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DMF提交信息库
使用说明:

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)。


项目持有人举例如下:

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


项目状态检索标识及释义:
“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

项目类型检索标识及释义:
Ⅰ Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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