Drug Master File (DMF)
A Drug Master File is a confidential submission to a regulator, most often the US FDA, that describes how a substance such as an API is manufactured, controlled and stored. It allows a manufacturer to support many customers' applications without revealing proprietary details to them. A drug applicant references the file through a letter of authorisation issued by the holder.
Related terms
ANDA
An Abbreviated New Drug Application is the route for approval of a generic medicine in the United States. Rat…
API (Active Pharmaceutical Ingredient)
An Active Pharmaceutical Ingredient is the substance in a medicine that produces its therapeutic effect. APIs…
Certificate of Suitability (CEP)
A Certificate of Suitability issued by EDQM confirming that the quality of a substance, typically an API or e…
GMP (Good Manufacturing Practice)
Good Manufacturing Practice is the set of quality rules that ensures medicines and their ingredients are cons…
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