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Types of Drug Master Files (DMFs)

08:23 EST 8 Nov 2019 | FDA

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.

Original Article: Types of Drug Master Files (DMFs)

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