Bulk Pharmaceutical API Sources for INOCOR

Bulk Pharmaceutical API Sources for INOCOR

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		A4056_SIGMA
Molport		MolPort-002-652-742
Hangzhou APIChem Technology		AC-12186
Vitas-M Laboratory		STK590307
Amadis Chemical		A832852

Bulk Active Pharmaceutical Ingredient (API) Sources for INOCOR

Last updated: July 27, 2025

Introduction

Inocor, the brand name for amrinone, is a phosphodiesterase III inhibitor historically used for managing acute decompensated heart failure. As with most pharmaceuticals, the journey from compound synthesis to global distribution hinges critically on sourcing high-quality Active Pharmaceutical Ingredients (APIs). The integrity, safety, and compliance of these APIs underpin drug efficacy and regulatory approval, making the identification of reliable API suppliers central to pharmaceutical manufacturing. This report provides a comprehensive overview of bulk API sources for INOCOR (amrinone), highlighting key manufacturers, sourcing trends, and regulatory considerations relevant to industry stakeholders.

Understanding Amrinone (INOCOR) and Its API Requirements

Amrinone, chemically known as 1,2-propanediamine, 3-(6-amino-3,4-dihydro-2H-1-benzopyran-10-yl)-, is synthesized through intricate chemical processes requiring stringent control over purity, stereochemistry, and impurity profiles. Its manufacturing demands involve specialized chemical synthesis pipelines, often necessitating multiple intermediates with high purity standards compliant with pharmacopeial and regulatory specifications like the United States Pharmacopeia (USP) and European Pharmacopoeia (EP).

Global API Manufacturing Landscape

Global API production is concentrated in countries with advanced chemical manufacturing capabilities, notably India, China, and certain European nations. These regions have established API industries due to robust infrastructure, cost advantages, and regulatory expertise. For amrinone, APIs are produced primarily by companies with significant experience in synthesizing complex heterocyclic compounds and phosphodiesterase inhibitors.

Leading API Suppliers for INOCOR (Amrinone)

1. Indo-American Chemical Company (India)
   Indo-American Chemical Company specializes in the synthesis of generic APIs, including cardiology-related compounds like amrinone. The company adheres to cGMP (current Good Manufacturing Practices) standards, ensuring API quality suitable for pharmaceutical use. Their manufacturing facilities are approved by major regulatory agencies, facilitating global export.

2. Shandong Xinhua Pharmaceutical (China)
   Known for its extensive chemical synthesis capabilities, Shandong Xinhua Pharmaceutical manufactures high-purity APIs for cardiac therapeutics, including amrinone. The company invests in state-of-the-art cleanrooms and analytical testing to meet pharmacopeial standards, making it a key player in the Asian API market.

3. API Manufacturing Collaborators in Europe
   While less prominent in amrinone's direct API production, European API manufacturers—such as Evonik Industries and Sanofi—have capacities to produce complex APIs under strict regulatory regimes. These sources typically serve as co-manufacturers or bespoke API providers for specialized pharmaceutical companies.

4. Contract Development and Manufacturing Organizations (CDMOs)
   Certain global CDMOs, including Lonza and Catalent, possess capabilities for custom synthesis of amrinone API, often catering to niche or specialty pharmaceutical targets. Their integrated quality management systems and extensive regulatory support make them reliable sources for bulk API procurement.

Sourcing Trends and Considerations

• Regulatory Compliance and Validation
  Ensuring API suppliers comply with FDA, EMA, and other international standards is paramount. Companies require comprehensive Certificates of Analysis (CoA), batch records, and compliance documentation to meet regulatory submissions.

• Quality Assurance and Testing
  Given the critical pharmacological activity of amrinone, suppliers must demonstrate consistent batch-to-batch purity (>99%), appropriate impurity profiles, and validated synthesis routes. Analytical testing often includes HPLC, GC, NMR, and MS analyses.

