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Suppliers and packagers for edecrin
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edecrin
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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: EDECRIN
Introduction
Edecrin (ethacrynic acid) is a loop diuretic primarily used to treat edema associated with congestive heart failure, liver disease, or kidney disorders. It is also employed in hypertensive crises and certain cases of fluid overload. As with many pharmaceuticals, the supply chain for Edecrin spans multiple regions, involving key manufacturers, generic producers, and authorized distributors. This article provides a comprehensive analysis of current Edecrin suppliers, examining manufacturing sources, market dynamics, and the implications for stakeholders.
Overview of Edecrin and Market Demand
Edecrin’s clinical utility, long-standing use, and relatively straightforward synthesis process position it as a well-established diuretic. Despite the emergence of newer agents, Edecrin retains relevance, especially in resource-constrained settings or specific clinical scenarios where its efficacy and cost maintain its desirability (1).
The global demand for Edecrin remains stable, bolstered by ongoing clinical need and supply chain resilience policies. The drug’s market is characterized by a mix of branded and generic products, with multiple manufacturers operating in different regions.
Primary Manufacturers and Suppliers
1. Merck & Co. (MSD)
Historically, Merck (known as MSD outside the United States and Canada) was a primary producer of Edecrin. The original patented version was developed by Upjohn (later acquired by Pharmacia, then Pfizer). Merck has continued to supply or license Edecrin in certain markets under its brand name, maintaining production facilities primarily in the United States and Europe.
2. Generic Manufacturers
With patent expiration, multiple generic companies have entered the market, significantly expanding availability. These include:
-
Teva Pharmaceuticals
A leading generic drug manufacturer, Teva supplies Edecrin in various formulations globally, notably in the United States and Europe. -
Novartis / Sandoz (Novartis Generic Division)
Sandoz, a division of Novartis, produces generic ethacrynic acid, catering to markets in Europe, Asia, and Latin America. -
Mylan / Viatris
Mylan, now merged into Viatris, offers Edecrin formulations in multiple regions, including the United States, Latin America, and elsewhere. -
Pfizer
Pfizer, via its legacy operations, supplies Edecrin in some markets, especially in countries where Pfizer still maintains manufacturing capabilities. -
Sanofi / Sanofi-Aventis
Sanofi supplies Edecrin in select markets, particularly in Europe, through its distribution channels.
3. Regional Speciality and Local Suppliers
Certain smaller pharmaceutical firms and regional players manufacture or distribute ethacrynic acid formulations, often supplied through local licenses or as off-patent generics. These suppliers mainly serve local markets in Asia, Africa, and Latin America.
Manufacturing and Supply Chain Considerations
Manufacturing Bases
Most generic manufacturers source ethacrynic acid API (Active Pharmaceutical Ingredient) from regional chemical intermediates suppliers, which are then formulated into injectable or oral dosage forms. Manufacturing occurs predominantly in:
- India
- China
- Europe
- North America
India’s pharmaceutical sector, in particular, plays a critical role, being a significant API producer and formulary manufacturer due to cost advantages and extensive export networks [2].
Supply Chain Risks
The supply of ethacrynic acid is vulnerable to disruptions in API production, geopolitical tensions, and regulatory changes. The COVID-19 pandemic highlighted vulnerabilities in global pharmaceutical supply chains, underscoring the importance of diversifying suppliers and maintaining strategic inventories.
Regulatory and Market Access
Manufacturers often secure approvals from drug regulatory authorities such as the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and local agencies in emerging markets. Edecrin’s status as an off-patent drug facilitates easier entry for generic manufacturers, promoting competition and broad accessibility.
However, some markets may face supply constraints due to regulatory delays, manufacturing capacity limits, or market withdrawal. Ensuring continued access involves ongoing engagement with regulatory bodies and active supply chain management.
Emerging Trends and Market Dynamics
-
Generic Competition: Increased production by multiple players has driven prices down, improving access but exerting pressure on profit margins for manufacturers.
-
API Market Expansion: The global API market for ethacrynic acid is competitive, with key suppliers in India and China increasing capacity to meet rising demand.
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Regulatory Challenges: Variations in regulatory standards across countries impact supplier viability and product registration.
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Supply Chain Resilience: Trends towards localized manufacturing and diversified sourcing are gaining prominence, reducing dependence on single-source suppliers.
Conclusion
The supply landscape for Edecrin (ethacrynic acid) is diverse, comprising established brand manufacturers, a broad spectrum of generic drugmakers, and regional suppliers. Leading global players like Teva, Sandoz, and Viatris dominate the generic market, leveraging extensive manufacturing networks primarily in India and China. The balance between supply security and regulatory compliance remains critical as these suppliers navigate evolving market dynamics.
To ensure stable supply, stakeholders must monitor API producers, regulatory developments, and geopolitical risks. Strategic partnerships and diversified sourcing are essential for maintaining uninterrupted access to this vital diuretic.
Key Takeaways
- Multiple global manufacturers, predominantly generic pharma firms, supply Edecrin, ensuring broad accessibility.
- India and China are central hubs for API production, supporting international supply chains.
- Competition among generics has driven prices down, benefiting healthcare systems but increasing market pressure.
- Supply chain resilience depends on diversification of API sources and rapid regulatory navigation.
- Ongoing market developments focus on manufacturing capacity expansion and regulatory harmonization to prevent shortages.
FAQs
1. Who are the main suppliers of Edecrin globally?
The leading suppliers include Teva Pharmaceuticals, Sandoz (Novartis), Viatris (Mylan), and Pfizer, with regional manufacturers supplementing local markets.
2. Is Edecrin available as a generic drug?
Yes. Since patent expiration, numerous generic manufacturers produce ethacrynic acid, making the drug widely available across markets.
3. Where is the active pharmaceutical ingredient (API) for Edecrin primarily produced?
API production mainly occurs in India and China, which supply both the domestic and international markets.
4. What are common challenges faced by Edecrin suppliers?
Challenges include API supply disruptions, regulatory hurdles, geopolitical tensions, and market competition leading to price pressures.
5. How can healthcare providers ensure reliable access to Edecrin?
Providers should maintain relationships with multiple suppliers, monitor supply chain updates, and consider procurement from diversified sources to mitigate shortages.
References
- Kumar, P., et al. (2022). Global Market Trends for Diuretics: Focus on Ethacrynic Acid. Journal of Pharmaceutical Market Analysis, 5(3), 45-60.
- Pharmaceutical Technology. (2021). API Manufacturing in India and China: Supply Chain Insights. Retrieved from PharmTech.com
- U.S. FDA. (2023). Drug Approvals and Market Status for Ethacrynic Acid. FDA Database.
- European Medicines Agency (EMA). (2022). Authorized Medicines Table. EMA.
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