Bulk Pharmaceutical API Sources for CORDARONE

Bulk Pharmaceutical API Sources for CORDARONE

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-003-703-670
Vitas-M Laboratory		STK529812
AKos Consulting & Solutions		AKOS005462717
TimTec		ST51014902
Finetech Industry Limited		FT-0601533
Mcule		MCULE-4156227717

Bulk Active Pharmaceutical Ingredient (API) Sources for: CORDARONE (Amiodarone)

Last updated: July 30, 2025

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Introduction

Cordarone, known generically as amiodarone, remains a pivotal antiarrhythmic agent employed globally for managing complex cardiac arrhythmias. Central to its production is the procurement of high-quality active pharmaceutical ingredients (APIs), which fundamentally influence drug safety, efficacy, and regulatory compliance. This article examines the current landscape of bulk API sourcing for amiodarone, highlighting leading suppliers, manufacturing practices, regulatory considerations, and emerging trends impacting the supply chain.

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Overview of Amiodarone API

Amiodarone is a benzofuran derivative characterized by a complex chemical structure, including iodine atoms critical for its pharmacologic activity. Its synthesis involves multi-step processes often demanding specialized chemistry expertise and strict quality controls. The API must meet stringent standards outlined by pharmacopoeias such as the USP, EP, and JP, and comply with regulations from agencies like the FDA and EMA.

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Leading Sources of Amiodarone API

1. Major Global API Manufacturers

a. Changzhou Qianhong Bio-pharma Co., Ltd.
Based in China, this company is recognized for its extensive portfolio in cardiovascular APIs, including amiodarone. Its manufacturing facilities adhere to ISO 9001, with GMP certifications aligned with international standards. The firm supplies bulk APIs to several top-tier pharmaceutical companies across Asia, Europe, and North America.

b. Zhejiang Huahai Pharmaceutical Co., Ltd.
Another Chinese industry leader, Huahai specializes in cardiovascular and central nervous system APIs. Their facilities are compliant with EU-GMP and US-FDA standards, providing high-quality amiodarone APIs with consistent batch-to-batch purity and stability.

c. Wuhan Pharmaceutical Industry Group
Wuhan-based manufacturer with a robust R&D pipeline and dedicated production lines for complex APIs, including amiodarone. Their APIs are routinely used by generic and innovator pharmaceutical companies worldwide.

d. Aurobindo Pharma Ltd.
An India-based pharmaceutical company with global manufacturing facilities, Aurobindo supplies APIs conforming to international quality standards, including amiodarone, supported by comprehensive documentation and batch records.

e. Teva Pharmaceuticals
While primarily known as a finished dosage manufacturer, Teva maintains a dedicated API division supplying high-quality amiodarone APIs globally, often serving as an OEM partner for generic formulations.

2. Regional and Emerging API Suppliers

a. Indian API Manufacturers
India embodies a significant share of the global API manufacturing sector. Several smaller producers supply amiodarone to regional markets, often at lower costs, though rigorous due diligence is necessary to assure quality compliance.

b. European Manufacturers
European companies such as Rottapharm and Sandoz maintain specialized manufacturing units offering APIs with advanced regulatory approval, catering to markets requiring stringent standards.

3. API Quality and Compliance Considerations

Suppliers must adhere to pharmacopoeial monographs—specifically, USP <781> and European Pharmacopoeia standards—for identity, potency, residual solvents, heavy metals, and microbiological safety. Certifications such as ISO 9001, ISO 13485, and cGMP alignment are indicative of manufacturing quality. Regulatory dossiers should include comprehensive stability data, process validation, and analytical methods.

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Supply Chain Dynamics and Risks

The global API market for amiodarone is influenced by geopolitical factors, trade policies, and pandemic-related disruptions. Chinese regulators have tightened API export controls at times, causing supply constraints. Conversely, India continues to be a dominant source for bulk APIs due to scale and cost advantages. Ensuring supply continuity involves selecting diversified suppliers, establishing long-term agreements, and rigorous qualification processes.

Regulatory and Quality Assurance

Manufacturers supplying amiodarone API must maintain compliance with international GMP standards, submit comprehensive dossiers to regulatory agencies, and participate in post-manufacturing audits. Suppliers with active Drug Master Files (DMFs) or Certificates of Suitability (CEPs) offer added assurance of quality and regulatory acceptance.

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Emerging Trends in API Sourcing for Amiodarone

• Sustainable and Green Chemistry: Manufacturers are focusing on environmentally friendly synthesis methods, reducing solvent use, and waste.
• Enhanced Analytical Technologies: Advanced characterization tools improve impurity profiling and batch consistency.
• Digital Supply Chain Integration: Blockchain and real-time tracking enhance transparency and traceability.
• Resilience Building: Diversification of sources and local manufacturing initiatives mitigate geopolitical risks.

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Conclusion

Reliable sourcing of high-quality amiodarone API hinges on a thorough evaluation of manufacturer capabilities, regulatory compliance, and supply chain resilience. Leading Chinese and Indian API producers dominate the global landscape, complemented by European providers offering premium standards. Ongoing industry advancements and geopolitical shifts will necessitate continuous monitoring to ensure uninterrupted access to safe, effective amiodarone APIs.

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Key Takeaways

• The principal API suppliers for amiodarone are located in China, India, and Europe, offering a broad spectrum of quality and compliance standards.
• Strict adherence to GMP and pharmacopoeial standards is essential for API suppliers to meet regulatory requirements.
• Geopolitical and supply chain disruptions reinforce the importance of diversification among API sources.
• Emerging trends emphasize sustainability, technological innovation, and digitalization in API manufacturing and procurement.
• Due diligence, comprehensive qualification, and ongoing quality assurance are critical in selecting API partners for amiodarone.

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FAQs

1. What are the main regions producing bulk amiodarone API?
China and India dominate global production due to their extensive manufacturing capacities, with Europe providing specialized, high-standard APIs.

2. How do regulatory standards impact API sourcing for amiodarone?
Manufacturers must comply with GMP, GMP-certified facilities, and pharmacopoeial monographs to ensure regulatory acceptance across markets such as the US, EU, and Japan.

3. Are there significant quality differences among API suppliers?
Yes. Suppliers with comprehensive quality systems, active DMFs or CEPs, and GMP certifications typically deliver APIs with higher purity, stability, and consistency.

4. What are the risks associated with sourcing amiodarone API from a single region?
Concentration risks include supply disruptions due to geopolitical issues, trade restrictions, or pandemics. Diversification reduces these vulnerabilities.

5. How is sustainability influencing amiodarone API manufacturing?
Manufacturers are adopting green chemistry practices, reducing hazardous solvents, and minimizing environmental impact to meet sustainability goals and regulatory expectations.

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References

1. U.S. Pharmacopeia. "USP General Chapter <781>: Dissolution." 2022.
2. European Pharmacopoeia. "Amiodarone Hydrochloride." 10th Edition, 2022.
3. World Health Organization. "Prequalification of Medicines Programme." API manufacturing standards, 2021.
4. PharmaIQ. "Global API Market Trends and Future Outlook." 2022.
5. Industry Reports. "Pharmaceutical API Suppliers Directory," 2022.

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This comprehensive overview assists pharmaceutical professionals, suppliers, and manufacturers in making informed decisions regarding amiodarone API sourcing, emphasizing quality, compliance, and supply chain resilience.