Regulatory Open Forum

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  • 1.  Original ANDA submission batch requirements

    Posted 05-Jul-2023 01:45

    Dear Experts,

    Is ANDA submission batch need to manufacture in the same facility where proposed commercial batch going to manufacture? If yes, then both of them will be inspected as a part of PAI

    Looking for your expert opinion and any guidance reference.



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    SUJAN BOSE
    M. Pharm
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  • 2.  RE: Original ANDA submission batch requirements

    Posted 05-Jul-2023 17:15

    The ANDA submission batch must be manufactured in the same facility as the commercial batch in GMP setting. Please refer to the below guidance for additional clarification. 

    https://www.fda.gov/files/drugs/published/ANDAs--Stability-Testing-of-Drug-Substances-and-Products--Questions-and-Answers.pdf



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    Mehul Govani RAC
    Regulatory Affairs Manager
    Bellerose NY
    United States
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