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Alternate APIs for NDA 505b2

  • 1.  Alternate APIs for NDA 505b2

    Posted 08-Aug-2016 12:17

    Hi,

    For alternate APIs for NDA 505b2, what are companies doing with regard to number of batches/presentation and months of stability data needed for the supplement?

    I have seen many variations on this and am wondering what most people are doing.

    Thanks

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    Cynthia Katsempris
    Director, Regulatory Affairs
    Three Bridges NJ
    United States
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