What is a Drug Master File (DMF)?
A DMF provides detailed, confidential information about a product’s manufacturing, processing, packaging, and storage, including chemistry, raw materials, stability, purity, and more.
Used to support an Investigational New Drug (IND) application, Biologic License Application (BLA), New Drug Application (NDA), Abbreviated New Drug Application (ANDA), or another DMF.
Enables the manufacturer to protect intellectual property by allowing regulators at the FDA to review the contents of the DMF in support of a third party’s submission.
In line with the FDA’s submission requirements, Akron submits DMFs (Type II) in Electronic Common Technical Document (eCTD) format.
Referencing our DMFs in your regulatory filings
The FDA can cross-reference our DMFs in conjunction with your IND, BLA, NDA, or ANDA. A cross-reference can be initiated via a request for a Letter of Authorization (LOA).
The LOA is a written statement by the DMF holder permitting the FDA to refer to information in the file in support of another organization’s submission.
If you wish to request a LOA in the context of one or more of your regulatory submissions, please e-mail firstname.lastname@example.org and include the following information in your e-mail in order to expedite the process: