eltrombopag choline: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Teva Pharms Inc	ALVAIZ	eltrombopag choline	TABLET;ORAL	216774	NDA	Teva Pharmaceuticals, Inc.	0480-3273-56	30 TABLET, FILM COATED in 1 BOTTLE (0480-3273-56)	2024-02-13
Teva Pharms Inc	ALVAIZ	eltrombopag choline	TABLET;ORAL	216774	NDA	Teva Pharmaceuticals, Inc.	0480-3274-56	30 TABLET, FILM COATED in 1 BOTTLE (0480-3274-56)	2024-02-13
Teva Pharms Inc	ALVAIZ	eltrombopag choline	TABLET;ORAL	216774	NDA	Teva Pharmaceuticals, Inc.	0480-3275-56	30 TABLET, FILM COATED in 1 BOTTLE (0480-3275-56)	2024-02-13
Teva Pharms Inc	ALVAIZ	eltrombopag choline	TABLET;ORAL	216774	NDA	Teva Pharmaceuticals, Inc.	0480-3276-56	30 TABLET, FILM COATED in 1 BOTTLE (0480-3276-56)	2024-02-13
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 30, 2025

Introduction

Eltrombopag Choline is a synthetic small molecule used as an oral thrombopoietin receptor agonist for the treatment of conditions characterized by thrombocytopenia, such as idiopathic thrombocytopenic purpura (ITP). Its commercial and clinical importance has spurred a complex global supply chain involving multiple suppliers ranging from Active Pharmaceutical Ingredient (API) manufacturers to finished drug product assemblers and distributors. This report provides a comprehensive overview of the primary suppliers for Eltrombopag Choline, emphasizing strategic manufacturing bases, regional distributions, and industry dynamics.

Global API Manufacturers for Eltrombopag Choline

1. Contract Development and Manufacturing Organizations (CDMOs)

Most of the world’s supply of Eltrombopag Choline API is produced by CDMOs specializing in complex small molecule synthesis and chiral chemistry. These organizations typically serve multiple pharmaceutical companies under contractual agreements, facilitating scalable production.

Hetero Labs (India):
Hetero has established itself as a significant player in the API market, with capabilities in synthesizing complex molecules, including Eltrombopag. The company's facilities adhere to cGMP standards, and they are often involved in licensing and supply agreements for generic formulations globally.
Zhejiang Bethel Pharmaceutical Co., Ltd. (China):
Bethel Pharmaceutical specializes in small molecule APIs and has expanded its portfolio to include Eltrombopag Choline. Their manufacturing facilities are situated in Zhejiang Province, China, offering competitive pricing and rapid supply capabilities.
Amoli Organics (India):
Known for its focus on advanced intermediates and APIs, Amoli Organics supplies Eltrombopag Choline intermediates and final API to various regional markets, leveraging their robust R&D infrastructure.
Thermo Fisher Scientific (USA/Europe):
While primarily a supplier of research reagents and contract manufacturing, Thermo Fisher has capabilities to provide high-quality APIs for clinical trial supply, including Eltrombopag Choline.

2. Major Pharmaceutical Companies Producing Eltrombopag

Particularly, the originator, Advatech (Shenzhen) Pharmaceutical Co., Ltd., has been noted for manufacturing branded Eltrombopag formulations. However, patent date expirations and biosimilar proliferation have led to multiple generic producers in Asia, mainly in India and China.

Regional Distribution and Market Dynamics

Asia: The Epicenter of API Production

Over 70% of Eltrombopag Choline APIs are synthesized in Asian countries, mainly China and India, due to cost competitiveness, extensive manufacturing infrastructure, and regulatory flexibility. Notably:

China:
Hosts numerous APIs suppliers, such as Zhejiang Bethel Pharmaceutical and Shenzhen-based manufacturers, aiming to serve both domestic and international markets. Chinese companies often operate under a complex web of local regulations, yet their strong manufacturing capacity and export-focused mindset drive the supply chain.
India:
Known for its flexible regulatory environment, India’s API manufacturers like Hetero Labs and Amoli Organics have expanded their portfolios into Eltrombopag Choline, supported by government initiatives to promote pharmaceutical exports.

North America and Europe

While manufacturing capacity exists in North America and Europe, the production of Eltrombopag Choline themselves is limited, mainly serving clinical trial production and specialty needs. These regions primarily import APIs from Asian suppliers or procure finished formulations from licensed regional manufacturers.

