FDA原辅包登记*DMF
Site information
药物主文件，即Drug Master File (DMF)，是呈交FDA的存档待审资料，资料内容包括有关在制造、加工、包装、储存、批发人用药品活动中所使用的生产设施、工艺流程、质量控制及其所用原料、包装材料等详细信息。
Highlights
**Drug Master Files (DMFs) are submissions to the FDA that contain information about the manufacturing, processing, packaging, and storage of human drug substances or excipients.** DMFs are used to support the approval of new drug applications (NDAs), abbreviated new drug applications (ANDAs), and other marketing applications. The list of DMFs is a valuable resource for researchers, manufacturers, and other stakeholders in the pharmaceutical industry.