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    Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.

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    Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.

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    IKF/Pharmasynthese have been with fine chemicals market and APIs performance for more than 40 years.

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    Cosma S.p.A., part of CFM Group with AMSA & Clarochem, provides global pharma & veterinary health with 300+ tons of FDA-approved APIs.

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    01 3Alverine

    02 1Aminolevulinic Acid HCl

    03 1Benzimidazole

    04 1Candesartan Cilexetil

    05 1Carglumic Acid

    06 1Carprofen

    07 1Chloropyramine

    08 1Chlorzoxazone

    09 1Clofazimine

    10 1Clofedanol

    11 1Delta-Aminolevulinic Acid Methyl Ester

    12 1Dimiracetam

    13 1Disopyramide

    14 2Divalproex Sodium

    15 1Efinaconazole

    16 1Embutramide

    17 1Ethacridine Lactate

    18 2Fampridine

    19 2Felbamate

    20 1Gabapentin

    21 2Guanfacine

    22 2Iloperidone

    23 1Isopropamide Iodide

    24 2Istradefylline

    25 2Labetalol Hydrochloride

    26 1Landiolol Hydrochloride

    27 1Levosulpiride

    28 1Lofexidine

    29 1Lotamilast

    30 1Lotilaner

    31 2Lurasidone Hydrochloride

    32 2Maropitant

    33 2Memantine Hydrochloride

    34 1Midostaurin

    35 1Minodronic Acid

    36 1N-Methyl Amisulpride

    37 2Nafronyl Oxalate

    38 2Naftopidil

    39 1Nalfurafine

    40 1Nimesulide

    41 2Orphenadrine

    42 1Orphenadrine Hydrochloride

    43 1Phenelzine Sulfate

    44 1Phenyltoloxamine Citrate

    45 2Pirfenidone

    46 1Pivagabine

    47 1Prenylamine Lactate

    48 1Proglumide

    49 2Propafenone Hydrochloride

    50 1Pyridostigmine

    51 1Ranolazine

    52 1Rimegepant Sulfate

    53 1Sivelestat Sodium Hydrate

    54 1Terfenadine

    55 1Thiaproline-M-Amino Benzoic Acid Hydrochloride

    56 1Tipiracil Hydrochloride

    57 2Trospium Chloride

    58 1Zonisamide

    59 3Blank

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    01

    Clofedanol

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

    SCOPE Summit
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    Clofedanol

    Italy

    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 : 22902

    Submission : 2009-06-25

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
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    Registration Number : 217MF11129

    Registrant's Address : Via Matteotti 249,28062 CAMERI (NOVARA)/ITALY　

    Initial Date of Registration : 2005-12-05

    Latest Date of Registration :

    EU-WC NDC arrow-down
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    NDC Package Code : 46016-5112

    Start Marketing Date : 2006-02-01

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (50kg/50kg)

    Marketing Category : BULK INGREDIENT

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    02

    Efinaconazole

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

    SCOPE Summit
    Not Confirmed
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    Efinaconazole

    Italy

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

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    SCOPE Summit
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2018-03-28

    Pay. Date : 2017-12-15

    DMF Number : 31933

    Submission : 2017-11-15

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
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    Registration Number : 305MF10015

    Registrant's Address : Via Matteotti 249,28062 CAMERI (NOVARA)/ITALY

    Initial Date of Registration : 2023-02-02

    Latest Date of Registration :

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    NDC Package Code : 46016-1642

    Start Marketing Date : 2017-03-06

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (50kg/50kg)

    Marketing Category : BULK INGREDIENT

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    Registrant Name : Sungjin Exim Co., Ltd.

    Registration Date : 2021-02-05

    Registration Number : Su133-12-ND

    Manufacturer Name : Procos SpA

    Manufacturer Address : Via Matteotti 249-28062 Cameri (NO) Italy

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    03

    Labetalol Hydrochloride

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

    SCOPE Summit
    Not Confirmed
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    Labetalol Hydrochloride

    Italy

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

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    SCOPE Summit
    Not Confirmed
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-06-24

    Pay. Date : 2013-06-18

    DMF Number : 10918

    Submission : 1994-06-08

    Status : Active

    Type : II

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    Registration Number : 224MF10101

    Registrant's Address : Via Matteotti 249,28062 CAMERI (NOVARA)/ITALY

    Initial Date of Registration : 2012-05-25

    Latest Date of Registration :

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    NDC Package Code : 46016-0117

    Start Marketing Date : 1994-06-08

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (50kg/50kg)

    Marketing Category : BULK INGREDIENT

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    04

    Memantine Hydrochloride

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

    SCOPE Summit
    Not Confirmed
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    Memantine Hydrochloride

    Italy

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

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    SCOPE Summit
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2016-06-03

    Pay. Date : 2016-01-21

    DMF Number : 26269

    Submission : 2012-07-30

    Status : Active

    Type : II

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    Registration Number : 229MF10004

    Registrant's Address : Via Matteotti 249,28062 CAMERI (NOVARA)/ITALY

    Initial Date of Registration : 2017-01-10

    Latest Date of Registration :

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    NDC Package Code : 46016-4111

    Start Marketing Date : 2012-07-13

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (50kg/50kg)

    Marketing Category : BULK INGREDIENT

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    Registrant Name : Sungjin Exim Co., Ltd.

