- Products & Services
APIs ＆ Intermediates
Including Botanical＆Animal source APIs、Oncology APIs＆Advanced Intermediates
CDMO Service
Including Contract manufacturing service of API ＆Advanced Intermediate products、Synthesis Process Optimization、Process Scale-Up etc.
Import Registration
Import Registration service for API ＆Finished products imported to China
- ABOUT US
Xieli Pharm was Founded in 1980's With cGMP\ EU GMP\ Japan GMP certified factory and independent R&D center.
Irinotecan certificated with Japan GMP and EU GMP.
Rutin and Troxerutin certificated with EU-GMP; CEP for Diosmin and Troxerutin
OEM for plant extracting and TCM Processing
CDMO for Process Development, Intermidate, APIs, Formulation and Clinic Study
CFDA
——2004 First GMP certificate granted for API product
COFEPRIS
——2017 COFEPRIS inspection approved for Erlotinib
EU EDQM
——2013 EU-GMP inspection approved, granules
——2015 EDQM inspection approved for Diosmin
JAPAN PMDA
——2010 Japan PMDA inspection, approved, IRT
US FDA
—— 2016 FDA inspection approved for Ingenol Mebutate
—— 2018 FDA surveillance inspection, “0 observation”