A Drug master File (US DMF) is a submission to the US FDA that may be used to provide confidential detailed information about facilities, processes or articles used in the manufacturing, processing, packaging and storing of one or more human drugs. Typically, a DMF is filed when two or more firms work in partnership on developing or manufacturing a drug product. The DMF filing allows a firm to protect its intellectual property from its partner while complying with regulatory requirements for disclosure of processing details.

The information contained in the DMF may be used to support an Investigational New Drug Application (IND), a New Drug Application (NDA), an Abbreviated New Drug Application (ANDA), another DMF, an Export Application or amendments and supplements to any of these.

The DMF contains factual and complete information on a drug product’s chemistry, manufacture, stability, purity, impurity profile, packaging, and the cGMP status of any human drug product.

In United States there are 5 types of Drug Master File:

 

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

We provide our service to firms focuses on the development of drug master files with the United States Food & Drug Administration (FDA).

Our DMF Submission Scope.

Option 01         Documentation and Technical Consultancy.

  • Provide a checklist containing documents to be provided by client to consultant for the DMP Preparation.
  • Preparation of Drug Master File for submission. ( Exclusive feature)
  • Identification of records, reports, chemistry needs to furnish in the submission file(for type II DMF and III DMF).
  • Edit and organize DMF information as per FDA required format.
  • Completed DMF for review and acceptance by the client.
  • Guidance on GMP.

Option 02         U.S Agent Service

  • Submitting DMF to FDA.( electronic or paper form)
  • Communicating with FDA on behalf of our client.
  • Assisting clients to issue LOA (letter of authorization) to FDA.
  • Annual Maintenance.

                                                                                             

Our Annual DMF Maintenance service includes…..

  • Respond to FDA concerns about DMF submitted by client.
  • Notify in advance if any changes in the submitted DMF.
  • Provide DMF changes, additions, and deletions to the FDA.
  • Submit any additional letters of authorization to the FDA.
  • Assist in the closure of a DMF on file with the U.S. FDA, as required.
  • Assistance with DMF Annual report submission to FDA.
  • Assistance in DMF Closure request submission to FDA.
  • Assistance in DMF Reactivation request submission to FDA. (for closed DMF)

Benefits of DMF submission

  • Gives you an edge over your competitors.
  • Adds prestige to your company and product
  • Confidence building with customers
  • Improve sales anywhere in the world
  • Penetrating high entry barrier US market.