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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Zhejiang Tianyu Pharmaceutical Co., Ltd

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    ZHEJIANG TIANYU PHARMACEUTICAL CO., LTD

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    Zhejiang Tianyu Pharmaceutical Co., Ltd
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    China
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    Jiangkou Development Zone, Huangyan
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    enquiries@pharmacompass.com
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    • FDA
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    Olmesartan Medoxomil

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    USDMF

    Found USDMF

    31888
    Active
    OLMESARTAN MEDOXOMIL
    2018-02-09
    CEP/COS

    Found CEP/COS

    R1-CEP 2013-268 - Rev 02
    Valid
    Olmesartan medoxomil
    2022-01-07
    Japanese DMF

    Found JDMF

    304MF10072
    Olmesartan Medoxomil at Jiangkou De...
    2022-05-12
    Written Confirmation

    Close WC

    Application Number
    31888
    R1-CEP 2013-268 - Rev 02
    304MF10072
    Status
    Active
    Fees Unpaid
    Reviewed
    Valid
     
    Filing Details
    OLMESARTAN MEDOXOMIL
    Olmesartan medoxomil
    Olmesartan Medoxomil at Jiangkou De...
    Issue/Submission Date
    2018-02-09
    2022-01-07
    2022-05-12
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    • FDA
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    Valsartan

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    USDMF

    Found USDMF

    32175
    Active
    VALSARTAN
    2017-12-16
    CEP/COS

    Found CEP/COS

    R1-CEP 2013-159 - Rev 02
    Valid
    Valsartan
    2021-07-23
    Japanese DMF

    Found JDMF

    226MF10107
    Valsartan at Jiangkou Development Z...
    2014-05-21
    Written Confirmation

    Close WC

    Application Number
    32175
    R1-CEP 2013-159 - Rev 02
    226MF10107
    Status
    Active
    Fees Unpaid
    Reviewed
    Valid
     
    Filing Details
    VALSARTAN
    Valsartan
    Valsartan at Jiangkou Development Z...
    Issue/Submission Date
    2017-12-16
    2021-07-23
    2014-05-21
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    Valsartan

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    USDMF

    Found USDMF

    33475
    Active
    VALSARTAN DISODIUM
    2018-12-30
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-389 - Rev 03
    Valid
    Valsartan, Process-II
    2023-06-28
    Japanese DMF

    Found JDMF

    304MF10056
    Valsartan at Jiangkou Development Z...
    2022-03-24
    Written Confirmation

    Close WC

    Application Number
    33475
    R0-CEP 2020-389 - Rev 03
    304MF10056
    Status
    Active
    Fees Unpaid
    Reviewed
    Valid
     
    Filing Details
    VALSARTAN DISODIUM
    Valsartan, Process-II
    Valsartan at Jiangkou Development Z...
    Issue/Submission Date
    2018-12-30
    2023-06-28
    2022-03-24
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    • FDA
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    Montelukast Sodium

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    USDMF

    Caution USDMF

    26097
    Inactive
    MONTELUKAST BACKONE DIOL
    2012-05-26
    CEP/COS

    Found CEP/COS

    R1-CEP 2014-115 - Rev 01
    Valid
    Montelukast sodium
    2021-07-16
    Japanese DMF

    Found JDMF

    229MF10094
    Montelukast sodium at Jiangkou Deve...
    2017-05-16
    Written Confirmation

    Close WC

    Application Number
    26097
    R1-CEP 2014-115 - Rev 01
    229MF10094
    Status
    Inactive
    Fees Unpaid
    N/A
    Valid
     
    Filing Details
    MONTELUKAST BACKONE DIOL
    Montelukast sodium
    Montelukast sodium at Jiangkou Deve...
    Issue/Submission Date
    2012-05-26
    2021-07-16
    2017-05-16
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    • FDA
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    Candesartan Cilexetil

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2013-256 - Rev 02
    Valid
    Candesartan cilexetil
    2020-09-10
    Japanese DMF

    Found JDMF

    227MF10168
    Candesartan cilexetil at Jiangkou D...
    2015-06-18
    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2013-256 - Rev 02
    227MF10168
    Status
    Valid
     
