Suppliers and packagers for digoxin

digoxin

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Amici Pharma	DIGOXIN	digoxin	ELIXIR;ORAL	215209	ANDA	Amici Pharma, Inc	69292-605-60	1 BOTTLE in 1 CARTON (69292-605-60) / 60 mL in 1 BOTTLE	2022-06-10
Hikma	DIGOXIN	digoxin	ELIXIR;ORAL	021648	NDA	Hikma Pharmaceuticals USA Inc.	0054-0057-46	60 mL in 1 BOTTLE (0054-0057-46)	2004-08-26
Hikma	DIGOXIN	digoxin	ELIXIR;ORAL	021648	NDA	Atlantic Biologicals Corps	17856-0057-1	2.5 mL in 1 CUP, UNIT-DOSE (17856-0057-1)	2004-08-26
Hikma	DIGOXIN	digoxin	ELIXIR;ORAL	021648	NDA	Atlantic Biologicals Corps	17856-0057-5	5 mL in 1 CUP (17856-0057-5)	2004-08-26

Suppliers for the Pharmaceutical Drug: Digoxin

Last updated: July 27, 2025

Introduction
Digoxin, a cardiac glycoside derived primarily from Digitalis species, remains a cornerstone in the treatment of atrial fibrillation, atrial flutter, and heart failure with reduced ejection fraction. Despite its long-standing history, the global supply chain of digoxin involves a complex network of manufacturers spanning multiple regions, influenced by stringent regulatory requirements, patent status, and manufacturing capacities. This analysis provides a comprehensive overview of key suppliers currently involved in the production of digoxin, exploring their market footprint, geographic distribution, and strategic significance.

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Global Manufacturing Landscape of Digoxin

The production of digoxin is predominantly concentrated among several multinational pharmaceutical companies and regional manufacturers, with a mix of originator and generic producers. The supply chain's robustness hinges on the capacity of these entities to meet global demand, adhere to quality standards, and navigate regulatory challenges.

1. Originator Manufacturers

Boehringer Ingelheim
Historically, Boehringer Ingelheim was among the earliest producers of digoxin, marketing their product under the brand name Lanoxin. Although branded formulations have declined in favor of generics, the company maintains manufacturing capabilities for bulk active pharmaceutical ingredients (APIs). Their global footprint ensures a consistent supply for regional markets, especially in Europe and North America.

Sanofi
Sanofi, operating primarily in Europe and North America, has historically supplied digoxin formulations. The company’s focus on high-quality drugs ensures compliance with regulatory standards like the EMA and FDA, though their role in active ingredient manufacturing has diminished in favor of licensing.

2. Generic Manufacturers

The transition of digoxin from branded to generic formulations has opened opportunities for multiple manufacturers, particularly in regions where regulatory barriers are lower and manufacturing costs are competitive.

India and China: Powerhouses in Digoxin Production

• Sun Pharmaceutical Industries Ltd. (India): As one of India’s largest pharmaceutical firms, Sun Pharma produces both generic digoxin tablets and APIs. Their manufacturing facilities are often inspected by USFDA and other regulatory bodies, bolstering global trust.
• Dr. Reddy’s Laboratories (India): Known for producing affordable generic drugs, Dr. Reddy’s supplies digoxin to markets across Asia, Africa, and Latin America.
• ego Pharmaceuticals (China): An emerging player with capacity for API production, focusing on cost-effective manufacturing suited for export markets.

European and North American Generic Suppliers

• Mylan (now part of Viatris): Historically supplied digoxin generics across North America and Europe, with robust distribution channels.
• Teva Pharmaceutical Industries Ltd.: Offers generic digoxin formulations and APIs, serving global markets with high regulatory standards.
• Pfizer: While primarily an originator, Pfizer has scaled back manufacturing but continues licensing agreements to ensure supply persistence.

3. API Producers

The active pharmaceutical ingredient (API) for digoxin is complex to synthesize, requiring specialized chemical processes. Many API manufacturers operate in India, China, and Eastern Europe, supplying the bulk material to formulators.

