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Strategy for EU submission for the drugs in pellets form with the involvement different mfg. facility

  • 1.  Strategy for EU submission for the drugs in pellets form with the involvement different mfg. facility

    Posted 28-Feb-2023 05:42

    Dear All,

    We would like to manufacture a finished product in a capsule form with the filling of the pellets. We have the facility for the filling of the pellets but not have the facility for manufacturing of the pellets. So in this case can we source the pellets as a intermediate from other manufacturer and as a FP manufacturer, we will fill the pellets in capsules at our site. Is it good to follow this strategy for the EU registrations and what criticality we may face on following of this strategy. Please guide.

    Thanks

    Manoj



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    MANOJ PANIGRAHI
    Mr.
    Vadodara
    India
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