Regulatory Open Forum

 View Only
Reg Intel Conference 2024
Back to discussions
Expand all | Collapse all

Ranging study requirement for parenteral ANDA

  • 1.  Ranging study requirement for parenteral ANDA

    Posted 10 days ago

    Dear All,

    We are developing parenteral solution for injection with generic buffer, and require information about the requirement of the ranging (excipients ranging study) for the parenteral ANDA.

    Could you please help us with this?

    Thanks and Regards

    Prashant Kshirsagar



    ------------------------------
    Prashant Kshirsagar
    Enzene biosciences limited,Pune
    Pune
    India
    ------------------------------


Related Content