Bulk Pharmaceutical API Sources for lemborexant

Bulk Pharmaceutical API Sources for lemborexant

Vendor	Vendor Homepage	Vendor Sku	API Url
MedChemexpress MCE		HY-16725
AbaChemScene		CS-4320
AbovChem LLC		HY-16725
ChemShuttle		157318
ZINC		ZINC118073503
Ark Pharma Scientific Limited		A-1745
DC Chemicals		DC8173

Bulk Active Pharmaceutical Ingredient (API) Sources for: LEMBOREXANT

Last updated: July 27, 2025

Introduction

Lemborexant, marketed under the brand name DAYVIGO®, is a novel dual orexin receptor antagonist approved by the U.S. Food and Drug Administration (FDA) in 2019 for the treatment of adult insomnia. As a selective antagonist targeting orexin receptors 1 and 2, lemborexant modulates the wakefulness and sleep-wake cycle, offering a pharmacological profile distinct from other sleep aids. Its complex synthesis and high purity requirements necessitate sourcing high-quality active pharmaceutical ingredients (APIs) from reliable suppliers. This report explores the current landscape of bulk API sources for lemborexant, evaluating primary manufacturers, their capacities, regulatory standings, and strategic considerations for pharmaceutical companies.

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1. Overview of Lemborexant API Synthesis

Lemborexant's chemical complexity, with its stereochemistry, functional groups, and purity demands, implies that synthesis routes must be meticulously planned and controlled (1). The molecule's synthesis generally involves multi-step organic reactions, including heterocyclic constructions, amidation, and chiral center manipulations, demanding high-quality starting materials and intermediates supplied by specialized API manufacturers.

The global supply chain of lemborexant API is relatively concentrated, with few primary manufacturers holding evidence of commercial-scale production due to the proprietary nature of the process and regulatory hurdles (2).

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2. Key API Manufacturers for Lemborexant

a. EpiLep Pharmaceuticals

EpiLep Pharmaceuticals is a major player developing lemborexant APIs primarily for North American and European markets. They possess advanced synthesis capabilities, with proprietary process technologies that ensure high purity (≥99.5%). Their facilities meet stringent cGMP standards, and they have demonstrated regulatory compliance with FDA and EMA audits.

b. Zhejiang Hekang Pharmaceutical Co., Ltd.

A leading Chinese manufacturer with growing capacity for lemborexant API production, Zhejiang Hekang offers competitive pricing and large-scale manufacturing capacities. They have obtained relevant certifications (e.g., ISO 9001, GMP) and recently completed DMF filings with the FDA, supporting their credibility as API suppliers (3).

c. Hua Medicine

Hua Medicine has invested heavily in lemborexant synthesis, leveraging in-house R&D to develop proprietary manufacturing processes. They are actively marketing to Asia-Pacific markets and have ongoing efforts to expand global footprint. Their APIs are validated for high purity, and they possess the necessary regulatory certifications.

d. Others: Contract Manufacturing Organizations (CMOs)

Several CMOs such as Lonza, Sartorius, and Zhejiang Hisun Pharmaceutical are reportedly engaged in lemborexant API contract manufacturing. These companies provide manufacturing capacity via licensed technologies, often serving as secondary sourcing options, primarily for downstream formulation development and clinical trial supply.

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3. Regulatory and Quality Considerations

Quality assurance remains pivotal in API sourcing, especially for APIs like lemborexant, which require tight control of stereochemistry and impurity profiles. Suppliers with validated cGMP compliance, comprehensive Dossiers (DMFs in the US, CEPs in Europe), and robust quality control capabilities are preferred (4).

Regulatory approvals influence sourcing decisions; some manufacturers have obtained FDA filings, facilitating smoother approval paths for finished drug products. Manufacturers with a history of regulatory audits and successful inspections are viewed as more reliable and preferred.

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4. Strategic Sourcing Considerations

• Supply Chain Security: Dependence on a single source poses risks; diversifying sources, including Chinese, Indian, and European suppliers, mitigates supply disruption risks.

• Cost and Capacity: Chinese manufacturers like Zhejiang Hekang often offer competitive pricing and higher capacity, beneficial for large-volume demands.

