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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Wanbury Limited

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    Wanbury Limited
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    Country
    Country
    India
    Address
    Address
    Wanbury Limited BSEL Techpark,'B' Wing, 10th Floor,Sector 30-A,Opp. Vashi Railway Station, Vashi, Navi Mumbai - 400705
    Telephone
    Telephone
    22-6794 2222
    Client Email
    Email
    enquiries@pharmacompass.com
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    http://www.wanbury.com/
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    Sertraline Hydrochloride

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    USDMF

    Found USDMF

    19035
    Active
    SERTRALINE HYDROCHLORIDE
    2005-12-13
    CEP/COS

    Found CEP/COS

    R1-CEP 2008-173 - Rev 06
    Valid
    Sertraline hydrochloride
    2022-04-08
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0122
    Valid
    Setraline HCL (BP/USP/Ph. Eur.)
    2022-06-23
    Application Number
    19035
    R1-CEP 2008-173 - Rev 06
    Indian CDSCO WC-0122
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    SERTRALINE HYDROCHLORIDE
    Sertraline hydrochloride
    Setraline HCL (BP/USP/Ph. Eur.)
    Issue/Submission Date
    2005-12-13
    2022-04-08
    2022-06-23
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    • FDA
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    Sertraline Hydrochloride

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    USDMF

    Found USDMF

    19931
    Active
    SERTRALINE HYDROCHLORIDE FORM I
    2006-10-10
    CEP/COS

    Found CEP/COS

    R1-CEP 2010-107 - Rev 02
    Valid
    Sertraline hydrochloride, Form I
    2017-10-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    19931
    R1-CEP 2010-107 - Rev 02
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    SERTRALINE HYDROCHLORIDE FORM I
    Sertraline hydrochloride, Form I
    Issue/Submission Date
    2006-10-10
    2017-10-17
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