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    Home > Active Ingredient News > Drugs Articles > 18 new varieties passed the consistency evaluation, with 3 being the first

    18 new varieties passed the consistency evaluation, with 3 being the first

    • Last Update: 2021-09-19
    • Source: Internet
    • Author: User
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    According to the incomplete statistics of the Medical Cloud Studio, there are currently 3,029 product regulations that have passed the consistency evaluation, and 353 product regulations have been evaluated by more than three (including three).

    3029 353

    According to statistics from the Medical Cloud Studio, from September 4, 2021 to September 11, 2021, 18 new varieties (deemed as equivalent) passed the consistency evaluation, of which 3 were the first in the country to have passed the evaluation
    .


    details as follows:

    CSPC Ouyi: Tramadol Hydrochloride Injection is the first nationally reviewed

    CSPC Ouyi: Tramadol Hydrochloride Injection is the first nationally reviewed

    Tramadol hydrochloride is a powerful non-morphine analgesic, used for various acute and chronic pains such as cancer pain, fracture or postoperative pain
    .

    Tramadol was developed in the late 1970s by the German company Grantai, and its trade name is Tramal.
    The drug is widely used for postoperative pain relief, childbirth, and cancer pain treatment.
    Other studies have shown that it can also Relieve the pain of depression and anxiety
    .


    In July 2007, the original research product was approved to enter China.


    According to data from Minai.
    com, the terminal sales of tramadol in domestic sample hospitals in 2020 were 49.
    81 million yuan, and in the first half of 2021 it was 40.
    97 million yuan, an increase of 103% over the same period
    .


    Germany Grantai occupies 43.


    Tramadol hydrochloride has been approved for production in many dosage forms in China, including ordinary tablets, sustained-release tablets, injections, dispersible tablets, capsules, and effervescent granules
    .


    Among them, only tramadol hydrochloride tablets and tramadol hydrochloride injection have passed the consistency evaluation, and the first company to pass the evaluation is CSPC Ouyi Pharmaceutical


    Gale Pharmaceuticals: Ritonavir tablets are approved as the first in the country

    Gale Pharmaceuticals: Ritonavir tablets are approved as the first in the country

    Ritonavir, a protease inhibitor, is clinically used alone or in combination with antiretroviral nucleoside drugs to treat patients with advanced or non-progressive AIDS
    .


    This product is generally effective for zidovudine sensitive and zidovudine and saquinavir resistant HIV strains


    Ritonavir tablets were developed and produced by AbbVie.
    In March 1996, it was the first to be approved by the FDA for listing in the United States.
    In August of the same year, it was approved for listing in the European Union.
    It officially entered the Chinese market in 2014 and has been used for anti-HIV infection treatment
    .

    In China, most of the drugs used for AIDS treatment are paid by the state (the patient’s drug costs are almost free, except for some imported drugs), so [lopinavir/ritonavir] the income source in the hospital is basically concentrated in For the combined treatment of other diseases, the sales of domestic sample hospitals in 2018, 2019 and 2020 will be 1.
    61 million yuan, 1.
    68 million yuan, and 1.
    06 million yuan respectively
    .

    Anshi Pharmaceutical: the approval of ursodeoxycholic acid capsules is regarded as the first in the country

    Anshi Pharmaceutical: the approval of ursodeoxycholic acid capsules is regarded as the first in the country

    Ursodeoxycholic acid is a gallstone dissolving drug, suitable for the treatment of: 1.
    Sterolic gallbladder stones-must be X-ray penetrable stones, and gallbladder contraction function must be normal; 2.
    Cholestatic liver disease (such as: original Primary biliary cirrhosis); 3.
    Bile reflux gastritis
    .

    The product has been included in the clinical pathways for the treatment of cholestatic jaundice, cholestatic drug-induced liver injury, chronic hepatitis C xanthogens, and other diseases.
    The 2018 edition of the "National Essential Medicines" catalog is also a national Class A medical insurance drug in 2020
    .

    Previously, about 20 companies across the country produced and sold ursodeoxycholic acid oral solid preparations (vegetable tablets, capsules and soft capsules), but failed to pass (or deemed to pass) the consistency evaluation.
    Anshi Pharmaceuticals was approved this time.
    Same review, the first in the country
    .


    It is reported that there are currently 3 domestic companies applying for the production of the new 4 generic drugs, and one importing company has submitted an import application for the 5.


    In recent years, domestic sales of ursodeoxycholic acid have soared.


    According to public reports, with its good curative effects, the sales of ursodeoxycholic acid will also grow steadily worldwide.


    The latest national review data bulletin:

    The latest national review data bulletin:

    According to incomplete statistics from the Medical Cloud Studio, there are currently 3,029 product regulations that have passed the consistency evaluation, and 353 product regulations have been evaluated by more than three (including three)


    3029 353

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