    Filing Details
    Candesartan cilexetil
    Candesartan cilexetil at Jiangkou D...
    Issue/Submission Date
    2020-09-10
    2015-06-18
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    • FDA
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    Ezetimibe

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    USDMF

    Found USDMF

    32716
    Active
    EZETIMIBE
    2021-09-22
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    305MF10070
    Ezetimibe at Jiangkou Development Z...
    2023-06-07
    Written Confirmation

    Close WC

    Application Number
    32716
    305MF10070
    Status
    Active
    Fees Unpaid
    Reviewed
     
    Filing Details
    EZETIMIBE
    Ezetimibe at Jiangkou Development Z...
    Issue/Submission Date
    2021-09-22
    2023-06-07
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    • FDA
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    Irbesartan

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2012-233 - Rev 02
    Valid
    Irbesartan
    2021-07-23
    Japanese DMF

    Found JDMF

    304MF10158
    Irbesartan at Jiangkou Development...
    2022-12-23
    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2012-233 - Rev 02
    304MF10158
    Status
    Valid
     
    Filing Details
    Irbesartan
    Irbesartan at Jiangkou Development...
    Issue/Submission Date
    2021-07-23
    2022-12-23
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    • FDA
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    Losartan Potassium

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    USDMF

    Found USDMF

    28346
    Active
    LOSARTAN POTASSIUM
    2014-05-29
    CEP/COS

    Found CEP/COS

    CEP 2009-227 - Rev 07
    Valid
    Losartan potassium
    2024-03-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    28346
    CEP 2009-227 - Rev 07
    Status
    Active
    Fees Unpaid
    Reviewed
    Valid
     
    Filing Details
    LOSARTAN POTASSIUM
    Losartan potassium
    Issue/Submission Date
    2014-05-29
    2024-03-20
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    Losartan Potassium

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    USDMF

    Found USDMF

    36226
    Active
    LOSARTAN POTASSIUM (L-3)
    2021-08-21
    CEP/COS

    Found CEP/COS

    CEP 2021-288 - Rev 01
    Valid
    Losartan potassium, Process-II
    2024-03-25
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36226
    CEP 2021-288 - Rev 01
    Status
    Active
    Fees Unpaid
    Reviewed
    Valid
     
    Filing Details
    LOSARTAN POTASSIUM (L-3)
    Losartan potassium, Process-II
    Issue/Submission Date
    2021-08-21
    2024-03-25
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    Losartan Potassium

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    USDMF

    Caution USDMF

    18780
    Inactive
    LOSARTAN POTASSIUM
    2005-08-22
    CEP/COS

    Found CEP/COS

    R0-CEP 2021-320 - Rev 00
    Valid
    Losartan potassium, Process-III
    2022-03-21
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    18780
    R0-CEP 2021-320 - Rev 00
    Status
    Inactive
    Fees Unpaid
    N/A
    Valid
     
    Filing Details
    LOSARTAN POTASSIUM
    Losartan potassium, Process-III
    Issue/Submission Date
    2005-08-22
    2022-03-21
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    • FDA
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    Olmesartan Medoxomil

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Caution CEP/COS

    R0-CEP 2022-058 - Rev 00
    Withdrawn by Holder
    Olmesartan medoxomil, Process - II
    2022-08-05
    Japanese DMF

    Found JDMF

    229MF10134
    Olmesartan medoxomil at Jiangkou De...
    2017-07-19
    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2022-058 - Rev 00
    229MF10134
    Status
    Withdrawn by Holder
     
    Filing Details
    Olmesartan medoxomil, Process - II
    Olmesartan medoxomil at Jiangkou De...
    Issue/Submission Date
    2022-08-05
    2017-07-19
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    • FDA
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    Telmisartan

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    25552
    Inactive
    TELMISARTAN METHYL ESTER
    2011-11-09
    CEP/COS

    Found CEP/COS

    R1-CEP 2014-190 - Rev 00
    Valid
    Telmisartan
    2021-08-05
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    25552
    R1-CEP 2014-190 - Rev 00
    Status
    Inactive
    Fees Unpaid
    N/A
    Valid
     
