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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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    Sumitomo Corporation

    EVENTS

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    ACTIVE PHARMA INGREDIENTS

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    01 14-Biphenylacetic Acid

    02 1Amrubicin

    03 3Bezafibrate

    04 1Bicalutamide

    05 1Bilastine

    06 1Blonanserin

    07 1Bovine Serum

    08 1Cefpiramide

    09 1Cinacalcet Hydrochloride

    10 1Citalopram Hydrobromide

    11 1Crotamiton

    12 1Dipivefrin Hydrochloride

    13 3Disopyramide

    14 1Droxidopa

    15 1Efinaconazole

    16 1Enoxacin

    17 1Fexofenadine Hydrochloride

    18 1Fidaresstat

    19 1Genaconazole

    20 1Glipizide

    21 1Hydralazine

    22 2Hydralazine Hydrochloride

    23 1Imatinib Mesylate

    24 1Ipriflavone

    25 1Ketosulfone

    26 1Lacosamide

    27 1Lanthanum Carbonate

    28 1Levobunolol

    29 2Lurasidone Hydrochloride

    30 1Mequitazine

    31 3Meropenem

    32 1Metaqualone

    33 1Milnacipran Hydrochloride

    34 1Mirabegron

    35 1Mirtazapine

    36 2Mosapride Citrate

    37 1Netoglitazone

    38 1Olmesartan Medoxomil

    39 2Olopatadine Hydrochloride

    40 1Orbifloxacin

    41 1Oteracil Potassium

    42 1Oxaprozin

    43 1Paroxetine Hydrochloride

    44 1Phenethicillin Potassium

    45 1Phenothrin

    46 1Prazosin Hydrochloride

    47 1Pregabalin

    48 1Probucol

    49 1Propylthiouracil

    50 1Quetiapine Hemifumarate

    51 1Ranirestat

    52 1Rimacalib

    53 1Rivaroxaban

    54 1Sb 210232

    55 1Sm-216601

    56 1Smp 797

    57 1Sodium Hyaluronate

    58 1Sodium Valproate

    59 1Sofpironium Bromide

    60 1Sparfloxacin

    61 1Telmisartan

    62 1Terazosin HCl

    63 1Thiazole

    64 1Timolol Maleate

    65 1Trientine Hydrochloride

    66 2Tulobuterol

    67 3Valsartan

    68 1Vibegron

    69 1Zonisamide

    70 15Blank

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    01

    Hydralazine Hydrochloride

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

    FNCE
    Not Confirmed
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    Hydralazine Hydrochloride

    Japan

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

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    FNCE
    Not Confirmed
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    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2023-09-20

    Pay. Date : 2023-09-15

    DMF Number : 2421

    Submission : 1975-03-14

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2018-170 - Rev 03

    Issue Date : 2024-10-22

    Type : Chemical

    Substance Number : 829

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 219MF10233

    Registrant's Address : 2-27-1 Shinkawa, Chuo-ku, Tokyo

    Initial Date of Registration : 2007-07-06

    Latest Date of Registration :

    EU-WC NDC arrow-down
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    NDC Package Code : 68259-1313

    Start Marketing Date : 2014-02-27

    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

    Disopyramide

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

    FNCE
    Not Confirmed
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    Disopyramide

    Japan

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

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    FNCE
    Not Confirmed
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 4687

    Submission : 1982-10-14

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 226MF10133

    Registrant's Address : 2-27-1 Shinkawa, Chuo-ku, Tokyo

    Initial Date of Registration : 2014-07-02

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 68259-1304

    Start Marketing Date : 2009-06-18

    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

    Bicalutamide

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

    FNCE
    Not Confirmed
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    Bicalutamide

    Japan

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

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    FNCE
    Not Confirmed
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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 19311

    Submission : 2006-03-31

    Status : Inactive

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 222MF10219

    Registrant's Address : 2-7-1 Nihonbashi, Chuo-ku, Tokyo

    Initial Date of Registration : 2010-08-10

    Latest Date of Registration :

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    04

    Mirtazapine

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

    FNCE
    Not Confirmed
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    Mirtazapine

    Japan

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

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    FNCE
    Not Confirmed
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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 15300

    Submission : 2001-02-22

    Status : Inactive

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 229MF10107

    Registrant's Address : 2-27-1 Shinkawa, Chuo-ku, Tokyo

    Initial Date of Registration : 2017-06-21

    Latest Date of Registration :

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    05

    Oteracil Potassium

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

    FNCE
    Not Confirmed
    arrow

    Oteracil Potassium

    Japan

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

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    FNCE
    Not Confirmed
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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 13908

    Submission : 1998-12-22

    Status : Inactive

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 219MF10375

    Registrant's Address : 2-7-1 Nihonbashi, Chuo-ku, Tokyo

    Initial Date of Registration : 2007-12-19

    Latest Date of Registration :

    EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Jeil Pharmaceutical Co., Ltd.

    Registration Date : 2003-07-22

    Registration Number : 21-2-ND

    Manufacturer Name : Sumitomo Chemicals Co., Ltd. Gifu Plant, Oita Works

    Manufacturer Address : 3750, Aza Juhachicho, Maki, Anpachicho, Anpachigun, Gifu Prefecture, 503-0125, Japan (27-1, Shinkawa 2-chome, Chuo-ku, Tokyo 104-8260, Japan)

     VMF Others AUDIT
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    06

    Paroxetine Hydrochloride

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

    FNCE
    Not Confirmed
    arrow

    Paroxetine Hydrochloride

    Japan

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

    arrow
    FNCE
    Not Confirmed
    • fda
    • EDQM
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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 13888

    Submission : 1998-12-07

    Status : Inactive

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 222MF10199

    Registrant's Address : 2-27-1 Shinkawa, Chuo-ku, Tokyo

    Initial Date of Registration : 2010-07-14

    Latest Date of Registration :

    EU-WC NDC KDMF VMF Others AUDIT
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    07

    Phenothrin

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

    FNCE
    Not Confirmed
    arrow

    Phenothrin

    Japan

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

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    FNCE
    Not Confirmed
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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 5631

    Submission : 1984-11-30

    Status : Inactive

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 225MF10106

    Registrant's Address : 2-7-1 Nihonbashi, Chuo-ku, Tokyo

    Initial Date of Registration : 2013-05-20

    Latest Date of Registration :

    EU-WC NDC KDMF VMF Others AUDIT
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    08

    4-Biphenylacetic Acid

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

    FNCE
    Not Confirmed
    arrow

    4-Biphenylacetic Acid

    Japan

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

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    FNCE
    Not Confirmed
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    Registration Number : 220MF10189

    Registrant's Address : 2-7-1 Nihonbashi, Chuo-ku, Tokyo

    Initial Date of Registration : 2008-08-18

    Latest Date of Registration :

    EU-WC NDC KDMF VMF Others AUDIT
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    09

    Bezafibrate

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

    FNCE
    Not Confirmed
    arrow

    Bezafibrate

    Japan

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

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    FNCE
    Not Confirmed
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    Registration Number : 223MF10164

    Registrant's Address : 2-7-1 Nihonbashi, Chuo-ku, Tokyo

    Initial Date of Registration : 2011-11-28

    Latest Date of Registration :

    EU-WC NDC KDMF VMF Others AUDIT
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    10

    Bezafibrate

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

    FNCE
    Not Confirmed
    arrow

    Bezafibrate

    Japan

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

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    FNCE
    Not Confirmed
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    Registration Number : 222MF10051

    Registrant's Address : 2-27-1 Shinkawa, Chuo-ku, Tokyo

    Initial Date of Registration : 2010-02-12

    Latest Date of Registration :

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