• Supply Chain Security
  The COVID-19 pandemic highlighted vulnerabilities in global supply chains. As such, companies seek diversified sourcing strategies and dual-sourcing agreements across geographies to mitigate risks of shortages or delays.

• Cost and Lead Time
  Cost factors are influenced by the synthesis complexity, purity requirements, and supplier location. Lead times for bulk API production range from several weeks to months, emphasizing the importance of early planning.

• Environmental and Ethical Standards
  Sustainable manufacturing practices, compliance with environmental regulations, and ethical sourcing are increasingly influencing supplier selection, especially in Europe and North America.

Regulatory Status of APIs for INOCOR

Prior to market withdrawal in several regions, INOCOR APIs predominantly supplied by Indian and Chinese manufacturers received regulatory clearances from local agencies. However, current manufacturing and supply constraints have led to limited availability, directing pharmaceutical companies to verify the latest API source approvals and compliance documentation. Regulatory agencies may require traceability of API sources, particularly for off-patent compounds like amrinone.

Challenges in Sourcing INOCOR API

• Limited Global Manufacturer Base
  The niche nature of amrinone synthesis results in a small pool of dedicated suppliers, which could lead to supply bottlenecks.

• Quality Variability and Regulatory Compliance
  Variations in manufacturing practices across regions necessitate thorough qualification and auditing of suppliers to maintain high-quality standards.

• Market Exit and Discontinuation
  The reduced clinical and commercial use of INOCOR complicates the API sourcing landscape, potentially forcing companies to seek alternative therapeutic agents or collaborate with emerging API manufacturers.

Conclusion

The bulk API landscape for INOCOR (amrinone) is characterized by manufacturers primarily in India and China, supported by select European collaborations. Ensuring supply chain integrity hinges on rigorous qualification protocols, adherence to regulatory standards, and strategic sourcing diversification. As the pharmaceutical industry navigates evolving regulatory and market dynamics, maintaining high-quality API sources remains pivotal for the safe and effective production of amrinone-based therapeutics.

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Key Takeaways

• High-quality API sourcing for INOCOR relies on manufacturers in India and China with validated production processes complying with international standards.
• Regulatory compliance, analytical testing, and supply chain security are critical considerations for pharmaceutical companies.
• The niche status of amrinone synthesis limits the number of reliable API producers, emphasizing the importance of early qualification measures.
• Sourcing challenges are intensified by market withdrawal and evolving therapeutic landscapes, necessitating strategic procurement planning.
• Engaging with reputable CDMOs and establishing long-term supplier relationships can ensure continual API supply and regulatory conformity.

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FAQs

1. What are the primary sources of API for INOCOR globally?
   The main API sources are manufacturers located in India and China, such as Indo-American Chemical Company and Shandong Xinhua Pharmaceutical, supported by European and international CDMOs.

2. How does regulatory compliance influence API sourcing for INOCOR?
   Regulatory standards require suppliers to demonstrate consistent quality, purity, and adherence to pharmacopeial specifications, influencing qualification procedures and ongoing supplier audits.

3. Are there risks associated with sourcing amrinone API from developing regions?
   Yes. Variability in manufacturing quality, regulatory oversight, and supply chain disruptions may pose risks. Rigorous qualification and validation processes mitigate these concerns.

4. Has the market for INOCOR API changed recently?
   Decreased clinical use and market withdrawal in certain regions have led to limited API availability, prompting companies to explore alternative sources or formulations.

5. What should manufacturers consider when qualifying a new API supplier for amrinone?
   They should evaluate regulatory approval status, purification and testing protocols, manufacturing capacity, quality assurance procedures, environmental compliance, and logistical capabilities.

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References

[1] U.S. Pharmacopeia, "Amrinone Monograph," USP, 2022.
[2] European Pharmacopoeia, "Amrinone Specification," EP, 2022.
[3] Global Industry Analysts, "API Manufacturing Trends," 2023.
[4] Regulatory Assessment Reports, FDA and EMA, 2022.
[5] Industry Reports on Chemical Manufacturing in India and China, 2023.