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

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    Zhejiang Ausun Pharmaceutical
    China Flag
    Country
    Country
    China
    Address
    Address
    No.5, Donghai 4th Avenue, Zhejiang Chemical Materials Base, Linhai Zone, Zhejiang Province, 317016
    Telephone
    Telephone
    +86-576-85589335
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    enquiries@pharmacompass.com
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    Website
    http://www.ausunpharm.com/
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    • FDA
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    Entecavir

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    USDMF

    Found USDMF

    25200
    Active
    ENTECAVIR MONOHYDRATE BULK DRUG SUB...
    2011-08-05
    CEP/COS

    Found CEP/COS

    R1-CEP 2016-152 - Rev 00
    Valid
    Entecavir monohydrate
    2022-06-27
    Japanese DMF

    Found JDMF

    227MF10302
    Entecavir monohydrate at No. 5, Don...
    2015-12-28
    Written Confirmation

    Close WC

    Application Number
    25200
    R1-CEP 2016-152 - Rev 00
    227MF10302
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    ENTECAVIR MONOHYDRATE BULK DRUG SUB...
    Entecavir monohydrate
    Entecavir monohydrate at No. 5, Don...
    Issue/Submission Date
    2011-08-05
    2022-06-27
    2015-12-28
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    • FDA
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    Efinaconazole

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    USDMF

    Found USDMF

    32076
    Active
    EFINACONAZOLE
    2017-11-06
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    305MF10025
    Efinaconazole at No. 5, Donghai 4th...
    2023-02-08
    Written Confirmation

    Close WC

    Application Number
    32076
    305MF10025
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    EFINACONAZOLE
    Efinaconazole at No. 5, Donghai 4th...
    Issue/Submission Date
    2017-11-06
    2023-02-08
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    • FDA
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    Febuxostat

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    USDMF

    Found USDMF

    29716
    Active
    FEBUXOSTAT HEMIHYDRATE
    2015-09-22
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    305MF10050
    Febuxostat at No. 5, Donghai 4th Av...
    2023-04-19
    Written Confirmation

    Close WC

    Application Number
    29716
    305MF10050
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    FEBUXOSTAT HEMIHYDRATE
    Febuxostat at No. 5, Donghai 4th Av...
    Issue/Submission Date
    2015-09-22
    2023-04-19
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    • FDA
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    Nebivolol

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    USDMF

    Found USDMF

    29730
    Active
    NEBIVOLOL HYDROCHLORIDE
    2015-09-28
    CEP/COS

    Found CEP/COS

    R0-CEP 2022-170 - Rev 00
    Valid
    Nebivolol hydrochloride
    2022-12-09
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    29730
    R0-CEP 2022-170 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    NEBIVOLOL HYDROCHLORIDE
    Nebivolol hydrochloride
    Issue/Submission Date
    2015-09-28
    2022-12-09
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    • FDA
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    Ramelteon

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    USDMF

    Found USDMF

    33719
    Active
    RAMELTEON
    2019-08-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    303MF10095
    Ramelteon at No. 5, Donghai 4th Ave...
    2021-06-15
    Written Confirmation

    Close WC

    Application Number
    33719
    303MF10095
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    RAMELTEON
    Ramelteon at No. 5, Donghai 4th Ave...
    Issue/Submission Date
    2019-08-31
    2021-06-15
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    • FDA
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    Febuxostat

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    303MF10005
    Febuxostat hydrate at No. 5, Dongha...
    2021-01-07
    Written Confirmation

    Close WC

    Application Number
    303MF10005
    Status
     
    Filing Details
    Febuxostat hydrate at No. 5, Dongha...
    Issue/Submission Date
    2021-01-07
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    • FDA
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    Febuxostat

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    303MF10031
    Febuxostat at No. 5, Donghai 4th Av...
    2021-02-10
    Written Confirmation

    Close WC

    Application Number
    303MF10031
    Status
     
    Filing Details
    Febuxostat at No. 5, Donghai 4th Av...
    Issue/Submission Date
    2021-02-10
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    Febuxostat

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    303MF10020
    Febuxostat at No. 5, Donghai 4th Av...
    2021-01-28
    Written Confirmation

    Close WC

    Application Number
    303MF10020
    Status
     
    Filing Details
    Febuxostat at No. 5, Donghai 4th Av...
    Issue/Submission Date
    2021-01-28
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    Febuxostat

