DMFs in The United States
In the United States, DMFs are submitted to the Food and Drug Administration (FDA). The Main Objective of the DMF is to support regulatory requirements and to prove the quality, safety and efficacy of the medicinal product for obtaining an Investigational New Drug Application (IND), a New Drug Application (NDA),As an Abbreviated New Drug Application (ANDA), another DMF, or an Export Application.
In United States there are 5 types of Drug Master file:
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- Type I Manufacturing Site, Facilities, Operating Procedures and Personnel
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- Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
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- Type III Packaging Material
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- Type IV Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
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- Type V FDA Accepted Reference Information
Read more about this topic: Drug Master File
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