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Drug Master File

Drug Master File

Search complete. 4 mentions across 2 episodes found for "Drug Master File".

Sep 19, 2026

speaker_4HOST
11:50
They matter immensely.
speaker_4HOST
11:51
This is why regulatory agencies demand a drugmaster file or a DMF from the supplier.
speaker_7HOST
11:57
What does that do?
speaker_4HOST
11:57
The DMF details the exact synthesis route and guarantees current good manufacturing practices.
speaker_4HOST
12:03
Because here's the danger.
speaker_4HOST
12:06
A unique trace impurity from a new supplier might be perfectly harmless sitting in a dry powder on a shelf.
Lee RosebushGUEST
22:40
HIMS, for example, just bought a, a peptide manufacturing facility in California outside of Menlo Park.
Lee RosebushGUEST
22:45
I can tell you that there's another one down in Florida who's in the process of filing what we call a DMF.
Lee RosebushGUEST
22:48
That's a drug master file with the FDA.
Lee RosebushGUEST
22:51
And so there are folks here in the United States who are making peptides.
Lee RosebushGUEST
24:03
know of at least two more manufacturers of peptides are in the process of doing so here in the United States.
Larry LipshultzHOST
24:08
Mm.
Lee RosebushGUEST
24:08
One in Texas and one in Florida that will have DMFs, drug master files, filed with the FDA by the end of the year.
Lee RosebushGUEST
24:14
Which means that you can and will be able to obtain BPC, and TB4, TB500, depending on what you wanna call it, right? From sources here in the United States.

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