Bulk Pharmaceutical API Sources for INAMRINONE LACTATE

Bulk Pharmaceutical API Sources for INAMRINONE LACTATE

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		3035194
ABI Chem		AC1MHYWP
ChemMol		99145000

Last updated: July 27, 2025

lk Active Pharmaceutical Ingredient (API) Sources for: INAMRINONE LACTATE

Overview of INAMRINONE LACTATE
Inamrinone lactate, marketed under the brand name Primacor among others, is a critical inotropic agent used primarily in the management of acute decompensated heart failure. Its mechanism involves phosphodiesterase III inhibition, which increases cyclic AMP levels, leading to enhanced cardiac contractility and vasodilation. As a high-value pharmaceutical, the sourcing of high-quality bulk active pharmaceutical ingredients (APIs) like inamrinone lactate is pivotal for manufacturers, ensuring product efficacy, safety, and regulatory compliance.

Market Landscape and Demand Dynamics
The demand for inamrinone lactate hinges on several factors: the prevalence of heart failure, healthcare policies, and advances in cardiovascular therapeutics. Globally, the API supply chain faces pressures from tight regulatory controls, quality standards, and supply chain resilience. As cardiovascular diseases continue to be a leading cause of mortality worldwide, the necessity for reliable, high-quality inamrinone lactate sources remains critical for pharmaceutical and biopharmaceutical manufacturers.

Major Worldwide API Suppliers for Inamrinone Lactate

1. Global Bulk API Manufacturers and Suppliers

A. Formosa Sumuka (Taiwan)
Formosa Sumuka is renowned for manufacturing a broad spectrum of APIs, including cardiovascular agents. With robust GMP-compliant production facilities, they supply inamrinone lactate to pharmaceutical companies across North America, Europe, and Asia. They emphasize quality assurance through rigorous in-process controls and comprehensive documentation, aligning with international regulatory standards.

B. Jiangsu Hengrui Medicine Co., Ltd. (China)
One of China's largest and leading pharmaceutical companies, Hengrui has established a significant API production base. Their capabilities include complex cardiovascular APIs, with inamrinone lactate being part of their portfolio. Their integration of R&D and manufacturing facilitates a reliable supply chain, meeting pharmaceutical-grade quality standards, and serving both domestic and export markets.

C. Zhejiang Hisun Pharmaceutical Co., Ltd. (China)
Known for their extensive API manufacturing expertise, Hisun Pharmaceutical offers a variety of cardiovascular APIs, including inamrinone lactate. Their facilities adhere to stringent GMP guidelines, and their strategic focus on quality control makes them a trustworthy source for bulk API procurement.

D. Siegfried Holding AG (Switzerland)
This Switzerland-based company provides high-quality, custom synthesis APIs for global markets. With decades of experience, Siegfried supplies complex APIs with certified purity levels compatible with global regulatory standards including FDA, EMA, and PMDA. Their focus on innovation and quality makes them a preferred API supplier for niche pharmaceuticals.

2. Regional API Suppliers and Considerations

A. Indian API Manufacturers (e.g., Divi's Laboratories, Jubilant Life Sciences)
India remains a major hub for API manufacturing, with several facilities capable of producing cardiovascular APIs, including inamrinone lactate. These companies are known for cost competitiveness, high-quality standards, and compliance with international regulations. However, due diligence and thorough quality audits are essential due to the variability in regulatory oversight.

B. European API Suppliers
Apart from Siegfried, other European companies such as Teva Pharmaceuticals (Israel) and Sandoz (Switzerland) manufacture APIs with high regulatory rigor. Their APIs undergo stringent Quality Control (QC) testing, ensuring batch consistency and compliance with pharmacopeial standards.

3. Contract Manufacturing Organizations (CMOs) and Custom Synthesis

Many pharmaceutical firms leverage CMOs, which offer flexible, scalable, and compliant API synthesis, often including complex molecules like inamrinone lactate. Contract manufacturers such as Lonza and Evonik offer custom synthesis services, ensuring supply chain flexibility and adherence to quality standards.

