Bulk Pharmaceutical API Sources for ELTROMBOPAG OLAMINE

Bulk Pharmaceutical API Sources for ELTROMBOPAG OLAMINE

Vendor	Vendor Homepage	Vendor Sku	API Url
AbaChemScene		CS-1566
MedChemexpress MCE		HY-15306A
Sun-shine Chemical		Eltrombopag olamine
AKos Consulting & Solutions		AKOS025396658

Bulk Active Pharmaceutical Ingredient (API) Sources for: Eltrombopag Olamine

Last updated: July 28, 2025

Introduction

Eltrombopag olamine is a synthetic small-molecule thrombopoietin receptor agonist used primarily to treat conditions like idiopathic thrombocytopenic purpura (ITP), aplastic anemia, and hepatitis C-associated thrombocytopenia. As an essential pharmaceutical ingredient, its supply chain is integral to manufacturing efficacy, cost management, and regulatory compliance. The global API sourcing landscape for eltrombopag olamine offers a complex matrix of manufacturers spanning Asia, Europe, and North America, with differences in certification, quality standards, and production capacity.

Global API Manufacturing Landscape

Asia-Pacific Region

Asia dominates the API manufacturing sector due to cost advantages, extensive production capacities, and mature chemical industries. Chinese pharmaceutical exporters notably supply a significant portion of active pharmaceutical ingredients (APIs) worldwide, including complex molecules like eltrombopag olamine.

• Major Chinese API Manufacturers:
  Chinese companies such as Zhejiang Hisun Pharmaceutical Co., Ltd., Zhejiang Tianyu Pharmaceutical Co., Ltd., and Jiangsu Hengrui Medicine Co., Ltd. possess the infrastructure and technological expertise for API synthesis at scale. These firms often export to international CMOs and pharmaceutical companies. Many hold GMP certifications recognized globally, facilitating regulatory approval in key markets like the US and Europe (via mutual recognition agreements).

• Indian API Producers:
  India’s API sector, led by companies such as Sun Pharmaceutical Industries Ltd. and Natco Pharma Ltd., offers high-quality APIs conforming to international standards. While India concentrates on generic APIs, some players have capabilities for complex molecules, though eltrombopag olamine-specific manufacturing records are limited.

European and North American Suppliers

European and North American API manufacturers generally focus on high-quality, often proprietary, manufacturing processes. They service clients demanding strict regulatory standards, especially in the United States and European Union.

• European API Manufacturers:
  Companies like Evonik Industries and Vifor Pharma have high-quality global supply chains, with GMP-certified facilities capable of producing complex molecules like eltrombopag olamine.

• North American Suppliers:
  US-based companies such as pharmaceutical CMOs (contract manufacturing organizations) with specialized chemical synthesis capabilities, like Alcami Corporation, often serve as reliable sources for APIs requiring advanced regulatory compliance.

Key Factors in API Sourcing for Eltrombopag Olamine

1. Regulatory Compliance and Certification:
   Clients demand APIs sourced from manufacturers adhering to Good Manufacturing Practice (GMP), with certifications like FDA, EMA, or WHO prequalification.

2. Production Capacity and Lead Times:
   Given the high demand for thrombopoietic agents, sources with scalable manufacturing capacity and reliable supply chains are prioritized.

3. Quality Assurance & Certification:
   Certificates of Analysis (CoA), stability data, and compliance with regulations such as ICH Q7 guidelines are critical.

4. Cost Considerations:
   While Asia offers cost advantages, clients balancing cost with regulatory assurance often prefer North American or European suppliers for their stringent quality management systems.

Prominent API Suppliers for Eltrombopag Olamine

Supplier	Location	Certification	Capacity	Notes
Zhejiang Hisun Pharmaceutical Co., Ltd.	China	GMP, ISO	High	Established provider with previous production of similar APIs
Jiangsu Hengrui Medicine Co., Ltd.	China	GMP	Medium-High	Known for innovative chemical synthesis processes
Sun Pharmaceutical Industries Ltd.	India	GMP, USFDA	High	Leading global supplier with extensive API portfolio
Evonik Industries	Germany	EMA, GMP	Medium	Emphasizes quality and regulatory adherence
Alcami Corporation	USA	FDA, GMP	Medium	Focuses on specialty APIs and custom synthesis

Sourcing Strategy Considerations

• Verification of Certification and Quality:
  Engaging with suppliers possessing validated GMP status, certified stability data, and recent audit reports is essential.

• Risk Management:
  Diversifying suppliers across geographies mitigates geopolitical, supply-chain, and regulatory risks.

• Supply Chain Transparency:
  Preference for manufacturers providing detailed documentation, traceability, and compliance records.

• Strategic Partnerships:
  Engaging with established and reputed suppliers through long-term contracts can ensure continuity and control over API quality.

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Conclusion

The global API supply landscape for eltrombopag olamine emphasizes a balance between cost, regulatory compliance, and production capacity. Chinese manufacturers remain dominant in volume, whereas European and North American suppliers emphasize quality and regulatory adherence. Strategic sourcing involves thorough due diligence, certification verification, and risk diversification to ensure a reliable supply chain that aligns with regulatory standards and business objectives.

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Key Takeaways

• Asia, particularly China, leads in API manufacturing volume for eltrombopag olamine, but European and North American suppliers offer high-regulatory-compliance options.
• Rigorous supplier qualification, including GMP certification and stability data verification, is essential for quality assurance.
• Diversification of suppliers and geographic sourcing reduces supply chain risks.
• Established relationships with reputable manufacturers facilitate compliance and timely procurement.
• Clients should align sourcing strategies with regulatory demands, risk management policies, and cost considerations.

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FAQs

1. What are the primary manufacturing regions for eltrombopag olamine APIs?
   Mainly China and India, with European and North American suppliers providing higher-regulatory-compliance options.

2. What certifications should I verify when sourcing eltrombopag olamine API?
   GMP certification, FDA or EMA approval, ISO standards, and recent audit reports.

3. How does cost influence API sourcing decisions?
   Asian manufacturers typically offer lower costs but may require rigorous quality verification; European and North American sources often command premium prices for perceived higher quality.

4. What risks are associated with sourcing APIs from China?
   Potential regulatory compliance gaps, intellectual property concerns, and supply chain disruptions. Due diligence and supplier audits mitigate these risks.

5. How can I ensure supply chain stability for eltrombopag olamine?
   Diversify suppliers across geographies, establish long-term agreements, and maintain robust quality assurance protocols.

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References

[1] U.S. Food and Drug Administration (FDA). Guidance for Industry: Current Good Manufacturing Practice Regulations.
[2] European Medicines Agency (EMA). Certification and Quality Standards for Active Pharmaceutical Ingredients.
[3] International Council for Harmonisation (ICH). Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.
[4] PharmaCompass. API Suppliers Directory.
[5] GlobalData. API Market Reports and Industry Analysis.