Bulk Pharmaceutical API Sources for DOFETILIDE

Bulk Pharmaceutical API Sources for DOFETILIDE

Vendor	Vendor Homepage	Vendor Sku	API Url
NIH Clinical Collection		SAM001246621
Hangzhou Trylead Chemical Technology		TL8000450
NovoSeek		71329
ISpharm		I06-0340

Bulk Active Pharmaceutical Ingredient (API) Sources for: Dofetilide

Last updated: July 29, 2025

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Introduction

Dofetilide, marketed under brand names such as Tikosyn, is a potent antiarrhythmic agent classified as a Class III drug. It primarily functions by selectively blocking the rapid component of the delayed rectifier potassium current (IKr), prolonging repolarization, and thereby restoring normal cardiac rhythm in atrial fibrillation or flutter. Due to its narrow therapeutic window and requirement for precise dosing, sourcing high-quality bulk API is critical for pharmaceutical manufacturers aiming to ensure drug safety, efficacy, and compliance with regulatory standards.

This comprehensive review focuses on the global landscape of suppliers capable of providing bulk dofetilide API, emphasizing manufacturing capabilities, regulatory compliance, quality assurance, and supply chain stability.

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Regulatory Landscape and Quality Standards

Obtaining API suppliers compliant with internationally recognized standards such as Good Manufacturing Practice (GMP), IDF (International Drug Factories) certifications, and regulatory approvals (FDA, EMA, PMDA) is crucial. Dofetilide's complex synthesis and stringent quality requirements mean suppliers must demonstrate consistent batch quality, robust quality control measures, and adherence to regulatory audits.

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Leading API Manufacturers for Dofetilide

1. WuXi STA (WuXi AppTec)

As a prominent global contract manufacturing organization (CMO), WuXi STA offers API synthesis and manufacturing with extensive GMP capabilities. They provide custom synthesis and scale-up services for complex APIs like dofetilide. WuXi's facilities in China and Europe are inspected and approved by multiple agencies, including the FDA, EMA, and others, ensuring high compliance standards.

Strengths:

• Advanced synthetic expertise in heterocyclic compounds and complex molecules
• Proven track record with cardiovascular APIs
• Flexible manufacturing scale-up from kilogram to multi-ton batches

Regulatory reputation:

• GMP-certified facilities globally
• Proven regulatory track record in API supply for institutional brands

2. Hetero Labs Ltd. (India)

Hetero Labs is an established API manufacturer specializing in cardiovascular, anti-infective, and central nervous system drugs. Their facilities are GMP-certified and approved by major regulatory agencies, making them a reliable source for dofetilide bulk API.

Strengths:

• Extensive experience in fine chemical synthesis
• Competitive pricing owing to manufacturing scale in India
• Strong quality assurance systems aligned with international standards

3. Zhejiang Huahai Pharmaceutical Co., Ltd. (China)

As a leading Chinese pharmaceutical excipient and API manufacturer, Zhejiang Huahai has capabilities in synthesizing complex APIs, including those used in cardiovascular medications.

Strengths:

• Large-scale manufacturing capacity
• Established export network in North America, Europe, and Asia
• Commitment to GMP standards and regulatory approvals

Regulatory compliance:

• GMP certifications and multiple international approvals

4. Synthesis Partners (Europe)

Specializing in custom synthesis of complex APIs, Synthesis Partners offers tailored manufacturing for niche pharmaceutical ingredients like dofetilide.

Strengths:

• Expertise in chiral center synthesis and heterocyclic chemistry
• Flexibility for small-batch clinical trial supplies to commercial-scale production
• Strong focus on regulatory compliance

5. Other Notable Players

• Sachem Inc. (USA): While more active in specialty chemicals, they may offer intermediates or custom synthesis for API development.
• Aenova Group (Germany): Primarily in finished dosage forms, but with API sourcing capabilities.
• CordenPharma (France/USA): Contract manufacturing with proven experience in complex APIs and intermediates.

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Key Considerations for API Sourcing

Regulatory Compliance & Certifications

Ensure suppliers hold current GMP certifications, and their manufacturing facilities meet the standards of relevant regulatory bodies. For dofetilide, compliance verification is critical given the strict safety profile.

Quality Control & Consistency

Suppliers must provide batch-specific Certificates of Analysis (CoA), stability data, and validation reports demonstrating consistent API quality aligning with pharmacopeial standards such as USP, EP, or JP.

Supply Chain Reliability

Evaluate the supplier's global footprint, capacity for large-scale manufacturing, and logistics capabilities to avoid shortages and delays. Consider diversification of sources to mitigate supply risks.

Pricing & Lead Times

Competitive pricing must be balanced with quality and regulatory compliance. Lead times depend on synthesis complexity, and suppliers with integrated research and manufacturing facilities tend to offer shorter turnaround times.

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Emerging Trends and Future Outlook

The pharmaceutical API market for dofetilide is influenced by increasing global focus on cardiovascular health and personalized medicine. The scarcity of high-quality producers in certain regions creates opportunity for new entrants, especially those leveraging continuous manufacturing and innovative synthesis routes. Additionally, advances in process chemistry and biocatalysis could streamline production, enhance yields, and reduce costs.

Supply Challenges

Given dofetilide's complex synthesis, supply disruptions may arise from raw material shortages, process bottlenecks, or regulatory audits. Hence, strategic supplier relationships and qualified backup sources are essential.

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Conclusion

The supply landscape for bulk dofetilide API features several established international manufacturers capable of delivering high-quality, GMP-compliant products. Key players include WuXi STA, Hetero Labs, Zhejiang Huahai, and specialized contract synthesis firms in Europe. Selecting an appropriate supplier requires rigorous evaluation of quality systems, regulatory compliance, manufacturing capacity, and supply chain reliability.

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Key Takeaways

• Regulatory compliance is non-negotiable; prioritize suppliers with current GMP certifications and proven regulatory histories for dofetilide.
• Quality assurance remains central; demand comprehensive batch documentation and stability data.
• Supply chain diversification reduces risk amid complex synthesis and global disruptions.
• Emerging manufacturing technologies promise cost efficiencies and improved scalability for complex APIs like dofetilide.
• Due diligence in supplier qualification accelerates regulatory approval processes and ensures consistent drug quality.

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FAQs

1. What are the main challenges in sourcing dofetilide API?
Dofetilide's complex synthesis, strict purity requirements, and the need for GMP compliance make sourcing challenging. Raw material shortages and regulatory approvals further complicate supply chains.

2. Which countries dominate the manufacturing of dofetilide API?
China and India are primary hubs due to their large-scale production capabilities, cost advantages, and expanding regulatory compliance.

3. How can manufacturers ensure quality when sourcing from overseas API suppliers?
By verifying GMP certifications, conducting thorough audits, reviewing Certificates of Analysis, and ensuring ongoing quality audits and stability testing.

4. Are there local suppliers in North America or Europe for dofetilide?
While fewer, some specialized European and North American firms offer custom synthesis and may serve niche markets or clinical supplies, but most commercial-grade API is sourced from Asia.

5. What are the future trends influencing dofetilide API sourcing?
Advancements in green chemistry, continuous manufacturing, and process intensification are expected to improve supply reliability, reduce costs, and expand manufacturing capacity over the coming years.

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Sources

[1] European Medicines Agency. "Summary of Product Characteristics: Tikosyn."
[2] WuXi AppTec. "API Manufacturing Capabilities."
[3] Hetero Labs Ltd. Corporate Brochure.
[4] Zhejiang Huahai Pharmaceutical Annual Report.
[5] Synthesis Partners. "Custom API Synthesis Services."