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    303MF10011
    Febuxostat at No. 5, Donghai 4th Av...
    2021-01-20
    Written Confirmation

    Close WC

    Application Number
    303MF10011
    Status
     
    Filing Details
    Febuxostat at No. 5, Donghai 4th Av...
    Issue/Submission Date
    2021-01-20
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    • FDA
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    Latanoprost

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    CEP 2022-174 - Rev 00
    Valid
    Latanoprost
    2023-10-23
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    CEP 2022-174 - Rev 00
    Status
    Valid
     
    Filing Details
    Latanoprost
    Issue/Submission Date
    2023-10-23
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    • FDA
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    Lubiprostone

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    USDMF

    Found USDMF

    30802
    Active
    LUBIPROSTONE
    2016-08-08
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    30802
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    LUBIPROSTONE
    Issue/Submission Date
    2016-08-08
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    • FDA
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    Miglitol

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    228MF10052
    Miglitol at No. 5, Donghai 4th Aven...
    2016-02-18
    Written Confirmation

    Close WC

    Application Number
    228MF10052
    Status
     
    Filing Details
    Miglitol at No. 5, Donghai 4th Aven...
    Issue/Submission Date
    2016-02-18
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    Miglitol

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    305MF10034
    Miglitol at No. 5, Donghai 4th Aven...
    2023-03-15
    Written Confirmation

    Close WC

    Application Number
    305MF10034
    Status
     
    Filing Details
    Miglitol at No. 5, Donghai 4th Aven...
    Issue/Submission Date
    2023-03-15
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    • FDA
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    Pilocarpine Hydrochloride

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    USDMF

    Found USDMF

    38901
    Active
    PILOCARPINE HYDROCHLORIDE
    2023-09-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    38901
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    PILOCARPINE HYDROCHLORIDE
    Issue/Submission Date
    2023-09-30
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    • FDA
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    Posaconazole

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    USDMF

    Found USDMF

    29731
    Active
    POSACONAZOLE
    2016-02-10
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    29731
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    POSACONAZOLE
    Issue/Submission Date
    2016-02-10
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    • FDA
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    Pranlukast Hydrate

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    228MF10119
    Pranlukast Hydrate at No. 5, Dongha...
    2016-06-24
    Written Confirmation

    Close WC

    Application Number
    228MF10119
    Status
     
    Filing Details
    Pranlukast Hydrate at No. 5, Dongha...
    Issue/Submission Date
    2016-06-24
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    • FDA
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    Sitafloxacin Hydrate

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    228MF10177
    Sitafloxacin hydrate at No. 5, Dong...
    2016-08-29
    Written Confirmation

    Close WC

    Application Number
    228MF10177
    Status
     
    Filing Details
    Sitafloxacin hydrate at No. 5, Dong...
    Issue/Submission Date
    2016-08-29
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    • FDA
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    Sugammadex Sodium

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    USDMF

    Found USDMF

    35151
    Active
    SUGAMMADEX SODIUM
    2020-09-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    35151
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    SUGAMMADEX SODIUM
    Issue/Submission Date
    2020-09-29
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    • FDA
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    Tasimelteon

    PDF Supplier PDF
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    USDMF

    Found USDMF

    32077
    Active
    TASIMELTEON
    2017-11-07
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    32077
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    TASIMELTEON
    Issue/Submission Date
    2017-11-07
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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 2021-081 - Rev 00
    Valid
    Ticagrelor
    2022-08-10
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2021-081 - Rev 00
    Status
    Valid
     
    Filing Details
    Ticagrelor
    Issue/Submission Date
    2022-08-10
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    • FDA
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    Tofacitinib Citrate

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    USDMF

    Found USDMF

    35152
    Active
    TOFACITINIB CITRATE
    2020-09-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    35152
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    TOFACITINIB CITRATE
    Issue/Submission Date
    2020-09-29
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    • FDA
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    Apixaban

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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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    Apremilast

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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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    • FDA
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    Asenapine Maleate

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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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    • FDA
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    Atropine

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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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    • FDA
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    Betrixaban Maleate

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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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    • FDA
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    Brexpiprazole

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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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    • FDA
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    Cangrelor

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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
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    Crisaborole

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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
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    • FDA
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    Dapagliflozin

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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
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    • FDA
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    Diquafosol Sodium

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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
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    • FDA
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    Edoxaban Tosylate

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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
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    • FDA
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    Eliglustat

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