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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

Under Construction...

Under Construction...

Core Value

Quality First、Customer First

Under Construction...

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.

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