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    DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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    Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

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    Vamsi Labs is one of the major manufacturers of Anti-asthmatic, Anti-migraine & Anti-psychotic APIs.

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    01 1Abrocitinib

    02 1Alcaftadine

    03 1Arginine Vasopressin

    04 1Aripiprazole

    05 1Ataluren

    06 1Avacopan

    07 1Avatrombopag Maleate

    08 1Azacitidine

    09 1Azathioprine

    10 1Bedaquiline

    11 1Belzutifan

    12 1Berotralstat Hydrochloride

    13 1Bexarotene

    14 1Bortezomib

    15 1Brinzolamide

    16 1Brivaracetam

    17 1Bromfenac Sodium

    18 1Busulfan

    19 1Cabotegravir

    20 1Carfilzomib

    21 1Cetrorelix Acetate

    22 1Cevimeline Hydrochloride

    23 1Cinitapride Hydrogen Tartrate

    24 1Clofarabine

    25 2Colestipol

    26 1Crizotinib

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    29 1Cysteamine Hydrochloride

    30 1Dacarbazine

    31 3Degarelix Acetate

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    33 1Diflunisal

    34 1Dimetindene

    35 1Dofetilide

    36 1Dolutegravir Sodium

    37 1Droxidopa

    38 1Elacestrant

    39 1Enasidenib

    40 1Ethacrynic Acid

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    42 1Felbamate

    43 2Ferric Carboxymaltose

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    45 1Ferric Derisomaltose

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    59 1Hydroxocobalamin Hydrochloride

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    74 1Lumacaftor

    75 1Lurbinectedin

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    77 1Maralixibat

    78 1Maralixibat Chloride

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    94 1Oseltamivir Phosphate

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    99 1Pentostatin

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    102 3Phentolamine Mesylate

    103 1Plerixafor

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    105 2Ponatinib

    106 1Pralatrexate

    107 1Primaquine Diphosphate

    108 1Procarbazine Hydrochloride

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    111 1Raltegravir Potassium

    112 1Regadenoson Monohydrate

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    114 1Riluzole

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    118 1Safinamide Methanesulfonate

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    140 1Umifenovir

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    01

    Bortezomib

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

    ASCO GU
    Not Confirmed
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    Bortezomib

    India

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

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    ASCO GU
    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

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    02

    Busulfan

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

    ASCO GU
    Not Confirmed
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    Busulfan

    India

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

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    ASCO GU
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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

    ASCO GU
    Not Confirmed
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    Cevimeline Hydrochloride

    India

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

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    ASCO GU
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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
    ✖

    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 : 42973-228

    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

    ASCO GU
    Not Confirmed
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    Miglustat

    India

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

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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
    ✖

    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)

    Marketing Category : BULK INGREDIENT

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    05

    Phentolamine Mesylate

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

    ASCO GU
    Not Confirmed
    arrow

    Phentolamine Mesylate

    India

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

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    ASCO GU
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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 ...

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    06

    Plerixafor

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

    ASCO GU
    Not Confirmed
    arrow

    Plerixafor

    India

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

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    ASCO GU
    Not Confirmed
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    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

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    07

    Trabectedin

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

    ASCO GU
    Not Confirmed
    arrow

    Trabectedin

    India

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

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    ASCO GU
    Not Confirmed
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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 : 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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    08

    Alcaftadine

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

    ASCO GU
    Not Confirmed
    arrow

    Alcaftadine

    India

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

    arrow
    ASCO GU
    Not Confirmed
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    • EDQM
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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 : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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    09

    Belzutifan

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

    ASCO GU
    Not Confirmed
    arrow

    Belzutifan

    India

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

    arrow
    ASCO GU
    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
    ✖

    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

    ASCO GU
    Not Confirmed
    arrow

    Bexarotene

    India

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

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    ASCO GU
    Not Confirmed
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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

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    Contact Apicore and get a quotation

    Apicore is a supplier offers 157 products (APIs, Excipients or Intermediates).

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