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    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.

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