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

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    Hanmi Pharmaceutical
    korearepublicofnew Flag
    Country
    Country
    South Korea
    Address
    Address
    45 Bangi-dong. Songpa. Seoul 138-724 Korea
    Telephone
    Telephone
    82 241 087 96
    Client Email
    Email
    enquiries@pharmacompass.com
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    https://www.hanmipharm.com/
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    Cefotaxime

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    USDMF

    Caution USDMF

    12632
    Inactive
    CEFOTAXIME ACID
    1997-08-27
    CEP/COS

    Found CEP/COS

    R1-CEP 1999-161 - Rev 05
    Valid
    Cefotaxime sodium, Sterile; process...
    2019-07-02
    Japanese DMF

    Found JDMF

    224MF10209
    Sterile cefotaxime sodium at 57, Gy...
    2012-10-29
    Written Confirmation

    Close WC

    Application Number
    12632
    R1-CEP 1999-161 - Rev 05
    224MF10209
    Status
    Inactive
    Fees Unpaid
    N/A
    Valid
     
    Filing Details
    CEFOTAXIME ACID
    Cefotaxime sodium, Sterile; process...
    Sterile cefotaxime sodium at 57, Gy...
    Issue/Submission Date
    1997-08-27
    2019-07-02
    2012-10-29
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    Ceftriaxone

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    USDMF

    Caution USDMF

    17884
    Inactive
    CEFTRIAXONE SODIUM, USP
    2004-12-04
    CEP/COS

    Found CEP/COS

    R1-CEP 2000-158 - Rev 05
    Valid
    Ceftriaxone sodium, Sterile; synthe...
    2019-07-02
    Japanese DMF

    Found JDMF

    219MF10097
    Ceftriaxone sodium hydrate at 57, G...
    2007-03-14
    Written Confirmation

    Close WC

    Application Number
    17884
    R1-CEP 2000-158 - Rev 05
    219MF10097
    Status
    Inactive
    Fees Unpaid
    N/A
    Valid
     
    Filing Details
    CEFTRIAXONE SODIUM, USP
    Ceftriaxone sodium, Sterile; synthe...
    Ceftriaxone sodium hydrate at 57, G...
    Issue/Submission Date
    2004-12-04
    2019-07-02
    2007-03-14
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    Cefixime

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2002-155 - Rev 06
    Valid
    Cefixime
    2019-07-02
    Japanese DMF

    Found JDMF

    217MF10415
    Cefixime at 57, Gyeongje-ro, Siheun...
    2005-08-19
    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2002-155 - Rev 06
    217MF10415
    Status
    Valid
     
    Filing Details
    Cefixime
    Cefixime at 57, Gyeongje-ro, Siheun...
    Issue/Submission Date
    2019-07-02
    2005-08-19
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    Ceftazidime

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2010-096 - Rev 04
    Valid
    Ceftazidime pentahydrate with sodiu...
    2023-05-25
    Japanese DMF

    Found JDMF

    219MF10007
    Ceftazidime hydrate at 57, Gyeongje...
    2007-01-18
    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2010-096 - Rev 04
    219MF10007
    Status
    Valid
     
    Filing Details
    Ceftazidime pentahydrate with sodiu...
    Ceftazidime hydrate at 57, Gyeongje...
    Issue/Submission Date
    2023-05-25
    2007-01-18
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    Ceftazidime

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2002-069 - Rev 07
    Valid
    Ceftazidime Pentahydrate, Sterile
    2023-06-14
    Japanese DMF

    Found JDMF

    225MF10225
    Sterile ceftazidime hydrate at 57, ...
    2013-12-10
    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2002-069 - Rev 07
    225MF10225
    Status
    Valid
     
    Filing Details
    Ceftazidime Pentahydrate, Sterile
    Sterile ceftazidime hydrate at 57, ...
    Issue/Submission Date
    2023-06-14
    2013-12-10
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    Bepotastine

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    229MF10032
    Bepotastine besilate at 57, Gyeongj...
    2017-02-08
    Written Confirmation

    Close WC

    Application Number
    229MF10032
    Status
     
    Filing Details
    Bepotastine besilate at 57, Gyeongj...
    Issue/Submission Date
    2017-02-08
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    Cefdinir

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    218MF10515
    Cefdinir at 57, Gyeongje-ro, Siheun...
    2006-05-18
    Written Confirmation

    Close WC

    Application Number
    218MF10515
    Status
     
    Filing Details
    Cefdinir at 57, Gyeongje-ro, Siheun...
    Issue/Submission Date
    2006-05-18
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    Cefotiam Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    219MF10006
    Cefotiam hydrochloride at 57, Gyeon...
    2007-01-18
    Written Confirmation

    Close WC

    Application Number
    219MF10006
    Status
     
    Filing Details
    Cefotiam hydrochloride at 57, Gyeon...
    Issue/Submission Date
    2007-01-18
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    Clarithromycin

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    219MF10173
    Clarithromycin F at 57, Gyeongje-ro...
    2007-06-01
    Written Confirmation

    Close WC

    Application Number
    219MF10173
    Status
     
    Filing Details
    Clarithromycin F at 57, Gyeongje-ro...
    Issue/Submission Date
    2007-06-01
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    Duloxetine

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    301MF10085
    Duloxetine Hydrochloride at 57, Gye...
    2019-10-25
    Written Confirmation

    Close WC

    Application Number
    301MF10085
    Status
     
    Filing Details
    Duloxetine Hydrochloride at 57, Gye...
    Issue/Submission Date
    2019-10-25
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    Ezetimibe

