Regulatory Open Forum

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  • 1.  dissolution data

    Posted 17-Dec-2015 22:51

    Dear all,

    Normally how many batches for each strength do you do for the intro dissolution in ANDA submission as below copy from ANDA check list. Is there any  requirements from FDA on this one? Somebody said one but somebody said three batches are necessary. Thanks in advance. Summary of Results of Individual Studies

     Table 5. Summary of In Vitro Dissolution

     (include complete comparative In Vitro Dissolution Data (individual) with Certificate of Analysis [CoA]

     for Test and Reference products including: potency, assay, content uniformity, date of manufacture

     and lot number)

    Sunny Zhu
    Exton, PA
    United States