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.
2.7.1.2 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)
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Sunny Zhu
Exton, PA
United States
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