【CDE Acceptance Fact Sheet】An overview of CDE acceptance from September 12 to September 18

From September 12 to September 18, CDE received a total of 96 drug applications (excluding supplementary applications and import re-registration, the same below

These acceptance numbers are from 17 companies and 18 kinds of drugs

There are 7 acceptance numbers for 2 types of drugs, including 3 chemical drugs, 3 therapeutic biological products, and 1 traditional Chinese medicine

These acceptance numbers are from 5 companies and 6 kinds of drugs

There are 32 acceptance numbers for 3 types of drugs, including 28 chemical drugs and 4 therapeutic biological products

These acceptance numbers are from 21 companies and 21 drugs

There are 25 acceptance numbers for 4 types of drugs, namely:

These acceptance numbers are from 21 companies and 21 drugs
.
Among them, Sichuan Huiyu Pharmaceutical Co.
, Ltd.
for injection with tekolanin; Chengdu Aobang Pharmaceutical Co.
, Ltd.
Tardospironone Citrate tablets; Jiangsu Wangao Pharmaceutical Co.
, Ltd.
has 2 applications for ethanesulfonate nidanib softgels accepted
.

There are 3 acceptance numbers for 5 types of drugs, namely:

These acceptance numbers are from DAEHWA PHARMACEUTICAL CO.
, LTD.
, DAEHWA PHARMACEUTICAL CO.
, LTD.
, Shanghai Haihe Drug Research and Development Co.
, Ltd.
Paclitaxel oral solution
.

The status of acceptance of the consistency evaluation is as follows:

There are 29 acceptance numbers for Class 1 drugs, including 23 chemical drugs and 6 therapeutic biological products
.
They are:

These acceptance numbers are from 17 companies and 18 kinds of drugs
.
Among them, Suzhou Yasheng Pharmaceutical Co.
, Ltd.
APG-2575 tablets and APG-115 capsules each had 2 applications accepted
.

There are 7 acceptance numbers for 2 types of drugs, including 3 chemical drugs, 3 therapeutic biological products, and 1 traditional Chinese medicine
.
They are:

These acceptance numbers are from 5 companies and 6 kinds of drugs
.
Among them, Chengdu Huahao Zhongtian Pharmaceutical Co.
, Ltd.
and Beijing Huahao Zhongtian Biopharmaceutical Co.
, Ltd.
have 2 applications for Utidelong capsules that have been accepted
.

There are 32 acceptance numbers for 3 types of drugs, including 28 chemical drugs and 4 therapeutic biological products
.
They are:

These acceptance numbers are from 21 companies and 21 drugs
.
Among them, Shanghai Xuantai Pharmaceutical Technology Co.
, Ltd.
and Jiangsu Xuantai Pharmaceutical Co.
, Ltd.
had 5 applications for dapagliflozin metformin extended-release tablets
.

There are 4 acceptance numbers for 25 types of drugs, namely:

These acceptance numbers are from 21 companies and 21 drugs
.
Among them, Sichuan Huiyu Pharmaceutical Co.
, Ltd.
for injection with tekolanin; Chengdu Aobang Pharmaceutical Co.
, Ltd.
Tardospironone Citrate tablets; Jiangsu Wangao Pharmaceutical Co.
, Ltd.
has 2 applications for ethanesulfonate nidanib softgels accepted
.

There are 5 acceptance numbers for 3 types of drugs, namely:

These acceptance numbers are from DAEHWA PHARMACEUTICAL CO.
, LTD.
, DAEHWA PHARMACEUTICAL CO.
, LTD.
, Shanghai Haihe Drug Research and Development Co.
, Ltd.
Paclitaxel oral solution
.

The status of acceptance of the consistency evaluation is as follows:

There are 29 acceptance numbers for Class 1 drugs, including 23 chemical drugs and 6 therapeutic biological products
.
They are:

These acceptance numbers are from 17 companies and 18 kinds of drugs
.
Among them, Suzhou Yasheng Pharmaceutical Co.
, Ltd.
APG-2575 tablets and APG-115 capsules each had 2 applications accepted
.

There are 7 acceptance numbers for 2 types of drugs, including 3 chemical drugs, 3 therapeutic biological products, and 1 traditional Chinese medicine
.
They are:

These acceptance numbers are from 5 companies and 6 kinds of drugs
.
Among them, Chengdu Huahao Zhongtian Pharmaceutical Co.
, Ltd.
and Beijing Huahao Zhongtian Biopharmaceutical Co.
, Ltd.
have 2 applications for Utidelong capsules that have been accepted
.

There are 32 acceptance numbers for 3 types of drugs, including 28 chemical drugs and 4 therapeutic biological products
.
They are:

These acceptance numbers are from 21 companies and 21 drugs
.
Among them, Shanghai Xuantai Pharmaceutical Technology Co.
, Ltd.
and Jiangsu Xuantai Pharmaceutical Co.
, Ltd.
had 5 applications for dapagliflozin metformin extended-release tablets
.

There are 4 acceptance numbers for 25 types of drugs, namely:

These acceptance numbers are from 21 companies and 21 drugs
.
Among them, Sichuan Huiyu Pharmaceutical Co.
, Ltd.
for injection with tekolanin; Chengdu Aobang Pharmaceutical Co.
, Ltd.
Tardospironone Citrate tablets; Jiangsu Wangao Pharmaceutical Co.
, Ltd.
has 2 applications for ethanesulfonate nidanib softgels accepted
.

There are 5 acceptance numbers for 3 types of drugs, namely:

These acceptance numbers are from DAEHWA PHARMACEUTICAL CO.
, LTD.
, DAEHWA PHARMACEUTICAL CO.
, LTD.
, Shanghai Haihe Drug Research and Development Co.
, Ltd.
Paclitaxel oral solution
.

The status of acceptance of the consistency evaluation is as follows: