Quality-Jiangsu Zhongbang Pharmaceutical Co., Ltd

Home / Quality / Regulatory Affairs

2023

· January 2023, Esomeprazole Magnesium Trihydrate API passed the compliance inspection of "Drug Production Quality Management Practices" issued by NMPA (China FDA).

2022

· July 2022, TDMF for Telmisartan API is approved by Taiwan FDA.

· March 2022, a Renewed CEP for Esomeprazole Magnesium Trihydrate API is available.

· January 2022, Telmisartan, Esomeprazole Magnesium Trihydrate and other 8 APIs obtained the source validation certificate issued by Bangladesh FDA.

2021

· June 2021, Rivaroxaban tablets - Won the bid for the fifth batch of national drug centralized procurement

· April 2021, Telmisartan API obtained W/C (Written Confirmation).

· January 2021, Rivaroxaban tablets passed the compliance inspection of "Drug Production Quality Management Practices" issued by NMPA (China FDA).

2020

· December 2020, Telmisartan API and Rivaroxaban API passed the compliance inspection of "Drug Production Quality Management Practices" issued by NMPA (China FDA).

· July 2020, DMF for Esomeprazole Magnesium Trihydrate API is approved by MFDS (South Korea FDA).

· June 2020, Esomeprazole Sodium API obtained W/C (Written Confirmation).

· March 2020, a Renewed CEP for Telmisartan API is available.

· February 2020, Esomeprazole Sodium API passed the compliance inspection of "Drug Production Quality Management Practices" issued by NMPA (China FDA).

· January 2020, Telmisartan API obtained W/C (Written Confirmation).

2019

· July 2019, Telmisartan API obtained the GMP certificate issued by PMDA (Japan FDA).

· May 2019, DMF for Telmisartan API is approved by Vietnam FDA.

· March 2019, a Renewed CEP for Telmisartan API is available.

2018

· July 2018, Telmisartan API obtained the GMP certificate issued by MFDS (South Korea FDA).

· March 2018, a Renewed CEP for Esomeprazole Magnesium Trihydrate API is available.

2017

· July 2017, Esomeprazole Magnesium Trihydrate API obtained W/C (Written Confirmation).

2016

· November 2016, Telmisartan API obtained W/C (Written Confirmation).

· November 2016, Esomeprazole Sodium API obtained CEP certification.

· September 2016, Esomeprazole Sodium API obtained W/C (Written Confirmation).

· March 2016, TDMF for Telmisartan API is approved by Taiwan FDA.

2015

· September 2015, Telmisartan API obtained the GMP certificate issued by NMPA (China FDA).

· January 2015, Telmisartan API obtained CEP certification.

quality