As of 30 October, the number of CDE acceptance conformity evaluations had reached 2,484 (557 varieties from 626 enterprises, as follows, according to supplementary applications);
17 varieties were evaluated by consistency, and 17 varieties of multi-billion-species injections were evaluated by consistency this week, four of which were re-applied for supplementary evaluation, namely, "Acetic Garnilik Injections", "Injection Boronzomi" by Qiru and Howson, "Sodium chloride injections of hydrochloric acid" in Curran, and "Injection meronin injections" in coastal pharmaceuticals. There are also four product rules first through the consistent evaluation, another stone drug Ouyi this week and 2 varieties passed, the details can be seen in the table below: this week's consistency review details table hydrochloric acid moxisa star sodium chloride injection moxicillin for the fourth generation of quinone antibiotics, together with left oxyfluoroxethadone (third generation), Jimmy sarin (fourth generation), known as "breathing quinoxone", especially for the current drug-resistant streptococcus.
Moxisa Star was originally developed by Bayer of Germany, and its sodium chloride injection was listed in China in 2004 with sales of 1.79 billion yuan in 2019.
According to the pharmaceutical data enterprise version of hospital sales data show that in 2019 the domestic sample hospital amount of sodium chloride injection of moxisa star hydrochloride was 827 million yuan, of which more than 98% of the share was occupied by the original research enterprise Bayer.
currently China's domestic sodium chloride injection market approval has 11, involving 11 manufacturers.
According to the pharmaceutical data consistency evaluation progress database shows that there are currently a total of 13 enterprises to declare / as if the declaration of consistency evaluation, of which Tianjin Red Day Pharmaceutical first passed the same, Sichuan Colum Pharmaceuticals third review, but the first in accordance with the consistency evaluation of the application for evaluation of enterprises.
Acetic Acid Canerik Injection Ghanerek is a gontagtrogen-releasing hormone (GnRH) antagonist used in women who receive assisted reproduction to avoid their premature emergence of progesterone (LH) peaks.
Its original drug, Orgalutran (Acetic Acid Ghanerik Injection) was listed in China in June 2013 and the first copy of the 2018 Acetic Acid Garnierk Injection was listed in 2018, according to pharmaceutical data, domestic enterprises only have a copy of Zhengtian qing, no other family has yet submitted clinical applications.
2019 acetate Canerik injection domestic sample hospital sales of 1958.60 million yuan, more than 99% of the share occupied by the original research, is now day clear the drug through the consistent evaluation, is expected to further break the monopoly of the original research, more market share.
is a new type of protease competitive inhibitor, clinically mainly used for multiple myeloma and heterocytic lymphoma.
, originally researched by Millennium (later acquired by Takeda), was approved by the FDA in May 2003 and imported from China in 2005.
2019, sales of sample hospitals for injection boron zomi amounted to 374 million yuan, with nearly 90% of the shares occupied by Janssen Pharmaceuticals, followed by Howson Pharmaceuticals and Zhengda Tianqing, according to the company's pharmaceutical data.
present, there are 8 enterprises with domestic injection boron tezome, 15 enterprises declare/treat the same declaration consistency evaluation, of which 3 enterprises have passed or as if through the consistency evaluation.
melopenan injection melopenan is suitable for infections in adults and children caused by one or more bacteria that are sensitive to meropenan.
According to IQVIA sampling statistics estimates, the domestic terminal sales amount for injection melo pena niqab in 2019 was about RMB4,998 million, according to pharmaceutical data enterprise hospital sales statistics, in 2019 injection meropeananan domestic sample hospital sales of 1.262 billion yuan, in addition to Sumayou Pharmaceuticals of Japan, the largest share of coastal pharmaceutical, 27.87 percent.
According to pharmaceutical data show that the current domestic injection of meropeanan market approval has 24, involving manufacturers price of more than 10, including Binhai Pharmaceuticals, a total of 6 enterprises declared consistency evaluation, this week Binhai Pharmaceuticals preempted, the first through the consistency evaluation, Health Yuan (Shenzhen Waterfront Pharmaceutical Co., Ltd. for health yuan subsidiary) enterprise announcement shows that injection Mero Pernam for its company's key varieties, 2019 sales revenue of about 1065 million yuan.
declaration accepted 24 varieties declaration consistency evaluation, injection re-eye-catching this week CDE new consistency evaluation acceptance number 42, involving 24 varieties, of which 12 varieties are injections, Zhengda Tianqing, Howson, Qilu, Yangzijiang and other enterprises have declared;