DMF (Drug Master File)
A confidential technical file on an API's manufacturing process, filed with a regulator such as the US FDA.
Definition
A Drug Master File contains detailed, confidential information about the facilities, processes and quality controls used to manufacture an API. In the US, an API supplier files a DMF with the FDA, which formulators can then reference in their own drug applications.
Why It Matters
A live US DMF (or EU equivalent CEP) is generally the entry ticket for an API to reach Tier 1 formulator customers.