WHAT WE DO
Xieli Pharm was Founded in 1980's as professional manufacturer on oncology＆animal/botanical derivative APIs and CMO services, with cGMP\ EU GMP\ Japan GMP certified factory and independent R&D center. R＆D team with rich experience in process development in R＆D, process scale-up and production, and succeed to finish many CMO projects. RA team with rich experience for global registration. DMF including 17 products registered in 100+ countries and submission 500+ times. Irinotecan certificated with Japan GMP and EU GMP. Rutin and Troxerutin certificated with EU-GMP; CEP for Diosmin ＆ Troxerutin＆Irinotecan Hcl＆Gefitinib＆Anastrozole. OEM for plant extracting and TCM Processing. CDMO for Process Development, Intermidate, APIs, Formulation and Clinic Study.
HISTORY
1980s
Founded in PengZhou City as professional manufacturer of oncology＆animal/botanical derivative active pharmaceutical substance product，with GMP certified facility＆independent R＆D center。
2004
First API product granted with GMP certificate.
2006
in 2006, new API manufacturing site came into use.
2010
Japan PMDA inspection, approved, IRT
2011
UK MHRA inspection, approved: Rutin, Troxerutin, IRT
2012
2013
EU-GMP inspection approved, granules
2014
CEP obtained: Diosmin
2015
EDQM inspection approved for Diosmin
2016
FDA inspection approved for Ingenol Mebutate
2017
COFEPRIS inspection approved for Erlotinib
2018
CEP obtained: Troxerutin, Anastrozole, IrinotecanFDA surveillance inspection, “0 observation”
CULTURE
Under Construction...
Core Value
Under Construction...
Qualifications
US FDA
Facility has been inspected ＆approved by US FDA since 2016 and passed the on-site audit again with zero observation on Aug. 2018.
JAPAN PMDA
Facility has been inspected ＆approved by Japan PMDA since 2010 and passed the on-site audit again in 2016.
EU EDQM
Five products certified with CEP certificate by EU EDQM. (Diosmin、Troxerutin、Gefitinib、Irinotecan Hcl、Anastrozole)
COFEPRIS
Facility has been inspected ＆approved by Mexico COFEPRIS for erlotinib since 2017.
CFDA
First API product granted with GMP certificate.