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  • 1.  ANDA with two manufacturing sites

    Posted 11-Aug-2014 16:19
    Hello All,

    I would like your suggestion and/or comments on this.

    Can we submit an ANDA with two finished product manufacturing sites (facilities would be very far apart) and if yes, what kind of data would be needed to prove equivalence. Would a BA/BE studies be required for both sites?


    Thanks,
    Mehul

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    Mehul Govani
    Regulatory Specialist
    United States
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  • 2.  RE: ANDA with two manufacturing sites

    Posted 09-Jul-2023 21:52

    Hello Sir,

    I am just curious to know how you handled above situation. If you have time please enlighten me. 



    ------------------------------
    SUJAN BOSE
    Tangail
    Bangladesh
    ------------------------------

    Original Message


  • 3.  RE: ANDA with two manufacturing sites

    Posted 10-Jul-2023 08:18
    Edited by Rhonda Noll 11-Jul-2023 14:24

    Hi,

     

    It would depend on what type of product it is.  Immediate release tablet/capsule/soft gel you would only need 1 batch of data from the second site with 3 – 6 months A/S and RT stability data.  No BE would be required.  For some ER or DR tablets, as BE might be required depending on the changes from site to site.

     

     

    Thank you,




    Original Message


  • 4.  RE: ANDA with two manufacturing sites

    This message was posted by a user wishing to remain anonymous
    Posted 10-Jul-2023 09:10
    This message was posted by a user wishing to remain anonymous

    It depends on the dosage form! The primary site should have three batches manufactured (for solid oral-100% of full scale batches etc) and the secondary site if everything is same/similar (i.e. process, equipment etc) one full scale batch would be a starting point to get an agreement from the FDA to approve the second site also! Distance between two sites is not a factor!


    Original Message


  • 5.  RE: ANDA with two manufacturing sites

    This message was posted by a user wishing to remain anonymous
    Posted 10-Jul-2023 12:46
    This message was posted by a user wishing to remain anonymous

    Typo: I meant 10% of full scale batches of primary site!


    Original Message


  • 6.  RE: ANDA with two manufacturing sites

    Posted 10-Jul-2023 13:00
    Edited by Rhonda Noll 11-Jul-2023 14:25

    So you are asking can the second site registration batch be 10% of full scale?

     

     

    Thank you,

              

     




    Original Message


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