[RegAffairs]Re: Excipient DMF

["Vamsikanth A" <vamsikanth.a@inogent.com>]

Dear Frank,

Complete Manufacturing process with all controls shall be submitted in
ANDA incase you are using the excipents from non-DMF sources.

Your vendor shall be ready for FDA audit and to show the compliance to
the documents he provided to you.

It is better to take a written commitment from your excipents source to
support you in answering ANDA deficiency.

Forum to correct me if I am wrong

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Thanks and Best Regards
Vamsi Kanth A