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Suppliers and packagers for generic pharmaceutical drug: ethacrynic acid
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ethacrynic acid
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Bausch | EDECRIN | ethacrynic acid | TABLET;ORAL | 016092 | NDA | Bausch Health US, LLC | 25010-215-15 | 100 TABLET in 1 BOTTLE (25010-215-15) | 1967-01-10 |
| Bausch | EDECRIN | ethacrynic acid | TABLET;ORAL | 016092 | NDA AUTHORIZED GENERIC | Oceanside Pharmaceuticals | 68682-011-10 | 100 TABLET in 1 BOTTLE (68682-011-10) | 1967-01-10 |
| Adaptis | ETHACRYNIC ACID | ethacrynic acid | TABLET;ORAL | 205609 | ANDA | Edenbridge Pharmaceuticals LLC. | 42799-405-01 | 100 TABLET in 1 BOTTLE (42799-405-01) | 2016-07-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Ethacrynic Acid
Introduction
Ethacrynic acid is a potent loop diuretic primarily used to treat edema associated with heart failure, liver disease, or kidney disorders. As a non-sulfonamide diuretic, it operates by inhibiting sodium and chloride reabsorption in the loop of Henle within the nephron, leading to increased urine output. Due to its significant therapeutic applications, a reliable supply chain for Ethacrynic acid is critical for pharmaceutical manufacturers, healthcare providers, and distributors globally.
This analysis aims to identify leading suppliers of Ethacrynic acid, examine their manufacturing capabilities, geographic distribution, regulatory compliance, and market positioning to inform procurement strategies effectively.
1. Global Manufacturing Landscape
The production of Ethacrynic acid involves complex chemical synthesis, primarily undertaken by pharmaceutical ingredient (API) manufacturers with advanced chemical R&D capabilities. Several regions, notably Asia-Pacific, Europe, and North America, dominate the API manufacturing sector. The supply chain can be traced through a mix of large multinational firms, regional specialty manufacturers, and generic API producers.
2. Major Suppliers and Manufacturers
a. Aurobindo Pharma Ltd. (India)
Known for extensive API manufacturing, Aurobindo supplies Ethacrynic acid to both generic and branded pharmaceutical companies. Their facilities are GMP-compliant, and they serve markets across Asia, Europe, and North America. The company emphasizes high-quality standards and regulatory adherence, making it a reliable supplier for Ethacrynic acid.
b. Zhejiang Hisun Pharmaceutical Co., Ltd. (China)
A significant Chinese API producer with capabilities in cardiovascular APIs, including Ethacrynic acid. Hisun maintains certifications from global regulatory bodies, making their products suitable for international markets. Their competitive pricing and scalable manufacturing capacity position them as a key regional supplier.
c. Sandoz (Novartis Group) (Switzerland)
As a leading global generics manufacturer, Sandoz (via Novartis) supplies high-quality Ethacrynic acid APIs, often integrated into their own formulations or supplied to third-party manufacturers. Their rigorous quality controls and adherence to international standards make their APIs highly trusted.
d. Wockhardt Ltd. (India)
A notable API producer and pharmaceutical group, Wockhardt offers Ethacrynic acid with compliance to CGMP standards. Their manufacturing facilities serve global markets, emphasizing consistent supply and regulatory compliance.
e. Sun Pharma (India)
One of the world's largest generics companies, Sun Pharma supplies Ethacrynic acid API to various geographies. Their extensive manufacturing facilities and capacity for bulk production ensure supply reliability.
3. Regional Suppliers & Emerging Players
a. India
India’s API manufacturing sector is robust, with numerous smaller firms producing Ethacrynic acid on a contract basis. Companies like Hetero Drugs and Strides Pharma are known for their high-volume API production, though specific data on Ethacrynic acid is often obtained through direct negotiations.
b. China
Chinese manufacturers are increasingly significant due to cost advantages and expanding GMP compliance. Several regional suppliers can provide Ethacrynic acid, such as Zhejiang Gamma Biopharmaceuticals.
c. Europe & North America
European firms, including Sandoz, have longstanding reputations for quality and regulatory rigor, often serving markets with strict compliance requirements such as the EU and US. North American suppliers are limited but include local GMP-certified manufacturers.
