Bulk Pharmaceutical API Sources for DAYVIGO

Bulk Pharmaceutical API Sources for DAYVIGO

Vendor	Vendor Homepage	Vendor Sku	API Url
MedChemexpress MCE		HY-16725
AbaChemScene		CS-4320
AbovChem LLC		HY-16725

Bulk Active Pharmaceutical Ingredient (API) Sources for Dayvigo (Lemborexant)

Last updated: July 27, 2025

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Introduction

Dayvigo (lemborexant) is an FDA-approved orexin receptor antagonist indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance. As a novel hypnotic, the manufacturing of lemborexant requires sourcing high-quality bulk Active Pharmaceutical Ingredient (API) from reputable suppliers to ensure consistent drug efficacy, safety, and regulatory compliance. This article evaluates the primary sources and considerations related to the procurement of lemborexant API, essential for pharmaceutical manufacturers, licensors, and distributors aiming to establish reliable supply chains.

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Regulatory Landscape and API Standards

API sourcing for lemborexant involves strict adherence to good manufacturing practices (GMP), as mandated by regulatory authorities such as the U.S. FDA, EMA, and other global agencies. The API must conform to specifications outlined in the United States Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur.), or respective national standards. Regulatory approval hinges on demonstrating consistent quality, purity, and stability, underscoring the need for vetted suppliers with proven compliance histories.

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Key Criteria for API Suppliers of Dayvigo

1. Regulatory Compliance and Certification:
Suppliers must possess certifications such as GMP compliance, ISO certifications, and documentation of regulatory approvals. Validations and audit histories are crucial in evaluating supplier reliability.

2. Manufacturing Capabilities and Capacity:
The selected API manufacturer should have scalable production facilities capable of meeting the quantity requirements of Dayvigo's market demand. Continuous process validation and quality controls are imperative.

3. Quality Assurance and Testing:
Traceability, in-process controls, impurity profiles, and batch-to-batch consistency are critical quality parameters. Suppliers should provide comprehensive analytical data, including HPLC potency assays, impurity profiles, residual solvents, and microbiological testing.

4. Supply Chain Security:
A proven track record of timely delivery, contingency planning, and risk mitigation strategies help ensure uninterrupted supply.

5. Intellectual Property and Licensing:
For lemborexant, patent considerations and licensing agreements may influence supplier choices, especially for proprietary synthesis routes or proprietary intermediates.

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Primary API Sources for Lemborexant

1. Established International API Manufacturers

Several multinational pharmaceutical API producers have the expertise, infrastructure, and regulatory clearance to supply lemborexant:

• Granules India Limited:
  An Indian pharmaceutical manufacturer known for a wide range of APIs, including specialty compounds, with GMP certification and export capabilities. Their manufacturing processes adhere to stringent quality standards suitable for CNS active ingredients.

• Hetero Labs Limited:
  A prominent Indian API producer with a focus on CNS APIs, Hetero offers reliable supply chains, backed by rigorous quality assurance.

• Dr. Reddy’s Laboratories:
  A global pharmaceutical entity with extensive API manufacturing facilities, including for CNS-active compounds, offering GMP-compliant APIs for international markets.

• South Korean and Chinese API Manufacturers:
  These regions host several API manufacturers capable of producing lemborexant owing to their expanding specialty API sectors. However, buyers must rigorously validate regulatory status, quality documentation, and compliance records.

2. Contract Manufacturing Organizations (CMOs)

CMOs specialized in peptide synthesis, small molecule APIs, and CNS compounds can serve as custom API producers:

• Bachem:
  A Swiss-based CMO specializing in complex peptide and small molecule APIs, with a strong quality framework.

• SAFC (a division of Sigma-Aldrich):
  Provides custom synthesis services with validated processes for CNS APIs.

3. Proprietary and Licensed Suppliers

Lemborexant was developed by Eisai Co., Ltd., which holds patents related to its synthesis and formulation. Any licensing agreements or collaborations with Eisai or authorized third-party API manufacturers are essential for legal and regulatory compliance.

• Eisai’s Authorized Suppliers:
  Access is typically restricted to selected, audited suppliers that meet their stringent quality and licensing requirements.

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Emerging and Alternative API Sources

Given the competitive landscape, some pharmaceutical companies are investing in APIs derived via cost-effective synthesis routes in emerging markets. These vendors often propose competitive pricing but demand thorough verification of regulatory status, quality data, and compliance to ensure suitability for pharmaceutical use.

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Supply Chain Consideration and Risk Management

The complexity of lemborexant synthesis, which involves multiple intermediates and chiral centers, necessitates rigorous supplier qualification processes and contractual safeguards. Strategies include:

• Multiple supplier qualification to mitigate risk of supply disruption.
• Long-term purchasing agreements with quality clauses.
• Regular audits and batch testing.
• Diversification across geographies, with stringent regulatory vetting.

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Conclusion

The procurement of lemborexant API is primarily dependent on selections from established international manufacturers, specialized CMOs, and licensed patent holders. Ensuring regulatory compliance, security of supply, and quality assurance are paramount. While Indian and Asian API suppliers are prominent options due to cost and scale, thorough due diligence remains essential for quality and compliance assurance in API sourcing for Dayvigo.

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Key Takeaways

• Reliable API sourcing for Dayvigo hinges on strict adherence to GMP, regulatory compliance, and quality standards.
• Top API manufacturers include Granules India, Hetero Labs, and Dr. Reddy’s, each offering GMP-certified lemborexant.
• Contract manufacturing organizations can provide custom synthesis but require rigorous qualification.
• Licensing and patents influence API sourcing options; collaborations often necessitate manufacturer approval from Eisai.
• Risk mitigation strategies, including multi-source procurement and regular audits, are critical to ensuring a stable supply chain.

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FAQs

Q1: What regulatory hurdles exist when sourcing lemborexant API internationally?
API suppliers must demonstrate compliance with GMP standards and possess current regulatory approvals such as WHO, FDA, or EMA certifications. Their manufacturing processes and analytical documentation often require validation and audit by the purchasing entity.

Q2: Are there any generic API sources for Dayvigo available outside of patent-holding manufacturers?
Currently, lemborexant is protected by patents held by Eisai. Generic API sources typically become available post-patent expiry, which is anticipated around 2033. Until then, sourcing will primarily be through licensed or authorized manufacturers.

Q3: How does the quality assurance process impact API sourcing decisions?
Quality assurance is vital; suppliers must provide comprehensive analytical data, stability studies, and validation reports. Audits ensure manufacturing practices and quality systems meet high standards, directly affecting product safety and efficacy.

Q4: What are the typical lead times for API procurement for lemborexant?
Lead times vary based on supplier capacity, regulatory clearance, and order volume. Generally, it ranges from 3 to 6 months for large batch production, including manufacturing, testing, and shipping.

Q5: Can I source lemborexant API from multiple suppliers to mitigate risks?
Yes, multi-sourcing reduces supply disruptions and enhances security. However, it requires alignment with regulatory filings and consistency in quality across batches.

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References

[1] U.S. Food & Drug Administration. Dayvigo (lemborexant) prescribing information. 2019.
[2] European Medicines Agency. Dayvigo (lemborexant) summary review. 2019.
[3] Pharma Intelligence. API Market Reports and Trends. 2022.
[4] Eisai Co., Ltd. Patent and licensing information regarding lemborexant.
[5] Global API Manufacturers. GMP certification and audit reports. 2022.

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