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The latest approval of the NMPA was released, and antidepressant class 1 new drugs and 2 heparin drugs were approved for marketing

 Last Update: 2022-11-14
 Source: Internet
 Author: User

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On November 7, the NMPA announced the delivery of drug approval documents on November 7, 2022, and a total of 30 regulated drugs were approved for marketing, including:

Shandong Luye Pharmaceutical Co.
, Ltd.
, 2-pin gauge toludiven lafaxine hydrochloride sustained-release tablets

Qilu Pharmaceutical Co.
, Ltd.
, linagliptin tablets

Yantai Dongcheng North Pharmaceutical Co.
, Ltd.
, nadroheparin calcium injection

Chenxin Pharmaceutical Co.
, Ltd.
, 2-pin regulation enoxaparin sodium injection

wait

Torudi lavaxine hydrochloride sustained-release tablets are a class 1 innovative drug independently developed by Luye Pharmaceutical for the treatment of depression
.

In addition, Natraparin calcium injection from Yantai Dongcheng North Pharmaceutical Co.
, Ltd.
and enoxaparin sodium injection from Chenxin Pharmaceutical Co.
, Ltd.
were successfully approved for marketing
.

Heparin anticoagulation is an important part of the prevention and treatment of thromboembolic diseases, compared with unfractionated heparin, low molecular weight heparin has the advantages of definite anticoagulant effect, strong antithrombotic effect, less adverse reactions, high bioavailability, etc
.
, the current low molecular weight heparin mainly includes enoxaparin sodium injection, nadroheparin calcium injection, dalteparin sodium injection and bemiparin sodium injection.

Nadroheparin calcium is a new type of antithrombotic drug, which is approved for ndroheparin
calcium injection and nadroheparin calcium for injection.
Previously, Nadroheparin calcium injection has been approved by 8 pharmaceutical companies including Nanjing Jianyou Biochemical Pharmaceutical, Zhaoke Pharmaceutical, Hebei Changshan Biochemical Pharmaceutical and Tianjin Hongri Pharmaceutical, and Nadroheparin Calcium Injection from 3 enterprises including Tianjin Hongri Pharmaceutical, Hebei Changshan Biochemical Pharmaceutical and Zhaoke Pharmaceutical has passed the consistency evaluation
.

Enoxaparin sodium injection is a low molecular weight heparin with anticoagulant properties, and the current low molecular weight heparin drugs, enoxaparin sodium injection accounts for a large
proportion of the global market.

According to the Yaorong cloud database, there are 10 enterprises that have previously approved enoxaparin sodium injection in China, among which Shenzhen Tiandao Pharmaceutical, Changzhou Qianhong Biochemical Pharmaceutical, Tianjin Hongri Pharmaceutical, Nanjing Jianyou Biochemical Pharmaceutical, Shandong New Times Pharmaceutical, Hebei Changshan Biochemical Pharmaceutical, Dongying Tiandong Pharmaceutical, and 7 enterprises have passed the consistency evaluation
of enoxaparin sodium injection.

Source: NMPA, listed company announcements, pharmaceutical cloud database, etc

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