    Registration Date : 2021-10-05

    Registration Number : 20211005-209-J-1116

    Manufacturer Name : Procos SpA

    Manufacturer Address : Via Matteotti, 249 - 28062 Cameri (NO), Italy

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    05

    Pirfenidone

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

    SCOPE Summit
    Not Confirmed
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    Pirfenidone

    Italy

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

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    SCOPE Summit
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 31815

    Submission : 2017-07-31

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : R0-CEP 2020-073 - Rev 00

    Issue Date : 2021-10-28

    Type : Chemical

    Substance Number : 2856

    Status : Valid

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    NDC Package Code : 46016-5312

    Start Marketing Date : 2020-02-06

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (50kg/50kg)

    Marketing Category : BULK INGREDIENT

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    06

    Propafenone Hydrochloride

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

    SCOPE Summit
    Not Confirmed
    arrow

    Propafenone Hydrochloride

    Italy

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

    arrow
    SCOPE Summit
    Not Confirmed
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    USDMF arrow-down
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-06-24

    Pay. Date : 2013-06-18

    DMF Number : 11426

    Submission : 1995-04-03

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 217MF11295

    Registrant's Address : Via Matteotti 249,28062 CAMERI (NOVARA)/ITALY

    Initial Date of Registration : 2005-12-22

    Latest Date of Registration :

    EU-WC NDC arrow-down
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    NDC Package Code : 46016-0320

    Start Marketing Date : 2006-07-01

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (50kg/50kg)

    Marketing Category : BULK INGREDIENT

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    07

    Pyridostigmine

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

    SCOPE Summit
    Not Confirmed
    arrow

    Pyridostigmine

    Italy

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

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    SCOPE Summit
    Not Confirmed
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-03-07

    Pay. Date : 2013-02-19

    DMF Number : 16035

    Submission : 2002-06-26

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2009-211 - Rev 01

    Issue Date : 2023-11-17

    Type : Chemical

    Substance Number : 1255

    Status : Valid

     JDMF EU-WC NDC arrow-down
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    NDC Package Code : 46016-1012

    Start Marketing Date : 2012-11-12

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (50kg/50kg)

    Marketing Category : BULK INGREDIENT

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    Registrant Name : Sungjin Exim Co., Ltd.

    Registration Date : 2021-05-12

    Registration Number : 20210512-211-J-632

    Manufacturer Name : Procos SPA

    Manufacturer Address : Viamatteotti 249, Cameri(Novara)28062 Italy

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    08

    Candesartan Cilexetil

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

    SCOPE Summit
    Not Confirmed
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    Candesartan Cilexetil

    Italy

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

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    SCOPE Summit
    Not Confirmed
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    Registration Number : 227MF10007

    Registrant's Address : Via Matteotti 249,28062 CAMERI (NOVARA)/ITALY

    Initial Date of Registration : 2015-01-05

    Latest Date of Registration :

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    Registrant Name : DKSH Korea Co., Ltd.

    Registration Date : 2021-03-12

    Registration Number : 20210312-209-J-874

    Manufacturer Name : Procos SpA@Dipharma Francis Srl

    Manufacturer Address : Via Matteotti 249, Cameri, Novara 28062, Italy@33036, Via XXIV Maggio, 40, Mereto di Tomba (MI), Italy

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    09

    Carglumic Acid

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

    SCOPE Summit
    Not Confirmed
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    Carglumic Acid

    Italy

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

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    SCOPE Summit
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2024-01-03

    Pay. Date : 2023-09-27

    DMF Number : 38477

    Submission : 2023-07-12

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC arrow-down
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    NDC Package Code : 46016-1180

    Start Marketing Date : 2019-05-13

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (50kg/50kg)

    Marketing Category : BULK INGREDIENT

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    10

    Embutramide

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

    SCOPE Summit
    Not Confirmed
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    Embutramide

    Italy

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

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    SCOPE Summit
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 11004

    Submission : 1994-07-21

    Status : Active

    Type : II

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    • Product listings are provided for informational purposes only. We do not supply or sell any products. Any products that may be covered by patent(s) are supplied solely for uses permitted under Section 107A of the Indian Patents Act and not for commercial sale.