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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”

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