    Filing Details
    TELMISARTAN METHYL ESTER
    Telmisartan
    Issue/Submission Date
    2011-11-09
    2021-08-05
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    • FDA
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    Azilsartan

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    305MF10041
    Azil sartan at Jiangkou Development...
    2023-03-29
    Written Confirmation

    Close WC

    Application Number
    305MF10041
    Status
     
    Filing Details
    Azil sartan at Jiangkou Development...
    Issue/Submission Date
    2023-03-29
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    Azilsartan

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    304MF10129
    Azilsartan at Jiangkou Development ...
    2022-09-08
    Written Confirmation

    Close WC

    Application Number
    304MF10129
    Status
     
    Filing Details
    Azilsartan at Jiangkou Development ...
    Issue/Submission Date
    2022-09-08
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    • FDA
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    CAS 482577-59-3

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    USDMF

    Found USDMF

    34011
    Active
    METHYL N-[(2'-CYANOBIPHENYL-4-YL)ME...
    2019-07-17
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    34011
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    METHYL N-[(2'-CYANOBIPHENYL-4-YL)ME...
    Issue/Submission Date
    2019-07-17
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    • FDA
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    Irbesartan

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    229MF10089
    Irbesartan \"production-only\" at J...
    2017-05-01
    Written Confirmation

    Close WC

    Application Number
    229MF10089
    Status
     
    Filing Details
    Irbesartan \"production-only\" at J...
    Issue/Submission Date
    2017-05-01
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    • FDA
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    Montelukast Sodium

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    USDMF

    Found USDMF

    32307
    Active
    MONTELUKAST SODIUM
    2018-03-24
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    32307
    Status
    Active
    Fees Unpaid
    Reviewed
     
    Filing Details
    MONTELUKAST SODIUM
    Issue/Submission Date
    2018-03-24
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    • FDA
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    Rivaroxaban

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2020-330 - Rev 01
    Valid
    Rivaroxaban
    2023-03-23
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2020-330 - Rev 01
    Status
    Valid
     
    Filing Details
    Rivaroxaban
    Issue/Submission Date
    2023-03-23
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    • FDA
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    Sacubitril Sodium

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    USDMF

    Found USDMF

    33476
    Active
    SACUBITRIL SODIUM
    2018-12-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    33476
    Status
    Active
    Fees Unpaid
    Reviewed
     
    Filing Details
    SACUBITRIL SODIUM
    Issue/Submission Date
    2018-12-31
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    Silodosin

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    230MF10036
    Silodosin at Jiangkou Development ...
    2018-02-26
    Written Confirmation

    Close WC

    Application Number
    230MF10036
    Status
     
    Filing Details
    Silodosin at Jiangkou Development ...
    Issue/Submission Date
    2018-02-26
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    • FDA
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    Sitagliptin Phosphate

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    CEP 2020-037 - Rev 01
    Valid
    Sitagliptin phosphate monohydrate
    2023-09-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    CEP 2020-037 - Rev 01
    Status
    Valid
     
    Filing Details
    Sitagliptin phosphate monohydrate
    Issue/Submission Date
    2023-09-20
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    • FDA
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    Ticagrelor

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2021-348 - Rev 00
    Valid
    Ticagrelor
    2022-07-29
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2021-348 - Rev 00
    Status
    Valid
     
    Filing Details
    Ticagrelor
    Issue/Submission Date
    2022-07-29
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    Vildagliptin

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    304MF10012
    Vildagliptin at Jiangkou Developmen...
    2022-01-13
    Written Confirmation

    Close WC

    Application Number
    304MF10012
    Status
     
    Filing Details
    Vildagliptin at Jiangkou Developmen...
    Issue/Submission Date
    2022-01-13
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    Acalabrutinib

    PDF Supplier PDF
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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
    ASK
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    Baricitinib

    PDF Supplier PDF
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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
    ASK
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    Brexpiprazole

    PDF Supplier PDF
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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
    ASK
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    Brivaracetam

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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
    ASK
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    • FDA
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    Cabozantinib

    PDF Supplier PDF
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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
    ASK
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