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A drug master file (DMF) is a confidential, detailed document submitted by Active Pharmaceutical Ingredient (API) manufacturers to the U.S. Food and Drug Administration (FDA). A DMF contains the chemistry, manufacturing and controls of a drug component.
A DMF is required to supply bulk materials to the United States but the FDA does not require all manufacturers to submit a DMF. However, the information contained in a 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 related documents.
The FDA says a DMF cannot be substituted for an IND, NDA, ANDA or Export Application. “It is not approved or disapproved,” according to the FDA. “Technical contents of a DMF are reviewed only in connection with the review of an IND, NDA, ANDA, or an Export Application.”
Before DMFs can be reviewed, a manufacturer must submit a dose form filing that references the DMF. Not all DMFs are reviewed by the FDA, and the possession of a DMF for a product does not ensure that a manufacturer is producing that product or able to supply it to the United States.
In the past, filing a DMF was a way for less established firms to claim a degree of credibility when trying to sell into the U.S. market and other regulated markets.
However, since DMFs are only reviewed when an ANDA or NDA references them, a DMF that has not been referenced is of questionable value even if the DMF holder thinks having a DMF makes them look legitimate. Filing DMFs without any customers in the U.S. has become much less common, so more recent DMFs are a better indicator of intent to manufacture than older DMFs.
The Five Types of DMFs
Type I: Manufacturing site, facilities, operating procedures and personnel not specific to a drug substance. Type I DMFs are no longer accepted by the FDA but old ones remain on file.
Type II: Drug substances, substance intermediates and materials used in their preparation, or a drug product. A Type II DMF, the most common form, can also cover dosage form drugs manufactured under contract for another company which would file an ANDA.
Type III: Packaging materials, from bottles and caps to PVC resin used in their manufacture must be covered in a DMF or other FDA document such as an NDA.
Type IV: Excipient, colorant, flavor, essence or material DMF. Excipients are chemically inactive substances such as starches or cellulose used to bind drug powder together so that it can be pressed into a tablet. Other examples include flavorings in children’s drugs, alcohol in liquids, etc.
Type V: FDA accepted reference information not included in the other types.
The FDA requires that DMFs be current at the time they’re reviewed. The FDA regulations regarding DMFs states: “Any addition, change, or deletion of information in a drug master file (except the list required under paragraph (d) of this section) is required to be submitted in two copies and to describe by name, reference number, volume, and page number the information affected in the drug master file.”
The FDA ensures that DMFs are current. If a company has not submitted an annual report in for three years, the agency sends an “Overdue Notification Letters” to DMF holders. The holder has 90 days in which to respond and submit its annual report. If they fail to respond, their DMF may be closed.
The FDA’s Guideline for Drug Master Files can be found on its website.