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    Home > Medical News > Latest Medical News > Guarantee approval? Consistency evaluations get together, these varieties still have enterprises to declare!

    Guarantee approval? Consistency evaluations get together, these varieties still have enterprises to declare!

    • Last Update: 2020-10-28
    • Source: Internet
    • Author: User
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    Pharmaceutical Network October 21st, the first three quarters of 2020, the declaration of consistency evaluation of the more concentrated varieties are mainly two categories: First, injections, especially cephalospora antibiotics and proton pump inhibitors.
    May 14, 2020, the State Drug Administration issued a "announcement on the implementation of chemical injection generic drug quality and efficacy consistency evaluation work", injection consistency evaluation declaration has gradually increased.
    category is other generics approved for market before the implementation of the new registration classification of chemicals.
    since the first variety has passed the consistency evaluation, the same varieties of other pharmaceutical production enterprises shall, in principle, complete the conformity evaluation within 3 years;
    want to preserve the approval, and these generic manufacturers will have to file a consistent review by 2020.
    to preserve the approval, the pile also declared to Amoxilin, for example, Amosilin in September 2020 issued the sixth batch of excessive repetitive drugs, 163 domestic manufacturers, 19 manufacturers have passed the consistent evaluation.
    still have five companies launching amoxilin capsule consistency evaluations by 2020.
    Amosilin capsules have entered the second batch of national centralized procurement catalog, the price has been reduced to less than 6 points per grain, manufacturers are still declaring consistency evaluation is expected to be more in order to preserve the approval.
    also have a guaranteed approval "task" of benzodiaxane chlorpyric tablets and acetaminophen tablets.
    34 companies have reported consistent evaluation of ammonia chloride in 2020, and four enterprises will still report consistent evaluation in 2020.
    some cold products such as anti-tuberculosis mycobacterium pyridoxic tablets in 2020 also have 4 enterprises to carry out a consistent evaluation.
    Invested tens of millions, mostly for large enterprises and listed pharmaceutical companies in view of the start of consistency evaluation is mainly chemicals new registration classification approved before the old approval, and can start the consistency evaluation of enterprises are usually more old approvals, the company's profitability is relatively good enterprises, so the start of consistency evaluation mainly concentrated in large enterprises and listed pharmaceutical companies.
    more than 20 companies have declared more than four projects in 2020 and invested more than 10 million.
    than 2 million to 3 million per project, 4 projects are over 10 million, and the need to do BE oral medicine a project 6 million to 12 million.
    the largest number of projects at present, 11 in total, but 9 are injections, in fact, the input may not be higher than the complex injection hydrochloric acid poly-flexible star lipid body injection group.
    new 3 categories mainly do exempt validated clinical products in 2020, no chemical drugs new 3 categories of declared manufacturers more than 5 varieties.
    most of the declared new Category 3 are domestic varieties listed with existing manufacturers of the common name, such as Meghan, Fluobilofen, Ida Lafeng, osetawe and ammonia bromoso.
    such varieties may be exempt from verifiable clinical evidence, and inhalation solutions and injections may not even be used in bioexual trials, at a cost similar to that of the new category 4.
    In the first three quarters of 2020, the most declared enterprises in the new three categories were Yangzijiang, which declared seven, namely: inhalation of ammonia hydrochloride solution, hydrochloric acid nabphon injection, azithatan tablets, sorine glutamate injection, sodium sulphate potassium magnesium oral solution, hydrochloric acid trophic acid injection and hydrochloric acid right metomide sodium chloride injection, mainly injection.
    Qilu 2020 declared six new categories of products, namely: Posaconazole injection, injection with fusapidamine, aptide tablets,acid tofatin cloth slow release tablets, citric acid bromonide eye drops and cisplatin injections.
    people declared four, namely: acetaminophen oxycodone tablets, metformin-based right amphetamine capsules, hydrochloric acid ascetnamin injection, hydrochloric acid methionine slow release capsules.
    the new 4 categories are still very active, there are conservative chemicals new registration classification of the new 4 categories of the most declared for apixaban tablets reported production, similar competitive devasaban tablets also have 5 manufacturers reported production.
    enterprises with more investment in the new 4 categories are also more invested.
    Yangzijiang declared 14 new 4 categories of products, namely: hydrochlorocarcinoid tablets, voliconazole tablets, sedina tablets, pribarin capsules, lulassin tablets hydrochloric acid tablets, apixaban tablets, rinazine grapes Sugar injections, palonoscent hydrochloride injections, dositamine injections, fumarate propofol tablets, tekmos ointments, cittasacin tablets, injections of phenylamostatin hydrochloride, injections of yew alcohol (albumin binding type).
    pharmaceutical declared 13 new category 4 products, namely: apixaban tablets, benzoic acid agritin tablets, doso-tea-alkali injections,acid tofatin tablets, gabapentin capsules, lacosa Amine tablets, liglitin tablets, phosphate oustamine capsules, Malay acid afatinib tablets, Pribarin capsules, sophosphobwe tablets, injections of sodium parexib, sodium chloride of moxisa chloride hydrochloric acid injection.
    Koren declared 11 new category 4 products, namely: pyridine injections, methyl sulfate lenphatini capsules, hydrochloric acid erlotini tablets, injection cephalosporine/glucose injections, hydrochloric acid moxisa Star drop eye drops,acid sidina non-oral collapse tablets, kagle net tablets, lynazine glucose injections, osethamiwe capsules phosphate, celexib capsules, LOX fluorosa tablets.
    times declared nine new categories of products, namely: non-bustam tablets, methionate lenvatinib capsules, oseltamiwe phosphate capsules, hydrobromobromite tablets, tigrillo tablets, pyrithione chloride tablets (I.), hydrochloric acid metformin tablets, injection of esomelatin sodium and injection of voliconazole.
    given the profitability of centralized procurement, individual companies that had invested heavily in generics were relatively conservative in the new category 4.
    such as Qilu only declared 3 items, namely, injection of acetic acid capofen net, methyl sulfate lunphatini capsules, hydrochloric acid Moxisa star eye drops.
    Huahai declared three projects for apixaban tablets, Pribarin capsules and pyrotaminated chloride tablets.
    Henri declared a project for the injection of niobol.
    .
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