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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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    Twitter

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    Gemcitabine

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    USDMF

    Found USDMF

    22229
    Active
    GEMCITABINE HYDROCHLORIDE USP
    2008-11-26
    CEP/COS

    Found CEP/COS

    R0-CEP 2022-499 - Rev 00
    Valid
    Gemcitabine hydrochloride, GA proce...
    2023-02-28
    Japanese DMF

    Found JDMF

    230MF10173
    Gemcitabine hydrochloride [D] at 7-...
    2018-12-21
    Written Confirmation

    Found WC

    Indian CDSCO WC-0041
    Valid
    Gemcitabine Hydrochloride (USP/Ph. ...
    2022-09-16
    Application Number
    22229
    R0-CEP 2022-499 - Rev 00
    230MF10173
    Indian CDSCO WC-0041
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-08-08
    Filing Details
    GEMCITABINE HYDROCHLORIDE USP
    Gemcitabine hydrochloride, GA proce...
    Gemcitabine hydrochloride [D] at 7-...
    Gemcitabine Hydrochloride (USP/Ph. ...
    Issue/Submission Date
    2008-11-26
    2023-02-28
    2018-12-21
    2022-09-16
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    • FDA
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    Gemcitabine

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2009-208 - Rev 02
    Valid
    Gemcitabine hydrochloride
    2020-11-02
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2009-208 - Rev 02
    Status
    Valid
     
    Filing Details
    Gemcitabine hydrochloride
    Issue/Submission Date
    2020-11-02
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