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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Estechpharma

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    Estechpharma
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    South Korea
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    25 Balangongdan-ro, Hyangnam-eup, Hwaseong-si, Gyeonggi-do
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    +82-031-831-4800
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    enquiries@pharmacompass.com
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    http://www.estechpharma.com/
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    Aripiprazole

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    228MF10024
    Aripiprazole at 25, Barangongdan-ro...
    2016-02-02
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    Application Number
    228MF10024
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    Filing Details
    Aripiprazole at 25, Barangongdan-ro...
    Issue/Submission Date
    2016-02-02
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    Bendazac

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    218MF11016
    Outsiders regulations bendazac (pro...
    2006-12-27
    Written Confirmation

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    Application Number
    218MF11016
    Status
     
    Filing Details
    Outsiders regulations bendazac (pro...
    Issue/Submission Date
    2006-12-27
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    Bunazosin Hydrochloride

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    223MF10013
    Bunazosin hydrochloride at 34BL/10,...
    2011-01-21
    Written Confirmation

    Close WC

    Application Number
    223MF10013
    Status
     
    Filing Details
    Bunazosin hydrochloride at 34BL/10,...
    Issue/Submission Date
    2011-01-21
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    Droxidopa

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    221MF10115
    Droxidopa at 25, Barangongdan-ro, H...
    2009-06-16
    Written Confirmation

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    Application Number
    221MF10115
    Status
     
    Filing Details
    Droxidopa at 25, Barangongdan-ro, H...
    Issue/Submission Date
    2009-06-16
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    Droxidopa

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    228MF10144
    Droxidopa at 25, Barangongdan-ro, H...
    2016-08-03
    Written Confirmation

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    Application Number
    228MF10144
    Status
     
    Filing Details
    Droxidopa at 25, Barangongdan-ro, H...
    Issue/Submission Date
    2016-08-03
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    Duloxetine

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    302MF10002
    Duloxetine Hydrochloride at 25, Bar...
    2020-01-07
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    Application Number
    302MF10002
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    Filing Details
    Duloxetine Hydrochloride at 25, Bar...
    Issue/Submission Date
    2020-01-07
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    Ebastine

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    227MF10114
    EBASTINE at 25, Barangongdan-ro, Hy...
    2015-04-21
    Written Confirmation

    Close WC

    Application Number
    227MF10114
    Status
     
    Filing Details
    EBASTINE at 25, Barangongdan-ro, Hy...
    Issue/Submission Date
    2015-04-21
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    Ebastine

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    219MF10038
    EBASTINE at 25, Barangongdan-ro, Hy...
    2007-02-13
    Written Confirmation

    Close WC

    Application Number
    219MF10038
    Status
     
    Filing Details
    EBASTINE at 25, Barangongdan-ro, Hy...
    Issue/Submission Date
    2007-02-13
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    Entecavir

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    Japanese DMF

    Found JDMF

    228MF10067
    Entecavir at 25, Barangongdan-ro, H...
    2016-02-29
    Written Confirmation

    Close WC

    Application Number
    228MF10067
    Status
     
    Filing Details
    Entecavir at 25, Barangongdan-ro, H...
    Issue/Submission Date
    2016-02-29
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    Entecavir

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    Found JDMF

    228MF10026
    Entecavir at 25, Barangongdan-ro, H...
    2016-02-02
    Written Confirmation

    Close WC

    Application Number
    228MF10026
    Status
     
    Filing Details
    Entecavir at 25, Barangongdan-ro, H...
    Issue/Submission Date
    2016-02-02
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    Fluvoxamine

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    USDMF

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    CEP/COS

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    Japanese DMF

    Found JDMF

    221MF10150
    Fluvoxamine maleate at 25, Barangon...
    2009-07-09
    Written Confirmation

    Close WC

    Application Number
    221MF10150
    Status
     
    Filing Details
    Fluvoxamine maleate at 25, Barangon...
    Issue/Submission Date
    2009-07-09
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    Gadodiamide

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    USDMF

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    29629
    Active
    GADODIAMIDE
    2015-10-05
    CEP/COS

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    Application Number
    29629
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    GADODIAMIDE
    Issue/Submission Date
    2015-10-05
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    Glimepiride

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    Japanese DMF

    Found JDMF

    221MF10077
    Glimepiride at 25, Barangongdan-ro,...
    2009-04-14
    Written Confirmation

    Close WC

    Application Number
    221MF10077
    Status
     
    Filing Details
    Glimepiride at 25, Barangongdan-ro,...
    Issue/Submission Date
    2009-04-14
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    Glimepiride

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    Found JDMF

    221MF10076
    Glimepiride at 25, Barangongdan-ro,...
    2009-04-14
    Written Confirmation

    Close WC

    Application Number
    221MF10076
    Status
     
    Filing Details
    Glimepiride at 25, Barangongdan-ro,...
    Issue/Submission Date
    2009-04-14
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    Montelukast Sodium

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    USDMF

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    CEP/COS

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    Japanese DMF

    Found JDMF

    227MF10211
    Montelukast sodium at 25, Barangong...
    2015-08-18
    Written Confirmation

    Close WC

    Application Number
    227MF10211
    Status
     
    Filing Details
    Montelukast sodium at 25, Barangong...
    Issue/Submission Date
    2015-08-18
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    Olmesartan Medoxomil

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    USDMF

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    CEP/COS

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    Japanese DMF

    Found JDMF

    227MF10287
    Olmesartan medoxomil at 25, Barango...
    2015-12-15
    Written Confirmation

