DRUG MASTER FILE SUBMISSION

What is drug master file- DMF ?

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

Why choose Pragmatic for DMF Filing Service?

• We are providing DMF Filing Service from more than 15 years.
• Our assure client confidentiality
• In-depth technical knowledge on all functional areas
• Complete solution, from a gap analysis of technical documentation, review and compilation in eCTD format to the submission through ESG.
• We support you until  receipt of   an acknowledgement letter or a complete technical evaluation of your DMF.
• We bring expertise in the evaluation of chemistry, manufacturing and control information.
• Offer guidance on the FDA general regulatory compliance requirements, including US Agent, Establishment registration, Labeler code, and NDC number listing.
• We respond promptly to all your questions, and don’t charge extra for the service.

If you have questions, please visit our FAQ section. Alternatively, you can contact us.

Remember: Failure to identify the right starting material or any other mistake may result in failure to pass the GDUFA Complete Assessment.