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A Drug Master File (DMF) is a type of submission made to the Food and Drug Administration (FDA) to provide important information related to facilities, processes or ingredients used for manufacturing, packaging or storing of any human drugs. Though it is not mandatory to file a DMF, the submission is subject to the discretion of the manufacturer. DMFs are generally filed to support an Investigational New Drug Application (IND), a New Drug Application (NDA), an Abbreviated New Drug Application (ANDA), any other DMF, application of export, or to support any of these.

Types of DMFs

DMF Type

Information Included

Type I

Information related to the manufacturing units such as the name of manufacturing sites, facilities, operating procedures and professionals

Type II

Information related to the drug such as drug substances and intermediates, the materials involved in the manufacturing etc.

Type III

Information regarding the packaging material

Type IV

Information about the excipients, colorants, flavors etc.

Type V

Reference information accepted by the FDA

Reference: FDA

DMF Submissions

DMFs submitted to the FDA must be in English. In case, it is in another language, a certified English translation must be included in the submission. A DMF must contain the following information:

1. Transmittal Letters

a. Original Submissions – Includes original submission identification, application identification, authorized representative’s signature and signer’s title with typewritten name.
b. Amendments – Includes amendments to the original submission identification, purpose of submission, authorized representative’s signature and signer’s title with typewritten name.

2. Administrative Information

a. Original Submissions – Includes name and addresses of DMF holder, corporate headquarters, manufacturing facility, agents etc., responsibilities of all the personnel involved in the manufacturing process, statement of commitment.
b. Amendments – Name of the DMF authorized person along with the address of correspondence, DMF number, page number of sections affected by the amendments, name and address of each responsible person of respective IND, NDA, ANDA, DMF, or Export Application along with the number of all the applications etc.

Authoring a DMF is a crucial task as it is required to convey all the necessary information related to a drug to the FDA. Are you looking for assistance to author a compliant DMF? Reach out to Freyr at sales@freyrsolutions.com.