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    EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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    Munit offers scalable GMP micronization and particle size engineering to enhance drug solubility, bioavailability, and performance.

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    Lupin Manufacturing Solutions – delivering high-quality APIs & end-to-end CDMO services for faster, cost-effective drug development.

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    Inke S.A: APIs manufacturing plant.

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    Alchem offers Botanical APIs for Pharmaceuticals, Cosmetics and Nutraceuticals// FDA-inspected and EU-GMP certified.

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    Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

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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 2Bortezomib

    15 1Brinzolamide

    16 1Brivaracetam

    17 1Bromfenac Sodium

    18 1Busulfan

    19 1Cabergoline

    20 1Cabotegravir

    21 1Carfilzomib

    22 1Cetrorelix Acetate

    23 1Cevimeline Hydrochloride

    24 1Cinitapride Hydrogen Tartrate

    25 1Clofarabine

    26 1Colestipol

    27 1Crizotinib

    28 1Cyclophosphamide

    29 1Cysteamine Bitartrate

    30 1Cysteamine Hydrochloride

    31 1Dacarbazine

    32 3Degarelix Acetate

    33 1Deucravacitinib

    34 1Diflunisal

    35 1Dimetindene

    36 1Dofetilide

    37 1Dolutegravir Sodium

    38 1Droxidopa

    39 1Elacestrant

    40 1Enasidenib

    41 1Ethacrynic Acid

    42 1Favipiravir

    43 2Felbamate

    44 2Ferric Carboxymaltose

    45 1Ferric Citrate

    46 1Ferric Derisomaltose

    47 1Ferric Maltol

    48 1Ferric Pyrophosphate Citrate

    49 1Ferumoxides

    50 1Ferumoxytol

    51 2Flibanserin

    52 1Fludrocortisone Acetate

    53 1Fluocytosine

    54 1Fluorescein

    55 1Fomepizole

    56 1Fondaparinux Sodium

    57 1Fosamprenavir

    58 1Ganirelix

    59 1Granisetron Hydrochloride

    60 1Histrelin

    61 1Hydroxocobalamin

    62 1Hydroxocobalamin Hydrochloride

    63 1Indocyanine Green

    64 1Iron Dextran

    65 1Iron Sucrose

    66 1Isavuconazonium Sulfate

    67 1Isosulfan Blue

    68 2Itraconazole

    69 1Ivacaftor

    70 1Lanreotide Acetate

    71 1Larotrectinib

    72 1Lenacapavir

    73 1Lenalidomide

    74 1Leuprolide Acetate

    75 1Linaclotide

    76 1Liraglutide

    77 1Lumacaftor

    78 1Lurbinectedin

    79 1Mafenide

    80 1Maralixibat

    81 1Maralixibat Chloride

    82 1Mavacamten

    83 2Methylene Blue

    84 2Methyltyrosine

    85 1Micafungin

    86 1Midostaurin

    87 1Miglustat

    88 1Mitapivat

    89 1Mobocertinib Succinate

    90 2Molindone

    91 1Molnupiravir

    92 1Momelotinib

    93 1Nadolol

    94 1Netupitant

    95 1Octreotide Acetate

    96 1Odevixibat

    97 1Oseltamivir Phosphate

    98 1Paliperidone Palmitate

    99 2Pantoprazole Sodium

    100 1Penicillamine

    101 2Pentosan Polysulfate Sodium

    102 1Pentostatin

    103 1Perphenazine

    104 1Phenoxybenzamine HCl

    105 1Phentolamine Mesylate

    106 1Plerixafor

    107 1Pomalidomide

    108 2Ponatinib

    109 1Pralatrexate

    110 2Primaquine Diphosphate

    111 1Procarbazine Hydrochloride

    112 1Protriptyline

    113 1Prucalopride Succinate

    114 1Raltegravir Potassium

    115 1Regadenoson Monohydrate

    116 1Rilpivirine Hydrochloride

    117 1Riluzole

    118 1Ritlecitinib

    119 1Romidepsin

    120 1Rucaparib Camsylate

    121 1Safinamide Methanesulfonate

    122 1Selegiline Hydrochloride

    123 1Selenious Acid

    124 1Selexipag

    125 1Semaglutide

    126 1Sincalide

    127 1Sodium Nitroprusside

    128 1Sodium Zirconium Cyclosilicate

    129 1Sparsentan

    130 2Sugammadex Sodium

    131 1Sulfiram

    132 1Tecovirimat

    133 1Teduglutide

    134 1Tenofovir Alafenamide Fumarate

    135 1Tetrabenazine

    136 1Tirzepatide

    137 2Trabectedin

    138 1Triamterene

    139 1Trientine Hydrochloride

    140 1Trifluridine

    141 1Trilaciclib

    142 1Triptorelin Pamoate

    143 1Umifenovir

    144 1Ursodeoxycholic Acid

    145 1VANDETANIB

    146 1Vismodegib

    147 2Voriconazole

    148 1Vortioxetine Hydrobromide

    149 1Vosoritide

    150 1Zavegepant HCl

    151 1Zileuton

    152 4Blank

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    01

    Bortezomib

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

    Aus. Peptide Conference
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    Bortezomib

    India

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

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    Aus. Peptide Conference
    Not Confirmed
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    • EDQM
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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

    Aus. Peptide Conference
    Not Confirmed
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    Busulfan