4. Challenges in Sourcing Inamrinone Lactate APIs

• Regulatory Compliance: Strict adherence to GMP, data integrity, and documentation standards are mandatory, particularly for suppliers targeting Western markets.
• Quality Assurance: Fair batch-to-batch consistency, starting material purity, and final API specifications are critical to meet pharmacopeial requirements.
• Supply Chain Risks: Geopolitical events, COVID-19 disruptions, and raw material shortages can impair reliable supply.
• Cost and Lead Times: The complexity of synthesis and regulatory processes influence pricing and delivery timelines.

5. Due Diligence and Procurement Strategies

• Supplier Verification: Thorough audits, quality certifications (ISO, GMP, WHO PQ), and on-site inspections are necessary before long-term engagement.
• Qualification Processes: Analytical method validation, stability testing, and batch certification should be verified to ensure API integrity and compliance.
• Supply Agreements: Establishing strong contractual frameworks to mitigate risks of shortages, price fluctuations, and regulatory changes.

Conclusion: Ensuring a Reliable API Supply for Inamrinone Lactate

Sourcing high-grade inamrinone lactate APIs requires a comprehensive approach, aligning quality, regulatory compliance, cost, and supply stability. Leading global suppliers like Formosa Sumuka, Jiangsu Hengrui, and Siegfried stand out for their quality assurance and reliability. Regional manufacturers in India and Europe complement the supply chain, offering competitive options. Strategic partnerships, rigorous supplier qualification, and an emphasis on regulatory compliance are essential to mitigate risks and ensure a continuous supply loop for pharmaceutical formulators and distributors.

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Key Takeaways

• Leading global API suppliers such as Formosa Sumuka, Jiangsu Hengrui, and Siegfried offer high-quality inamrinone lactate with proven regulatory compliance.
• Indian manufacturers, including Divi's Laboratories and Jubilant Life Sciences, provide cost-effective alternatives but require careful due diligence.
• Contract manufacturing organizations afford flexibility and scalability, vital during supply chain disruptions.
• Regulatory adherence, quality assurance, and Supply Chain Security are paramount to maintaining API integrity and compliance.
• Establishing long-term, transparent supplier relationships and conducting comprehensive audits minimizes risks and ensures a reliable API supply.

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FAQs

Q1: Is inamrinone lactate readily available from multiple suppliers globally?
A1: Yes, several reputable manufacturers worldwide, including those in Taiwan, China, Switzerland, and India, supply high-quality inamrinone lactate APIs, ensuring competitive options for pharmaceutical companies.

Q2: What are key criteria for selecting an API supplier for inamrinone lactate?
A2: Critical factors include GMP compliance, consistent batch quality, regulatory certifications (FDA, EMA), supply stability, scalability, and transparent quality documentation.

Q3: How can manufacturers mitigate risks associated with API supply disruptions?
A3: By diversifying suppliers, establishing long-term supply agreements, conducting rigorous supplier audits, and maintaining strategic stockpiles.

Q4: Are there any regulatory hurdles in importing inamrinone lactate APIs from Asian manufacturers?
A4: Potential hurdles include compliance with local import regulations, validation of manufacturing standards, and ensuring the supplier's adherence to international Good Manufacturing Practices (GMP). Proper documentation and validation can mitigate these risks.

Q5: How does the cost of APIs influence the final drug pricing?
A5: API costs constitute a significant portion of manufacturing expenses. Higher quality, regulatory compliance, and supply chain stability may increase costs, but these investments are critical to ensure drug safety and efficacy, ultimately influencing product pricing.

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Sources

[1] Pharmaceutical Intelligence. "Global API Market Report," 2022.
[2] US FDA. "Guidance for Industry: Good Manufacturing Practices," 2021.
[3] European Medicines Agency. "API Manufacturing Guidelines," 2022.
[4] Industry Reports. "API Supply Chain Resilience Amidst Global Disruptions," 2023.
[5] Company Websites and Product Catalogs (Formosa Sumuka, Jiangsu Hengrui, Siegfried).