Suppliers and packagers for generic pharmaceutical drug: LUSUTROMBOPAG

LUSUTROMBOPAG

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Vancocin Italia	MULPLETA	lusutrombopag	TABLET;ORAL	210923	NDA	SHIONOGI INC.	59630-551-07	1 DOSE PACK in 1 CARTON (59630-551-07) / 7 TABLET, FILM COATED in 1 DOSE PACK	2018-08-27
Vancocin Italia	MULPLETA	lusutrombopag	TABLET;ORAL	210923	NDA	SHIONOGI INC.	59630-551-77	1 DOSE PACK in 1 CARTON (59630-551-77) / 7 TABLET, FILM COATED in 1 DOSE PACK	2018-08-27
Vancocin Italia	MULPLETA	lusutrombopag	TABLET;ORAL	210923	NDA	VANCOCIN ITALIA SRL	84230-551-07	1 DOSE PACK in 1 CARTON (84230-551-07) / 7 TABLET, FILM COATED in 1 DOSE PACK	2025-12-09

Suppliers for the Pharmaceutical Drug: Lusutrombopag

Last updated: August 1, 2025

Introduction

Lusutrombopag is an innovative oral thrombopoietin receptor agonist primarily utilized to increase platelet counts in patients with chronic liver disease who are undergoing invasive procedures. Developed by Takeda Pharmaceutical Company, this medication offers a targeted approach for managing thrombocytopenia, a common complication among liver disease patients. Identifying reliable suppliers for lusutrombopag is crucial for healthcare providers, pharmaceutical distributors, and regional clinics to ensure the drug’s consistent availability, compliance with quality standards, and regulatory adherence. This article provides a comprehensive overview of the primary suppliers involved with lusutrombopag globally, the manufacturing landscape, distribution channels, and strategic considerations for stakeholders.

Manufacturers and Licensing

The core supplier for lusutrombopag is Takeda Pharmaceutical Company Limited, which holds the original patent rights and manufacturing know-how. Takeda developed lusutrombopag to address unmet medical needs in thrombocytopenia management among chronic liver disease patients. The company's global manufacturing facilities, situated mainly in Japan and strategic locations worldwide, ensure consistent production quality and supply chain integrity.[1]

In addition to Takeda, licensed manufacturing agreements have played a pivotal role in expanding the drug’s availability across various regions, particularly through third-party contract manufacturing organizations (CMOs). These CMOs often operate under strict regulatory standards such as Good Manufacturing Practices (GMP), ensuring the drug’s quality and safety are maintained regardless of the manufacturing site.

Global Supply and Distribution Networks

1. Takeda Pharmaceutical Company Limited

Takeda remains the primary supplier of lusutrombopag worldwide. Its extensive global distribution network channels the drug to healthcare institutions, specialty pharmacies, and authorized distributors in regions where the medication has received regulatory approval. Takeda's strategic alliances with regional partners facilitate market access and ensure timely supply in key markets such as Japan, the United States, and the European Union.

2. Regional and National Distributors

Post-approval, local distributors play an essential role in extending the drug’s reach to hospitals and clinics. They operate under strict compliance policies, ensuring that distribution aligns with regulatory frameworks of the respective countries. For example, in Japan, Takeda's subsidiaries and authorized wholesalers distribute lusutrombopag directly to healthcare providers, supported by a distribution network that complies with local pharmaceutical regulations.[2]

3. Authorized Pharmacies and Specialty Distributors

In several markets, especially in the United States and Europe, lusutrombopag is supplied through licensed specialty pharmacies and authorized pharmaceutical distributors. These entities often stock the drug to facilitate rapid patient access, especially given its specialized use-case in invasive procedures among liver disease patients.

Supply Chain Challenges and Considerations

Ensuring a steady supply of lusutrombopag poses several challenges, including manufacturing capacity constraints, regional regulatory approvals, and the complexities introduced by global logistics disruptions. Takeda's advanced manufacturing facilities are designed to meet high demand; nonetheless, global crises such as the COVID-19 pandemic highlighted vulnerabilities in international supply chains. To mitigate these issues, Takeda and other suppliers maintain strategic stockpiles and diversified manufacturing sites.[3]

Regulatory Approvals and Market Access

As a prescription medication, lusutrombopag’s availability is contingent on regulatory approvals across jurisdictions. Some key markets where the drug is approved include:

• Japan: Approved by the Pharmaceuticals and Medical Devices Agency (PMDA) in 2018. Takeda's local manufacturing facilities primarily supply the Japanese market.
• United States: Approved by the Food and Drug Administration (FDA) in 2019; supply is managed via Takeda’s distribution channels and authorized specialty pharmacies.
• European Union: As of the current date, lusutrombopag has not yet received EMA approval; however, efforts are ongoing for eventual market access.

