LESUN PHARMA provides an efficient, flexible and high-quality solutions for small molecule, ranging from route design, process improvement and optimization, process scale-up and multi-gram to multi-kilo manufacturing of Active Pharmaceutical Ingredients (APIs). Our solutions will enable you to maximize your efficiency, minimize your cost and shorten your lead times.

Route Design & Evaluation

●Route scouting and selection

●Carry out material and production cost analysis of each route

●Enviromental friendly assessment

Process Optimization

●Process Optimization of key parameters such as reagent, catalyst, solvent, reaction temperatures and time

●Isolation, characterization, synthesis and control of the impurities in process chemistry research and development

●Material balance

●The Innovative technical scheme for wastewater treatment

Scale up Service

●Process validation on kilogram scale

●Supply non-GMP drug substances for IND toxicology studies

●Scale-up for preclinical and early phase clinical under the GMP

Filing Document Preparation

●CFDA/TGA/FDA dossier filling support