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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Hetero Drugs Limited (Unit IX)

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    HETERO DRUGS LIMITED (UNIT IX)

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    Hetero Drugs
    india-flag Flag
    Country
    Country
    India
    Address
    Address
    7-2-A2, Hetero Corporate Industrial Estates, Sanath Nagar Hyderabad,Telangana
    Telephone
    Telephone
    +91 40 23704923/24
    Client Email
    Email
    enquiries@pharmacompass.com
    Client Website
    Website
    https://www.hetero.com/
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    Linkedin
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    Twitter

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    Sertraline Hydrochloride

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    USDMF

    Caution USDMF

    15731
    Inactive
    SERTRALINE HCL USP (FORM II PROCESS...
    2001-11-14
    CEP/COS

    Found CEP/COS

    R1-CEP 2012-218 - Rev 04
    Valid
    Sertraline hydrochloride, Alternate...
    2022-09-06
    Japanese DMF

    Found JDMF

    226MF10175
    Sertraline hydrochloride at 7-2-A2,...
    2014-09-01
    Written Confirmation

    Found WC

    Indian CDSCO WC-0040
    Valid
    Sertraline Hydrochloride (USP/Ph. E...
    2022-07-04
    Application Number
    15731
    R1-CEP 2012-218 - Rev 04
    226MF10175
    Indian CDSCO WC-0040
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-07-03
    Filing Details
    SERTRALINE HCL USP (FORM II PROCESS...
    Sertraline hydrochloride, Alternate...
    Sertraline hydrochloride at 7-2-A2,...
    Sertraline Hydrochloride (USP/Ph. E...
    Issue/Submission Date
    2001-11-14
    2022-09-06
    2014-09-01
    2022-07-04
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    • FDA
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    Sertraline Hydrochloride

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    USDMF

    Found USDMF

    25238
    Active
    SERTRALINE HYDROCHLORIDE, USP (FORM...
    2011-08-25
    CEP/COS

    Found CEP/COS

    CEP 2014-195 - Rev 02
    Valid
    Sertraline hydrochloride, Form-II, ...
    2023-09-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0066
    Expired
    Sertraline Hydrochloride (USP/Ph.Eu...
    2019-08-09
    Application Number
    25238
    CEP 2014-195 - Rev 02
    Indian CDSCO WC-0066
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-08-08
    Filing Details
    SERTRALINE HYDROCHLORIDE, USP (FORM...
    Sertraline hydrochloride, Form-II, ...
    Sertraline Hydrochloride (USP/Ph.Eu...
    Issue/Submission Date
    2011-08-25
    2023-09-20
    2019-08-09
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    Sertraline Hydrochloride

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    USDMF

    Found USDMF

    25426
    Active
    SERTRALINE HYDROCHLORIDE, USP (FORM...
    2011-10-27
    CEP/COS

    Found CEP/COS

    R1-CEP 2012-292 - Rev 02
    Valid
    Sertraline hydrochloride, Form-I
    2023-08-25
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    25426
    R1-CEP 2012-292 - Rev 02
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    SERTRALINE HYDROCHLORIDE, USP (FORM...
    Sertraline hydrochloride, Form-I
    Issue/Submission Date
    2011-10-27
    2023-08-25
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    your Marketing & Sales content
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    • FDA
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    Sertraline Hydrochloride

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    URL Supplier Web Content
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    USDMF

    Close USDMF

    CEP/COS

    Caution CEP/COS

    R1-CEP 2010-059 - Rev 01
    Withdrawn by Holder
    Sertraline hydrochloride
    2017-09-04
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2010-059 - Rev 01
    Status
    Withdrawn by Holder
     
    Filing Details
    Sertraline hydrochloride
    Issue/Submission Date
    2017-09-04
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