Tuesday, June 19, 2018 4:42:36 PM
To my knowledge based on talks with people in pharma, steps are as follows.
1) application to FDA as excipient followed by a period of clinical testing. This was completed last October.
2) filing of DMF for review. This was completed and filed. The DMF was issued a number and activated the first week in May.
There is nothing left for APDN to do.
If an interested pharma gives APDN’s agent a LOA for approval and APDN approves, they give the LOA to FDA and access the info in the activated DMF.
If the pharma decides to use Colorcon/APDN marking, tracking and tracing, they update their own excipient DMF and reference Colorcon and APDN.
If I’m missing something here, please give that info.
Btw, the DMF has been accessed.
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