How to Source Lemborexant for Pharmaceutical Formulation

Lemborexant (Tablets, 5mg, 10 mg) is classified under Neurology. It is therapeutically aligned with reference brands such as Dayvigo (USA). This guide highlights key sourcing factors buyers should consider when procuring high-quality Lemborexant for formulation, R&D, or bulk manufacturing.

Product Overview: Lemborexant is a dual orexin receptor antagonist used for treating adult patients with insomnia characterized by difficulties with sleep onset and/or sleep maintenance. It works by competitively blocking the wake-promoting orexin receptors (OX1 and OX2), thus reducing the “wake drive” and enabling sleep. Clinical trials have shown improvements in both sleep onset latency and wake-after-sleep-onset, with maintenance of effect over up to 12 months and a favorable tolerability profile.

1. Regulatory Compliance & Documentation

Ensure suppliers provide:

• ✔ Valid DMF (Drug Master File)
• ✔ COA (Certificate of Analysis) for each batch
• ✔ GMP, ISO, or ICH Q7 compliance certificates

2. Purity, Grade & Specification Matching

Lemborexant must meet exact grade and purity for your dosage form:

• ✔ USP / EP / JP grade verification
• ✔ Particle size distribution check
• ✔ Residual solvent and heavy metal limits

3. Supplier Reliability & Audit History

• ✔ Positive past audit reports
• ✔ Pharma client references
• ✔ Years of proven API manufacturing experience

4. Commercial Terms: Pricing, MOQ & Flexibility

• ✔ Transparent pricing
• ✔ Pilot batch MOQ flexibility
• ✔ Volume-based discounts

5. Lead Time, Inventory & Logistics

Typical lead time for Lemborexant is 4–6 weeks.

• ✔ Emergency dispatch options
• ✔ Regional warehousing
• ✔ Special storage if needed

6. Formulation Support

• ✔ Technical datasheets
• ✔ Sample availability
• ✔ Stability study support

Conclusion

Sourcing Lemborexant is more than procurement—it’s a strategic partnership. With its tablets form and 5mg, 10 mg specification, choosing a compliant supplier ensures consistent quality and regulatory approval. Prioritize documentation, verify compatibility, and build relationships with transparent, reliable suppliers to secure long-term success.

Frequently Asked Questions For Sourcing of Lemborexant