Luohe Chief Pharmaceutical Co., Ltd. (afterwards named as Luohe Chief) located in Luohe City, Henan Province, China, is a newly established pharmaceutical company, which is planned to manufacture APIs for antituberculosis and HIV infection. US FDA certification for 4 products and EDQM CEP certification for 3 products were planned by Luohe Chief.

Foshan RuiTong Consulting Co.,Ltd. (afterwards named as RuiTong) is a GMP consulting and execution company located in Foshan City, Guangdong Province, China, its main service contents include GMP consulting and execution, DMF/CEP/ASMF/WHO PQ registration, Audit.

Therefore, Luohe Chief would like RuiTong to provide GMP, CEP, DMF services to Luohe Chief according to Chinese GMP, EU GMP, US cGMP requirements and drug registration regulation requirements related to EDQM CEP and US FDA DMF.

RuiTong fully participated in construction of this project, main service contents provided by RuiTong include:

n  Documentation

n  URS and Risk assessment

n  Qualification of equipment and facilities

n  Validation

n  Training

n  Drug Manufacturing License application

n  4 US DMF number application

n  3 EDQM CEP Certificates application

The project was initiated on May 08, 2020 and until now, Luohe Chief has successfully created complete quality system by combined effort of all person of Luohe Chief and RuiTong. Luohe Chief had been inspected by Henan Medical Products Administration from January 16 to 17, 2021, and obtained the Drug Manufacturing License on January 21,2021.  From February 2021 to now ,Luohe Chief has successfully passed the on-site inspection of many well-known pharmaceutical enterprise at home and aboard and the GMP on-site inspection of Henan Medical Products Administration.

At present, RuiTong has successfully helped Luohe Chief to submit 3 US DMF dossiers and 2 EDQM CEP dossiers , Luohe Chief has received the acceptance letters from US FDA and EU EDQM.

The process validation, analytical methods validation, and cleaning validation for another product are on going , its relevant structure identification, metal elemental impurity analysis, analysis of genotoxic impurities are studying, relevant registration application materials are prepared, the US DMF and EDQM CEP application materials are planned to be submitted in December, 2021.

Highly appreciated sincere cooperation of all project team members of Luohe Chief Pharmaceutical Co.,Ltd. and Foshan RuiTong Consulting Co.,Ltd. Every step of life is not in vain, all the road through will become“stepping stone”, when you harvest the fruits of victory you should thank your own efforts and persistent! RuiTong insists concept of “Customer needs as the center and results-oriented”, helps customers in every detail strictly, If you need to know more about our GMP and registration (CEP/DMF/ASMF/WHO PQ) services, please do not hesitate to contact us.

Foshan RuiTong Consulting Co.,Ltd.

Room 803, Fuwei Building, Huangqi, GuangFo Road No.1, Nanhai District, Foshan City, Guangdong Province, China

Website: http://www.gdruitong.cn/

Tel.: 0086-13660057841, 0086-13695153512

E-mail: ruitong01@gdruitong.cn