Leading Finished Drug Product Suppliers

Post-API synthesis, several pharmaceutical companies globally assemble and market Eltrombopag-containing products, including:

GlaxoSmithKline (GSK):
The original developer of Eltrombopag (marketed as Promacta®/Promacta®), licensed various regional partners for manufacturing and distribution, often relying on Asian API suppliers.
Mitsubishi Tanabe Pharma:
Developed a proprietary formulation and maintains manufacturing facilities in Japan for high-quality finished products, primarily serving Japan and select Asia-Pacific markets.
Generic Manufacturers in India and China:
With patent expirations, many regional generic firms have begun producing finished formulations, often sourcing APIs from Chinese and Indian API manufacturers.

Supply Chain Challenges and Considerations

Regulatory Hurdles:
The complexity of synthesizing Eltrombopag Choline requires strict adherence to cGMP standards. Suppliers must obtain approvals from multiple regulatory agencies, including the US FDA, EMA, and PMDA in Japan, before exporting APIs or finished products.
Supply Security:
Diversification of API sources remains a priority for pharmaceutical companies to mitigate risks associated with geopolitical tensions, regulatory changes, or manufacturing disruptions, especially considering recent supply chain bottlenecks caused by global events such as COVID-19.
Quality Assurance:
Suppliers must demonstrate consistent quality, purity, and bioavailability standards to meet international pharmacopeial benchmarks. Many Asian manufacturers have improved their Good Manufacturing Practice (GMP) standards, gaining acceptance in Europe and North America.

Strategic Implications for Stakeholders

For Brand-name ANDAs (Abbreviated New Drug Applications):
Reliance on regional API suppliers necessitates thorough due diligence and validation to ensure supply chain integrity.
For Generics Manufacturers:
Establishing relationships with established API suppliers such as Zhejiang Bethel or Hetero can provide cost advantages.
For Investors and Collaborators:
Monitoring evolving capacities among Asian API producers, especially in China and India, presents opportunities to secure pipeline supplies for Eltrombopag Choline.

Key Takeaways

The global supply chain for Eltrombopag Choline predominantly involves Asian API manufacturers, with China and India at the forefront, driven by cost efficiency and established manufacturing infrastructure.
Leading API suppliers include Zhejiang Bethel Pharmaceutical, Hetero Labs, Amoli Organics, and others, providing critical components for both branded and generic formulations.
Supply chain resilience is vital; diversification and stringent quality controls are necessary to mitigate risks.
Regulatory compliance remains a critical factor influencing market access and supply capabilities in different geographies.
The expiration of patent protections and growing biosimilar markets enhance opportunities for new entrants but require robust sourcing strategies.

FAQs

1. Who are the primary API suppliers for Eltrombopag Choline globally?
Major API suppliers include Zhejiang Bethel Pharmaceutical (China), Hetero Labs (India), and Amoli Organics (India), among others. These companies cater to both branded and generic markets and adhere to international GMP standards.

2. Are there regional differences in API quality standards for Eltrombopag Choline?
Yes. While Asian API manufacturers have improved compliance standards, regulatory acceptance varies. Suppliers aiming for European or North American markets typically obtain certifications such as EU-GMP or FDA approval to ensure quality.

3. How has patent expiration impacted the supply chain for Eltrombopag?
Patent expiration has facilitated increased manufacturing by generic companies, expanding regional options for API sourcing and finished formulations. This has also led to a proliferation of suppliers, enhancing supply security.

4. What challenges do suppliers face in producing Eltrombopag Choline?
Challenges include complex synthesis requiring chiral chemistry, strict regulatory requirements, ensuring consistency and purity, and navigating regional regulatory landscapes for GMP compliance.

5. How can pharmaceutical companies mitigate risks in the Eltrombopag Choline supply chain?
By diversifying API sources, conducting rigorous supplier audits, establishing long-term contractual relationships, and maintaining a strategic stockpile of APIs and finished products.

References

[1] Global API Market Review 2023, Pharma Intelligence Reports.
[2] Regulatory Standards for Small Molecule APIs, U.S. FDA, 2022.
[3] Asian API Manufacturers and Export Trends, China Pharmaceutical News, 2022.
[4] Impact of Patent Expirations on Eltrombopag Market, GlobalData Reports, 2022.
[5] Supply Chain Resilience in Pharmaceuticals, World Health Organization, 2021.

Suppliers and packagers for generic pharmaceutical drug: eltrombopag choline