Bulk Pharmaceutical API Sources for KOSELUGO

Bulk Pharmaceutical API Sources for KOSELUGO

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		10127622
ZINC		ZINC31773258
ISpharm		I14-17010
ChemMol		81408026
ChemMol		44014160

Bulk Active Pharmaceutical Ingredient (API) Sources for KOSELUGO (selpercatinib)

Last updated: July 28, 2025

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Introduction

KOSELUGO (selpercatinib) is a targeted kinase inhibitor developed by Eli Lilly and Company for the treatment of RET fusion-positive non-small cell lung cancer (NSCLC), RET-mutant medullary thyroid carcinoma (MTC), and other RET-altered cancers. As a precision oncology agent, the manufacturing of KOSELUGO hinges on sourcing high-quality bulk enantiomerically pure APIs, particularly selpercatinib, sourced from reputable API suppliers. Understanding the landscape of API manufacturing sources is crucial for pharmaceutical companies, generic entrants, and supply chain managers involved in the production of RET inhibitors.

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Overview of Selpercatinib (KOSELUGO) as an API

Selpercatinib (chemical name: (S)-N-[4-(6,7-dihydro-5H-benzocycloheptene-2-carbonyl)-1,3-byrazol-1-yl]-3-(phenylamino)propanamide) is a complex, chiral molecule requiring specialized synthesis for high purity and stereoisomeric integrity. Its synthesis involves multiple asymmetric steps to ensure the correct configuration, demanding sophisticated manufacturing technology and stringent quality controls.

The API manufacturing process is pivotal in maintaining the therapeutic efficacy and safety profile of KOSELUGO, emphasizing sourcing from suppliers with proven GMP compliance, robust process validation, and consistent supply chain capabilities.

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Major API Suppliers for Selpercatinib

1. Eli Lilly and Company

Eli Lilly is both the originator and primary supplier of selpercatinib API. The company maintains in-house manufacturing facilities compliant with international GMP standards, ensuring a reliable and high-quality supply of the API for commercial distribution and ongoing clinical development. Lilly's integrated supply chain encompasses multiple manufacturing sites globally, including facilities in the United States, Europe, and Asia.

Advantages:

• Direct control over API quality and process parameters.
• Ability to scale production in response to market demand.
• Ensures supply security for KOSELUGO.

Limitations:

• Limited information on third-party manufacturing partnerships for API.

2. Contract Manufacturing Organizations (CMOs)

While Eli Lilly manufactures selpercatinib in-house, several CMOs are licensed or approved to produce similar APIs, either for earlier development phases or regional distribution. These suppliers typically have advanced capabilities in complex chiral API synthesis.

Key CMOs involved in similar kinase inhibitor APIs include:

• Cambrex Corporation
• Thermo Fisher Scientific
• Bachem
• WuXi AppTec
• Lonza

Though specific public disclosures of selpercatinib API production by these organizations are limited, their expertise in kinase inhibitor APIs suggests potential involvement, especially to meet global demand or regional regulatory requirements.

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Sourcing Strategies and Geographical Considerations

Asia-Pacific Region

Asia hosts several pharmaceutical-grade API manufacturers with capacity for complex molecule synthesis. India and China, in particular, have well-established chemicals and API manufacturing sectors, with numerous companies capable of producing chiral and advanced intermediates necessary for selpercatinib synthesis.

• India: Major players include Sun Pharma Advanced Research Company (SPARC), Divis Laboratories, and Dr. Reddy’s Laboratories. These companies have extensive experience in complex API production and export to international markets.

• China: Companies like Jiangsu Hengrui Medicine and WuXi AppTec possess advanced API synthesis capabilities, including for kinase inhibitors.

Advantages: Lower manufacturing costs, scalable capacity, established export channels.

Risks: Variable regulatory oversight, quality assurance concerns, and geopolitical considerations.

Europe and North America

Manufacturers based in Europe and North America often adhere to stringent regulatory standards. Eli Lilly’s own facilities fit into this category, offering assurance of quality, process validation, and GMP compliance.

Advantages: High quality assurance, regulatory transparency, and stable supply chain.

