Bulk Pharmaceutical API Sources for ORILISSA

Bulk Pharmaceutical API Sources for ORILISSA

Vendor	Vendor Homepage	Vendor Sku	API Url
BOC Sciences		834153-87-6
MedChemexpress MCE		HY-14789
AbaChemScene		CS-5329
ChemShuttle		160300
DC Chemicals		DC7407

Bulk Active Pharmaceutical Ingredient (API) Sources for ORILISSA

Last updated: July 30, 2025

Introduction

ORILISSA (elagolix sodium) is a groundbreaking oral gonadotropin-releasing hormone (GnRH) antagonist developed by AbbVie for managing pain associated with endometriosis and uterine fibroids. As a critical component in pharmaceutical manufacturing, the active pharmaceutical ingredient (API)—elagolix sodium—must be sourced from reliable suppliers capable of delivering high-quality, compliant, and cost-effective raw materials. This article provides an in-depth analysis of current bulk API sources for ORILISSA, examining global suppliers, regulatory considerations, and supply chain dynamics essential for pharmaceutical industry stakeholders.

Overview of Elagolix Sodium API

Elagolix sodium, chemically known as N-[(1s,4s,5s)-2-[[6-(2,4-difluorophenyl)pyridin-3-yl]ethynyl]-2-azabicyclo[2.2.2]octan-2-yl]acetamide sodium salt, is synthesized through complex multistep processes, involving chiral chemistry, heterocyclic modifications, and precise control of stereochemistry. The manufacturing process demands high purity, stringent quality control, and compliance with Good Manufacturing Practices (GMP), ensuring safety and efficacy for patients.

Global API Manufacturing Landscape

Major API Producers

The global landscape features several established pharmaceutical API manufacturers offering elagolix sodium or its intermediates. Key players include:

• AbbVie Inc.: As the originator, AbbVie controls initial synthesis and bulk supply chains directly from manufacturing sites primarily based in the United States and Ireland. The company may also establish secondary sourcing arrangements to mitigate supply risks.

• Boehringer Ingelheim (Germany): Known for high-quality chemical synthesis capabilities, Boehringer is capable of producing complex APIs including GnRH antagonists, potentially serving as a reliable supplier.

• Suzhou Transfar Chemicals (China): An emerging player with manufacturing capacity for complex APIs, offering competitive pricing and scale advantages for pharmaceutical companies seeking cost-effective sources.

• Hetero Labs (India): Recognized for API manufacturing expertise, Hetero offers chemical synthesis services and has experience in producing hormonal APIs, potentially including elagolix sodium or intermediates.

• Hanwha Chemical (South Korea): Specializes in fine chemicals and APIs, with investments in process development for complex molecules.

Contract Manufacturing Organizations (CMOs)

Several CMOs provide dedicated services for the synthesis and scale-up of APIs like elagolix sodium:

• Catalent: Offers comprehensive API development, scale-up, and manufacturing services, including high-potency and complex molecules, with facilities compliant with GMP standards.

• Lonza: Known for extensive chemical synthesis expertise, Lonza caters to clinical and commercial API manufacturing for hormonal compounds.

• Fujifilm Diosynth Biotechnologies: While primarily focused on biopharmaceuticals, they also have chemical process capabilities relevant to API synthesis.

Supply Chain Considerations

The sourcing of elagolix sodium API involves balancing quality, regulatory compliance, lead times, costs, and geopolitical factors. The current geopolitical landscape, with trade tensions and pandemic-related disruptions, influences the stability and reliability of supply chains. Hence, pharmaceutical companies increasingly pursue dual sourcing strategies, establishing relationships with manufacturers across multiple regions.

Regulatory and Quality Assurance Factors

Manufacturers must adhere to stringent regulatory standards, particularly from agencies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. The selected API suppliers should possess:

• GMP compliance certification
• Registration or dossier approval for the API
• Traceability of raw material sources
• Robust quality management systems

Due diligence includes auditing manufacturing facilities, verifying batch-to-batch consistency, and ensuring data transparency.

Emerging Trends in API Sourcing for ORILISSA

Localization and Nearshoring

In response to supply chain vulnerabilities, several pharmaceutical companies consider moving manufacturing closer to end markets, favoring regional API production facilities.

Advancements in Synthesis Technology

Innovations such as continuous manufacturing and process intensification are increasingly adopted by API producers to enhance efficiency, reduce costs, and improve environmental sustainability.

Supply Chain Diversification

Given recent disruptions, diversifying API suppliers reduces dependency on single sources, ensuring continuity of supply.

Challenges in API Sourcing

• Intellectual Property (IP) Access: Some manufacturers might face IP restrictions, requiring licensing agreements with original developers such as AbbVie.
• Complexity of Synthesis: The sophisticated chemistry involved limits the number of qualified producers.
• Regulatory Acceptance: Ensuring that suppliers meet international standards to facilitate global distribution.

Conclusion

Reliable sourcing of elagolix sodium API is a critical component in the global supply chain for ORILISSA. Leading pharmaceutical companies often engage with a combination of original manufacturer AbbVie and third-party producers, including established CMOs and regional suppliers spanning North America, Europe, and Asia. Strategic procurement, rigorous quality assurance, and diversification are key to maintaining supply stability and regulatory compliance.

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Key Takeaways

• The primary API for ORILISSA, elagolix sodium, involves a complex synthesis process demanding high-quality manufacturing.

• Major global suppliers include AbbVie, Boehringer Ingelheim, Hetero Labs, and Suzhou Transfar Chemicals, among others.

• Contract manufacturers such as Catalent and Lonza play vital roles in scaling and ensuring compliance.

• Geopolitical factors, regulatory standards, and technological advancements influence sourcing decisions.

• Diversification and regionalization of API supply chains enhance resilience against disruptions.

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FAQs

1. Who are the primary suppliers of elagolix sodium API?
AbbVie initially produces the API internally, with secondary sources including CMOs like Catalent and Lonza, along with regional manufacturers in China, India, and South Korea.

2. What regulatory standards must API suppliers meet for ORILISSA?
Suppliers must comply with GMP guidelines set by agencies such as the FDA, EMA, and PMDA. Additionally, they should maintain rigorous quality control, batch consistency, and traceability.

3. How does geopolitical risk impact API sourcing for ORILISSA?
Trade tensions and global disruptions can threaten supply stability. Companies mitigate this by establishing multiple sourcing relationships and exploring nearshoring options.

4. What are the challenges associated with sourcing complex APIs like elagolix sodium?
The synthetically intricate process, strict quality requirements, and potential IP restrictions limit the number of qualified suppliers globally.

5. Are there emerging trends influencing API sourcing strategies?
Yes, trends include regional manufacturing, process innovation like continuous synthesis, strategic diversification, and sustainability initiatives.

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References

[1] AbbVie Product Documentation. (2023). ORILISSA (elagolix) Prescribing Information.
[2] PharmSource. (2022). Global API Manufacturing and Supply Chain Trends.
[3] EMA Guidelines. (2021). Good Manufacturing Practice for Active Substances.
[4] Industry Reports. (2022). Contract API Manufacturing: Opportunities and Challenges.
[5] Company Websites and Public Disclosures from Boehringer Ingelheim, Hetero Labs, Suzhou Transfar Chemicals, Catalent, and Lonza.