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

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    Jiangxi Synergy Pharmaceutical
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    China
    Address
    Address
    Jiangxi Fengxin Industrial Park, Fengxin,Jiangxi
    Telephone
    Telephone
    +86-795-4605771
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    enquiries@pharmacompass.com
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    http://www.jxsynergy.com/
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    • FDA
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    Celecoxib

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    USDMF

    Found USDMF

    25582
    Active
    CELECOXIB
    2011-08-16
    CEP/COS

    Found CEP/COS

    R1-CEP 2012-404 - Rev 00
    Valid
    Celecoxib
    2019-07-04
    Japanese DMF

    Found JDMF

    230MF10124
    Celecoxib at Jiangxi Fengxin Indust...
    2018-09-03
    Written Confirmation

    Close WC

    Application Number
    25582
    R1-CEP 2012-404 - Rev 00
    230MF10124
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    CELECOXIB
    Celecoxib
    Celecoxib at Jiangxi Fengxin Indust...
    Issue/Submission Date
    2011-08-16
    2019-07-04
    2018-09-03
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    • FDA
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    Rivaroxaban

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    USDMF

    Found USDMF

    31601
    Active
    RIVAROXABAN
    2017-03-16
    CEP/COS

    Found CEP/COS

    CEP 2021-047 - Rev 01
    Valid
    Rivaroxaban
    2023-09-28
    Japanese DMF

    Found JDMF

    304MF10027
    Rivaroxaban at Jiangxi Fengxin Indu...
    2022-02-10
    Written Confirmation

    Close WC

    Application Number
    31601
    CEP 2021-047 - Rev 01
    304MF10027
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    RIVAROXABAN
    Rivaroxaban
    Rivaroxaban at Jiangxi Fengxin Indu...
    Issue/Submission Date
    2017-03-16
    2023-09-28
    2022-02-10
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    • FDA
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    Candesartan Cilexetil

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    USDMF

    Caution USDMF

    23649
    Inactive
    CANDESARTAN CILEXETIL
    2010-03-18
    CEP/COS

    Found CEP/COS

    CEP 2013-007 - Rev 03
    Valid
    Candesartan cilexetil
    2023-09-20
    Japanese DMF

    Found JDMF

    230MF10146
    Candesartan Cilexetil at Jiangxi Fe...
    2018-11-05
    Written Confirmation

    Close WC

    Application Number
    23649
    CEP 2013-007 - Rev 03
    230MF10146
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    CANDESARTAN CILEXETIL
    Candesartan cilexetil
    Candesartan Cilexetil at Jiangxi Fe...
    Issue/Submission Date
    2010-03-18
    2023-09-20
    2018-11-05
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    • FDA
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    Gabapentin

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    USDMF

    Found USDMF

    25825
    Active
    GABAPENTIN
    2012-02-22
    CEP/COS

    Found CEP/COS

    R1-CEP 2011-264 - Rev 00
    Valid
    Gabapentin
    2017-10-25
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    25825
    R1-CEP 2011-264 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    GABAPENTIN
    Gabapentin
    Issue/Submission Date
    2012-02-22
    2017-10-25
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    • FDA
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    Ticagrelor

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    USDMF

    Found USDMF

    31620
    Active
    TICAGRELOR
    2017-03-24
    CEP/COS

    Found CEP/COS

    R0-CEP 2021-303 - Rev 00
    Valid
    Ticagrelor
    2023-08-08
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    31620
    R0-CEP 2021-303 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    TICAGRELOR
    Ticagrelor
    Issue/Submission Date
    2017-03-24
    2023-08-08
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    • FDA
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    Vildagliptin

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    USDMF

    Found USDMF

    31663
    Active
    VILDAGLIPTIN
    2017-04-05
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    305MF10024
    Vildagliptin at Jiangxi Fengxin Ind...
    2023-02-08
    Written Confirmation

    Close WC

    Application Number
    31663
    305MF10024
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    VILDAGLIPTIN
    Vildagliptin at Jiangxi Fengxin Ind...
    Issue/Submission Date
    2017-04-05
    2023-02-08
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    • FDA
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    Aceclofenac

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    24210
    Inactive
    ACECLOFENAC
    2010-09-24
    CEP/COS

    Found CEP/COS

    R1-CEP 2013-274 - Rev 01
    Valid
    Aceclofenac
    2021-07-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    24210
    R1-CEP 2013-274 - Rev 01
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    ACECLOFENAC
    Aceclofenac
    Issue/Submission Date
    2010-09-24
    2021-07-20
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    • FDA
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    Gabapentin

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    See Less

    USDMF

    Caution USDMF

    21401
    Inactive
    GABAPENTIN
    2008-02-29
    CEP/COS

    Found CEP/COS

    R0-CEP 2019-343 - Rev 01
    Valid
    Gabapentin, Process II
    2023-02-16
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    21401
    R0-CEP 2019-343 - Rev 01
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    GABAPENTIN
    Gabapentin, Process II
    Issue/Submission Date
    2008-02-29
    2023-02-16
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    • FDA
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    Rebamipide

