Last updated: July 27, 2025
ppliers for the Pharmaceutical Drug: Eltrombopag Olamine
Introduction
Eltrombopag Olamine is an oral thrombopoietin receptor agonist primarily prescribed for the treatment of thrombocytopenia associated with chronic immune thrombocytopenic purpura (ITP), hepatitis C–related thrombocytopenia, and severe aplastic anemia. Its commercial success hinges on a reliable supply chain, making supplier identification a critical component for pharmaceutical companies, healthcare providers, and distributors. This report explores the current landscape of suppliers for Eltrombopag Olamine, encompassing key manufacturers, procurement channels, and market dynamics.
Development and Manufacturing Background
First approved by the U.S. Food and Drug Administration (FDA) in 2015 (brand name: Promacta or Promacta), Eltrombopag Olamine is produced predominantly by pharmaceutical giants with advanced biopharmaceutical manufacturing capabilities. The synthesis involves complex organic chemistry, necessitating high-quality raw materials and specialized production facilities that adhere to Good Manufacturing Practices (GMP).
Typically, the supply chain comprises APIs (Active Pharmaceutical Ingredients) manufacturers, finished-dose producers, and authorized distributors.
Key API Suppliers for Eltrombopag Olamine
1. Supplier Landscape Overview
Given the complexity of Eltrombopag Olamine synthesis, the API market is concentrated among a handful of qualified manufacturers capable of meeting stringent quality standards. These suppliers generally operate in regions with established pharmaceutical manufacturing infrastructure, notably India, China, and certain European countries.
2. Major API Manufacturers
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Hetero Labs Ltd (India):
Hetero is a leading API supplier known for its robust portfolio of complex APIs. It manufactures Eltrombopag Olamine API under strict GMP conditions, supplying to global pharmaceutical companies. Hetero’s capacity for large-scale production and quality assurance makes it a prominent supplier in this market segment.
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Jiangsu Hengrui Medicine Co., Ltd. (China):
Hengrui, a notable Chinese pharmaceutical entity, produces various oncology and hematology-related APIs. It is reported to manufacture Eltrombopag Olamine, leveraging its advanced synthetic chemistry capabilities to meet international standards.
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Jubilant Life Sciences (India):
Jubilant has expanded its API manufacturing infrastructure, offering a wide range of pharmaceutical ingredients. Its capacity to produce Eltrombopag Olamine with high quality standards positions it as a key supplier in the global market.
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Amneal Pharmaceuticals (USA):
While primarily a finished-dose manufacturer, Amneal has been involved in API sourcing or licensing arrangements to secure the supply of Eltrombopag APIs for its formulations. Its strategic partnerships facilitate access to high-quality ingredients.
3. Other Notable API Suppliers
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Zhejiang Hisun Pharmaceutical Co., Ltd. (China):
Potential supplier, involved in the synthesis of complex APIs, possibly including Eltrombopag Olamine, depending on licensing and distribution agreements.
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Sichuan Haisco Pharmaceutical Group Co., Ltd. (China):
Engaged in the development and production of APIs and finished pharmaceuticals, with potential capabilities for Eltrombopag Olamine synthesis owing to their R&D infrastructure.
Finished-Dose Manufacturing and Distribution
The finished-dose product of Eltrombopag Olamine is manufactured primarily by a handful of firms with licensed production facilities, notably Novartis, the original patent holder and marketer of Promacta. Various regional licensors and generic producers also participate, especially in markets where patent exclusivity has expired or in countries permitting generic competition.
Relevant suppliers include:
- Novartis Pharmaceuticals: The original patent holder, responsible for large-scale manufacturing for global distribution, including licensing arrangements.
- Mylan (now part of Viatris): Active in generic formulations and sourcing APIs from third-party suppliers.
- Intas Pharmaceuticals: An Indian generic manufacturer licensed to produce Eltrombopag formulations for several markets.
- Fresenius Kabi and Hikma Pharmaceuticals: Distributors and generic manufacturers sourcing from authorized API suppliers to produce their formulations, ensuring quality compliance.
Market Dynamics and Supplier Considerations
Regulatory Factors:
Suppliers must adhere to regional regulatory requirements (FDA, EMA, PMDA, etc.). Suppliers with validated regulatory dossiers and GMP certifications are preferred for seamless approval and supply continuity.
Supply Chain Risks:
The complexity of chemical synthesis, geopolitical tensions, pandemic-related disruptions, and raw material availability can impact supply stability. Diversification across multiple qualified suppliers mitigates risks.
Pricing and Contracts:
Supply agreements often involve exclusive licensing, bulk purchase commitments, and long-term contracts to stabilize prices and ensure uninterrupted supply.
Emerging Suppliers:
Advancements in synthetic chemistry and process optimization are enabling new entrants in China's emerging pharmaceutical manufacturing sectors, potentially expanding the supplier base in the near future.
Conclusion
The supply of Eltrombopag Olamine hinges on a select group of high-capacity, high-reliability Chinese and Indian manufacturers capable of producing GMP-grade APIs. Major pharmaceutical companies like Hetero Labs, Jiangsu Hengrui, and Jubilant Life Sciences lead the API production landscape, providing the foundation for finished-dose manufacturers globally. Strategic sourcing, regulatory compliance, and supply chain resilience remain critical considerations for stakeholders seeking stable access to this vital hematology drug.
Key Takeaways
- Consolidation dominates: A handful of API suppliers—primarily from India and China—serve as primary sources for Eltrombopag Olamine.
- Regulatory compliance is critical: Only suppliers with validated GMP certifications and regulatory approvals secure long-term contracts.
- Supply chain resilience depends on diversification**: Relying on multiple suppliers mitigates geopolitical, logistical, and manufacturing risks.
- Market potential for new suppliers exists: Advances in chemical synthesis and capacity expansion in China may introduce new API manufacturers.
- Strategic partnerships enable stability: Licensing, long-term agreements, and quality assurance programs are essential to maintaining supply continuity.
FAQs
1. Who are the top API suppliers for Eltrombopag Olamine?
The leading API manufacturers include Hetero Labs (India), Jiangsu Hengrui (China), and Jubilant Life Sciences (India), each with validated GMP production capabilities.
2. Are there alternative regional suppliers for Eltrombopag Olamine?
Emerging Chinese manufacturers and potential new entrants in India are expanding capacity, but verification of quality and regulatory compliance remains essential.
3. How does patent status affect supplier choice?
Patent expiration or licensing agreements influence access to generic manufacturing, expanding supplier options in various markets.
4. What are supply chain risks associated with Eltrombopag Olamine?
Risks include geopolitical tensions, raw material shortages, regulatory delays, and pandemic disruptions, emphasizing the need for diversified sourcing.
5. How do regulatory standards impact supplier selection?
Suppliers must demonstrate GMP compliance and regulatory approvals to ensure product quality, facilitate registration, and avoid manufacturing interruptions.
References:
[1] U.S. Food and Drug Administration. Promacta (Eltrombopag) NDA Approval. 2015.
[2] Pharma intelligence reports on API manufacturing markets, 2022.
[3] Company websites and public filings from Hetero Labs, Jiangsu Hengrui, Jubilant Life Sciences.
[4] European Medicines Agency (EMA) product and manufacturing license data.
[5] Industry analysis reports on pharmaceutical raw materials, 2023.
