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Suppliers and packagers for DOFETILDE
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DOFETILDE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Aurobindo Pharma Ltd | DOFETILDE | dofetilide | CAPSULE;ORAL | 210740 | ANDA | Aurobindo Pharma Limited | 59651-118-05 | 500 CAPSULE in 1 BOTTLE (59651-118-05) | 2019-01-22 |
| Aurobindo Pharma Ltd | DOFETILDE | dofetilide | CAPSULE;ORAL | 210740 | ANDA | Aurobindo Pharma Limited | 59651-118-60 | 60 CAPSULE in 1 BOTTLE (59651-118-60) | 2019-01-22 |
| Aurobindo Pharma Ltd | DOFETILDE | dofetilide | CAPSULE;ORAL | 210740 | ANDA | Aurobindo Pharma Limited | 59651-119-05 | 500 CAPSULE in 1 BOTTLE (59651-119-05) | 2019-01-22 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Dofetilide
Introduction
Dofetilide, a class III anti-arrhythmic agent, is utilized primarily to maintain normal sinus rhythm in patients with atrial fibrillation or flutter. As a potent medication with specific manufacturing and quality control requirements, its supply chain is global and highly regulated. Ensuring reliable access to dofetilide involves understanding its leading suppliers, production dynamics, regulatory considerations, and market trends. This analysis provides a comprehensive overview of key suppliers, market landscape, and insights critical for pharmaceutical companies, healthcare providers, and investors.
Market Overview of Dofetilide
Dofetilide’s market presence is relatively niche, given its specific therapeutic indications and the availability of alternative treatments. It was first approved by the U.S. Food and Drug Administration (FDA) in 2000 and is marketed under various brand names, such as Tikosyn in the United States. The total global demand remains stable but is regionally concentrated, with North America representing the largest market share due to high prevalence of atrial fibrillation and advanced healthcare infrastructure.
The production of dofetilide demands strict adherence to Good Manufacturing Practices (GMP), given its critical role in cardiac electrophysiology and the potential for severe adverse effects, including proarrhythmia. The limited number of manufacturers contributing to global supplies reflects its complex synthesis process and regulatory barriers.
Leading Suppliers of Dofetilide
1. Hikma Pharmaceuticals
Hikma Pharmaceuticals ranks among the foremost licensed producers of dofetilide, particularly in the United States, where it holds an FDA-approved manufacturing site compliant with GMP standards. Hikma offers its version of dofetilide under the brand Tikosyn, with a significant market share driven by its production scale and regulatory approval. The company invests heavily in quality assurance systems, ensuring consistent supply and regulatory compliance across markets.
2. Dr. Reddy’s Laboratories
Dr. Reddy’s Laboratories, an Indian multinational, produces dofetilide for various regional markets. The company has demonstrated capability in synthesizing complex molecules and meeting international standards. While their focus remains more prominent on generic cardiovascular medications, their involvement in dofetilide manufacturing reflects their broader strategic emphasis on critical care drugs.
3. Mylan (now part of Viatris)
Mylan, before its merger with Pfizer’s Upjohn unit to form Viatris, was one of the prominent suppliers for a range of cardiovascular drugs, including dofetilide. They possessed multiple manufacturing facilities dedicated to high-quality generics, some of which produce dofetilide under strict GMP conditions. Their role remains relevant in markets with latitude for generic drug procurement.
4. Other Notable Suppliers
- Sandoz (a Novartis division): Focused mainly on biosimilars but has in some contexts supplied cardiovascular generics.
- Teva Pharmaceuticals: Known for a broad portfolio of generics, including some anti-arrhythmic agents, though not a primary supplier of dofetilide.
- Local and Regional Manufacturers: In emerging markets, several regional companies produce dofetilide under licensing agreements, but these are generally less prominent on the global stage.
Manufacturing Challenges and Regulatory Considerations
Dofetilide’s synthesis involves multiple complex steps, including chiral separation and high purity requirements. Manufacturing quality is paramount to prevent impurities or incorrect dosages, which could precipitate life-threatening adverse reactions.
