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FDA原辅包登记*DMF

FDA原辅包登记*DMF

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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。

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Highlights

**FDA Drug Master Files (DMFs)** The FDA's Drug Master File (DMF) program allows manufacturers of active pharmaceutical ingredients (APIs) and finished dosage forms to submit detailed information about their manufacturing processes and facilities to the FDA for review. This information is used to support the safety and effectiveness of drug products that use these APIs or finished dosage forms. **Highlights:** * Provides a central repository for information on API and finished dosage form manufacturing * Supports the safety and effectiveness of drug products * Facilitates the exchange of information between manufacturers and the FDA