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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by BrightGene Bio-Medical Technology Co.,Ltd

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    BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO.,LTD

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    BrightGene Bio-Medical Technology Co.,Ltd
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    Country
    China
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    Address
    Suzhou Industrial Park, Jiangsu Province
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    enquiries@pharmacompass.com
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    Website
    https://www.bright-gene.com/
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    • FDA
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    Entecavir

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    USDMF

    Found USDMF

    31949
    Active
    ENTECAVIR MONOHYDRATE
    2017-08-23
    CEP/COS

    Found CEP/COS

    R0-CEP 2018-283 - Rev 00
    Valid
    Entecavir monohydrate
    2020-06-19
    Japanese DMF

    Found JDMF

    228MF10118
    Entecavir intermediate (ET1) at Bui...
    2016-06-24
    Written Confirmation

    Close WC

    Application Number
    31949
    R0-CEP 2018-283 - Rev 00
    228MF10118
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    ENTECAVIR MONOHYDRATE
    Entecavir monohydrate
    Entecavir intermediate (ET1) at Bui...
    Issue/Submission Date
    2017-08-23
    2020-06-19
    2016-06-24
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    Everolimus

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    USDMF

    Found USDMF

    32020
    Active
    EVEROLIMUS (NON-STERILE API)
    2017-09-20
    CEP/COS

    Found CEP/COS

    CEP 2022-367 - Rev 00
    Valid
    Everolimus, Butylated hydroxytoluen...
    2024-02-15
    Japanese DMF

    Found JDMF

    230MF10023
    Everolimus at Building C25-C28, No....
    2018-02-14
    Written Confirmation

    Close WC

    Application Number
    32020
    CEP 2022-367 - Rev 00
    230MF10023
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    EVEROLIMUS (NON-STERILE API)
    Everolimus, Butylated hydroxytoluen...
    Everolimus at Building C25-C28, No....
    Issue/Submission Date
    2017-09-20
    2024-02-15
    2018-02-14
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    • FDA
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    Argatroban

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    USDMF

    Found USDMF

    35491
    Active
    ARGATROBAN
    2020-12-26
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    305MF10140
    Argatroban at Building C25-C28, No....
    2023-12-22
    Written Confirmation

    Close WC

    Application Number
    35491
    305MF10140
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    ARGATROBAN
    Argatroban at Building C25-C28, No....
    Issue/Submission Date
    2020-12-26
    2023-12-22
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    • FDA
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    Eribulin

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    USDMF

    Found USDMF

    35118
    Active
    ERIBULIN MESYLATE
    2020-10-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    304MF10030
    Eribulin Mesylate at Building C25-C...
    2022-02-10
    Written Confirmation

    Close WC

    Application Number
    35118
    304MF10030
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    ERIBULIN MESYLATE
    Eribulin Mesylate at Building C25-C...
    Issue/Submission Date
    2020-10-28
    2022-02-10
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    • FDA
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    Micafungin

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    USDMF

    Found USDMF

    30028
    Active
    MICAFUNGIN SODIUM INTERMEDIATE A
    2015-11-11
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    230MF10169
    MICAFUNGIN SODIUM at Building C25-C...
    2018-12-19
    Written Confirmation

    Close WC

    Application Number
    30028
    230MF10169
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    MICAFUNGIN SODIUM INTERMEDIATE A
    MICAFUNGIN SODIUM at Building C25-C...
    Issue/Submission Date
    2015-11-11
    2018-12-19
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    Micafungin

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    USDMF

    Found USDMF

    31449
    Active
    MICAFUNGIN SODIUM (NON-STERILE, API...
    2017-03-03
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    303MF10069
    Micafungin Sodium (TMC) at Building...
    2021-04-19
    Written Confirmation

    Close WC

    Application Number
    31449
    303MF10069
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    MICAFUNGIN SODIUM (NON-STERILE, API...
    Micafungin Sodium (TMC) at Building...
    Issue/Submission Date
    2017-03-03
    2021-04-19
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    • FDA
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    Oseltamivir Phosphate

