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    01 1Abrocitinib

    02 1Alcaftadine

    03 1Arginine Vasopressin

    04 1Aripiprazole

    05 1Ataluren

    06 1Avacopan

    07 1Avatrombopag Maleate

    08 1Azacitidine

    09 1Azathioprine

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    11 1Belzutifan

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    14 1Bexarotene

    15 1Bortezomib

    16 1Brinzolamide

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    32 3Degarelix Acetate

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    40 1Elacestrant

    41 1Enasidenib

    42 1Ethacrynic Acid

    43 1Favipiravir

    44 1Felbamate

    45 2Ferric Carboxymaltose

    46 1Ferric Citrate

    47 1Ferric Derisomaltose

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    49 1Ferric Pyrophosphate Citrate

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    54 1Fluorescein

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    77 1Lurbinectedin

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    79 1Maralixibat

    80 1Maralixibat Chloride

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    91 1Momelotinib

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    93 1Netupitant

    94 1Octreotide Acetate

    95 1Odevixibat

    96 1Oseltamivir Phosphate

    97 1Paliperidone Palmitate

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    100 1Pentosan Polysulfate Sodium

    101 1Pentostatin

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    103 1Phenoxybenzamine HCl

    104 3Phentolamine Mesylate

    105 1Plerixafor

    106 1Pomalidomide

    107 2Ponatinib

    108 1Pralatrexate

    109 1Primaquine Diphosphate

    110 1Procarbazine Hydrochloride

    111 1Protriptyline

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    113 1Raltegravir Potassium

    114 1Regadenoson Monohydrate

    115 1Rilpivirine Hydrochloride

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    117 1Ritlecitinib

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    120 1Safinamide Methanesulfonate

    121 2Selegiline Hydrochloride

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    01

    Bortezomib

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

    AMWC Asia-TDAC
    Not Confirmed
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    Bortezomib

    India

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

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    AMWC Asia-TDAC
    Not Confirmed
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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 : 2026-12-31

    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

    AMWC Asia-TDAC
    Not Confirmed
    arrow

    Busulfan

    India

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

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    AMWC Asia-TDAC
    Not Confirmed
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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 : 42973-392

    Start Marketing Date : 2024-11-22

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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    03

    Cevimeline Hydrochloride

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

    AMWC Asia-TDAC
    Not Confirmed
    arrow

    Cevimeline Hydrochloride

    India

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

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    AMWC Asia-TDAC
    Not Confirmed
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    USDMF arrow-down
    ✖

    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
    ✖

    Date of Issue : 2025-11-27

    Valid Till : 2028-07-02

    Written Confirmation Number : WC-0110

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 42973-228

    Start Marketing Date : 2017-08-01

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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    04

    Miglustat

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

    AMWC Asia-TDAC
    Not Confirmed
    arrow

    Miglustat

    India

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

    arrow
    AMWC Asia-TDAC
    Not Confirmed
    • fda
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    USDMF arrow-down
    ✖

    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
    ✖

    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 : 42973-166

    Start Marketing Date : 2011-12-01

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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    05

    Phentolamine Mesylate

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

    AMWC Asia-TDAC
    Not Confirmed
    arrow

    Phentolamine Mesylate

    India

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

    arrow
    AMWC Asia-TDAC
    Not Confirmed
    • fda
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    • WHO-GMP
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    USDMF arrow-down
    ✖

    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 :

    NDC arrow-down
    ✖

    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 ...

    KDMF VMF Others AUDIT
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    06

    Plerixafor

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

    AMWC Asia-TDAC
    Not Confirmed
    arrow

    Plerixafor

    India

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

    arrow
    AMWC Asia-TDAC
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Flag India
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    Digital Content Digital Content
    USDMF arrow-down
    ✖

    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
    ✖

    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

    KDMF VMF Others AUDIT
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    07

    Trabectedin

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

    AMWC Asia-TDAC
    Not Confirmed
    arrow

    Trabectedin

    India

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

    arrow
    AMWC Asia-TDAC
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Flag India
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    Digital Content Digital Content
    USDMF arrow-down
    ✖

    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 :

    NDC KDMF VMF Others AUDIT
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    Market
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    08

    Alcaftadine

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

    AMWC Asia-TDAC
    Not Confirmed
    arrow

    Alcaftadine

    India

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

    arrow
    AMWC Asia-TDAC
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Digital Content Digital Content
    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 : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    09

    Belzutifan

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

    AMWC Asia-TDAC
    Not Confirmed
    arrow

    Belzutifan

    India

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

    arrow
    AMWC Asia-TDAC
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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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
    ✖

    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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    10

    Bexarotene

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

    AMWC Asia-TDAC
    Not Confirmed
    arrow

    Bexarotene

    India

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

    arrow
    AMWC Asia-TDAC
    Not Confirmed
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    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    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 : 42973-420

    Start Marketing Date : 2025-06-10

    End Marketing Date : 2027-12-31

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

    Marketing Category : BULK INGREDIENT

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    Contact Apicore and get a quotation

    Apicore is a supplier offers 159 products (APIs, Excipients or Intermediates).

    Find Bortezomib bulk with DMF, JDMF offered by Apicore

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