4. Regulatory and Quality Considerations
Suppliers must comply with international standards such as GMP (Good Manufacturing Practice), ISO certifications, and regional regulatory requirements from agencies like the FDA, EMA, or CFDA. Supply reliability hinges on maintaining quality, consistent batch-to-batch production, and transparent documentation.
Importantly, regulatory approval may require suppliers to provide stability data, Certificates of Analysis (CoA), and raw material sourcing documentation. Suppliers with FDA approval or equivalent certifications typically dominate supplies for the US and European markets.
5. Supply Chain Challenges & Risk Mitigation
The supply of Ethacrynic acid faces challenges such as raw material shortages, geopolitical tensions, and regulatory changes. To mitigate risks:
- Diversify supplier base across regions
- Prioritize GMP-certified manufacturers
- Establish long-term contracts with multiple suppliers
- Maintain quality audits and supplier qualification programs
6. Key Market Dynamics
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Price Trends: With increased competition among Indian and Chinese suppliers, API prices for Ethacrynic acid are competitive, enabling cost-effective procurement.
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Supply Security: Due to the generic nature of Ethacrynic acid, numerous suppliers ensure backup options, but capacity constraints or regulatory issues could disrupt supplies.
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Future Outlook: Rising demand for cardiovascular therapies sustains Ethacrynic acid's market, prompting existing suppliers to expand capacity and new entrants to develop manufacturing capabilities.
7. Conclusion
The supply ecosystem for Ethacrynic acid is well-established, with prominent players primarily based in India, China, and Europe. Leading suppliers such as Aurobindo, Zhejiang Hisun, Wockhardt, and Sandoz provide high-quality APIs meeting global regulatory standards. Businesses seeking reliable procurement should focus on establishing relationships with GMP-compliant suppliers, ensuring regulatory alignment, and monitoring geopolitical influences on supply chains.
Key Takeaways
- Diversify supplier relationships, primarily choosing GMP-certified manufacturers from India, China, and Europe to ensure supply reliability and quality.
- Prioritize regulatory compliance by verifying certifications and documentation to facilitate market approval and avoid supply disruptions.
- Monitor raw material availability and geopolitical developments, which could impact production and export capabilities of Chinese and Indian suppliers.
- Leverage economies of scale by engaging with large, established API manufacturers that can provide consistent quality at competitive pricing.
- Plan for contingencies by maintaining backup suppliers and long-term contracts, especially amid fluctuating market demands and regulatory landscapes.
Frequently Asked Questions (FAQs)
Q1. What are the primary regions producing Ethacrynic acid APIs?
India, China, and Europe are the main regions, with India and China dominating due to cost advantages and large manufacturing capacities.
Q2. How does regulatory compliance influence supplier selection?
Suppliers with GMP and international certifications ensure quality, regulatory approval readiness, and supply chain stability, critical for market authorization and patient safety.
Q3. Are there risks associated with sourcing Ethacrynic acid from Chinese suppliers?
Yes, potential risks include raw material shortages, regulatory hurdles, and geopolitical tensions. Diversification and thorough qualification mitigate these risks.
Q4. Can generic manufacturers produce Ethacrynic acid at scale?
Yes, many Indian and Chinese API manufacturers have the capacity for large-scale production, catering to global demand.
Q5. How can companies ensure continuous supply of Ethacrynic acid?
By establishing multiple supplier relationships, securing long-term contracts, and maintaining good communication with manufacturers regarding capacity and quality issues.
Sources:
- PharmaCompass, "Ethacrynic Acid API Manufacturers," 2022.
- GlobalData, "API Market Analysis," 2022.
- US FDA Database, "Approved API Manufacturers," 2023.
- Company websites: Aurobindo Pharma, Zhejiang Hisun Pharmaceutical, Wockhardt, Sandoz.
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