
Drug Master File
4
MENTIONS
2
EPISODES
2
PODCASTS
Search complete. 4 mentions across 2 episodes found for "Drug Master File".
Sep 19, 2026
Handbook of Pharmaceutical Manufacturing Formulations: Sterile Products
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11:50speaker_4HOST
They matter immensely.
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11:51speaker_4HOST
This is why regulatory agencies demand a drugmaster file or a DMF from the supplier.
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11:57speaker_7HOST
What does that do?
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11:57speaker_4HOST
The DMF details the exact synthesis route and guarantees current good manufacturing practices.
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12:03speaker_4HOST
Because here's the danger.
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12:06speaker_4HOST
A unique trace impurity from a new supplier might be perfectly harmless sitting in a dry powder on a shelf.
The Peptide Industry Explained by the Pharmacist & Attorney Fighting for Its Future
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22:40Lee RosebushGUEST
HIMS, for example, just bought a, a peptide manufacturing facility in California outside of Menlo Park.
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22:45Lee RosebushGUEST
I can tell you that there's another one down in Florida who's in the process of filing what we call a DMF.
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22:48Lee RosebushGUEST
That's a drug master file with the FDA.
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22:51Lee RosebushGUEST
And so there are folks here in the United States who are making peptides.
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24:03Lee RosebushGUEST
know of at least two more manufacturers of peptides are in the process of doing so here in the United States.
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24:08Larry LipshultzHOST
Mm.
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24:08Lee RosebushGUEST
One in Texas and one in Florida that will have DMFs, drug master files, filed with the FDA by the end of the year.
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24:14Lee RosebushGUEST
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.