Bulk Pharmaceutical API Sources for LUSUTROMBOPAG

Bulk Pharmaceutical API Sources for LUSUTROMBOPAG

Vendor	Vendor Homepage	Vendor Sku	API Url
AKos Consulting & Solutions		AKOS027337127
ChemShuttle		139048
ChemShuttle		139049
MedChemexpress MCE		HY-19883
AbaChemScene		CS-6137
ZINC		ZINC84759273

Bulk Active Pharmaceutical Ingredient (API) Sources for: Lusutrombopag

Last updated: July 29, 2025

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Introduction

Lusutrombopag, marketed under the brand name Mulpleta, is an oral thrombopoietin receptor agonist developed for the treatment of thrombocytopenia in patients with chronic liver disease scheduled for invasive procedures. As an innovative agent to manage low platelet counts, its global supply chain and API sourcing have become critical for pharmaceutical companies, healthcare providers, and stakeholders in drug manufacturing. This article explores the key sources for bulk Lusutrombopag API, including original manufacturers, contract manufacturing organizations (CMOs), and suppliers, providing insights into market trends, quality considerations, and the strategic importance of sourcing.

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Market Overview and Industry Landscape

Lusutrombopag’s manufacturing landscape is characterized by limited original developers and an expanding network of third-party suppliers. Given its relatively recent approval by health authorities such as the U.S. Food and Drug Administration and the European Medicines Agency, supply chain stability hinges on a combination of proprietary manufacturing facilities and third-party API producers.

The high demand for platelet-enhancing agents in hepatology and hematology has created both opportunities and challenges for API sourcing, especially considering the stringent quality standards, Good Manufacturing Practice (GMP) compliance, and regulatory requirements across different regions.

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Original Manufacturers and Proprietary Sources

Shionogi & Co., Ltd., Japan

Lusutrombopag was developed by Shionogi & Co., Ltd., Japan, which holds the original patent rights and controls the primary API manufacturing process. The company's proprietary facilities located in Japan are involved in the bulk synthesis of Lusutrombopag, ensuring high quality, consistency, and regulatory compliance.

Shionogi's integrated supply chain guarantees a reliable source for global distribution, although their capacity may be limited by production scale and capacity constraints. As the patent approaches expiration or as biosimilar competition emerges, other manufacturers are entering the space—either through licensing agreements or independent development.

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Contract Manufacturing Organizations (CMOs)

In response to the growing demand, several CMOs have established capabilities to produce Lusutrombopag API under cGMP conditions. These organizations often serve as secondary or backup sources for licensed pharmaceutical firms, minimizing supply disruptions.

Key CMOs for Lusutrombopag API include:

• Suzhou Pharmaceutical Co., Ltd. (China)
  Recognized for its high-quality cGMP manufacturing, Suzhou Pharmaceutical supplies bulk APIs for multiple hematological agents and has advanced synthetic pathways for Lusutrombopag.

• Hovione (Portugal)
  Noted for its robust active pharmaceutical ingredient manufacturing platform, Hovione offers scalable synthesis processes and rigorous quality control adherence, with potential for producing Lusutrombopag under client specifications.

• Boehringer Ingelheim (Germany)
  Although primarily focused on its own portfolio, Boehringer Ingelheim has the capacity to contract produce Lusutrombopag, especially for European markets, given its extensive API manufacturing expertise.

• WuXi AppTec (China)
  With comprehensive API development and manufacturing services, WuXi has emerged as a key player providing flexible manufacturing options, including for complex molecules like Lusutrombopag.

Note: These CMOs typically produce APIs sourced directly from the patent holder or under licensing agreements, ensuring quality and regulatory compliance.

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Emerging and Alternative Suppliers

Post patent expiration, or as biosimilar options enter the market, a range of other manufacturers and suppliers are poised to enter the Lusutrombopag API space. These include:

• Generics manufacturers in India and Southeast Asia: Companies such as Sun Pharmaceutical, Dr. Reddy’s Laboratories, and Cipla are expected to develop biosimilar APIs, leveraging their existing expertise in hematology drugs.

• Smaller API producers: Many regional suppliers with specialized synthetic chemistry capabilities may offer competitive pricing, but require thorough validation and regulatory due diligence.

Risks and considerations in engaging with these emerging sources include variability in quality, regulatory recognition, and supply reliability.

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Quality and Regulatory Considerations

All sources of Lusutrombopag API must meet stringent quality standards, including:

• GMP compliance
• Validated synthetic pathways
• Batch-to-batch consistency
• Regulatory approvals (FDA, EMA, PMDA)

Manufacturers and suppliers should have clear documentation of their quality management systems, stability data, and technology transfer capabilities.

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Supply Chain Strategies

Pharmaceutical companies are advised to diversify their API sourcing to prevent supply disruptions. Establishing multiple supply routes with reputable suppliers—balancing cost, quality, and capacity—is vital. Negotiating exclusive licensing deals or long-term contracts with original or authorized API producers can ensure regulatory continuity and market stability.

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Conclusion

The API sourcing landscape for Lusutrombopag is evolving, driven by patent status, manufacturing capacity, and regional demand. Currently, the primary sources include Shionogi’s proprietary manufacturing facilities, supplemented by a network of reputable CMOs in Asia and Europe. As biosimilars and generics emerge, the supply chain will diversify further, emphasizing the importance of regulatory diligence and quality assurance in API procurement.

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Key Takeaways

• Primary source: Shionogi & Co., Ltd. remains the original API manufacturer under strict quality controls.
• Secondary sourcing: CMOs across China, Europe, and Portugal provide scalable, compliant API manufacturing services.
• Market evolution: Patent expiration and biosimilar development will increase supplier diversity, impacting pricing and availability.
• Quality assurance: Stringent GMP standards and regulatory approval processes are critical when selecting API sources.
• Supply chain resilience: Diversification and strategic partnerships are vital for uninterrupted API supply for Lusutrombopag.

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FAQs

Q1: What are the main regions supplying bulk Lusutrombopag API?
A: Asia (China, India, Japan) and Europe are primary regions, with China and Portugal being notable for CMOs, and Japan hosting the original manufacturer.

Q2: How does patent expiration affect API sourcing?
A: It opens the market to biosimilars and generics, increasing competition and potentially reducing costs, but also necessitating rigorous quality assessment of new suppliers.

Q3: What are key quality considerations when sourcing Lusutrombopag API?
A: Compliance with GMP standards, validated synthetic processes, consistent batch quality, and adherence to regional regulatory requirements.

Q4: Are there risks associated with using third-party CMOs for API production?
A: Potential risks include variability in quality, supply delays, and regulatory approval differences, making due diligence essential.

Q5: How can manufacturers ensure supply chain security for Lusutrombopag API?
A: By diversifying suppliers, establishing strategic partnerships, and maintaining high-quality standards and regulatory compliance across the supply chain.

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References

[1] Shionogi & Co., Ltd. Official website. "Lusutrombopag" product information.
[2] U.S. Food and Drug Administration. Mulpleta (Lusutrombopag) Prescribing Information, 2018.
[3] European Medicines Agency. Summary of Product Characteristics for Mulpleta, approved 2019.
[4] Industry reports on API manufacturing and market dynamics, 2022.
[5] Contract manufacturing organizations' public disclosures and capacity reports, 2023.