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FDA 全域目录:药品/生物制品制造质量指南·· 6 小时前AI 评分42

FDA 药品主文件(DMF)清单更新至 2026 年第三季度(截至 DMF 044931)

List of Drug Master Files (DMFs)

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FDA 发布药品主文件(DMF)清单,本季度更新收录截至 2026 年 9 月 30 日收到、且在 2026 年 10 月 12 日前发出确认函的 DMF,清单更新至 DMF 044931。

正文

The list of DMFs, which is updated quarterly, contains DMFs received by September 30, 2026, for which acknowledgment letters were sent before October 12, 2026.

The list is current through DMF 044931. Changes to the DMF activity status (A=active ; I=inactive), DMF type, holder name and subject (title) made since the last update of June 30, 2026, are included.

来源:FDA 全域目录:药品/生物制品制造质量指南 · fda.gov