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  • 中国化工网首页 >> 化工助手 >> DMF提交信息库


    DMF号  项目持有人  项目名称  
    使用说明:
    1 本数据库收录了向美国FDA提交的药物主文档(Drug Master File,DMF)目录。
    2 您可以在DMF提交信息库中搜索DMF号、项目持有人(Holder)、项目名称(Subject)。
    项目持有人举例如下:
    Ampacet Corp Basf Aktiengesellschaft Cipla Ltd
    Dr Reddys Laboratories Ltd Diosynth Bv Flavors North America Inc
    Chemicals Inc Lupin Ltd Ganes Mallinckrodt Inc
    Matrix Laboratories Ltd Polyone Corp Ranbaxy Laboratories Ltd
    Sigma F And D Div Ltd Teva Pharmaceutical Industries Ltd Sun Pharmaceutical Industries Ltd
    项目状态检索标识及释义:
    “A” = Active. This means that the DMF was found acceptable for filing, administratively, and is up-to-date.
    “I” = Inactive
    “N” = Not an assigned number
    “P” = DMF Pending Filing Review
    项目类型检索标识及释义:
    Ⅰ Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)
    Ⅱ Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
    Ⅲ Packaging Material
    Ⅳ Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
    Ⅴ FDA Accepted Reference Information
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