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  • 1.  Site change

    This message was posted by a user wishing to remain anonymous
    Posted 16-May-2018 13:00
    This message was posted by a user wishing to remain anonymous

    Hello Everyone,

    This is a question regarding post approval submission requirements for a site change. Company A sold an ANDA (extended release product) to Company B. Company A's commercial batch size was 1 Million units and their submission batch size was 100,000 units. Now Company B wants to submit a PAS for the site change but at a batch size of 100,000 units which is the submission batch size. Would this be acceptable?


    Thank you.


  • 2.  RE: Site change

    Posted 17-May-2018 01:06
    Hi,

    Yes. An exhibit batch of minimum 100,000 dosage units is acceptable for PAS, site change. The batch size need not same as commercial batch size at approved site, Site A. Please refer to FDA guidance, SUPAC-MR: Modified Release Solid Oral Dosage Forms (V.Site changes) for required documentation. 

    Hope this answers your query.

    Thanks,
    Sailaja

    ------------------------------
    Sailaja Chirravuri
    Regulatory professional
    Hyderabad
    India
    ------------------------------

    Original Message


  • 3.  RE: Site change

    Posted 17-May-2018 15:47

    Yes – this is acceptable. You'll need a dissolution profile comparison and a BE study since extended release per SUPAC-MR guidance.  Submit an executed BR for a 100,000 batch (minimum per guidance) with 3 months accelerated and real time stability data.

    Tom

    Chicago

     




    Original Message


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