Regulatory hurdles are significant; approval from agencies such as the FDA, EMA, or equivalent bodies requires comprehensive chemistry, manufacturing, and controls (CMC) documentation. Tampering with the synthesis process or lapses in GMP compliance can lead to supply disruptions, emphasizing the importance of established, verified manufacturing partners.
Supply Chain Risks
- Regulatory compliance failures can halt production.
- Raw material shortages impact manufacturing continuity.
- Geopolitical factors influence regional availability.
- Manufacturing capacity constraints in response to global demand fluctuations.
Market Trends and Future Outlook
The pharmaceutical industry is witnessing increased scrutiny on drug quality, leading to stricter supplier qualification standards. The consolidation within the generic cardiovascular drug sector aims to streamline supply chains and enhance quality; for example, Viatris’ consolidation post-merger impacts the landscape.
Emerging markets are exploring local manufacturing options to reduce reliance on a limited number of global suppliers. Innovations in synthetic chemistry and process improvements may lower production costs, potentially increasing supply stability.
Additionally, patent expirations and regulatory shifts could expand the number of qualified suppliers for dofetilide, enhancing market competition. However, given the drug’s complex manufacture and safety profile, new entrants must navigate significant quality assurance hurdles.
Strategic Considerations for Stakeholders
For pharmaceutical companies seeking to source dofetilide, securing partnerships with established suppliers like Hikma and Dr. Reddy’s offers assurances of quality and regulatory compliance. Emerging market entrants should invest in robust manufacturing practices and adhere to international standards to ensure market access.
Healthcare providers, meanwhile, should evaluate supply chain stability when considering formulary inclusion, given recent industry consolidations and potential supply disruptions.
Policymakers and regulators play a crucial role in maintaining drug quality standards, ensuring that the few qualified suppliers continue to meet global demands without compromising safety.
Key Takeaways
- Limited but Diverse Suppliers: The global supply of dofetilide primarily revolves around a handful of manufacturers, notably Hikma Pharmaceuticals and Dr. Reddy’s Laboratories, with regional suppliers filling niche markets.
- Regulatory Compliance is Critical: GMP adherence and rigorous quality controls are essential to prevent supply disruptions or safety issues.
- Manufacturing Complexity: The synthesis process’s complexity limits the proliferation of producers and underscores the importance of strategic supplier selection.
- Market Concentration Risks: Industry consolidations and regional manufacturing shifts may impact supply stability; diversification strategies are advisable.
- Future Supply Dynamics: Advances in synthetic chemistry, regulatory approvals, and regional manufacturing initiatives could broaden the supplier base, improving supply security.
FAQs
1. Who are the primary global suppliers of dofetilide?
Hikma Pharmaceuticals and Dr. Reddy’s Laboratories are among the leading suppliers, with Hikma primarily serving the North American market and others operating regionally or as generic producers.
2. What factors influence the supply stability of dofetilide?
Regulatory compliance, manufacturing capacity, raw material availability, and geopolitical stability significantly impact supply consistency.
3. Can new manufacturers enter the dofetilide market easily?
Entry is challenging due to complex synthesis processes, stringent quality requirements, and regulatory hurdles, which serve as significant barriers.
4. Are there regional variations in dofetilide availability?
Yes. Availability depends on regional manufacturing approvals, licensing agreements, and local regulatory environments, with North America and Europe having more established supplies.
5. How might industry trends affect future dofetilide supply?
Consolidation, technological advancements, and regional manufacturing initiatives are expected to diversify and stabilize supply, though regulatory and quality standards will remain pivotal.
Sources:
- U.S. Food and Drug Administration (FDA). Tikosyn (Dofetilide) Prescribing Information.
- Pharma analyst reports on cardiovascular drugs 2022.
- Hikma Pharmaceuticals official website and disclosures.
- Dr. Reddy’s Laboratories product portfolio and manufacturing guidelines.
- Market research from IQVIA and EvaluatePharma on global anti-arrhythmic drug markets.
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