Regulatory Experience

Over the years, Sinopep has filed over 100 dossiers to regulatory agencies such as FDA, NMPA, EDQM and PMDA covering ANDA, DMF, CEP and VMF submissions. There has been no delay or failure on deficiency response in any of our filings. Today, our APls and pharmaceutical products have been successfully marketed in over 40 countries.

100+ Dossiers filed to regulatory agencies
40+ APIs or Pharmaceutical Products Marketed