API R&D Platform
- Internationalized API (including related intermediates) R&D and registration platform. The R&D team is familiar with drug registration regulations and chemical drug R&D technical guidelines in various countries, and has rich experience in submitting DMF registration applications for APIs in CDE, FDA, and EDQM, as well as supplementary research and response based on expert review opinions, and has accepted research and development many times and the inspection of the production site.
- The professional team assesses whether the R&D project has infringement risks, proposes strategies to avoid patent risks, explores the patentability of R&D projects and applies for patents.
- The synthesis team has the ability and large-scale production experience for the process development, process optimization and process conversion of a variety of difficult products, especially APIs and intermediates in the multi-chiral center. It can quickly open up routes, optimize the process while taking into account cost control and environmental protection requirements, and the factory conversion efficiency is high.
- The team is familiar with the quality research of various APIs, and has rich research experience on the purity, content, impurities, isomers, crystal form, crystal habit, particle size, and fluidity of APIs.
- Good at reaction types include hydrogenation, asymmetric catalysis, low temperature reaction, Grignard reaction, etc.
- It can provide customized synthesis services of gram-level to ton-level products of various small molecule new drug compounds.
- The company has more than 400 sets of various synthesis, preparation, and analysis equipment, and has a complete set of synthesis, preparation pilot/pilot research and development equipment, including rotary evaporator, glass reactor, liquid phase preparation, fluidized bed, and granulator , Tablet press, coating machine, capsule filling machine, freeze dryer, etc.; various analysis and testing equipment, including LC-MS, HPLC, UPLC, GC, TGA, DSC, etc.