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Drug Master File

What is a Drug Master File?

A Drug Master File (DMF) is a compliance to the Food and Drug Administration (FDA) that can be used to offer classified comprehensive information about services, courses, or items used in the manufacturing, storing drugs, and also processing and packaging. In simpler words, DMF is a confidential document primed by a pharmaceutical company and submitted to the appropriate regulatory establishment in the wished-for drug marketplace.

In the US, DMFs are presented to the Food and Drug Administration (FDA). The key purpose of the DMF is to prop up rigid supplies and to demonstrate the class, worth, security and efficiency of the medical good in order to acquire an Investigational New Drug Application (IND), a New Drug Application (NDA), as an Abbreviated New Drug Application (ANDA), another DMF, or an Export Application.

Drug Master file is categorized into 5 types, which are:

Type 1: Industrialized and manufacturing site, services, working measures and workforce

Type 2: Drug material, drug material intermediary, and substance used while preparing it, or drug good

Type 3: Packaging matter/ substance

Type 4: Color, essence, taste/ flavor, or substance used in their making

Type 5: FDA customary reference Info

The DMF review process

On receiving a DMF (Drug Master File), firstly, the FDA reviews it for managerial and administrative content. The time duration of this is usually between two to three weeks. Once the DMF passes the administrative standpoint, an acknowledgement letter is issued by the FDA. It informs the holder of the DMF number. However, there is always a possibility that the FDA rejects the DMF, then they inform the holder of the shortcomings they must look into.

The following must happen in order to get the FDA reviewing the DMF for technical info.

  • The DMF holder provides with a Letter of Authorization (LOA) to the DMF which contains the DMF number.
  • An authorized copy (LOA)is sent to the customer.
  • An application is then filed to the FDA that contains a copy of the LOA.