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    List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by Zentiva to the U.S. FDA. Original Data : FDA Website

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    Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.
    Zentiva
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    U kabelovny 529/16, Dolni Mecholupy 102 00 Prague 10
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    +420 267 241 111
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    VaclavMatyas.Hafinec@zentiva.com
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    ARTICAINE HYDROCHLORIDE

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    ZENTIVA KS
    Active
    20287
    Complete
    2013-01-31
    2013-01-03
    2007-02-20
    II
    Zentiva Company banner

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    Not Confirmed

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    CARVEDILOL

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    ZENTIVA AS
    Inactive
    16530
    N/A
    2003-04-08
    II
    Zentiva Company banner

    Cophex 2024

    Not Confirmed

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    D,L-METIPRANOLOL

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    ZENTIVA AS
    Inactive
    11637
    N/A
    1995-08-28
    II
    Zentiva Company banner

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    Not Confirmed

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    GLYBURIDE USP (GLIBENCLAMIDE), MILL...

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    ZENTIVA KS
    Active
    18018
    N/A
    2005-01-21
    II
    Zentiva Company banner

    Cophex 2024

    Not Confirmed

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    METOPROLOL SUCCINATE

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    ZENTIVA KS
    Inactive
    11600
    N/A
    1995-08-15
    II
    Zentiva Company banner

    Cophex 2024

    Not Confirmed

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    PENTOXIFYLLINE

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    ZENTIVA AS
    Inactive
    10374
    N/A
    1993-07-21
    II
    Zentiva Company banner

    Cophex 2024

    Not Confirmed

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    TAMSULOSIN HYDROCHLORIDE

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    ZENTIVA KS
    Inactive
    18186
    N/A
    2005-03-14
    II
    Zentiva Company banner

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    Not Confirmed

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    TETRAHYDROZOLINE HYDROCHLORIDE USP

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    ZENTIVA KS
    Inactive
    15191
    N/A
    2000-12-15
    II
    Zentiva Company banner

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    Not Confirmed

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    TRAMADOL HYDROCHLORIDE

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    ZENTIVA AS
    Inactive
    12404
    N/A
    1997-02-28
    II
    Zentiva Company banner

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    Not Confirmed

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    ZOLPIDEM TARTRATE

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    ZENTIVA KS
    Inactive
    16624
    N/A
    2003-06-02
    II
    Zentiva Company banner

    Cophex 2024

    Not Confirmed

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    Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

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