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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:
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:
.
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:
.
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: