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  • 1.  single CBE 30/PAS for 03 /04 chnages at a time.

    Posted 21-Jun-2018 04:06

    Hi, 
    One approved ANDA has 04 strengths ( tablet). Now need to change the approved formulation that falls under SUPAC Label II. 
    Also need to change the source of container closure system (MOC is same) along with no of count / Bt. 

    Taking 01 Exhibit batch of each strengths (for 04 strengths 04 EB batches) to perform the dissolution and stability studies in the proposed source /count as per SUPAC.

    Would appreciate your valuable comments /suggestions on below :

    1. Is it okay to proceed with 01 EB from each strength or need to take 03 EB from each strength (03 x 04 strengths = 12 EB)? 

    2.Is it okay to submit single CBE 30 covering all these changes (Formulation change, container source change, count change)?  


    Thank you.

    ------------------------------
    Mir Hossain PharmD
    Gulshan Model Town
    Bangladesh
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  • 2.  RE: single CBE 30/PAS for 03 /04 chnages at a time.

    Posted 22-Jun-2018 12:55
    1. Yes. One batch of each strength is suffice.
    2. Yes. Can combine all changes into a single supplement, but according to SUPAC-IR a level II change requires a Prior Approval Supplement

     

    Tom

    Chicago




    Original Message


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