Generic drug development and consistency evaluation  



     The generic drugs department is responsible for the evaluation of R&D    

and conformance of generic medicines. The four sections under the departm-

  ent are API material section, the analysis section, the drug formulation section    

and the quality assurance section, can undertake all the pharmaceutical  reser-

  ach work independently. All of employee have college degree or above. Each    
  project leader has more than 10 years of experience in the development of ge-    
  enric drugs or new drugs, can also good understand rules of drug R&D and    
  R&D requirements, and has good experience on drug research and licences of    
  medicine product applications.     
 The company has established a Scientific Committee for drug research
  and development composed of experts from all disciplines. The director of the    
  committee is Liu Ye, a senior pharmaceutical expert, responsible for the proj-    
  ect initiation and conclusion of all drug research and development projects, in-    
  ternal audit of application materials and technical support of the company.      


          Our company has good communication channels with the center for drug evaluation, NMPA, the National Institures for Food and Drug Control. We carry out project design and research in strict accordance with relevant laws and regulations, guiding principles and ther requirements, and pay attention to the current policy requirements in a timely manner.
           The company has a relatively complete quality management system of drug research and development , a independent quality assurance section and few full-time QA persons to supervise the authenticity and compliance of drug research and development. The key analysis and detection equipment such as HPLC and GC all adopt chromeleon network workstation, which has perfect audit tracking and authority analysis, and all data are automatically backed up regularly.
         The Generic Drug Department has a modern and standardized drug development laboratory, including a drug synthesis laboratory that can meet the requirements of trial production from milligram to kilogram  products. The pharmaceutical analysis laboratory has high performance liquid chromatography (Waters, Agilent and other brands, Equip with a variety of detectors), gas chromatograph (Agilent), infrared spectrometer, ultraviolet spectrometer, thermal analyzer, drug stability chamber (BINDER), polarimeter, melting point instrument, polarizing microscope and other necessary equipment for drug research and development. The drug fromulation lab is equipped with automatic hard capsule filling machine, coating machine with high efficiency, multi-function fluidized bed, the steam sterilizer, airflow crusher, granulator, tablet machine, coating machine, automatic dissolution tester and the domestic and foreign well-known brands of equipment, can meet the tablet, capsule, dry suspension , injection, oral liquid, such as a variety of dosage forms of trial production.

           Generics department set up has nearly 10 years, has accumulated rich experience in varieties of technology and research and development, the  R&D project indications are mainly concentrated in anticoagulant, fall hematic fat, fall blood pressure, diabetes, nerve system and etc. For APIs, focus on varieties that are difficult to synthesize or have more impurities, For preparation is good at tablet, capsule, dry suspension agent, double layer tablets, injection, etc.


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