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    231MF10020
    Ezetimibe at 57, Gyeongje-ro, Siheu...
    2019-01-29
    Written Confirmation

    Close WC

    Application Number
    231MF10020
    Status
     
    Filing Details
    Ezetimibe at 57, Gyeongje-ro, Siheu...
    Issue/Submission Date
    2019-01-29
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    Febuxostat

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    305MF10121
    Febuxostat at 57, Gyeongje-ro, Sihe...
    2023-11-15
    Written Confirmation

    Close WC

    Application Number
    305MF10121
    Status
     
    Filing Details
    Febuxostat at 57, Gyeongje-ro, Sihe...
    Issue/Submission Date
    2023-11-15
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    Febuxostat

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    303MF10010
    Febuxostat at 57, Gyeongje-ro, Sihe...
    2021-01-20
    Written Confirmation

    Close WC

    Application Number
    303MF10010
    Status
     
    Filing Details
    Febuxostat at 57, Gyeongje-ro, Sihe...
    Issue/Submission Date
    2021-01-20
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    Irbesartan

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    228MF10121
    Irbesartan at 57, Gyeongje-ro, Sihe...
    2016-07-01
    Written Confirmation

    Close WC

    Application Number
    228MF10121
    Status
     
    Filing Details
    Irbesartan at 57, Gyeongje-ro, Sihe...
    Issue/Submission Date
    2016-07-01
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    Itraconazole

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    222MF10208
    Itraconazole at 57, Gyeongje-ro, Si...
    2010-07-26
    Written Confirmation

    Close WC

    Application Number
    222MF10208
    Status
     
    Filing Details
    Itraconazole at 57, Gyeongje-ro, Si...
    Issue/Submission Date
    2010-07-26
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    Linagliptin

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    305MF10132
    Linagliptin at 57, Gyeongje-ro, Sih...
    2023-12-12
    Written Confirmation

    Close WC

    Application Number
    305MF10132
    Status
     
    Filing Details
    Linagliptin at 57, Gyeongje-ro, Sih...
    Issue/Submission Date
    2023-12-12
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    Losartan Potassium

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    222MF10273
    Losartan potassium at 57, Gyeongje-...
    2010-12-10
    Written Confirmation

    Close WC

    Application Number
    222MF10273
    Status
     
    Filing Details
    Losartan potassium at 57, Gyeongje-...
    Issue/Submission Date
    2010-12-10
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    Pioglitazone Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    222MF10023
    Pioglitazone Hydrochloride at 57, G...
    2010-01-22
    Written Confirmation

    Close WC

    Application Number
    222MF10023
    Status
     
    Filing Details
    Pioglitazone Hydrochloride at 57, G...
    Issue/Submission Date
    2010-01-22
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    Raloxifene Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    227MF10053
    Raloxifene hydrochloride hydrate at...
    2015-02-18
    Written Confirmation

    Close WC

    Application Number
    227MF10053
    Status
     
    Filing Details
    Raloxifene hydrochloride hydrate at...
    Issue/Submission Date
    2015-02-18
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    Rosuvastatin Calcium

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    230MF10059
    Rosuvastatin calcium at 57, Gyeongj...
    2018-05-01
    Written Confirmation

    Close WC

    Application Number
    230MF10059
    Status
     
    Filing Details
    Rosuvastatin calcium at 57, Gyeongj...
    Issue/Submission Date
    2018-05-01
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    LAPS CARRIER, A RECOMBINANT HUMAN IMMUNOGLOBULIN FC FRA...

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    USDMF

    Found USDMF

    32372
    Active
    LAPS CARRIER, A RECOMBINANT HUMAN I...
    2017-12-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    32372
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    LAPS CARRIER, A RECOMBINANT HUMAN I...
    Issue/Submission Date
    2017-12-27
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    Cefotaxime

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    USDMF

    Close USDMF

    CEP/COS

    Caution CEP/COS

    R1-CEP 1997-108 - Rev 02
    Withdrawn by Holder
    Cefotaxime sodium, Sterile Process ...
    2004-11-12
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 1997-108 - Rev 02
    Status
    Withdrawn by Holder
     
    Filing Details
    Cefotaxime sodium, Sterile Process ...
    Issue/Submission Date
    2004-11-12
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    Cefpodoxime Proxetil

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    USDMF

    Close USDMF

    CEP/COS

    Caution CEP/COS

    R0-CEP 2012-166 - Rev 02
    Withdrawn by Holder
    Cefpodoxime proxetil
    2016-06-22
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2012-166 - Rev 02
    Status
    Withdrawn by Holder
     
    Filing Details
    Cefpodoxime proxetil
    Issue/Submission Date
    2016-06-22
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    Ceftriaxone

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    USDMF

    Close USDMF

    CEP/COS

    Caution CEP/COS

    R1-CEP 1998-013 - Rev 02
    Withdrawn by Holder
    Ceftriaxone sodium, Sterile; Proces...
    2004-11-12
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 1998-013 - Rev 02
    Status
    Withdrawn by Holder
     
    Filing Details
    Ceftriaxone sodium, Sterile; Proces...
    Issue/Submission Date
    2004-11-12
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    BULK PHARMACEUTICAL CHEMICAL FACILITY AND QUALITY CONTR...

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    USDMF

    Caution USDMF

    10632
    Inactive
    BULK PHARMACEUTICAL CHEMICAL FACILI...
    1993-12-22
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    10632
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    BULK PHARMACEUTICAL CHEMICAL FACILI...
    Issue/Submission Date
    1993-12-22
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    Amlodipine Camsylate

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
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