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    01

    Bortezomib

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

    Bioprocess International Europe
    Not Confirmed
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    Bortezomib

    India

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

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    Bioprocess International Europe
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    DMF Review : Reviewed

    Rev. Date : 2014-01-22

    Pay. Date : 2013-09-20

    DMF Number : 22922

    Submission : 2009-06-30

    Status : Active

    Type : II

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    Registration Number : 231MF10057

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

    Initial Date of Registration : 2019-02-25

    Latest Date of Registration :

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    NDC Package Code : 42973-140

    Start Marketing Date : 2009-11-15

    End Marketing Date : 2026-12-31

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    02

    Busulfan

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

    Bioprocess International Europe
    Not Confirmed
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    Busulfan

    India

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

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    Bioprocess International Europe
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    DMF Review : Reviewed

    Rev. Date : 2015-06-10

    Pay. Date : 2015-05-27

    DMF Number : 23924

    Submission : 2010-08-05

    Status : Active

    Type : II

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    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
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    NDC Package Code : 42973-392

    Start Marketing Date : 2024-11-22

    End Marketing Date : 2026-12-31

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    03

    Cevimeline Hydrochloride

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

    Bioprocess International Europe
    Not Confirmed
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    Cevimeline Hydrochloride

    India

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

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    Bioprocess International Europe
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2024-09-12

    Pay. Date : 2024-08-24

    DMF Number : 40223

    Submission : 2024-07-23

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
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    Date of Issue : 2025-11-27

    Valid Till : 2028-07-02

    Written Confirmation Number : WC-0110

    Address of the Firm :

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    NDC Package Code : 42973-228

    Start Marketing Date : 2017-08-01

    End Marketing Date : 2026-12-31

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    04

    Miglustat

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

    Bioprocess International Europe
    Not Confirmed
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    Miglustat

    India

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

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    Bioprocess International Europe
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 41867

    Submission : 2025-06-09

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
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    Date of Issue : 2025-11-27

    Valid Till : 2028-07-02

    Written Confirmation Number : WC-0110

    Address of the Firm :

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    NDC Package Code : 42973-166

    Start Marketing Date : 2011-12-01

    End Marketing Date : 2026-12-31

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

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    05

    Phentolamine Mesylate

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

    Bioprocess International Europe
    Not Confirmed
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    Phentolamine Mesylate

    India

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

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    Bioprocess International Europe
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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 : 2025-11-27

    Valid Till : 2028-07-02

    Written Confirmation Number : WC-0110

    Address of the Firm :

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    NDC Package Code : 42973-423

    Start Marketing Date : 2025-03-14

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT FOR ...

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    06

    Plerixafor

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

    Bioprocess International Europe
    Not Confirmed
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    Plerixafor

    India

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

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    Bioprocess International Europe
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 40546

    Submission : 2024-10-04

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-11-27

    Valid Till : 2028-07-02

    Written Confirmation Number : WC-0110

    Address of the Firm :

    NDC arrow-down
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    NDC Package Code : 42973-202

    Start Marketing Date : 2017-12-01

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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    07

    Trabectedin

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

    Bioprocess International Europe
    Not Confirmed
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    Trabectedin

    India

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

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    Bioprocess International Europe
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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 : 2025-11-27

    Valid Till : 2028-07-02

    Written Confirmation Number : WC-0110

    Address of the Firm :

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    08

    Voriconazole

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

    Bioprocess International Europe
    Not Confirmed
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    Voriconazole

    India

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

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    Bioprocess International Europe
    Not Confirmed
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 35114

    Submission : 2020-09-04

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : CEP 2022-362 - Rev 00

    Issue Date : 2024-08-02

    Type : Chemical

    Substance Number : 2576

    Status : Valid

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    NDC Package Code : 73223-005

    Start Marketing Date : 2019-08-05

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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    09

    Alcaftadine

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

    Bioprocess International Europe
    Not Confirmed
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    Alcaftadine

    India

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

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    Bioprocess International Europe
    Not Confirmed
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    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
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    NDC Package Code : 42973-204

    Start Marketing Date : 2017-12-01

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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    10

    Belzutifan

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

    Bioprocess International Europe
    Not Confirmed
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    Belzutifan

    India

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

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    Bioprocess International Europe
    Not Confirmed
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2025-07-01

    Pay. Date : 2025-05-27

    DMF Number : 41515

    Submission : 2025-05-06

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC arrow-down
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    NDC Package Code : 42973-376

    Start Marketing Date : 2025-08-06

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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