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    See Less

    USDMF

    Caution USDMF

    21700
    Inactive
    REBAMIPIDE
    2008-06-09
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    228MF10089
    Rebamipide at Jiangxi Fengxin Indu...
    2016-04-15
    Written Confirmation

    Close WC

    Application Number
    21700
    228MF10089
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    REBAMIPIDE
    Rebamipide at Jiangxi Fengxin Indu...
    Issue/Submission Date
    2008-06-09
    2016-04-15
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    • FDA
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    Apixaban

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    USDMF

    Found USDMF

    32781
    Active
    APIXABAN
    2018-04-21
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    32781
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    APIXABAN
    Issue/Submission Date
    2018-04-21
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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

    302MF10016
    Azilsartan at Jiangxi Fengxin Indus...
    2020-01-31
    Written Confirmation

    Close WC

    Application Number
    302MF10016
    Status
     
    Filing Details
    Azilsartan at Jiangxi Fengxin Indus...
    Issue/Submission Date
    2020-01-31
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    • FDA
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    Azilsartan

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    305MF10141
    Azilsartan at Jiangxi Fengxin Indus...
    2023-12-22
    Written Confirmation

    Close WC

    Application Number
    305MF10141
    Status
     
    Filing Details
    Azilsartan at Jiangxi Fengxin Indus...
    Issue/Submission Date
    2023-12-22
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    • FDA
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    Canagliflozin

    PDF Supplier PDF
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    USDMF

    Found USDMF

    38734
    Active
    CANAGLIFLOZIN HEMIHYDRATE
    2023-09-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    38734
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    CANAGLIFLOZIN HEMIHYDRATE
    Issue/Submission Date
    2023-09-27
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    • FDA
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    Candesartan Cilexetil

    PDF Supplier PDF
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    224MF10057
    Candesartan cilexetil at Jiangxi Fe...
    2012-03-30
    Written Confirmation

    Close WC

    Application Number
    224MF10057
    Status
     
    Filing Details
    Candesartan cilexetil at Jiangxi Fe...
    Issue/Submission Date
    2012-03-30
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    • FDA
    • EDQM
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    Dabigatran Etexilate Mesylate

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    USDMF

    Found USDMF

    32782
    Active
    DABIGATRAN ETEXILATE MESYLATE
    2018-04-21
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    32782
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    DABIGATRAN ETEXILATE MESYLATE
    Issue/Submission Date
    2018-04-21
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    • FDA
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    Edoxaban Tosylate

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    USDMF

    Found USDMF

    38513
    Active
    EDOXABAN TOSILATE
    2023-09-20
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    38513
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    EDOXABAN TOSILATE
    Issue/Submission Date
    2023-09-20
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    • FDA
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    Empagliflozin

    PDF Supplier PDF
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    USDMF

    Found USDMF

    37622
    Active
    EMPAGLIFLOZIN
    2022-11-02
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    37622
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    EMPAGLIFLOZIN
    Issue/Submission Date
    2022-11-02
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    • FDA
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    Febuxostat

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    32780
    Active
    FEBUXOSTAT
    2018-04-21
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    32780
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    FEBUXOSTAT
    Issue/Submission Date
    2018-04-21
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    • FDA
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    Gabapentin

    PDF Supplier PDF
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    USDMF

    Found USDMF

    34315
    Active
    GABAPENTIN (E)
    2020-01-07
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    34315
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    GABAPENTIN (E)
    Issue/Submission Date
    2020-01-07
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    • FDA
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    Mirabegron

    PDF Supplier PDF
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    USDMF

    Found USDMF

    31661
    Active
    MIRABEGRON
    2017-04-05
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    31661
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    MIRABEGRON
    Issue/Submission Date
    2017-04-05
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    • FDA
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    Rebamipide

    PDF Supplier PDF
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    222MF10239
    Rebamipide \"M\" at Jiangxi Fengxin...
    2010-10-06
    Written Confirmation

    Close WC

    Application Number
    222MF10239
    Status
     
    Filing Details
    Rebamipide \"M\" at Jiangxi Fengxin...
    Issue/Submission Date
    2010-10-06
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    • FDA
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    Rebamipide

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    221MF10056
    Rebamipide \"S\" at Jiangxi Fengxin...
    2009-03-16
    Written Confirmation

    Close WC

    Application Number
    221MF10056
    Status
     
    Filing Details
    Rebamipide \"S\" at Jiangxi Fengxin...
    Issue/Submission Date
    2009-03-16
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    • FDA
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    Telmisartan

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Caution USDMF

    24211
    Inactive
    TELMISARTAN
    2010-09-24
    CEP/COS

    Caution CEP/COS

    R1-CEP 2013-135 - Rev 00
    Withdrawn by Holder
    Telmisartan
    2020-09-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    24211
    R1-CEP 2013-135 - Rev 00
    Status
    Inactive
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    TELMISARTAN
    Telmisartan
    Issue/Submission Date
    2010-09-24
    2020-09-17
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