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      1. 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  
        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)。
        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
        “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
        Ⅰ Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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