    India

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

    arrow
    Aus. Peptide Conference
    Not Confirmed
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    • EDQM
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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

    KDMF VMF Others AUDIT
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    03

    Voriconazole

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

    Aus. Peptide Conference
    Not Confirmed
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    Voriconazole

    India

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

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    Aus. Peptide Conference
    Not Confirmed
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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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    04

    Miglustat

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

    Aus. Peptide Conference
    Not Confirmed
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    Miglustat

    India

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

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    Aus. Peptide Conference
    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 : 41867

    Submission : 2025-06-09

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCInactive-api
    ✖

    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 : 42973-166

    Start Marketing Date : 2011-12-01

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    05

    Phentolamine Mesylate

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

    Aus. Peptide Conference
    Not Confirmed
    arrow

    Phentolamine Mesylate

    India

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

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    Aus. Peptide Conference
    Not Confirmed
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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-WCInactive-api
    ✖

    Date of Issue : 2022-07-15

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0110n

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
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    06

    Trabectedin

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

    Aus. Peptide Conference
    Not Confirmed
    arrow

    Trabectedin

    India

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

    arrow
    Aus. Peptide Conference
    Not Confirmed
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    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-WCInactive-api
    ✖

    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 : 42973-310

    Start Marketing Date : 2020-12-06

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    07

    Alcaftadine

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

    Aus. Peptide Conference
    Not Confirmed
    arrow

    Alcaftadine

    India

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

    arrow
    Aus. Peptide Conference
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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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
    ✖

    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

    KDMF VMF Others AUDIT
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    08

    Belzutifan

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

    Aus. Peptide Conference
    Not Confirmed
    arrow

    Belzutifan

    India

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

    arrow
    Aus. Peptide Conference
    Not Confirmed
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    • WHO-GMP
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    USDMF arrow-down
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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 KDMF VMF Others AUDIT
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    09

    Bexarotene

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

    Aus. Peptide Conference
    Not Confirmed
    arrow

    Bexarotene

    India

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

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    Aus. Peptide Conference
    Not Confirmed
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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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    10

    Cetrorelix Acetate

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

    Aus. Peptide Conference
    Not Confirmed
    arrow

    Cetrorelix Acetate

    India

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

    arrow
    Aus. Peptide Conference
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 41854

    Submission : 2025-05-30

    Status : Active

    Type : II

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

    NDC Package Code : 42973-326

    Start Marketing Date : 2021-05-26

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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