Regulatory Open Forum

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  • 1.  ANDA ammendment requirments

    Posted 03-Dec-2012 11:40
    Hello All,
    I am new to regulatory environment and curious to know about " If you are taking over responsiblity of one generic drug production as third party, then what kind of amendments and/or regular submissions do we have to perfor to be in compliance".
    Really appreciate for your time and responce.
    Thanks,
    Hardik

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  • 2.  RE:ANDA ammendment requirments

    Posted 27-Dec-2012 07:35
    Hardik,

    Just so I am clear on your question. Are you saying that your company has taken over the responsibilty of a ANDA and not the ownership? Are you located in the US and you are acting as the US agent? Please contact me at jlay@vistapharm.com and I can give you all the details that you need. But you do have to inform FDA that you are the agent for the company and all communications would come directly to your company.

    Regards,

    John

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    John Lay
    Director, Regulatory and Quality
    VistaPharm Inc.
    United States
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