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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
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    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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    Quetiapine Hemifumarate

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    USDMF

    Found USDMF

    20845
    Active
    QUETIAPINE FUMARATE
    2007-09-12
    CEP/COS

    Found CEP/COS

    R1-CEP 2015-153 - Rev 02
    Valid
    Quetiapine Fumarate
    2023-06-15
    Japanese DMF

    Found JDMF

    228MF10094
    Quetiapine fumarate at 7-2-A2,Heter...
    2016-04-27
    Written Confirmation

    Found WC

    Indian CDSCO WC-0041
    Valid
    Quetiapine Fumarate (IH)
    2022-09-16
    Application Number
    20845
    R1-CEP 2015-153 - Rev 02
    228MF10094
    Indian CDSCO WC-0041
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-08-08
    Filing Details
    QUETIAPINE FUMARATE
    Quetiapine Fumarate
    Quetiapine fumarate at 7-2-A2,Heter...
    Quetiapine Fumarate (IH)
    Issue/Submission Date
    2007-09-12
    2023-06-15
    2016-04-27
    2022-09-16
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    • FDA
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    Quetiapine Hemifumarate

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    USDMF

    Found USDMF

    25770
    Active
    QUETIAPINE FUMARATE (PROCESS II)
    2012-02-09
    CEP/COS

    Caution CEP/COS

    R0-CEP 2017-179 - Rev 00
    Withdrawn by Holder
    Quetiapine Fumarate, Process III
    2019-02-15
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0065
    Expired
    Quetiapine Fumarate (USP/Ph. Eur.)
    2019-08-16
    Application Number
    25770
    R0-CEP 2017-179 - Rev 00
    Indian CDSCO WC-0065
    Status
    Active
    Fees Paid
    Reviewed
    Withdrawn by Holder
     
    Expired
    2022-08-15
    Filing Details
    QUETIAPINE FUMARATE (PROCESS II)
    Quetiapine Fumarate, Process III
    Quetiapine Fumarate (USP/Ph. Eur.)
    Issue/Submission Date
    2012-02-09
    2019-02-15
    2019-08-16
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    • FDA
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    Quetiapine Hemifumarate

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    URL Supplier Web Content
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    USDMF

    Found USDMF

    30627
    Active
    QUETIAPINE FUMARATE
    2016-07-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0065a
    Expired
    QUETIAPINE FUMERATE USP/EP
    2019-08-16
    Application Number
    30627
    Indian CDSCO WC-0065a
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-08-15
    Filing Details
    QUETIAPINE FUMARATE
    QUETIAPINE FUMERATE USP/EP
    Issue/Submission Date
    2016-07-01
    2019-08-16
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