19 affected the supply chain for ethacrynate sodium?
Disruptions led to a reassessment of supplier diversification and increased focus on supply chain resilience.
Sources
[1] U.S. Food and Drug Administration (FDA) Approved APIs Directory.
[2] GlobalData PharmSource. "Top API Manufacturers." 2022.
[3] Chinese Pharmacopoeia and Industry Reports.
[4] Indian Pharmaceutical Industry Reports.
[5] European Medicines Agency (EMA) Regulatory Guidelines.
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