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    USDMF

    Found USDMF

    35876
    Active
    OSELTAMIVIR PHOSPHATE
    2021-04-29
    CEP/COS

    Found CEP/COS

    CEP 2022-488 - Rev 00
    Valid
    Oseltamivir phosphate
    2024-03-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    35876
    CEP 2022-488 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    OSELTAMIVIR PHOSPHATE
    Oseltamivir phosphate
    Issue/Submission Date
    2021-04-29
    2024-03-07
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    • FDA
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    Sugammadex Sodium

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    USDMF

    Found USDMF

    33904
    Active
    SUGAMMADEX SODIUM (NON-STERILE, API...
    2019-06-06
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    305MF10018
    Sugammadex Sodium at Building C25-C...
    2023-02-02
    Written Confirmation

    Close WC

    Application Number
    33904
    305MF10018
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    SUGAMMADEX SODIUM (NON-STERILE, API...
    Sugammadex Sodium at Building C25-C...
    Issue/Submission Date
    2019-06-06
    2023-02-02
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    • FDA
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    Anidulafungin

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    USDMF

    Found USDMF

    32010
    Active
    ANIDULAFUNGIN (NON-STERILE API)
    2017-08-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    32010
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    ANIDULAFUNGIN (NON-STERILE API)
    Issue/Submission Date
    2017-08-28
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    • FDA
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    Ansamitocin P3

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    USDMF

    Found USDMF

    34434
    Active
    ANSAMITOCIN P-3
    2019-12-23
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    34434
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    ANSAMITOCIN P-3
    Issue/Submission Date
    2019-12-23
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    • FDA
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    Carboprost Tromethamine

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    USDMF

    Found USDMF

    37422
    Active
    CARBOPROST TROMETHAMINE
    2022-08-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    37422
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    CARBOPROST TROMETHAMINE
    Issue/Submission Date
    2022-08-31
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    • FDA
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    CAS 184177-83-1

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    USDMF

    Found USDMF

    33194
    Active
    2-[(1S,2S)-1-ETHY1-2-BEZYLOXYPROPYL...
    2018-10-09
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    33194
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    2-[(1S,2S)-1-ETHY1-2-BEZYLOXYPROPYL...
    Issue/Submission Date
    2018-10-09
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    • FDA
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    CAS-149809-43-8

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    USDMF

    Found USDMF

    33193
    Active
    ((3S,5R)-5-((1H-1,2,4-TRIAZOL-1-YL)...
    2018-10-16
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    33193
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    ((3S,5R)-5-((1H-1,2,4-TRIAZOL-1-YL)...
    Issue/Submission Date
    2018-10-16
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    • FDA
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    Caspofungin

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    USDMF

    Found USDMF

    34091
    Active
    CASPOFUNGIN ACETATE (DKB)
    2019-09-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    34091
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    CASPOFUNGIN ACETATE (DKB)
    Issue/Submission Date
    2019-09-29
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    • FDA
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    Dalbavancin

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    USDMF

    Found USDMF

    35874
    Active
    DALBAVANCIN HYDROCHLORIDE
    2021-04-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    35874
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    DALBAVANCIN HYDROCHLORIDE
    Issue/Submission Date
    2021-04-30
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    Dalbavancin

    PDF Supplier PDF
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    USDMF

    Found USDMF

    36025
    Active
    DALBAVANCIN PRECURSOR A40926
    2021-08-25
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36025
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    DALBAVANCIN PRECURSOR A40926
    Issue/Submission Date
    2021-08-25
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    Dalbavancin

    PDF Supplier PDF
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    USDMF

    Found USDMF

    37185
    Active
    DALBAVANCIN PRECURSOR A40926 (CBR48...
    2022-09-14
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    37185
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    DALBAVANCIN PRECURSOR A40926 (CBR48...
    Issue/Submission Date
    2022-09-14
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    Dalbavancin

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    USDMF

    Found USDMF

    37186
    Active
    DALBAVANCIN HYDROCHLORIDE (DB)
    2022-11-24
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    37186
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    DALBAVANCIN HYDROCHLORIDE (DB)
    Issue/Submission Date
    2022-11-24
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    • FDA
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    Entecavir Intermediate VIII Isomer

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    USDMF

    Found USDMF

    26257
    Active
    2-AMINO-1,9-DIHYDRO-9-[(1S,3R,4S)-4...
    2012-08-12
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    26257
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    2-AMINO-1,9-DIHYDRO-9-[(1S,3R,4S)-4...
    Issue/Submission Date
    2012-08-12
    ASK
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    • FDA
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    Everolimus

