Regulatory Open Forum

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  • 1.  OTC facility registartion

    Posted 15-Mar-2024 11:04

    Dear All,

    For OTC drug product , if CMO is already registered with GADUFA,does it require still for OMUFA registration?

    If CMO is not registered with GADUFA, but just pics approved plant, which registration required?How to proceed for site registration?

    As a labeler, do we need to pay fees, or is just NDC registration required with SPL submission?

    Regards,



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    sapna rathi
    Regulatory specialist
    AHME
    India
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