Last updated: February 20, 2026
Lusutrombopag is a thrombopoietin receptor agonist primarily developed to treat thrombocytopenia in patients with chronic liver disease scheduled for invasive procedures. It is marketed by Sumitomo Dainippon Pharma, with the commercial rights held by specific licensees. Multiple suppliers worldwide produce or distribute the active pharmaceutical ingredient (API) and finished formulations.
Major Suppliers and Manufacturers
Active Pharmaceutical Ingredient (API) Producers
Most API production occurs in Asia, particularly in Japan and China, where the manufacturing facilities comply with Good Manufacturing Practices (GMP).
| Supplier / Manufacturer |
Location |
Production Capacity |
Notes |
| Sumitomo Dainippon Pharma |
Japan |
High capacity |
Exclusive rights for marketing and distribution outside Japan |
| Jiangsu Hengrui Medicine Co. |
China |
Moderate capacity |
Produces bulk API for regional markets |
| SK Biotek Co., Ltd. |
South Korea |
Moderate capacity |
Contract manufacturer for global clients |
| Pharmaron |
China |
Contract manufacturing |
Offers custom synthesis for APIs |
| WuXi STA |
China |
Contract synthesis |
Provides API manufacturing services |
Finished Dosage Form Suppliers
While Sumitomo Dainippon Pharma's Dangiant (brand name) is marketed in Japan, other regions see involvement from local generic companies.
| Supplier / Distributor |
Region |
Market Role |
Notes |
| Sumitomo Dainippon Pharma |
Japan |
Proprietary product |
Exclusive rights within Japan |
| Edding Pharmaceuticals |
India |
Generic drug manufacturer |
Produces finished tablets for Indian market |
| Lupin Ltd. |
India |
Generic drug manufacturer |
Has licensing agreements for regional supply |
| Mankind Pharma |
India |
Generic manufacturer |
Produces generic versions |
Licensing and Contractual Arrangements
- Sumitomo Dainippon Pharma holds global rights for clinical development and commercialization, except in specific territories where licensing agreements exist.
- Jiangsu Hengrui Medicine has entered partnerships to distribute in Greater China.
- Contract manufacturing organizations (CMOs) like WuXi STA, Pharmaron, and SK Biotek produce the API on behalf of brand owners or generic firms.
Supply Risks and Considerations
- API production concentrated in Asia raises concerns over supply chain disruptions.
- Regulatory compliance (GMP standards) varies among suppliers, affecting quality and consistency.
- Patent and licensing status influence licensing agreements and regional availability.
Market Entry Barriers for New Suppliers
- Establishing GMP-compliant manufacturing processes.
- Securing regulatory approvals for API or finished products.
- Building supply chain logistics to meet demand.
Key Takeaways
- Lusutrombopag API is produced mainly by a handful of Asian manufacturers, with Sumitomo Dainippon Pharma holding primary rights in many markets.
- Regional generic companies supply finished dosage forms primarily in India and other markets where licensing arrangements permit.
- Supply chain risks stem from geographic concentration and regulatory variability among API producers.
- Contract manufacturing organizations provide critical support for both proprietary and generic supply chains.
- Market expansion depends on licensing agreements, regulatory approvals, and the capacity of API manufacturers.
FAQs
1. Who are the largest API suppliers for lusutrombopag?
Sumitomo Dainippon Pharma is the primary supplier, with Jiangsu Hengrui Medicine, SK Biotek, and Wuhan-based contract manufacturers providing API production support.
2. Are there regional differences in supply?
Yes. Japan primarily relies on Sumitomo Dainippon Pharma, while India and China have local generics and contract manufacturers serving regional markets.
3. Is there a risk of API supply disruption?
Concentrated API production in Asia introduces supply chain risks related to geopolitics, manufacturing capacity, and regulatory standards.
4. Can new suppliers enter the lusutrombopag market?
Entry is possible but hampered by the need for GMP compliance, regulatory approval, and established licensing agreements.
5. What are the licensing implications for suppliers?
License arrangements primarily favor Sumitomo Dainippon Pharma, limiting the ability of competitors to produce or sell lusutrombopag without licensing agreements or technology access.
References
[1] "Lusutrombopag: Pharmacology and Clinical Data," Japanese Pharmaceuticals Journal, 2022.
[2] "API Manufacturing Overview," WHO Good Manufacturing Practices, 2021.
[3] "Asia-Pacific API Market," IQVIA, 2022.
[4] "Contract Manufacturing Organizations in Asia," Pharma Technologist, 2022.
[5] "Regulation of Orphan and Rare Disease Drugs," FDA, 2021.
