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    Home > Active Ingredient News > Drugs Articles > The catalogue of 32 ginseng preparations was published, covering 81 varieties.

    The catalogue of 32 ginseng preparations was published, covering 81 varieties.

    • Last Update: 2020-08-28
    • Source: Internet
    • Author: User
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    On August 5, CDE released a draft for comments on the 32nd batch of chemical generics ginseng preparations, covering a total of 81 varieties, including 8 varieties that were not considered.
    the list of 29 product standard-referennicants not considered in the previous two batches, a total of 70 product regulations have not been considered so far.
    can see that with the promotion of generic consistency evaluation policy, a large number of generic drugs will be eliminated from the market, some industry insiders expect that the existing 160,000 generic approvals, the future of about half will disappear.
    , pharmaceutical companies are also actively promoting generic consistency evaluation.
    according to the China List of Listed Drugs, more than 400 drugs have passed the review.
    in addition to solid oral preparations, there are also some injection varieties on the list.
    according to drug intelligence network data, by the end of 2019 CDE to undertake the consistency evaluation acceptance number, through the consistency evaluation acceptance number, respectively, reached 1038 and 237, respectively, an increase of nearly 70% and 111.61 percent year-on-year.
    addition, injection varieties companies are also actively preparing for evaluation work.
    data show that as of 8 June 2020, 120 declared varieties had been evaluated for injection consistency, with 623 applications, of which 41 applications for sodium cephalosporine for injection were made, followed by 33 injections of ampicillin bromine.
    In this published list, of the 81 varieties involved, 18 are injectables and 3 are large varieties of heavy injections, including volicazole for injection, potassium amoxilin sodium clavitamin for injection, and tygacyclin for injection.
    In this case, the injection of volicazole is a broad-spectrum antifungal drug, injection of potassium amoxicillin sodium clavic acid, including upper respiratory tract infection, lower respiratory tract infection, skin and soft tissue infection, etc., injection of tyrocyclin is applicable to patients over 18 years of age in complex abdominal infection, complex skin and soft tissue infection, community-obtained pneumonia in the case of infection caused by specific bacteria. According to
    meters intranet data, in 2019 China's urban public hospitals, county-level public hospitals, urban community centers and township hospitals (China's public medical institutions) terminals, injection of voliconazole, injection of amoxicillin sodium clavina potassium, injection of tygacyclin three injection varieties of sales of more than 2 billion yuan.
    , the injection of volicin and injection of tyrone has not been evaluated by enterprises.
    Although Qilu, Yangzijiang, Hainan Peter and other 6 enterprises have laid out the consistent evaluation of Vollikang for injection, and all with the new classification of production, approved production will be treated as if through consistency evaluation;
    , this list also includes an inhaler variety, acrylic pyromisson inhaler aerosols.
    this variety of adaptive disorders for the treatment and prevention of bronchial asthma and allergic rhinitis.
    the current variety has not been evaluated by enterprises, Sichuan Prit Medicine to copy 3 categories of declared clinical, and in October 2017 was approved for clinical.
    preparation is the starting point of the evaluation of generic drug consistency.
    industry believes that with the announcement of more relevant preparations, the market competition for related products will also be opened.
    can be seen, compared with the release of dosage form to further enrich, the product is no shortage of large varieties, is expected to have a more significant impact on the market.
    .
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