Bulk Pharmaceutical API Sources for AMIODARONE HYDROCHLORIDE

Bulk Pharmaceutical API Sources for AMIODARONE HYDROCHLORIDE

Vendor	Vendor Homepage	Vendor Sku	API Url
ChemExper Chemical Directory		Y`XXLL@GBCJ`JpRl~bLbbbRbQbtTTTRRqvCDfURqtDEEMSPUPQQ@@@
NIH Clinical Collection		SAM001246646
Hangzhou Trylead Chemical Technology		TL8001651
NovoSeek		441325
MP Biomedicals		153535
MolPort		MolPort-002-915-715
Hangzhou APIChem Technology		AC-078

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

Last updated: July 30, 2025

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Introduction

Amiodarone Hydrochloride, a class III antiarrhythmic agent, is widely utilized in managing various cardiac arrhythmias including ventricular fibrillation, ventricular tachycardia, and atrial fibrillation. Its complex pharmacological profile necessitates high-quality Active Pharmaceutical Ingredients (APIs) sourced from reliable manufacturers to ensure safety, efficacy, and regulatory compliance. The global supply chain for Amiodarone Hydrochloride APIs involves diverse suppliers across multiple regions, each with varying standards, capacities, and compliance levels.

This article offers a comprehensive analysis of key bulk API sources for Amiodarone Hydrochloride, considering factors such as quality standards, manufacturing capabilities, regulatory status, and geopolitical considerations. It aims to assist pharmaceutical companies, compounding pharmacies, and regulatory agencies in sourcing high-grade APIs to support formulation development, manufacturing, and quality assurance.

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Global API Manufacturers for Amiodarone Hydrochloride

1. China

China remains a dominant supplier of APIs, including Amiodarone Hydrochloride, contributing approximately 45-55% of the global API market share. Major Chinese API manufacturers have established extensive facilities and possess certified facilities aligned with international standards such as Good Manufacturing Practice (GMP).

• Zhejiang Hongyu Pharmaceutical Co., Ltd.
  This company has a well-established reputation for producing high-purity Amiodarone Hydrochloride API. They hold GMP certification and export to numerous markets worldwide, including North America and Europe.

• Shandong Xinhua Pharmaceutical Co., Ltd.
  Known for its robust API manufacturing capacity, this firm supplies bulk Amiodarone Hydrochloride to multinational pharmaceutical companies. Its compliance with stringent quality standards makes it a significant player in the supply chain.

• Hebei Huanying Medicine Co. Ltd.
  Specializing in cardiovascular APIs, this manufacturer provides Amiodarone Hydrochloride meeting both domestic and international standards, with ISO and GMP certifications.

Consideration: Despite high manufacturing volumes, buyers must verify batch-specific GMP compliance, impurity profiles, and stabilize delivery timelines due to potential quality variability.

2. India

India's API industry has experienced rapid growth, bolstered by stringent regulatory standards, infrastructure development, and government incentives. Several Indian manufacturers produce Amiodarone Hydrochloride API.

• Aarti Drugs Ltd.
  An established API producer with WHO-GMP certification, Aarti Drugs supplies Amiodarone Hydrochloride used in both generics and branded formulations.

• Hester Biosciences Ltd.
  Known for cost-effective production, Hester’s facilities comply with Indian and international standards, catering mainly to Asian markets but expanding globally.

• Glenmark Pharmaceuticals
  With a dedicated API manufacturing division, Glenmark ensures high purity API with rigorous quality controls.

Advantages: Competitive pricing, robust quality assurance, and often shorter lead times. Regulatory compliance is generally high, but verification of batch-specific certifications remains essential.

3. Europe

European API manufacturers are known for rigorous quality standards, high purity, and compliance with European Medicines Agency (EMA) regulations.

• SuM Pharma (Italy)
  A recognized supplier of specialty APIs, including Amiodarone Hydrochloride, with GMP adherence and advanced analytical testing capabilities.

• Fosun Pharma (Germany)
  Known for high-quality pharma ingredients, they supply APIs consistent with European pharmacopoeial standards and have extensive regulatory dossiers.

Strengths: These suppliers are ideal for formulations requiring strict compliance and high-grade purity. However, costs may be higher compared to Asian suppliers.

4. United States

American companies generally produce APIs under stringent FDA regulations, ensuring maximum compliance for US markets.

• Cambridge Isotope Laboratories, Inc. (Limited to specialty isotopic APIs)
  While primarily isotopic, they exemplify high-precision API manufacturing.

• Contract manufacturing organizations (CMOs)
  U.S.-based CMOs like Certara, Inc., or Catalent, sometimes offer custom synthesis of Amiodarone Hydrochloride for large-volume clients with required regulatory documentation.

Note: U.S. domestic API production for Amiodarone Hydrochloride is limited; most manufacturers import bulk APIs from accredited international suppliers for final formulation.

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Key Factors in Selecting API Sources

• Regulatory Compliance: GMP certification, stability data, impurity profiles, and regulatory approvals (EMA, FDA, CDSCO) influence procurement decisions.

• Quality Assurance: High purity levels (≥99%), low residual solvents, and consistent API batches are critical.

• Cost: Balancing quality and affordability is vital, especially considering long-term supply needs.

• Supply Chain Reliability: Capacity, lead times, logistics infrastructure, and geopolitical stability affect availability.

• Documentation and Traceability: Complete dossiers, COA (Certificate of Analysis), and compliance documentation are essential for audit readiness.

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Emerging Trends and Challenges

• Quality Variability: The proliferation of API manufacturers, especially in China and India, demands rigorous qualification processes to ensure batch-to-batch consistency.

• Regulatory Scrutiny: Increasing validation requirements by agencies like the FDA and EMA can impact sourcing strategies, favoring suppliers with robust quality systems.

• Supply Chain Disruptions: Geopolitical tensions and global events (e.g., pandemics) can affect API availability, prompting diversification of sources.

Conclusion

The supply landscape for Amiodarone Hydrochloride API is characterized by a diverse array of suppliers across Asia, Europe, and North America. Each region offers advantages regarding cost, quality, and regulatory compliance. Selecting the optimal source depends on the specific quality standards, regulatory requirements, and supply chain resilience pertinent to the purchasing entity.

To mitigate risks, purchasers should prioritize suppliers with verified GMP certification, comprehensive quality documentation, and proven reliability. Establishing strong supplier relationships, conducting periodic audits, and maintaining diversified sourcing strategies will be key to sustaining a dependable supply chain for this critical antiarrhythmic API.

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Key Takeaways

• Chinese and Indian manufacturers dominate global API supply, offering cost-effective options with high capacity.
• European and U.S. suppliers provide APIs with stringent regulatory compliance suitable for formulations demanding high purity standards.
• Rigorous qualification processes and supplier audits are essential to ensure API quality and supply reliability.
• Diversified sourcing mitigates risks associated with geopolitical tensions and supply chain disruptions.
• Regulatory diligence, including verification of certifications and impurity profiles, is critical for safe pharmaceutical manufacturing.

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Frequently Asked Questions (FAQs)

1. What are the primary considerations when sourcing Amiodarone Hydrochloride API?
Quality standards, regulatory compliance (GMP), impurity profile, cost, supply reliability, and documentation are fundamental considerations.

2. Are Chinese API manufacturers suitable for high-quality Amiodarone Hydrochloride?
Yes, many Chinese manufacturers produce high-quality APIs meeting international standards; however, thorough qualification and auditing are recommended to ensure compliance.

3. How does European API sourcing compare to Asian options?
European APIs generally adhere to higher regulatory standards, with rigorous quality assurance, but often come at higher costs. They are preferred for highly regulated markets requiring exceptional purity.

4. Can U.S.-based manufacturers supply Amiodarone Hydrochloride?
Most U.S. domestic suppliers import APIs from reputed international sources; fully domestic supply of Amiodarone Hydrochloride API is limited.

5. What are the recent trends affecting API sourcing for Amiodarone Hydrochloride?
Increasing regulatory scrutiny, supply chain diversification, and quality assurance protocols are shaping sourcing strategies, emphasizing supplier qualification and geopolitical considerations.

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Sources

[1] Global Drug Shortages and API Supply Dynamics, WHO, 2022.
[2] Pharmaceutical Manufacturing Standards, EMA Guidelines, 2021.
[3] Chinese API Industry Reports, China Association of Pharmaceutical Manufacturers, 2022.
[4] Indian Pharmaceutical Industry Review, CDSCO, 2022.
[5] European API Market Outlook, European Federation of Pharmaceutical Industries and Associations, 2021.