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    Home > Active Ingredient News > Drugs Articles > 【CDE Acceptance Overview】CDE Acceptance Status from November 7th to November 13th

    【CDE Acceptance Overview】CDE Acceptance Status from November 7th to November 13th

    • Last Update: 2022-11-26
    • Source: Internet
    • Author: User
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    From November 7 to November 13, CDE accepted a total of 124 drug applications (excluding supplementary applications and import re-registration, the same below).

    Among them, there are 111 domestic drug acceptance numbers and 13 imported drug acceptance numbers
    .
    24 consistency evaluations
    were accepted.

    There are 37 Class 1 drug acceptance numbers, including 19 chemical drugs, 16 therapeutic biological products and 2 traditional Chinese
    medicines.
    They are:

    There are 37 Class 1 drug acceptance numbers, including 19 chemical drugs, 16 therapeutic biological products and 2 traditional Chinese
    medicines.
    They are:

    These acceptance numbers come from 24 companies and 26 drugs
    .
    Among them, 5 applications for antimicrobial peptide PL-18 plugs of Jiangsu Pulai Biotechnology Co.
    , Ltd.
    were accepted
    .

    There are 7 Class 2 drug acceptance numbers, including 6 chemical drugs and 1 therapeutic biological product
    .
    They are:

    There are 7 Class 2 drug acceptance numbers, including 6 chemical drugs and 1 therapeutic biological product
    .
    They are:

    These acceptance numbers are from 5 enterprises and 5 drugs
    .
    Among them, HECB1701001 sustained-release tablets of Guangdong East Sunshine Pharmaceutical Co.
    , Ltd.
    ; Qilu Pharmaceutical Co.
    , Ltd.
    's semeglutide injection has 2 applications accepted
    .

    There are a total of 25 Class 3 drug acceptance numbers, all of which are chemical drugs
    .
    They are:

    There are a total of 25 Class 3 drug acceptance numbers, all of which are chemical drugs
    .
    They are:

    These acceptance numbers come from 18 companies and 15 drugs
    .
    Among them, brodrocodone tablets of Yichang Renfu Pharmaceutical Co.
    , Ltd.
    ; Fexofenadine hydrochloride dry suspension of Jichuan Pharmaceutical Group Co.
    , Ltd.
    ; Nicorandil for injection from Kebeyuan (Beijing) Pharmaceutical Technology Co.
    , Ltd.
    and Shanxi Pude Pharmaceutical Co.
    , Ltd.
    ; Fexodine fumarate sustained-release tablets of Jiangsu Wanbang Biochemical Pharmaceutical Group Co.
    , Ltd.
    ; ibuprofen injection from Shandong Bainuo Pharmaceutical Co.
    , Ltd.
    and Zhongfu Pharmaceutical Co.
    , Ltd.
    ; ibuprofen injection from Shandong Xinhua Pharmaceutical Co.
    , Ltd.
    ; Nanjing Entai Pharmaceutical Technology Co.
    , Ltd.
    and Jiangsu Dahongying Hengshun Pharmaceutical Co.
    , Ltd.
    have 2 applications for acetic acid maintenance solution (including glucose) accepted
    .

    There are 48 Class 4 drug acceptance numbers, namely:

    There are 48 Class 4 drug acceptance numbers, namely:

    These acceptance numbers come from 36 companies and 35 drugs
    .
    Among them, pregabalin capsules of Yantai Luyin Pharmaceutical Co.
    , Ltd.
    ; Xi'an Hanfeng Pharmaceutical Co.
    , Ltd.
    tranexamic acid injection has 3 applications accepted
    .

    There are 7 Class 5 drug acceptance numbers, namely:

    There are 7 Class 5 drug acceptance numbers, namely:

    The acceptance status of the consistency evaluation is as follows:

    The acceptance status of the consistency evaluation is as follows:

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