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    05 1Ataluren

    06 1Avacopan

    07 1Avatrombopag Maleate

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    01

    Bortezomib

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    STLE Annual Meeting
    Not Confirmed
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    Bortezomib

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    STLE Annual Meeting
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-01-22

    Pay. Date : 2013-09-20

    DMF Number : 22922

    Submission : 2009-06-30

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 231MF10057

    Registrant's Address : 49 Napoleon Ct. , Somerset, NJ 08873, USA

    Initial Date of Registration : 2019-02-25

    Latest Date of Registration :

    EU-WC NDC arrow-down
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    NDC Package Code : 42973-140

    Start Marketing Date : 2009-11-15

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    02

    Busulfan

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    STLE Annual Meeting
    Not Confirmed
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    Busulfan

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    STLE Annual Meeting
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-06-10

    Pay. Date : 2015-05-27

    DMF Number : 23924

    Submission : 2010-08-05

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2016-270 - Rev 00

    Issue Date : 2023-05-17

    Type : Chemical

    Substance Number : 542

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 14096-147

    Start Marketing Date : 2011-07-01

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    03

    Phentolamine Mesylate

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    STLE Annual Meeting
    Not Confirmed
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    Phentolamine Mesylate

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    STLE Annual Meeting
    Not Confirmed
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 39948

    Submission : 2024-06-07

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-07-15

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0110n

    Address of the Firm :

    NDC arrow-down
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    NDC Package Code : 42973-389

    Start Marketing Date : 2024-04-12

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : INJECTION, POWDER, FOR SOLUTION (1kg/kg)

    Marketing Category : BULK INGREDIENT FOR ...

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    04

    Trabectedin

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    STLE Annual Meeting
    Not Confirmed
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    Trabectedin

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    STLE Annual Meeting
    Not Confirmed
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    • EDQM
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    USDMF arrow-down
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2021-07-13

    Pay. Date : 2021-06-07

    DMF Number : 35828

    Submission : 2021-04-19

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-07-15

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0110n

    Address of the Firm :

    NDC arrow-down
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    NDC Package Code : 42973-310

    Start Marketing Date : 2020-12-06

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    05

    Voriconazole

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    STLE Annual Meeting
    Not Confirmed
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    Voriconazole

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    STLE Annual Meeting
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 35114

    Submission : 2020-09-04

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2022-362 - Rev 00

    Issue Date : 2024-08-02

    Type : Chemical

    Substance Number : 2576

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 73223-005

    Start Marketing Date : 2019-08-05

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    06

    Alcaftadine

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    STLE Annual Meeting
    Not Confirmed
    arrow

    Alcaftadine

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    STLE Annual Meeting
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 32382

    Submission : 2018-01-07

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 42973-204

    Start Marketing Date : 2017-12-01

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    07

    Bexarotene

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    STLE Annual Meeting
    Not Confirmed
    arrow

    Bexarotene

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    STLE Annual Meeting
    Not Confirmed
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    USDMF arrow-down
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-08-07

    Pay. Date : 2015-07-29

    DMF Number : 23631

    Submission : 2010-04-26

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 14096-150

    Start Marketing Date : 2009-10-01

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    08

    Bromfenac Sodium

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    STLE Annual Meeting
    Not Confirmed
    arrow

    Bromfenac Sodium

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    STLE Annual Meeting
    Not Confirmed
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    • EDQM
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    USDMF CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-07-15

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0110n

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 42973-144

    Start Marketing Date : 2008-11-01

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    09

    Cevimeline Hydrochloride

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    STLE Annual Meeting
    Not Confirmed
    arrow

    Cevimeline Hydrochloride

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    STLE Annual Meeting
    Not Confirmed
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    • EDQM
    • WHO-GMP
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    USDMF CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-07-15

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0110n

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 42973-228

    Start Marketing Date : 2017-08-01

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    10

    Clofarabine

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    STLE Annual Meeting
    Not Confirmed
    arrow

    Clofarabine

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    STLE Annual Meeting
    Not Confirmed
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    • EDQM
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    USDMF CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-07-15

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0110n

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 42973-173

    Start Marketing Date : 2011-09-01

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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