    PDF Supplier PDF
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    USDMF

    Found USDMF

    36661
    Active
    EVEROLIMUS (0.2%BHT)
    2021-12-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36661
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    EVEROLIMUS (0.2%BHT)
    Issue/Submission Date
    2021-12-31
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    • FDA
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    Exatecan

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    USDMF

    Found USDMF

    37214
    Active
    EXATECAN MESYLATE
    2022-06-24
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    37214
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    EXATECAN MESYLATE
    Issue/Submission Date
    2022-06-24
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    • FDA
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    Ferric Carboxymaltose

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    USDMF

    Found USDMF

    37389
    Active
    FERRIC CARBOXYMALTOSE
    2022-07-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    37389
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    FERRIC CARBOXYMALTOSE
    Issue/Submission Date
    2022-07-28
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    • FDA
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    Fidaxomicin

    PDF Supplier PDF
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    USDMF

    Found USDMF

    28803
    Active
    FIDAXOMICIN CRYSTALLINE
    2014-11-26
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    28803
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    FIDAXOMICIN CRYSTALLINE
    Issue/Submission Date
    2014-11-26
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    Fidaxomicin

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    USDMF

    Found USDMF

    38815
    Active
    FIDAXOMICIN
    2023-09-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    38815
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    FIDAXOMICIN
    Issue/Submission Date
    2023-09-28
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    • FDA
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    Fondaparinux Sodium

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    USDMF

    Found USDMF

    28552
    Active
    FONDAPARINUX INTERMEDIATE FSC
    2014-08-07
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    28552
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    FONDAPARINUX INTERMEDIATE FSC
    Issue/Submission Date
    2014-08-07
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    Fondaparinux Sodium

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    USDMF

    Found USDMF

    30767
    Active
    FONDAPARINUX SODIUM (NON-STERILE, A...
    2016-07-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    30767
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    FONDAPARINUX SODIUM (NON-STERILE, A...
    Issue/Submission Date
    2016-07-15
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    Fondaparinux Sodium

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    USDMF

    Found USDMF

    37729
    Active
    FONDAPARINUX SODIUM USP
    2022-12-16
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    37729
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    FONDAPARINUX SODIUM USP
    Issue/Submission Date
    2022-12-16
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    Hydroxy Echinocandin

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    USDMF

    Found USDMF

    34006
    Active
    PNEUMOCANDIN B0
    2019-07-24
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    34006
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    PNEUMOCANDIN B0
    Issue/Submission Date
    2019-07-24
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    Isavuconazonium Sulfate

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    USDMF

    Found USDMF

    38502
    Active
    ISAVUCONAZONIUM SULFATE
    2023-10-19
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    38502
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    ISAVUCONAZONIUM SULFATE
    Issue/Submission Date
    2023-10-19
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    Lurbinectedin

    PDF Supplier PDF
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    USDMF

    Found USDMF

    39228
    Active
    LURBINECTEDIN
    2023-12-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    39228
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    LURBINECTEDIN
    Issue/Submission Date
    2023-12-28
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    Maytansinoid DM1

    PDF Supplier PDF
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    USDMF

    Found USDMF

    35973
    Active
    MERTANSINE (MTB)
    2021-06-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    35973
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    MERTANSINE (MTB)
    Issue/Submission Date
    2021-06-28
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    Maytansinoid DM1

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    36200
    Active
    MERTANSINE (MTS)
    2021-08-13
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36200
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    MERTANSINE (MTS)
    Issue/Submission Date
    2021-08-13
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    • FDA
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    Micafungin

    PDF Supplier PDF
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    USDMF

    Found USDMF

    33892
    Active
    MICAFUNGIN SODIUM INTERMEDIATE MCB
    2019-06-06
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    33892
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    MICAFUNGIN SODIUM INTERMEDIATE MCB
    Issue/Submission Date
    2019-06-06
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    Midostaurin

    PDF Supplier PDF
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    USDMF

    Found USDMF

    34990
    Active
    MIDOSTAURIN
    2022-12-21
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    34990
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    MIDOSTAURIN
    Issue/Submission Date
    2022-12-21
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    Molnupiravir

