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As of 13 November, there were 2,514 CDE acceptance numbers (560 varieties from 629 enterprises, according to supplementary applications, the same as between 7 and 13 November), 790 acceptance numbers have been evaluated, and last week (November 7 to November 13), 3 varieties were evaluated by consistency, all of which were heavy injections, and 20 varieties were accepted.
review details of 3 varieties over-evaluation, The first of the 2 billion injections in Columbine through this week three varieties through a consistent evaluation, all injections, are Colum Pharmaceuticals fat lactate (17) glucose (11%) injections, Howson Pharmaceuticals injections with cyclocycline, and Chengdu Zhengkang Pharmaceuticals' sodium hydrochloride injections.
This week's consistent evaluation of the details of the table fat lactic amino acids (17) glucose (11%) injections of fatty lactose (17) glucose (11%) injections ("all-in-one" intestinal nutrition three-cavity bag) is mainly used for nutritional supplementation in adult patients with incomplete function 2 or can not be ingested through the mouth/intestine nutrition. The original research company for
fat lactose (17) glucose (11%) injections, called Fresenius KabiAB, was first listed in Sweden and Denmark in 1999 and has been marketed in more than 85 countries and regions, including the United States, the United Kingdom, France and China, and has been used for the treatment of more than 9 million patients.
Koren Pharmaceuticals company announcement shows that fat lactate amino acid (17) glucose (11%) injection is Colum's first approved market for intestinal nutrition three-cavity bag, with flexible route of drug supply (external or central intravenous drug), to meet the nutritional needs of patients with different disease conditions advantages, in 2019 China sales of 1.94 billion yuan.
According to pharmaceutical data, domestic sample hospital sales of fatty lactose (17) glucose (11%) injections in 2019 were 428 million yuan, with Fessenyuska accounting for nearly 97.44 percent of the market share (Faison Yuscabi Pharmaceuticals 38.79 percent, FessenyuskaBivary Pharmaceuticals 58.68 percent), Colum and Hesco respectively Only 2.33% and 0.23% of the pharmaceutical database shows that the current fat lactate amino acids (17) glucose (11%) injection domestic market approval 6, Fessen yuscabivary Pharmaceuticals, Colum Pharmaceuticals, Hesco three enterprises were approved for listing, all three enterprises have declared a consistent evaluation, now, Colum Pharmaceuticals first evaluation, or will further break the original research monopoly to share a larger market share.
company announcement shows that Colum in the high-end infusion layout of a single room bag 5 items, two room bags 3 items, three room bags 5 items, the most product line, the most complete structure.
at present, Colon has been approved to market 8 new intestinal nutrition products, covering single bags, double-room bags, three cavity bags in different packaging forms.
Koren Pharmaceuticals in addition to fat lactate (17) glucose (11%) injection, its amino acid (16)/glucose (48%) electrolyte injection has been treated as consistent evaluation;
Koren Pharmaceutical Injection Consistency Evaluation through/as well as through the consistency evaluation details table injection of cyclocycline is known as a "super antibiotic", is the first glycamine tetrogen antibiotics, can effectively overcome the external pump and ribosome protection resistance mechanism, half-life of up to 40 hours, for the treatment of multi-drug resistant bacteria and pan-resistant bacteria caused by severe infection, is currently the last line of defense for antibiotic use.
, which was acquired by Pfizer for $68 billion in 2009, was approved in the U.S. in June 2005 and entered China in October 2010 with global sales of $197 million in 2019.
pharmaceutical data enterprise version of hospital sales data show that the domestic sample hospital sales of injection dicin is 3373 million yuan, the original research enterprises almost monopolized the sample hospital market.
has been listed as a Class B drug in the new national health insurance list for 2019.
public data show that the current size of the domestic market has been close to 2.3 billion yuan, is expected to quickly exceed 3 billion yuan in recent years.
At present, there are 8 approvals for the domestic injection of tygacycline market, involving 8 production enterprises;
Sodium chloride injection of moxisa chloride hydrochloride is a fourth generation quinoxone antibiotic, together with Loxyfluoxa star (third generation), Jimmy sassin (fourth generation), known as "breathing quinoxone", especially for the current drug-resistant severe streptococcus pneumoniae efficacy.
, originally researched by Bayer of Germany, was listed in China in 2004 with sales of 1.79 billion yuan in 2019.
so far, five enterprises have adopted/treated the sodium chloride injection of moxisa star hydrochloride as the injection of the largest number of enterprises through consistency evaluation.
Sodium chloride injection consistency evaluation of hydrochloric acid sodium chloride evaluation details table declaration accepted 20 varieties were undertaken, the shortage of drugs in this week's CDE new consistency evaluation acceptance number 24 (20 varieties), nearly half of the injections, There are 9 varieties, of which 3 injections are the first declared accepted varieties, for Yangzhou Zhongbao Pharmaceuticals' calcium glucosphate injection, Tianjin Jinyao Pharmaceuticals' heavy saline serotonin injection, and Lunanbet Pharmaceutical's hydrochloric acid terpharmain injection.
This week's consistent evaluation declaration acceptance details note: red font for the first declared accepted varieties of which are worth mentioning is the clinical injection of serotonin, used to prevent and control intravertebral obstruction anesthesia occurs acute hypotension;
has been included in the list of drug shortages in several provinces on several occasions.
heavy staphate serotonin injection currently has 12 domestic market approvals, involving 11 manufacturers, 2019 domestic sample hospital sales of 14.1472 million yuan, Shanghai Yifeng Pharmaceuticals accounted for 55.98 percent, Tianjin Jinyao Pharmaceuticals accounted for 15.2 percent, Tianjin Jinyao Pharmaceutical Industry's first declaration of consistency evaluation was accepted, improve product quality at the same time, to help solve the drug shortage problem! Data sources: pharmaceutical intelligence data, enterprise announcements and other network public data sources: pharmaceutical intelligence network, corporate announcements and other network public information