A Drug Master File – or DMF – is a submission to the FDA that provides ‘confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. Submitting a DMF is a complex process, and involves the gathering and submission of product-related technical information in an electronic common technical document filing format.
FDA reviews drug master file against pharmaceutical products application (NDA/ANDA) for which letter of authorization (LOA) from the DMF holder is required .
Types of DMF
United States Food and Drug Administration (FDA) has classified DMF in four types.
I : Manufacturing Site, Facilities, Operating Procedures, and Personnel
II : Drug Substance (active pharmaceutical ingredients API), 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
FDA has mandated to file DMF in the eCTD (electronic common technical document) format.
Pragmatic offers a complete solution for all types of original Drug Master Filing, including amendments and Annual Reports. Our comprehensive services cover compilation, review, and technical gap analysis, drawing on over 15 years of experience of supporting companies across the globe.
Fees for DMF filing assistance start from as low as $399. Charges vary based on the nature of services required
Remember: Failure to identify the right starting material or any other mistake may result in failure to pass the GDUFA Complete Assessment.