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  • October 7, 2026
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Types of Drug Master Files (DMFs)

Types of Drug Master Files (DMFs)

The types of DMFs are Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation; or Drug Product, Type III Packaging Material, Type IV Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation, Type V FDA-Accepted Reference Information.

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