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    Home > Medical News > Latest Medical News > Qilu Cefepime Hydrochloride for Injection passed the consistency evaluation

    Qilu Cefepime Hydrochloride for Injection passed the consistency evaluation

    • Last Update: 2021-05-09
    • Source: Internet
    • Author: User
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    On April 20, the official website of the State Food and Drug Administration showed that Qilu Pharmaceutical's cefepime hydrochloride for injection passed the consistency evaluation and was the first in China.
    According to data from Minai.
    com, there are currently 65 products of Qilu Pharmaceutical that have passed or deemed consistency evaluation, of which 18 are injections (7 were first reviewed), and the consistency evaluation supplementary application under review or the injections submitted for production in the new classification are still available.
    There are 26.

    Source: official website of the State Food and Drug Administration

    Cefepime hydrochloride can inhibit bacterial cell wall synthesis.
    It is a broad-spectrum bactericide for gram-positive and gram-negative bacteria.
    It is clinically used to treat moderate to severe infections caused by the above-mentioned sensitive bacteria in adults and children aged 2 months to 16 years.
    , Can also be used for bacterial cerebrospinal meningitis in children.

    Cefepime hydrochloride currently on the market in China only has one dosage form for injection.
    According to Meinenet data, this product will be used at the end of China's urban public hospitals, county-level public hospitals, urban community centers, and township health centers (Chinese public medical institutions) in 2019.
    Sales exceed 500 million yuan.

    Application status of consistency evaluation of cefepime hydrochloride for injection

    Source: Meinenet MED2.
    0 Chinese Drug Evaluation Database

    At present, 9 companies have submitted supplementary applications for the consistency evaluation of cefepime hydrochloride for injection.
    Among them, Qilu Pharmaceutical's products have been successfully evaluated and are the first in China.
    According to data from Minaiwang, currently, Qilu Pharmaceutical has 65 products passed or deemed to have passed the consistency evaluation, of which 18 are injections.

    Qilu Pharmaceutical has reviewed injections

    Source: Meinenet MED2.
    0 Chinese Drug Evaluation Database

    Among the 18 over-reviewed injections, Cefepime Hydrochloride, Palonosetron Hydrochloride Injection, Ondansetron Hydrochloride Injection, Irinotecan Hydrochloride Injection, Fasudil Hydrochloride Injection, Oxaliplatin Seven injections for injection and bivalerudin for injection have been reviewed for the first time.

    A wealth of over-reviewed varieties allows Qilu Pharmaceutical to "make a big show" in the national centralized procurement.
    The fifth batch of centralized procurement has begun to report.
    Injections account for more than half.
    Qilu Pharmaceutical has 8 injections listed, namely oxaliplatin.
    Injection, docetaxel injection, fasudil hydrochloride injection, palonosetron hydrochloride injection, ceftriaxone sodium for injection, ceftazidime for injection, gemcitabine hydrochloride for injection, and ropivacaine hydrochloride injection .

    Qilu Pharmaceutical's products for consistency evaluation of injections (including new classifications for production)

    Note: With *, no company has reviewed

    Source: Meinenet MED2.
    0 Chinese Drug Evaluation Database

    According to data from Minai.
    com, among the supplementary applications for consistency evaluation submitted by Qilu or the injections submitted for production under the new classification, there are still 26 models under review, of which 16 models have not yet been reviewed by the company.

    Source: Minei.
    com database, official website of the State Food and Drug Administration

    Note: The statistics are as of April 21.
    If there are any omissions, please correct me!

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