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    Home > Active Ingredient News > Drugs Articles > 7 injections have been rated 3 times! 5 billion varieties to pass through again; Yangzijiang, Xiansheng, Koren...

    7 injections have been rated 3 times! 5 billion varieties to pass through again; Yangzijiang, Xiansheng, Koren...

    • Last Update: 2020-12-30
    • Source: Internet
    • Author: User
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    As of November 20, the number of CDE acceptance conformity evaluation received reached 2526 (561 varieties of 632 enterprises, according to supplementary applications, the same between 801, there have been 801 acceptance numbers reviewed;
    Review details of 9 varieties through consistency evaluation, heavy injection re-evaluation this week there are 9 varieties through consistency evaluation, of which 4 enterprises have 4 injections through, injection with sodium palalatin over-evaluation enterprises up to 3, injection with Parexib sodium over-evaluation enterprises up to 5, and 6 varieties of the first over-evaluation.
    This week's consistent review of the details of the injection of cephalosporine sodium injection with cephalosporine sodium for the second generation of cephalosporin, is a broad-spectrum, efficient, low-toxic antimicrobial drug, mainly used to treat sensitive bacteria caused by the lower respiratory tract, urinary tract infections, intra-abdominal infections, gynecological infections, sepsis, bone and joint infections and skin, skin, soft tissue infections.
    injection of cephalosporine as a best-selling antibiotic products, it is reported that in 2019 China's terminal hospital sales reached 4.48 billion yuan, according to the pharmaceutical data enterprise version of the hospital sales database shows that in 2019 domestic sample hospital sales reached 2,097 million yuan, of which Haikou Pharmaceutical Factory, Yangzijiang, Guopharma Zhijun accounted for the largest share, 25.47 percent, 19.37 percent, 18.3 percent, respectively.
    the current domestic injection cephalosporine sodium market approval has 101, involving 48 manufacturers, of which 6 enterprises declared consistency evaluation was accepted.
    In recent years, due to the restricted use of antibiotic products by the state, the growth rate of the market size of this category has declined significantly, and now Yangzijiang is the first variety to pass a consistent evaluation, whether it can buck the trend upward, break through the bottleneck, it remains to be seen.
    Injection Idalafon is a brain protector (free-form remover) used to improve neurological symptoms, daily activity and dysfunction caused by acute cerebral infarction.
    was first developed by Mitsubishi Pharmaceuticals in Japan, approved in Japan in 2001 for the treatment of stroke, and approved by the FDA in 2017 for the treatment of amyotrophic lateral sclerosis (ALS).
    two adaptations are currently approved in China.
    2019, China will include it in the second batch of clinically urgent need for overseas drugs.
    public data show that the domestic terminal hospital sales of Idarafeng injections exceeded 5 billion yuan, and according to the sales statistics of Pharmaceuticals Hospital, the domestic sample hospital sales of Ida Lafeng injections reached 1.424 billion yuan in 2019, of which the first sound pharmaceutical industry accounted for 41.33 percent of sales, followed by Boda Pharmaceuticals, accounting for 18.68 percent.
    , a total of 34 domestic market approvals for Idarafeng injections, manufacturers 27.
    among them, 9 enterprises have been accepted for declaration consistency evaluation, Jiangsu Zhengda Fenghai, Hebei Renhe Yikang Pharmaceuticals, China Pharmaceutical Group Xinjiang Pharmaceuticals, Harbin Sanlian Pharmaceuticals 4 enterprises new chemical drugs registered for listing.
    It is worth mentioning that there are currently 3 enterprises consistent evaluation and approval completed, of which Jilin Boda Pharmaceuticals, one of the product standards consistent evaluation supplementary application has not been approved, the other product regulations are being reviewed;
    In addition to the details of the consistent evaluation of the declaration of Idala's injections, Ida Lafeng injections are the first imitation products of the acoustic pharmaceutical industry, the second in the world, the first heavy-duty products approved for listing in China, and in 2004 the first acoustic pharmaceutical industry was approved for use in this variety. Treatment of stroke, August 28, 2020, was approved for muscular dystrophy lateral sclerosis (ALS, also known as freezing human disease, motor neurone disease) of the new adaptation, become an effective treatment for this incurable disease.
    company's financial results show that in 2019, the first sound pharmaceutical industry Ida Lafeng injection sales reached 937 million yuan, accounting for 19.5% of the first sound pharmaceutical industry's product sales revenue during the same period.
    In July of this year, Idarafeng's upgraded variety 1 new drug Ida Lafeng right-handalcohol injection (Ida Lafeng compound preparation) was approved for the market, and now its Idarafeng injection consistency evaluation, is expected to further enhance product competitiveness, growth performance.
    libavirin tablet libawelin as a synthetic nucleoside antiviral drug, is the only treatment of severe respiratory syncytial virus (RSV) capillary bronchitis registered antiviral drugs, can also be used in patients with skin herpes virus infection, listed abroad in the 1970s, China developed libavirin in the 1980s.

    included in the 2018 Guidelines for the Treatment of Hand, Foot and Mouth Disease and the National Antimicrobial Treatment Guidelines for the treatment of foot and mouth disease, endemic haemorrhagic fever and adult measles.
    sales of domestic sample hospitals for Libawelin tablets in 2019 amounted to 5.4985 million yuan, with Sichuan Meidakang Pharmaceuticals accounting for the largest share of 31.04 percent, followed by Beijing Shuanglu Pharmaceuticals with 26.94 percent.
    Libawelin tablets domestic market approval has 163, manufacturers 126, only 3 enterprises declared consistency evaluation was accepted, this week, Guangdong South China Pharmaceutical Industry, Jiangsu Morning Brand Pharmaceutical Industry has passed the variety consistency evaluation.
    Previously, in the "new coronavirus infection of pneumonia diagnosis and treatment program (trial fifth edition)," Libawelin was listed as a relatively important antiviral drug, the new crown outbreak has not completely passed, Guangdong South China Pharmaceuticals, Jiangsu Chen brand pharmaceutical industry is now the variety through consistent evaluation, market competitiveness instantly improved.
    has not been declared to accept 9 varieties to be undertaken; 7 of the 3 varieties of injections have been evaluated this week CDE new consistency evaluation acceptance number 12 (9 varieties), of which 5 varieties are injections.
    This week's consistency evaluation declaration acceptance details table recently continued to have large varieties of injections through the consistent evaluation, since May this year, the State Drug Administration officially issued the injection consistency evaluation work officially launched, injections have become the focus of the consistent evaluation declaration.
    According to pharmaceutical intelligence data, so far, CDE cumulative acceptance of injection consistency evaluation number 994 (193 varieties of 220 enterprises), 51 varieties have passed / treated with the same evaluation, of which the number of over-evaluated enterprises reached 3 and above there are 7 varieties, in addition to 9 varieties of over-evaluation enterprises for 2.
    Injection consistency evaluation has been evaluated up to 3 and above details table according to the previous national collection related policy information, collection mechanism gradually normal, as long as the number of drugs that meet the conditions of collection or its amount reached the level of collection, that is, trigger the national collection switch, two batches of collection work each year.
    According to combing only 7 injections are currently included in the national collection, namely, fluorobilofen ester injection, injection with pyrethroids, hydrochloric acid right metomide injection (4 plus 7 band volume procurement), injection with yew alcohol (white protein binding type) (second batch of band procurement) ), injection with Azatsin, left ethyl laxitan injection with a thick solution, hydrochloric acid Moxisa star sodium chloride injection (third batch of sodium chloride procurement);
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