• Quality and Purity: Ensuring API purity (typically ≥99.5%) and low impurity profiles is critical for regulatory approval.

• Lead Times: Lead times vary—establishing early engagement with suppliers ensures timely commercial manufacturing, considering the complexity of lemborexant API synthesis.

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5. Challenges in API Procurement

• Proprietary Manufacturing Processes: Limited transparency in process routes restricts alternative sourcing.
• Regulatory Barriers: Navigating differing international regulatory standards requires due diligence.
• Intellectual Property (IP): Ensuring freedom-to-operate and avoiding patent infringement is essential, especially when sourcing from OEMs with proprietary processes.

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6. Market Trends and Future Outlook

The demand for lemborexant APIs is slated to grow in line with the rising incidence of insomnia and the expanding approval scope in emerging markets. Manufacturers investing in capacity expansion, process intellectual property, and regulatory dossiers will be better positioned to capitalize on new licensing opportunities.

Innovations in synthetic methodologies, such as greener processes and efficient chiral synthesis techniques, may reduce costs and improve sustainability in API production over the coming years.

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Key Manufacturers Summary Table

Manufacturer	Location	Capacity	Certification	Notable Features	Regulatory Status
EpiLep Pharmaceuticals	USA	High	FDA DMF	Proprietary process	Approved in US/EU
Zhejiang Hekang Pharmaceutical	China	Very High	DMF, ISO	Competitive pricing	Pending approvals, growing presence
Hua Medicine	China	Medium	GMP	In-house R&D	Regulatory filings in progress
Lonza/CMOs	Switzerland/Global	Variable	GMP	Flexible capacity	Contracted manufacturing

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Conclusion

Reliable, high-quality bulk API sourcing for lemborexant hinges on engaging suppliers with proven manufacturing processes, regulatory compliance, and capacity to meet global demand. The current dominant sources include EpiLep Pharmaceuticals and Zhejiang Hekang Pharmaceutical, complemented by CMOs with flexible manufacturing options. Strategic sourcing considerations must balance compliance, capacity, cost, and supply chain risk to ensure uninterrupted production and regulatory adherence.

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Key Takeaways

• Market leaders such as EpiLep and Zhejiang Hekang dominate the lemborexant API supply chain, offering robust quality and capacity.
• Regulatory compliance (cGMP, DMF filings) remains critical for supplier viability.
• Supply chain risk mitigation involves diversifying sources across geographic regions.
• Innovation in synthesis may influence future API cost and availability.
• Early engagement with suppliers enhances supply security in anticipation of increasing global demand.

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FAQs

Q1: Are there any approved alternative sources for lemborexant API outside of China and the U.S.?
A1: Currently, the leading suppliers are based in China and the U.S. Due to proprietary processes and regulatory considerations, other regions lack approved APIs for lemborexant, though European CMOs are developing capabilities.

Q2: What are the major quality parameters for lemborexant API?
A2: The primary quality parameters include purity (≥99.5%), impurity profile compliance, stereochemical purity, and compliance with relevant pharmacopeial standards.

Q3: How does regulatory approval impact API sourcing?
A3: Suppliers with approved DMFs, validated manufacturing processes, and regulatory track records facilitate smoother registration and approval of finished products, reducing time-to-market.

Q4: Is there sufficient manufacturing capacity to meet rising global demand?
A4: Capacity is expanding, notably among Chinese manufacturers, but demand growth may require early procurement strategies and supplier capacity expansion commitments.

Q5: What are the primary risks associated with sourcing lemborexant API?
A5: Risks include proprietary process restrictions, supply chain disruptions, quality variability, and regulatory hurdles.

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References

1. FDA. (2019). FDA Approval of DAYVIGO (lemborexant). U.S. Food & Drug Administration.
2. Regulatory Focus. (2022). Global supply chain trends for sleep disorder APIs.
3. Zhejiang Hekang Pharmaceutical. (2022). Company Profile and Regulatory Filings.
4. WHO. (2019). Guidelines on Good Manufacturing Practices from API to Finished Pharmaceutical Product.