[RegAffairs]Excipient DMF

["Frank w" <kant.wmf@gmail.com>]

Dear all:

In CMC of FDA, there requires novel-excipients used in drug product 
to be provided detail informations when the drug product provides 
DMF. If I apply an ANDA, the used excipients are 
non-novel-excipients, can I use the excipients conforming with USP 
but don't have DMF in FDA? As same as in production.

Except your reference. Thank you in advance.

Frank W