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    Home > Active Ingredient News > Drugs Articles > Injection consistency evaluation opens, these companies may usher in a positive

    Injection consistency evaluation opens, these companies may usher in a positive

    • Last Update: 2020-05-19
    • Source: Internet
    • Author: User
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    pharmacy network market analysisRecently, the State Food and Drug Administration issued "regarding the development of chemical injection drug quality and efficacy of generic consistency of evaluation," clearly listed chemicals injectable generic drugs, not in accordance with the original quality and medical research agreement in principle approval of the species are required to carry out evaluation of conformityThis means that injection conformance assessment was officially launched, industry concentration will usher in further enhancedconformance assessment injection on, these companies, or welcome goodworth noting that the news came out, people in the industry have begun to express different opinions, some people think the same injection evaluation will be more intense than the oral solid dosage forms, the listed companies will usher in the corresponding riskBut others think this is a good opportunity for development, many pharmaceutical segments and related businesses will welcome goodFor example, the following three categories of enterprisesCRO businessin the increasingly fierce competition in the industry, whether it is the consistency of evaluation of injection, or innovative drug research and development, not only to fight technology, but also to fight speed , the cost to fight, it is clear to see in recent years, pharmaceutical companies have been out in the "borrowing." Among them, the "selling water" role exists CRO business is undoubtedly medicine is becoming the big winner in the reform processto know, since CDE requires special injection (such as liposomes, intravenous milk, microspheres and the like) require tests or clinical trials BE consistency evaluation process, and the standard is going to international standards, Therefore injections to evaluate the agreement after the official opening, the pharmaceutical outsourcing industry is expected to greatly enhance the role of the marketIn addition, the adoption and CRO enterprises, many enterprises want to expand product categories, it can save more manpower, material and financial resources, so that enterprises continue to develop in the injection process, or CRO companies will usher in sustained business growthaexcipients and packaging materialsknown enterprises, injections compared to oral solid preparations higher product safety requirements, the use of higher riskTherefore, the state has been on injection products have clear quality control requirementsAs materials shall comply with the requirements for injection, except in special circumstances, should comply with Chinese pharmacopoeia requirements As well as packaging materials and containers in direct contact with the drug injection should comply with standards Administration has issued the package material, not recommended low borosilicate glass and soda-lime glass these standards, better protection drug quality, consistency also means evaluating injections after the official launch, only those excellent quality, better performance of suppliers to be able to give an injection pharmaceutical companies all ages The industry is expected, such as upstream pharmaceutical glass, especially vials (anti-mold bottle) and other production companies, or future performance will be further enhanced a new injection enterprise injection as a basic clinical mode of administration, which is rapid onset, the dose and easy to control, high bioavailability advantages long-term hospital prescription drug sales dominate the half, but also pharmaceutical companies tie push the development of one of the dosage form But (conventional) injection left under various defects can not be ignored, such as patient pain, convenient administration, and other complications So in recent years, many also strictly control injections, which have included an adjuvant, focusing on monitoring medication directory this juncture, the development of new injection has become a choice of many enterprises Some domestic enterprises have achieved good results in the development of new areas of injection The past 30 years, liposomes, suspensions, nanoparticles, microspheres, inclusion complexes, etc administration by injection systems have available, compared to conventional injection can reduce degradation of the drug in vivo, but also has long-term, targeting, etc., relatively speaking, in the future the market will be more competitive, and related businesses will also usher in a Polly good.
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