
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
CULTURE



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Core Value



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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.