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  • Site Change + Renewal

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    Menuka Khadka
    13 views6 pages
    The document lists 7 generic antibiotic products - Cefaxone, Cefantral, and Cetil in various dosages - and indicates they require site change and renewal applications. It specifies the documents required for the applications, including manufacturing licenses, Good Manufacturing Practice and Certificate of Pharmaceutical Product certifications, process revalidation reports, samples, stability data, price commitments, and other documentation like certificates of analysis and annual product quality reviews.

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    Original Title

    SITE CHANGE + RENEWAL

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    The document lists 7 generic antibiotic products - Cefaxone, Cefantral, and Cetil in various dosages - and indicates they require site change and renewal applications. It specifies the documents required for the applications, including manufacturing licenses, Good Manufacturing Practice and Certificate of Pharmaceutical Product certifications, process revalidation reports, samples, stability data, price commitments, and other documentation like certificates of analysis and annual product quality reviews.

    Copyright:

    © All Rights Reserved
    Download as XLSX, PDF, TXT or read online from Scribd
    Flag for inappropriate content
    13 views6 pages

    Site Change + Renewal

    Uploaded by

    Menuka Khadka
    The document lists 7 generic antibiotic products - Cefaxone, Cefantral, and Cetil in various dosages - and indicates they require site change and renewal applications. It specifies the documents required for the applications, including manufacturing licenses, Good Manufacturing Practice and Certificate of Pharmaceutical Product certifications, process revalidation reports, samples, stability data, price commitments, and other documentation like certificates of analysis and annual product quality reviews.

    Copyright:

    © All Rights Reserved
    Download as XLSX, PDF, TXT or read online from Scribd
    Flag for inappropriate content
    of 6

    S.

    N Product name Purpose

    Site change &


    1 Cefaxone 250mg
    Renewal

    Site change &


    2 Cefaxone 500mg
    Renewal

    Site change &


    3 Cefaxone 1 gm
    Renewal

    Site change &


    4 Cefantral 250 mg
    Renewal

    Site change &


    5 Cefantral 500 mg
    Renewal

    Site change &


    6 Cefantral 1 gm
    Renewal
    Site change &
    6 Cefantral 1 gm
    Renewal

    Site change &


    7 Cetil 750 mg
    Renewal
    Documents Required
    Application for site change & renewal
    Notarized Hard copy of Mfg License, GMP & CoPP
    Process Revalidation Report
    Samples
    Stability data
    Price commitment letter
    Notarized Hard copy of Mfg License, GMP & CoPP
    Process Revalidation Report
    Samples
    Price commitment letter
    Notarized Hard copy of Mfg License, GMP & CoPP
    Process Revalidation Report
    Samples
    Price commitment letter
    Notarized Hard copy of Mfg License, GMP & CoPP
    Process Revalidation Report
    Samples
    Stability data
    Price commitment letter
    COA
    APQR
    Notarized Hard copy of Mfg License, GMP & CoPP
    Process Revalidation Report
    Samples
    Stability data
    Price commitment letter
    COA
    APQR
    Notarized Hard copy of Mfg License, GMP & CoPP
    Process Revalidation Report
    Samples
    Stability data
    Price commitment letter
    APQR
    Notarized Hard copy of Mfg License, GMP & CoPP
    Process Revalidation Report
    Manufacturing process
    Samples
    Stability data
    Price commitment letter
    COA
    APQR
    Remarks

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