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  • 1.  DMF for Sterile APIs

    This message was posted by a user wishing to remain anonymous
    Posted 19-Jul-2023 09:13
    This message was posted by a user wishing to remain anonymous

    This is a question about DMFs for Sterile Starting Materials / APIs (FDA):

    1. The DMF will have to include the Sterility testing of the Starting Material / API ?
    2. Can we please get links to guidances on the contents of the DMF for Sterile Starting materials / APIs ?

    Thank You.



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