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  • 1.  USDMF submission

    This message was posted by a user wishing to remain anonymous
    Posted 06-Aug-2020 11:56
    This message was posted by a user wishing to remain anonymous

    Hi Everyone 

    Hope everyone is doing fine and safe!

    My query is regarding DMF submission with FDA- If we have a product/ excipient with 2 different specifications, Can we submit a single DMF for that as the manufacturing process is same and the difference is only in the specifications

    Please advice
    Thanks in advance!


  • 2.  RE: USDMF submission

    Posted 08-Aug-2020 21:22
    Can you provide more details. When you say 2 different specifications for the excipient,  what's the impact on the product? Have you done comparison studies?

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    Vandana Dole
    Andover MA
    United States
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    Original Message


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