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    Home > Active Ingredient News > Drugs Articles > 23 new varieties (deemed as the same) passed the consistency evaluation, and 6 were the first ones (list attached)

    23 new varieties (deemed as the same) passed the consistency evaluation, and 6 were the first ones (list attached)

    • Last Update: 2021-09-13
    • Source: Internet
    • Author: User
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    According to incomplete statistics from the Medical Cloud Studio, 2935 product regulations have passed the consistency evaluation, and 343 product regulations have been evaluated by more than three (including three).


    2935 343

    According to statistics from the Medical Cloud Studio, from August 22, 2021 to August 28, 2021, 23 new varieties (deemed as equivalent) passed the consistency evaluation, of which 6 were the first in the country to have passed the evaluation


    North China Pharmaceutical: Amoxicillin Sodium and Clavulanate Potassium for Injection Passed the Consistency Evaluation

    North China Pharmaceutical: Amoxicillin Sodium and Clavulanate Potassium for Injection Passed the Consistency Evaluation

    Amoxicillin and clavulanate potassium compound preparations are widely used clinically to treat upper respiratory tract infections, lower respiratory tract infections, genitourinary tract infections, skin and soft tissue infections and other infections caused by sensitive bacteria


    Amoxicillin and Clavulanate Potassium Compound is the world's first β-lactamase inhibitor compound.


    At present, there are 59 domestic production approvals for amoxicillin sodium and clavulanate potassium for injection, and 3 import approvals.


    According to the information on the website of the Ministry of Industry and Information Technology of the People's Republic of China, in 2019, the domestic output of amoxicillin sodium and clavulanate potassium (0.


    According to the announcement of North China Pharmaceutical, since the start of the consistency evaluation work, the company has invested a total of 9.


    Shubang Pharmaceutical: The first nationwide review of Nimesulide Dispersible Tablets

    Shubang Pharmaceutical: The first nationwide review of Nimesulide Dispersible Tablets

    Nimesulide is a cyclooxygenase-2 inhibitor, suitable for rheumatoid arthritis and osteoarthritis; pain and inflammation after surgery and acute trauma; pain caused by inflammation of the ear, nose, and throat; dysmenorrhea; upper respiratory tract infection Treatment of fever and other symptoms caused by it


    In China, Nimesulide is approved to produce many dosage forms, including ordinary tablets, dispersible tablets, sustained-release tablets, dry suspensions, capsules, sustained-release capsules, granules, orally disintegrating tablets and gels


    According to statistics from Meinenet, the sales data of nimesulide in domestic sample hospitals in 2020 is 13.


    Hengrui: The first nationwide review of ioverol injection

    Hengrui: The first nationwide review of ioverol injection

    Ioverol injection is an X-ray contrast agent, which belongs to the second-generation iodine contrast agent.


    According to public information, the size of China's current contrast agent market is about 12 billion, and the compound growth rate in the past five years is close to about 15%.


    Ioverol and iodixanol are Hengrui Medicine's two major contrast media products


    Tianjin Jinyao: Aminophylline Injection is the first nationwide company to pass the consistency evaluation

    Tianjin Jinyao: Aminophylline Injection is the first nationwide company to pass the consistency evaluation

    Aminophylline injection is indicated for bronchial asthma, chronic asthmatic bronchitis, chronic obstructive pulmonary disease, etc.


    The drug is a national 685 base drug and a national medical insurance category A product.


    Renfu Medicine: Metoprolol tartrate injection is the first nationwide appraisal

    Renfu Medicine: Metoprolol tartrate injection is the first nationwide appraisal

    Metoprolol tartrate injection is indicated for supraventricular tachyarrhythmia


    As a national basic drug and a national medical insurance Class A drug, metoprolol tartrate injection was included in the shortage drug list by many provinces at the same time
    .

    Public data shows that there are nearly 20 domestic companies that have been approved for this product, and only Renfu Pharmaceutical submitted a consistency evaluation
    .
    According to the sales data of domestic sample hospitals on Minai.
    com, Metoprolol has continued to grow in the past six years.
    In 2020, sales of 598 million yuan, a year-on-year increase of 4.
    41%, add in retail pharmacies and online terminal data, the market capacity is very considerable
    .

    Hainan Sanye Meihao Pharmaceutical: Cefpodoxime Proxetil Dry Suspension is the first nationally reviewed

    Hainan Sanye Meihao Pharmaceutical: Cefpodoxime Proxetil Dry Suspension is the first nationally reviewed

    Cefpodoxime proxetil belongs to the third generation of oral cephalosporins, which was developed and marketed by Daiichi Sankyo
    .

    Cefpodoxime proxetil is the precursor of cefpodoxime, which shows good antibacterial activity after absorption.
    Its antibacterial activity lies in its inhibition of bacterial cell wall synthesis and high stability to β-lactamase
    .
    The broad antibacterial spectrum includes strong antibacterial activity against traditional drug-resistant pathogens, a variety of gram-positive and gram-negative bacteria, especially high activity against Staphylococcus, Streptococcus, etc.
    , providing excellent The important advantages of other third-generation cephalosporins
    .

    Experimental results show that the MBC range of cefpodoxime proxetil against Streptococcus pneumoniae and Haemophilus influenzae is significantly lower than that of cefixime, showing stronger bactericidal activity; meanwhile, the drug resistance rate of cefpodoxime proxetil is significantly lower than that of cefixime Oxime
    .

    Domestic market cefpodoxime proxetil tablets, capsules, granules, dry suspension and the like
    .
    Among them, the domestic market of cefpodoxime proxetil dry suspension is Hainan Sanye Meihao Pharmaceutical, Guangzhou Baiyunshan Tianxin Pharmaceutical, and Chongqing Kerui Pharmaceutical
    .

    Public data shows that the global sales of cephalosporins in 2017 were 11.
    86 billion U.
    S.
    dollars, in 2018 it was 12.
    94 billion U.
    S.
    dollars, and in 2019 it will reach 13.
    5 billion U.
    S.
    dollars or more
    .
    At present, cephalosporin products in the antibiotic market in China account for about 40%-45% of the market
    .

    The latest national review data bulletin:

    The latest national review data bulletin:

    According to incomplete statistics from the Medical Cloud Studio, there are currently 2,935 product regulations that have passed the consistency evaluation, and 343 product regulations have been evaluated by more than three (including three)
    .

    2935 343

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