Given the near term FDA meeting is hopefully still on the agenda...

Given the near term FDA meeting is hopefully still on the agenda and further to the recently granted patent in the US https://hotcopper.com.au/posts/36600726/single nice to see POH have at least also kept up their annual review (& any additions to) of their FDA MDF (Master Drug File) first lodged in 2011. These are not required by law, submitted by holders, but do appear to serve some purpose as the list is quite extensive. Just fyi search to kill some time this eve. Happy Fri all.

As per FDA site (where the spreadsheet was DL) & a lot of other info:

A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.

https://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/DrugMasterFilesDMFs/default.htm

As per pharma-excipients site:

A Drug Master File (DMF) is a submission of information to the U.S. FDA to permit the Agency to review information on a drug component in support of a third party’s drug application. The submission of a DMF is not required by law or FDA regulation. The Drug Master File Guidance states “The submission of a DMF is not required by law or FDA regulation. A DMF is submitted solely at the discretion of the holder„.Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug ProductType III Packaging MaterialType IV Excipient, Colorant, Flavor, Essence, or Material Used in Their PreparationType V FDA Accepted Reference Information

https://www.pharmaexcipients.com/excipient-sources/excipient-dmf-list/

Downloading the FDA excel file for active & inactive MDF;s updated to 30 Sept 18 and then filtering for Active Type IV (excipients incl'd) for TPM & TPGS (Antares came up), then Mylan, POH, Terumo, Agila, Strides & you only get the following:

	DMF#	STATUS	TYPE	SUBMIT DATE	HOLDER	SUBJECT
1	22569	A	IV	2/23/2009	MYLAN PHARMACEUTICALS INC	POLYOLPREPOLYMER -02
2	24966	A	IV	5/18/2011	PHOSPHAGENICS LTD	TOCOPHERYL PHOSPHATE MIXTURE
3	28188	A	IV	4/7/2014	ANTARES HEALTH PRODUCTS INC	ANTARES VITAMIN E TPGS, NF GRADE

From pharmacompass https://www.pharmacompass.com/dmf-24966