Drug Master File (DMF) Submissions

A DMF is a file that is used to provide confidential, detailed information about facilities, processes, and articles used in the manufacturing, processing, collection, packaging, and storing of one or more human drugs or biologics to FDA. DMFs usually cover the Chemistry, Manufacturing and Controls (CMC) of a component of a drug product, for example, drug substance, excipient, and packaging material.

Manufacturers with many DMFs are often considered to be more reliable in terms of quality, regulatory standards, and capability to meet Current Good Manufacturer Practice (cGMP) requirements.

We offer the following DMF services:

    • Type I: Manufacturing Site, Facilities, Operating Procedures, and Personnel

    • 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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