Key API suppliers include:

• Mylan (Viatris)
• Fuan Pharmaceutical Co. (China)
• Zhejiang Tianyu Pharmaceutical Co. (China)
• Viatris (India-based API manufacturing centers)

These firms undergo rigorous quality assessments, often meeting USFDA, EMA, and WHO standards, enabling their exports to diverse markets.

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Regulatory and Market Dynamics Affecting Suppliers

Regulatory Stringency
Manufacturers need to comply with Good Manufacturing Practices (GMP), submit dossiers for regulatory approval, and conduct stability and bioequivalence studies. This often limits the number of compliant suppliers, favoring large, well-established firms.

Patent and Market Exclusivity
As digoxin patents have long expired, generic manufacturing dominates. Hence, suppliers focusing on cost-effective production tend to have competitive advantages.

Supply Chain Disruptions
Global events, such as the COVID-19 pandemic, have emphasized the importance of diversified manufacturing bases. Regions like India and China have faced particular scrutiny but remain vital suppliers.

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Emerging Trends and Strategic Highlights

Manufacturing Consolidation
Large players like Viatris and Teva have integrated supply chains to ensure steady API production, leveraging economies of scale.

Focus on Quality Assurance
Given the narrow therapeutic index of digoxin, suppliers prioritize rigorous quality controls to prevent adverse effects and regulatory sanctions.

Localization of Production
Several regions are incentivizing local manufacturing of APIs to reduce dependence on imports, thus affecting global supplier distribution.

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Conclusion

The global supply of digoxin relies on an intricate network of originator firms, generic manufacturers, and API producers, predominantly based in India, China, and Europe. The landscape is characterized by high regulatory standards, evolving regional mandates, and strategic sourcing considerations. Ensuring a reliable supply chain necessitates ongoing monitoring of these suppliers and their compliance standing, especially amid geopolitical and logistical challenges.

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Key Takeaways

• Market leaders like Boehringer Ingelheim and Sanofi historically supplied branded digoxin, but current market reliance is predominantly on generic manufacturers.
• India and China dominate as API producers and generic formulators, owing to cost advantages and expanding manufacturing capacity.
• Regulatory compliance remains a critical barrier, with only suppliers meeting stringent standards maintaining global market access.
• Supply chain resilience is increasingly vital, prompting diversification strategies among major pharmaceutical companies.
• Quality assurance is paramount given digoxin’s narrow therapeutic window, influencing supplier selection and regulatory approval processes.

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FAQs

1. Who are the major global suppliers of digoxin?
Major suppliers include Indian companies like Sun Pharma and Dr. Reddy’s, Chinese API producers such as Zhejiang Tianyu Pharmaceutical, and regional formulators like Viatris (formerly Mylan). Originator companies like Boehringer Ingelheim historically contributed but now focus mainly on licensing.

2. Are there regional differences in digoxin supply chains?
Yes. In North America and Europe, high-regulatory-compliant manufacturers dominate. In Asia, particularly India and China, cost-efficient generic and API production is prevalent, influencing global supply dynamics.

3. What challenges do digoxin suppliers face?
Key challenges include stringent regulatory approval requirements, maintaining quality control for a narrow therapeutic index drug, geopolitical tensions affecting supply routes, and the need to adapt to evolving manufacturing standards.

4. How has the patent landscape affected digoxin manufacturing?
Since patent protections have long expired, the market is saturated with generics, fostering competition but also necessitating high compliance standards to avoid quality issues.

5. What is the outlook for future digoxin supply?
Continued diversification of API sources and increasing regulatory audits are expected to shape the supply landscape. Emphasis on quality, stability, and supply chain resilience will remain central to market stability.

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Citations:
[1] World Health Organization. WHO List of Essential Medicines. 2022.
[2] U.S. Food & Drug Administration. Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). 2023.
[3] India's Directorate General of Commercial Intelligence and Statistics. Pharmaceutical Industry Data. 2022.
[4] European Medicines Agency. Human Regulatory Procedures. 2023.