Master Files
What is a Master File (MF)?
An MF 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 MF.
Enables the manufacturer to protect intellectual property by allowing regulators at the FDA to review the contents of the MF in support of a third party’s submission.
In line with the FDA’s submission requirements, Akron submits MFs (Type II) in Electronic Common Technical Document (eCTD) format.
Akron’s Current eCTD MFs
- Recombinant Human Interleukin-2 (rHu IL-2) - MF#026152
- Recombinant Human Interleukin-21 (rHu IL-21) - MF #026086
- Recombinant Human Interleukin-7 (rHu IL-7) - MF #026084
- Recombinant Human Interleukin-15 (rHu IL-15) - MF #026085
- Recombinant Human Erythropoietin (rHu EPO) - MF #027160
- Recombinant Human Insulin - MF #027051
- Human Serum Albumin (HSA) 25% - MF#019354
- Heparin Sodium Salt - MF #026153
Coming in 2021:
- rHu G-CSF, rHu GM-CSF, rHu bFGF, rHu SCF, rHu IL-12, rHu IL-18, rHu PDGF-BB, AB Serum (Xeno-Free, Virus Inactivated), Human Fibronectin (Virus Inactivated)
- Click here to inquire about others
Referencing our MFs in your regulatory filings
The FDA can cross-reference our MFs 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 MF holder permitting the FDA to refer to information in the file in support of another organization’s submission.
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