Bulk Pharmaceutical API Sources for CORLANOR

Bulk Pharmaceutical API Sources for CORLANOR

Vendor	Vendor Homepage	Vendor Sku	API Url
Hangzhou APIChem Technology		AC-543
Molport		MolPort-005-943-399
Amadis Chemical		A808815

Bulk Active Pharmaceutical Ingredient (API) Sources for Corlanor (Ivabradine)

Last updated: July 27, 2025

Introduction

Corlanor (brand name for ivabradine) is a pharmaceutical product indicated primarily for the treatment of heart failure and certain arrhythmias. Its efficacy depends entirely on the quality of its active pharmaceutical ingredient (API), ivabradine, which must meet stringent purity and potency standards. The global supply chain for ivabradine API is critical for pharmaceutical manufacturers, healthcare providers, and regulatory authorities. This article examines key sources of bulk ivabradine API, highlighting manufacturing regions, major suppliers, and regulatory considerations vital for stakeholders involved in procurement, manufacturing, and compliance.

Overview of Ivabradine API

Ivabradine, chemically known as (S)-3-[7,2-dichloro-1,3-benzofurazan-4-yl]-3.C-3,4-dihydro-2H-1-benzopyran-4-yl]-N-methylprop-2-en-1-amine, selectively inhibits the funny current (I) in sinoatrial node cells, reducing heart rate without affecting blood pressure or myocardial contractility. Originally developed by Servier, ivabradine’s patent expiry has prompted a proliferation of API manufacturing sources, especially in Asia, to meet global demand.

Major API Manufacturing Regions for Ivabradine

1. China

China serves as the dominant supplier of bulk ivabradine API, hosting several large-scale facilities capable of high-volume production adhering to Good Manufacturing Practice (GMP) standards. Chinese manufacturers operate under a heavily regulated environment, with some companies undergoing rigorous inspections by global regulatory authorities. Key Chinese API producers include:

• Zhejiang Huadong Pharmaceutical Co., Ltd.
  Specializes in cardiovascular APIs, including ivabradine, with multiple GMP-certified plants.

• Hunan Acebright Pharmaceutical Co., Ltd.
  Known for integrating advanced synthetic routes, ensuring competitive pricing and quality.

• Shenzhen Second Pharmaceutical Factory
  Provides APIs with extensive export experience to North America and Europe.

2. India

India's pharmaceutical industry is well-established in chemical synthesis and export-oriented manufacturing of APIs. Indian producers often provide cost-effective alternatives without compromising quality when properly certified. Leading API manufacturers for ivabradine include:

• Glenmark Pharmaceuticals
  Has developed synthetic processes compliant with international standards, supplying both APIs and intermediate compounds.

• Aanjaneya Lifecare Ltd.
  Offers GMP-certified ivabradine API with proven reliability in meeting specifications.

• Jiangxi Specialized Pharmaceutical Co., Ltd.
  An emerging player with competitive pricing and extensive export experience.

3. Europe and the United States

While European and US-based companies traditionally focused on finished dosage forms, a few contract manufacturing organizations (CMOs) and specialty chemical producers supply high-purity APIs for niche markets or ongoing clinical trials.

• Servier Research Laboratories (France)
  The original innovator with some manufacturing facilities, now licensing manufacturing to other parties.

• Contract Manufacturers in Europe/US
  Often procure APIs from Chinese or Indian producers and perform final quality assurance testing.

Criteria for Selecting API Suppliers

Given the criticality of API quality, healthcare stakeholders should consider the following when sourcing ivabradine API:

• Regulatory compliance: Ensure suppliers hold GMP certifications recognized by authorities such as the FDA, EMA, or equivalent.

• Quality certifications: ISO certifications, batch-to-batch consistency, and detailed analytical data.

• Traceability: Transparent supply chain data, including source of raw materials and manufacturing processes.

• Supply reliability: Capacity to fulfill large and sustained orders, especially amid market fluctuations.

• Pricing and lead times: Competitive costs balanced with response times and quality standards.

Regulatory Considerations

Sourcing from approved and compliant suppliers minimizes regulatory risk. International agencies require thorough documentation, including Drug Master Files (DMFs) and Certificates of Analysis (COA). Due diligence is essential when importing APIs, with verification of supplier GMP status and adherence to ICH Q7 guidelines for APIs.

Global Supply Chain Challenges & Opportunities

The supply of ivabradine API faces several challenges like geopolitical tensions, trade regulations, and disruptions due to global crises such as COVID-19. Conversely, emerging API producers in Southeast Asia and Eastern Europe present new opportunities, diversifying supply bases to mitigate risks. Strategic stockpiling and qualification of multiple suppliers remain best practices to ensure uninterrupted access.

Conclusion

The sourcing landscape for ivabradine API is predominantly centered in China and India, supported by a smaller but significant presence of European and North American suppliers. The choice of supplier hinges on quality standards, regulatory compliance, pricing, and supply security. Stakeholders should conduct rigorous due diligence to align procurement strategies with global regulatory frameworks and manufacturing best practices.

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Key Takeaways

• Dominant Suppliers: Chinese and Indian manufacturers lead the ivabradine API market, offering scalable and cost-effective solutions.
• Regulatory Compliance: Verify GMP certification and documentation to ensure quality and facilitate regulatory approval.
• Supply Chain Resilience: Diversify suppliers and establish long-term partnerships to mitigate supply disruptions.
• Quality Assurance: Prioritize suppliers with established traceability, consistent batch quality, and adherence to international standards.
• Emerging Markets: Consider emerging API producers that meet global quality standards, expanding options beyond traditional sources.

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FAQs

1. What are the primary factors to consider when sourcing ivabradine API?
Regulatory compliance, GMP certification, quality consistency, supply reliability, lead times, and cost are critical factors.

2. Are Chinese API manufacturers suitable for global pharmaceutical supply?
Yes, many Chinese API producers have achieved GMP certification and supply quality APIs globally, but due diligence and verification of certifications are essential.

3. How do I verify the quality of an ivabradine API supplier?
Request detailed Certificates of Analysis, audit the manufacturing facilities, review GMP certifications, and conduct site visits if feasible.

4. What are the risks associated with sourcing from emerging markets?
Potential regulatory gaps, variable quality standards, and supply chain uncertainties. Conduct thorough assessments before engagement.

5. How has the COVID-19 pandemic affected the API supply chain?
Disruptions in manufacturing and transportation have impacted supply reliability. Diversification and strategic inventory management are recommended strategies.

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References

[1] Servier. Ivabradine (Corlanor) API documentation and regulatory filings.
[2] U.S. Food and Drug Administration (FDA). API manufacturing guidelines and approved suppliers.
[3] European Medicines Agency (EMA). Good Manufacturing Practice (GMP) guidelines for APIs.
[4] Iranmanesh, F., et al. "Global API Market Dynamics," Journal of Pharmaceutical Supply Chain, 2022.
[5] International Conference on Harmonisation (ICH). Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.