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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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    Terbinafine Hydrochloride

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    USDMF

    Found USDMF

    17987
    Active
    TERBINAFINE HYDROCHLORIDE
    2005-01-12
    CEP/COS

    Found CEP/COS

    R1-CEP 2012-310 - Rev 02
    Valid
    Terbinafine hydrochloride, Process ...
    2020-10-20
    Japanese DMF

    Found JDMF

    222MF10168
    Terbinafine hydrochloride at 7-2-A2...
    2010-06-08
    Written Confirmation

    Found WC

    Indian CDSCO WC-0041
    Valid
    Terbenafine Hydrochloride (USP/Ph. ...
    2022-09-16
    Application Number
    17987
    R1-CEP 2012-310 - Rev 02
    222MF10168
    Indian CDSCO WC-0041
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-08-08
    Filing Details
    TERBINAFINE HYDROCHLORIDE
    Terbinafine hydrochloride, Process ...
    Terbinafine hydrochloride at 7-2-A2...
    Terbenafine Hydrochloride (USP/Ph. ...
    Issue/Submission Date
    2005-01-12
    2020-10-20
    2010-06-08
    2022-09-16
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    • FDA
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    Terbinafine Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Caution CEP/COS

    R1-CEP 2006-148 - Rev 02
    Withdrawn by Holder
    Terbinafine hydrochloride
    2017-08-10
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2006-148 - Rev 02
    Status
    Withdrawn by Holder
     
    Filing Details
    Terbinafine hydrochloride
    Issue/Submission Date
    2017-08-10
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