    Close WC

    Application Number
    227MF10287
    Status
     
    Filing Details
    Olmesartan medoxomil at 25, Barango...
    Issue/Submission Date
    2015-12-15
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    Pioglitazone Hydrochloride

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    USDMF

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    CEP/COS

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    Japanese DMF

    Found JDMF

    222MF10014
    Pioglitazone hydrochloride at 25, B...
    2010-01-07
    Written Confirmation

    Close WC

    Application Number
    222MF10014
    Status
     
    Filing Details
    Pioglitazone hydrochloride at 25, B...
    Issue/Submission Date
    2010-01-07
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    Pitavastatin

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    USDMF

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    CEP/COS

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    Japanese DMF

    Found JDMF

    224MF10141
    Pitavastatin calcium at 25, Barango...
    2012-07-30
    Written Confirmation

    Close WC

    Application Number
    224MF10141
    Status
     
    Filing Details
    Pitavastatin calcium at 25, Barango...
    Issue/Submission Date
    2012-07-30
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    Pranlukast Hydrate

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    USDMF

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    CEP/COS

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    Japanese DMF

    Found JDMF

    224MF10149
    Pranlukast hydrate (production only...
    2012-07-31
    Written Confirmation

    Close WC

    Application Number
    224MF10149
    Status
     
    Filing Details
    Pranlukast hydrate (production only...
    Issue/Submission Date
    2012-07-31
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    Pranlukast Hydrate

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    USDMF

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    CEP/COS

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    Japanese DMF

    Found JDMF

    218MF10455
    Pranlukast hydrate (production only...
    2006-04-27
    Written Confirmation

    Close WC

    Application Number
    218MF10455
    Status
     
    Filing Details
    Pranlukast hydrate (production only...
    Issue/Submission Date
    2006-04-27
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    Rebamipide

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    USDMF

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    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    218MF10732
    Outsiders regulations rebamipide (p...
    2006-09-06
    Written Confirmation

    Close WC

    Application Number
    218MF10732
    Status
     
    Filing Details
    Outsiders regulations rebamipide (p...
    Issue/Submission Date
    2006-09-06
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    Rebamipide

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    USDMF

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    CEP/COS

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    Japanese DMF

    Found JDMF

    222MF10259
    Rebamipide (production only) at 25,...
    2010-11-18
    Written Confirmation

    Close WC

    Application Number
    222MF10259
    Status
     
    Filing Details
    Rebamipide (production only) at 25,...
    Issue/Submission Date
    2010-11-18
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    Rebamipide

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    USDMF

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    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    222MF10140
    Rebamipide at 25, Barangongdan-ro, ...
    2010-04-14
    Written Confirmation

    Close WC

    Application Number
    222MF10140
    Status
     
    Filing Details
    Rebamipide at 25, Barangongdan-ro, ...
    Issue/Submission Date
    2010-04-14
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    Roxatidine Acetate Hydrochloride

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    USDMF

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    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    228MF10110
    Roxatidine acetate hydrochloride at...
    2016-06-08
    Written Confirmation

    Close WC

    Application Number
    228MF10110
    Status
     
    Filing Details
    Roxatidine acetate hydrochloride at...
    Issue/Submission Date
    2016-06-08
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    Roxatidine Acetate Hydrochloride

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    USDMF

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    CEP/COS

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    Japanese DMF

    Found JDMF

    218MF10789
    Roxatidine acetate hydrochloride (p...
    2006-09-22
    Written Confirmation

    Close WC

    Application Number
    218MF10789
    Status
     
    Filing Details
    Roxatidine acetate hydrochloride (p...
    Issue/Submission Date
    2006-09-22
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    Acamprosate Calcium

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    USDMF

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    CEP/COS

    Caution CEP/COS

    R1-CEP 2001-160 - Rev 02
    Withdrawn by EDQM Failure to CEP procedure
    Acamprosate calcium
    2008-08-28
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2001-160 - Rev 02
    Status
    Withdrawn by EDQM Failure to CEP procedure
     
    Filing Details
    Acamprosate calcium
    Issue/Submission Date
    2008-08-28
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    Aceclofenac

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    USDMF

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    CEP/COS

    Caution CEP/COS

    R1-CEP 2004-006 - Rev 00
    Withdrawn by EDQM Failure to CEP procedure
    Aceclofenac
    2010-04-23
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2004-006 - Rev 00
    Status
    Withdrawn by EDQM Failure to CEP procedure
     
    Filing Details
    Aceclofenac
    Issue/Submission Date
    2010-04-23
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    Triflusal

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    USDMF

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    CEP/COS

    Caution CEP/COS

    R1-CEP 2004-195 - Rev 01
    Withdrawn by EDQM Failure to CEP procedure
    Triflusal
    2012-01-13
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2004-195 - Rev 01
    Status
    Withdrawn by EDQM Failure to CEP procedure
     
    Filing Details
    Triflusal
    Issue/Submission Date
    2012-01-13
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    Acemetacin

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    USDMF

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    CEP/COS

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    Japanese DMF

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    Blonanserin

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    USDMF

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    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Close WC

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    Dabigatran Etexilate Mesylate

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    USDMF

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    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Close WC

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    Erlotinib

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    USDMF

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    CEP/COS

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    Japanese DMF

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    Close WC

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    Flurbiprofen

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    USDMF

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    Japanese DMF

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