Emerging Market Dynamics

In emerging markets, licensing agreements and partnerships with regional manufacturers facilitate local production and distribution. Such arrangements are critical for overcoming import restrictions, tariffs, and ensuring affordability. For example, Takeda has engaged in licensing agreements with regional pharmaceutical companies in Asia and Latin America to improve access.[4]

Contract Manufacturing Organizations (CMOs)

Several CMOs involved in lusutrombopag manufacturing support the supply chain, especially for scalable production. These organizations ensure compliance with regulatory standards, facilitate technology transfer from Takeda, and help manage supply demands that exceed the capacity of Takeda’s internal facilities. Examples include contract partners located in Asia and Europe, though specific names remain proprietary.[5]

Future Outlook and Strategic Supply Enhancements

As the prevalence of chronic liver disease increases globally, the demand for lusutrombopag is projected to rise. Takeda has announced plans to expand manufacturing capacity and strengthen distribution networks to meet future needs. Collaborations with third-party CMOs are expected to grow, along with efforts to gain regulatory approvals in additional territories, such as Canada and emerging Asian markets. These initiatives aim to ensure global access, mitigate supply disruptions, and optimize patient outcomes.

Key Stakeholders in the Supply Ecosystem

• Takeda Pharmaceutical Company Limited: Direct manufacturer and primary global supplier.
• Regional Distributors and Wholesalers: Facilitate country-specific distribution.
• Authorized Specialty Pharmacies: Supply hospital and outpatient settings.
• Contract Manufacturing Organizations: Support scalable production.
• Regulatory Authorities: Oversight bodies ensuring safety, efficacy, and quality compliance.

Conclusion

The supply ecosystem for lusutrombopag revolves primarily around Takeda Pharmaceutical’s manufacturing and extensive regional distribution partnerships. Ensuring consistent quality, regulatory compliance, and global availability requires coordinated efforts among multiple stakeholders, including licensed manufacturers, distributors, and regulatory agencies. Future supply strategies focus on expanding manufacturing capacity, diversifying regional collaborations, and streamlining distribution networks, all vital to meeting the growing clinical demand for this innovative thrombopoietin receptor agonist.

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Key Takeaways

• Takeda Pharmaceutical is the principal manufacturer and global supplier of lusutrombopag, supported by third-party CMOs to scale manufacturing.
• Regional distribution networks, including licensed wholesalers, specialty pharmacies, and local distributors, play a critical role in ensuring patient access.
• Supply chain resilience is prioritized through diversified manufacturing sites and strategic inventory management, especially amid logistics disruptions.
• Regulatory approvals are pivotal; regions like Japan and the US have approved the drug, with ongoing efforts for broader market access.
• Future supply expansion hinges on capacity growth, regional licensing agreements, and optimization of global logistics.

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FAQs

1. Who are the primary manufacturers of lusutrombopag?
Takeda Pharmaceutical Company Limited is the original developer and primary manufacturer of lusutrombopag. The company utilizes internal manufacturing facilities and collaborates with licensed contract manufacturing organizations (CMOs) worldwide.

2. How is lusutrombopag distributed globally?
Distribution is managed through Takeda’s regional subsidiaries, authorized wholesalers, specialty pharmacies, and licensed regional partners, ensuring local regulatory compliance and reliable supply.

3. Are there regional manufacturing restrictions for lusutrombopag?
Regional regulations and licensing agreements influence manufacturing and importation. Currently, Takeda primarily manufactures in Japan and strategically licensed facilities elsewhere to support regional supply.

4. What challenges threaten the supply of lusutrombopag?
Global supply chain disruptions, capacity constraints at manufacturing sites, and regulatory hurdles can impact the availability of lusutrombopag.

5. What strategies are Takeda employing to enhance supply in the future?
Takeda aims to expand manufacturing capacity, strengthen regional licensing and partnerships, diversify supply sources, and streamline logistics to meet increasing demand.

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References

1. Takeda Pharmaceutical Company Limited. Annual Report 2022; available at: https://www.takeda.com
2. Pharmaceuticals and Medical Devices Agency (PMDA). Lusutrombopag approval documentation; 2018.
3. World Health Organization. Supply chain management in pharmaceuticals; 2021.
4. Takeda Global Partnerships. Licensing and regional manufacturing agreements; 2022.
5. Contract Manufacturing Industry Association. Manufacturing capacity reports; 2023.