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DMF提交信息庫(kù)


使用說(shuō)明:

1 本數(shù)據(jù)庫(kù)收錄了向美國(guó)FDA提交的藥物主文檔(Drug Master File,DMF)目錄。

2 您可以在DMF提交信息庫(kù)中搜索DMF號(hào)、項(xiàng)目持有人(Holder)、項(xiàng)目名稱(Subject)。


項(xiàng)目持有人舉例如下:

Ampacet Corp

Basf Aktiengesellschaft

Cipla Ltd

Dr Reddys Laboratories Ltd

Diosynth Bv

Flavors North America Inc

Chemicals Inc

Mallinckrodt Inc

Matrix Laboratories Ltd

Polyone Corp

Ranbaxy Laboratories Ltd

Sun Pharmaceutical Industries Ltd

Teva Pharmaceutical Industries Ltd

Sigma F And D Div Ltd


項(xiàng)目狀態(tài)檢索標(biāo)識(shí)及釋義:
“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

項(xiàng)目類型檢索標(biāo)識(shí)及釋義:
Ⅰ Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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