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    Home > Medical News > Medicines Company News > Yuandong Bio-Caffeine Citrate Injection Passes the Consistency Evaluation of Injection Quality and Efficacy

    Yuandong Bio-Caffeine Citrate Injection Passes the Consistency Evaluation of Injection Quality and Efficacy

    • Last Update: 2021-07-25
    • Source: Internet
    • Author: User
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    On February 24, Yuandong Biotechnology issued an announcement that the company recently received the "Drug Supplementary Application Approval Notice" for the chemical drug "Caffeine Citrate Injection" approved and issued by the State Food and Drug Administration, which is used for the treatment of preterm birth.
    Primary apnea in newborns

    .


    Caffeine citrate injection was approved in France on December 31, 1997 for the treatment of primary apnea in premature newborns

    .
    Obtained the US Orphan Drug Qualification in September 1998, and obtained the US FDA marketing authorization on September 21, 1999

    .
    At present, the domestic imported caffeine citrate injection is produced by Casey Pharmaceuticals of Italy, and the trade name is "Beiyouno"

    .
    The company's caffeine citrate injection was included in the first batch of priority review and approval children's drug categories, and it was the first imitation listing in China

    .
    The industrialization project of caffeine citrate injection was included in the major science and technology project of "Major New Drug Development"

    .
    As of February 24, 2021, following the company for the domestic Limin, China Resources Double-Crane Pharmaceutical (Jinan) Co.
    , Ltd.
    by the second home / company deemed by the consistency of evaluation

    .
    In addition, Shanxi Guorun Pharmaceutical Co.
    , Ltd.
    filed a supplementary application for consistency evaluation of caffeine citrate injection.
    Southwest Pharmaceutical Co.
    , Ltd.
    , Anhui Hengxing Pharmaceutical Co.
    , Ltd.
    , and Shanghai Hefeng Pharmaceutical Co.
    , Ltd.
    were registered as new companies.
    Classification has submitted an application for registration of caffeine citrate injection to the State Food and Drug Administration, and it will be deemed to have passed the consistency evaluation after the pending review is approved

    .
    According to the enlarged version of the national database of Meinenet, the terminal sales of caffeine citrate injection in public hospitals in Chinese cities in 2019 were approximately RMB 229.
    66 million

    .
    On April 19, 2019, the company's application for consistency evaluation of caffeine citrate injection submitted to the State Food and Drug Administration was accepted

    .
    As of the announcement date, the company has invested about 973,900 yuan in research and development expenses in the product consistency evaluation project

    .
    In 2019, the company's sales revenue of caffeine citrate injection was RMB 71,447,100

    .

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