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

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    01 Alcaftadine (1)

    02 Bexarotene (1)

    03 Bortezomib (1)

    04 Bromfenac Sodium (2)

    05 Busulfan (1)

    06 Cevimeline Hydrochloride (2)

    07 Clofarabine (2)

    08 Cyclophosphamide (1)

    09 Dacarbazine (3)

    10 Degarelix Acetate (2)

    11 Dimetindene (2)

    12 Enasidenib (1)

    13 Felbamate (1)

    14 Ferric Carboxymaltose (1)

    15 Ferumoxytol (1)

    16 Flibanserin (1)

    17 Ganirelix (1)

    18 Methyltyrosine (1)

    19 Miglustat (2)

    20 Nadolol (2)

    21 Penicillamine (1)

    22 Perphenazine (1)

    23 Phentolamine Mesylate (2)

    24 Plerixafor (1)

    25 Ponatinib (2)

    26 Protriptyline (1)

    27 Safinamide Mesylate (1)

    28 Selegiline Hydrochloride (1)

    29 Selexipag (1)

    30 Sugammadex Sodium (2)

    31 Sulfiram (2)

    32 Trabectedin (2)

    33 Blank (1)

    filter

    01 Active (19)

    02 Inactive (2)

    03 Blank (26)

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    01 Valid (1)

    02 Blank (46)

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    01 231MF10057 (1)

    02 Blank (46)

    filter

    01 WC-0110 (13)

    02 WC-0110A3 (1)

    03 WC-0110A4 (1)

    04 WC-0110A5 (1)

    05 WC-0110A6 (1)

    06 WC-0110a (9)

    07 Blank (21)

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    • FDA
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    Bortezomib

    PDF Supplier PDF
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    USDMF

    Found USDMF

    22922
    Active
    BORTEZOMIB
    2009-06-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    231MF10057
    Bortezomib at 49 Napoleon Ct. , Som...
    2019-02-25
    Written Confirmation

    Close WC

    Application Number
    22922
    231MF10057
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    BORTEZOMIB
    Bortezomib at 49 Napoleon Ct. , Som...
    Issue/Submission Date
    2009-06-30
    2019-02-25
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    Busulfan

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    USDMF

    Found USDMF

    23924
    Active
    BUSULFAN USP
    2010-08-05
    CEP/COS

    Found CEP/COS

    R1-CEP 2016-270 - Rev 00
    Valid
    Busulfan
    2023-05-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23924
    R1-CEP 2016-270 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    BUSULFAN USP
    Busulfan
    Issue/Submission Date
    2010-08-05
    2023-05-17
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    Trabectedin

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    USDMF

    Found USDMF

    35828
    Active
    TRABECTEDIN
    2021-04-19
    CEP/COS

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    Japanese DMF

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    Written Confirmation

    Found WC

    Indian CDSCO WC-0110
    Valid
    Trabectedin IH
    2022-07-15
    Application Number
    35828
    Indian CDSCO WC-0110
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-07-02
    Filing Details
    TRABECTEDIN
    Trabectedin IH
    Issue/Submission Date
    2021-04-19
    2022-07-15
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    Alcaftadine

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    USDMF

    Found USDMF

    32382
    Active
    ALCAFTADINE
    2018-01-07
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    32382
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    ALCAFTADINE
    Issue/Submission Date
    2018-01-07
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    Bexarotene

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    USDMF

    Found USDMF

    23631
    Active
    BEXAROTENE
    2010-04-26
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    23631
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    BEXAROTENE
    Issue/Submission Date
    2010-04-26
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    Bromfenac Sodium

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0110
    Valid
    Bromfenac Sodium IH
    2022-07-15
    Application Number
    Indian CDSCO WC-0110
    Status
     
    Valid
    2025-07-02
    Filing Details
    Bromfenac Sodium IH
    Issue/Submission Date
    2022-07-15
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    Cevimeline Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0110
    Valid
    Cevimeline HCl IH
    2022-07-15
    Application Number
    Indian CDSCO WC-0110
    Status
     
    Valid
    2025-07-02
    Filing Details
    Cevimeline HCl IH
    Issue/Submission Date
    2022-07-15
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    Clofarabine

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0110
    Valid
    Clofarabine IH
    2022-07-15
    Application Number
    Indian CDSCO WC-0110
    Status
     
    Valid
    2025-07-02
    Filing Details
    Clofarabine IH
    Issue/Submission Date
    2022-07-15
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    Cyclophosphamide

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    USDMF

    Found USDMF

    36089
    Active
    CYCLOPHOSPHAMIDE USP (STERILE BULK)
    2021-07-28
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    36089
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    CYCLOPHOSPHAMIDE USP (STERILE BULK)
    Issue/Submission Date
    2021-07-28
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    Dacarbazine

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0110
    Valid
    Dacarbazine (USP/EP) 
    2022-07-15
    Application Number
    Indian CDSCO WC-0110
    Status
     
    Valid
    2025-07-02
    Filing Details
    Dacarbazine (USP/EP) 
    Issue/Submission Date
    2022-07-15
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