Active pharmaceutical ingredient R&D services


 
  • Research services for the synthesis process of active pharmaceutical ingredients:Process route evaluation and design, process optimization, scale-up production, process validation, etc.
  • Quality research services:Research on the purity of active pharmaceutical ingredients, impurities, crystal forms, particle size, genotoxic impurities, development and transfer of analytical methods, validation, establishment of quality standards and stability studies.
  • Reaction types:Hydrogenation, nitration, asymmetric catalysis, enzyme catalysis, continuous flow, low-temperature reactions, format reactions, etc.
  • Drugs with multiple chiral centers:Designing, developing, optimizing processes and transferring production.
  • Application materials:Material writing and registration application.

 

 

Service advantages

 
  • The quality of API and intermediate products meets the standards of China, the USA, Europe and Japan. Some active pharmaceutical products have completed NMPA, FDA and EDQM registration and obtained sales licenses. There are over a hundred global associated clients.
  • More than 30 unique active pharmaceutical ingredients and intermediate products have achieved industrial production and have passed on-site audits by domestic and international clients multiple times with positive feedback from clients.
  • R&D of unique active pharmaceutical ingredients - covering indications such as tumor immunology, mental neurology, digestive respiratory diseases etc., such as YBTN, APTA, WTXT, LKXA, BLXT, ASKZ and BQLSN all have advantages that help formulation products enter centralized procurement to gain market share.

 

 

Resource equipment

 

The company currently has over 400 sets of advanced experimental equipment for synthesis, formulation and analysis. It has a complete set of small-scale/mid-scale R&D equipment for synthesis and formulation including rotary evaporators, glass reactors, preparative liquid chromatography systems, fluidized beds, granulators, tablet presses, coating machines , capsule filling machines , freeze dryers , etc.; various analytical testing equipment including LC-MS , HPLC , UPLC , GC , TGA , DSC , etc.