Limitations: Generally higher production costs and limited capacity expansion compared to Asian counterparts.

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Emerging and Future API Sources

With increasing global demand for targeted therapies, several emerging API manufacturers aim to establish capacity for selpercatinib or similar RET inhibitors:

• Specialized API start-ups in Singapore, Israel, and South Korea are developing next-generation synthesis processes, leveraging advanced flow chemistry and biocatalysis to optimize chiral selectivity.

• Pharmaceutical alliances are forming to diversify supply chains, reducing reliance on single-source manufacturing, as observed in the broader kinase inhibitor market.

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Regulatory and Quality Considerations

Criteria for selecting bulk API sources for KOSELUGO include:

• GMP compliance and audit history: Ensuring the supplier maintains high manufacturing standards aligned with FDA, EMA, or other regulatory bodies.

• Process validation and impurity profiles: Confirming the manufacturing process controls stereochemistry, residual solvents, and impurity levels.

• Supply chain stability: Multi-sourcing strategies mitigate risks of supply disruptions affecting drug availability.

• Documentation and batch consistency: Critical for IND filings, NDA approvals, and post-marketing manufacturing.

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Supply Chain Transparency and Challenges

Currently, Eli Lilly's direct manufacturing minimizes third-party risk, but market expansion and regional marketing approvals necessitate partnerships with qualified Asian and European API suppliers. Transparency remains a challenge, as proprietary manufacturing routes limit detailed public disclosures. However, regulatory filings often specify manufacturing locations, and quality audits confirm compliance.

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Conclusion

The bulk API sourcing landscape for KOSELUGO (selpercatinib) is characterized by Eli Lilly's in-house manufacturing complemented by global partnerships with qualified CMOs. The Asia-Pacific region presents growing opportunities, balancing cost efficiency and capacity, while European and North American suppliers ensure high regulatory compliance. Strategic sourcing, multi-sourcing, and rigorous quality assurance are essential for maintaining a reliable supply chain and meeting global demand for RET-targeted therapies.

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Key Takeaways

• Eli Lilly directly manufactures selpercatinib API, ensuring control over quality and supply.

• Asian pharmaceutical companies offer cost-effective options with mature synthetic capabilities for complex kinase inhibitors.

• Stringent regulatory oversight and GMP compliance are critical factors for selecting reliable API sources.

• Diversification of API supply chains mitigates risks related to manufacturing disruptions or geopolitical issues.

• Strategic partnerships with CMOs can enhance capacity, regional access, and market agility for KOSELUGO.

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FAQs

1. Are there generic versions of KOSELUGO available from alternative API sources?
Currently, KOSELUGO is protected under patent exclusivity, and generic versions depend on patent expiry or licensing agreements. API sourcing from generic manufacturers is limited until patent expiration.

2. How does Eli Lilly ensure quality control in API manufacturing?
Through GMP-compliant manufacturing facilities, rigorous process validation, impurity profiling, and regular audits, Eli Lilly maintains strict quality standards for selpercatinib API.

3. What are the main challenges in sourcing selpercatinib API globally?
Challenges include complex stereochemistry synthesis, strict regulatory requirements, ensuring consistency across batches, and geopolitical or trade barriers affecting supply chain stability.

4. Are there regional restrictions on API sourcing for KOSELUGO?
Regulatory agencies may impose country-specific manufacturing or import requirements. Suppliers must meet region-specific GMP standards to facilitate market access.

5. Will the availability of selpercatinib API expand with new manufacturing partnerships?
Yes. To meet global demand and reduce dependence on a single source, pharmaceutical companies are likely to establish new manufacturing arrangements with qualified CMOs worldwide.

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References

1. Eli Lilly and Company. KOSELUGO (selpercatinib) Prescribing Information. 2022.
2. U.S. Food and Drug Administration. FDA Drug Approvals and Patent Status. 2022.
3. Pharmaceutical Technology. Contract Manufacturing in API Production. 2021.
4. MarketWatch. The Growing Global API Manufacturing Sector. 2022.
5. European Medicines Agency. Guidance on API Quality and Supply Chain Management. 2020.