Lemborexant API

CAS No.	1369764-02-2
Therapeutic Category	Neurology & Psychiatry
Technology	Synthetic
Dosage Form	Oral Solids
Innovator Brand	Dayvigo (Japan）
Registration Status	PV
Polymorph	/
GMP	FDA(USA)/NMPA(China)/MFDS(Korea) approved
EHS	ISO 14001 & 45001 certified

Product Description

Grade: Active Pharmaceutical Ingredient(API)
Chemical Name: (1R,2S)-2-{[(2,4-dimethylpyrimidin-5-yl)oxy]methyl}-2-(3-fluorophenyl)-N-(5-fluoropyridin-2-yl)cyclopropanecarboxamide
Molecular Formula:C₂₂H₂₀F₂N₄O₂
Molecular Weight:410.42
Specification: Enterprise Standard established according to ChP/USP/EP
Appearance: Powder
Total impurities: not more than 0.5%
Purity: not less than 99%
Residual Solvents: fully comply with ICH Q3C
Mutagenic impurities: fully comply with ICH M8
Nitrosamine assessment: available
Particle size: regular grade or milling/sieving according to customer’s requirement.
Storage: Room temperature
Production capacity: Commercial
Standard Package: 1kg/bag, 5kg/bag, or according to the customer’s requirement

Lemborexant (E-2006) is a dual inhibitor of orexin receptors OX1 and OX2, which is in phase II clinical trials for the treatment of insomnia.Lemborexant interferes with orexinergic neurotransmission to purposefully promote the initiation and maintenance of sleep.

Qingmu’s Lemborexant API has been filed in China(DMF filed and listed on CDE’s website), DMF in CTD format is available and can be supported for registration worldwide.
Qingmu’s factory is established according to ICH/USFDA/EU/JAPAN/China regulations and current GMP, totally complies with environmental law in China, no risk to remove factory. A new API factory is under design and is predicted to be put into use in 2025.
As a China manufacturer, Qingmu’s team has rich experience in patent challenges on crystalline form & synthesis processes and also synthetic route development and scale-up & quality research.
Qingmu’s lab is equipped with HPLC, GC, ICP-MS, GC-MS, CAD, microbalance, Malvern particle analyzer, etc. Qingmu passed the site inspection from NMPA(China), FDA(USA) and MFDS(Korea) and also customer audits from Europe, USA and Japan, etc.
Qingmu successfully exported products to more than 40 countries including Japan, USA, Germany, Spain, the Netherlands, Russia, South Korea, and Brazil. So please feel free to choose us.