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  • 1.  Additional manufacturer question

    Posted 13-Jul-2017 17:08
    When an additional manufacturer is added to an approved ANDA and later that manufacturer no longer wants to be "additional", do they have to submit another ANDA or would this be an administrative amendment?

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    Sarah Green
    Cyclomedical International Inc.
    Knoxville TN
    United States
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  • 2.  RE: Additional manufacturer question

    Posted 13-Jul-2017 21:33
    ​Hope you are aware that first adding another manufacturer (depending on the class of drugs etc...) to an approved ANDA requires a prior approval supplement. Deleting would be just an annual reporting change.

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    GRSAOnline
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    Original Message


  • 3.  RE: Additional manufacturer question

    This message was posted by a user wishing to remain anonymous
    Posted 14-Jul-2017 08:32
    This message was posted by a user wishing to remain anonymous

    ​Deleting newly added site will be annual reportable change provided first site still maintains satisfactory GMP status.
    Original Message


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