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  • 1.  Impurity Level in ANDA Compared to RLD

    Posted 28-Sep-2022 11:43
    Hello Colleagues,

    Would the FDA approve an ANDA for a generic product that is not identical to the RLD in terms of impurity profile?

    Thank you.


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    David Lucking
    Coral Gables FL
    United States
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  • 2.  RE: Impurity Level in ANDA Compared to RLD
    Best Answer

    This message was posted by a user wishing to remain anonymous
    Posted 28-Sep-2022 14:50
    This message was posted by a user wishing to remain anonymous

    Let's say if your ANDA has an impurity that was not present in the RLD and its level is above the ICH threshold for an unknown impurity, its unlikely the ANDA would be approved!
    Another scenario, if the impurity levels of ANDA which are identical to the RLD but if anyone of them above the limits approved for RLD, it is very unlikely the ANDA would be approved unless you bring the level down to the level seen in RLD.
    Original Message


  • 3.  RE: Impurity Level in ANDA Compared to RLD

    Posted 29-Sep-2022 14:10
    Your drug impurity profile should complying USP (if the specification is available in USP) as well as ICH threshold limit.

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    Md Saddam Nawaz
    Head of Quality Management
    Naryanaganj
    Bangladesh
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    Original Message


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