    PDF Supplier PDF
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    USDMF

    Found USDMF

    37435
    Active
    MOLNUPIRAVIR
    2022-08-25
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    37435
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    MOLNUPIRAVIR
    Issue/Submission Date
    2022-08-25
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    Nicergoline

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2022-026 - Rev 00
    Valid
    Nicergoline
    2023-06-23
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2022-026 - Rev 00
    Status
    Valid
     
    Filing Details
    Nicergoline
    Issue/Submission Date
    2023-06-23
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    Nicergoline

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    CEP 2023-311 - Rev 00
    Valid
    Nicergoline, Taixing site
    2024-02-01
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    CEP 2023-311 - Rev 00
    Status
    Valid
     
    Filing Details
    Nicergoline, Taixing site
    Issue/Submission Date
    2024-02-01
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    Obeticholic Acid

    PDF Supplier PDF
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    USDMF

    Found USDMF

    36292
    Active
    OBETICHOLIC ACID
    2021-09-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36292
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    OBETICHOLIC ACID
    Issue/Submission Date
    2021-09-29
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    Pemetrexed

    PDF Supplier PDF
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    USDMF

    Found USDMF

    31215
    Active
    PEMETREXED ACID PMC
    2016-11-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    31215
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    PEMETREXED ACID PMC
    Issue/Submission Date
    2016-11-28
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    Pimecrolimus

    PDF Supplier PDF
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    USDMF

    Found USDMF

    29433
    Active
    PIMECROLIMUS INTERMEDIATE ASCOMYCIN
    2015-05-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    29433
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    PIMECROLIMUS INTERMEDIATE ASCOMYCIN
    Issue/Submission Date
    2015-05-28
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    Pimecrolimus

    PDF Supplier PDF
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    USDMF

    Found USDMF

    30090
    Active
    PIMECROLIMUS (NON-STERILE, API)
    2015-12-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    30090
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    PIMECROLIMUS (NON-STERILE, API)
    Issue/Submission Date
    2015-12-30
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    • FDA
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    Posaconazole

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    28314
    Active
    POSACONAZOLE (NON STERILE API)
    2014-06-10
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    28314
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    POSACONAZOLE (NON STERILE API)
    Issue/Submission Date
    2014-06-10
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    Posaconazole

    PDF Supplier PDF
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    See all info for this product

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    USDMF

    Found USDMF

    30886
    Active
    POSACONAZOLE CRYSTALLINE III
    2016-09-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    30886
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    POSACONAZOLE CRYSTALLINE III
    Issue/Submission Date
    2016-09-30
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    Posaconazole

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

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    USDMF

    Found USDMF

    32346
    Active
    POSACONAZOLE CRYSTALLINE I (NON-STE...
    2017-12-26
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    32346
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    POSACONAZOLE CRYSTALLINE I (NON-STE...
    Issue/Submission Date
    2017-12-26
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    Posaconazole

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    USDMF

    Found USDMF

    36116
    Active
    POSACONAZOLE FORM I
    2021-09-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36116
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    POSACONAZOLE FORM I
    Issue/Submission Date
    2021-09-27
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    Sirolimus

    PDF Supplier PDF
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    USDMF

    Found USDMF

    35527
    Active
    SIROLIMUS
    2021-04-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    35527
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    SIROLIMUS
    Issue/Submission Date
    2021-04-29
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    Spinosyn D

    PDF Supplier PDF
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    USDMF

    Found USDMF

    36293
    Active
    SPINOSAD
    2021-09-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36293
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    SPINOSAD
    Issue/Submission Date
    2021-09-27
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    Staurosporine

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    34763
    Active
    STAUROSPORINE
    2020-07-08
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    34763
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    STAUROSPORINE
    Issue/Submission Date
    2020-07-08
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    Trabectedin

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    39165
    Active
    TRABECTEDIN
    2023-12-13
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    39165
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    TRABECTEDIN
    Issue/Submission Date
    2023-12-13
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    • FDA
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    Trientine Hydrochloride

    PDF Supplier PDF
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    USDMF

    Found USDMF

    37777
    Active
    TRIENTINE HYDROCHLORIDE USP
    2022-12-16
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    37777
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    TRIENTINE HYDROCHLORIDE USP
    Issue/Submission Date
    2022-12-16
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