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    FAMAR CDMO- From early development to commercial manufacturing.

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

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    AbbVie Contract Manufacturing partners globally to develop, scale, and manufacture pharmaceutical products successfully.

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

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    Quimica Sintetica

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    01 16-Aminopenicillanic Acid

    02 1Abiraterone Acetate

    03 1Acebutolol Hydrochloride

    04 2Acyclovir

    05 1Amoxicillin Trihydrate

    06 2Apremilast

    07 1Astemizole

    08 1Azithromycin

    09 1Beclomethasone Dipropionate

    10 1Benazepril Hydrochloride

    11 1Benznidazole

    12 1Besifloxacin Hydrochloride

    13 1Betamethasone

    14 1Betamethasone Acetate

    15 1Betamethasone Dipropionate

    16 1Betamethasone Sodium Phosphate

    17 1Betamethasone Valerate

    18 1Bumetanide

    19 1Buspirone

    20 1Butoconazole Nitrate

    21 1Candesartan Cilexetil

    22 1Captopril

    23 1Celecoxib

    24 1Chloramphenicol Palmitate

    25 2Chloramphenicol Succinate Acid

    26 1Cimetidine

    27 1Cinoxacin

    28 2Ciprofloxacin

    29 3Ciprofloxacin Hydrochloride

    30 1Dexamethasone

    31 1Difloxacin

    32 1Drospirenone

    33 1Droxidopa

    34 1Edaravone

    35 1Eltrombopag

    36 2Esomeprazole Magnesium

    37 1Etodolac

    38 2Famotidine

    39 1Flecainide

    40 1Fluconazole

    41 1Fluoxetine Hydrochloride

    42 1Fosfomycin Trometamol

    43 1Fosinopril

    44 2Guanfacine

    45 1Hydrocortisone Sodium Succinate

    46 2Indapamide

    47 1Irbesartan

    48 2Isradipine

    49 2Itraconazole

    50 3Ketoconazole

    51 5Ketorolac Trometamol

    52 1Ketotifen Fumarate

    53 2Lansoprazole

    54 2Levofloxacin

    55 2Levofloxacin Hemihydrate

    56 1Loperamide Hydrochloride

    57 2Loratadine

    58 1Losartan Potassium

    59 1Meclofenamic Acid

    60 1Mefenamic Acid

    61 1Meloxicam

    62 1Methylprednisolone

    63 1Miconazole Nitrate

    64 2Milnacipran HCl

    65 1Norfloxacin

    66 1Ofloxacin

    67 2Omeprazole

    68 1Pantoprazole Sodium

    69 1Posaconazole

    70 1Praziquantel

    71 1Prednisolone Sodium Phosphate

    72 1Progesterone

    73 3Rabeprazole Sodium

    74 2Ranitidine Hydrochloride

    75 2Rivaroxaban

    76 1Sarafloxacin

    77 1Sitagliptin Phosphate

    78 1Spinosyn D

    79 2Sumatriptan

    80 1Tamsulosin

    81 1Terbinafine Hydrochloride

    82 1Terconazole

    83 1Terfenadine

    84 1Tianeptine Sodium

    85 1Triamcinolone Acetonide

    86 1Tulathromycin

    87 2Valsartan

    88 2Venlafaxine Hydrochloride

    89 1Zolpidem Tartrate

    90 1Zopiclone

    91 3Blank

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    01

    Omeprazole

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

    PEGS Boston Summit
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    Omeprazole

    Spain

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

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    PEGS Boston Summit
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    USDMF arrow-down Click Us! arrow-down
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-04-18

    Pay. Date : 2014-04-15

    DMF Number : 12605

    Submission : 1997-07-23

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 1999-093 - Rev 08

    Issue Date : 2019-02-04

    Type : Chemical

    Substance Number : 942

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 218MF10191

    Registrant's Address : Calle Dulcinea, s/n 28805 Alcala De Henares Madrid Spain

    Initial Date of Registration : 2006-02-08

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 53069-0260

    Start Marketing Date : 1997-07-23

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT arrow-down
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    02

    Lansoprazole

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

    PEGS Boston Summit
    Not Confirmed
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    Lansoprazole

    Spain

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

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    PEGS Boston Summit
    Not Confirmed
    • fda
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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 17329

    Submission : 2004-04-27

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2010-361 - Rev 02

    Issue Date : 2020-06-24

    Type : Chemical

    Substance Number : 2219

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 220MF10029

    Registrant's Address : Calle Dulcinea, s/n 28805 Alcala De Henares Madrid Spain

    Initial Date of Registration : 2008-01-23

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 53069-0850

    Start Marketing Date : 2004-04-27

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Taejun Pharmaceutical Co., Ltd.

    Registration Date : 2020-12-17

    Registration Number : 20201217-3-B-438-21

    Manufacturer Name : Quimica Sintetica SA

    Manufacturer Address : C/ Dulcinea s/n, Alcala de Henares, 28805 Madrid, Spain

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    03

    Acyclovir

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

    PEGS Boston Summit
    Not Confirmed
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    Acyclovir

    Spain

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

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    PEGS Boston Summit
    Not Confirmed
    • fda
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-02-07

    Pay. Date : 2014-01-29

    DMF Number : 8584

    Submission : 1990-05-25

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 1998-126 - Rev 03

    Issue Date : 2017-04-27

    Type : Chemical

    Substance Number : 968

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 53069-0120

    Start Marketing Date : 1998-01-01

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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    04

    Ciprofloxacin

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

    PEGS Boston Summit
    Not Confirmed
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    Ciprofloxacin

    Spain

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

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    PEGS Boston Summit
    Not Confirmed
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 15913

    Submission : 2002-03-20

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2021-219 - Rev 03

    Issue Date : 2024-10-30

    Type : Chemical

    Substance Number : 1089

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 53069-0680

    Start Marketing Date : 2002-03-20

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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    05

    Famotidine

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

    PEGS Boston Summit
    Not Confirmed
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    Famotidine

    Spain

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

    arrow
    PEGS Boston Summit
    Not Confirmed
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    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2022-03-07

    Pay. Date : 2022-03-02

    DMF Number : 13036

    Submission : 1998-06-17

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 218MF10922

    Registrant's Address : Calle Dulcinea, s/n 28805 Alcala De Henares Madrid Spain

    Initial Date of Registration : 2006-11-21

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 53069-0570

    Start Marketing Date : 1998-01-01

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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    06

    Fluconazole

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Fluconazole

    Spain

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

    arrow
    PEGS Boston Summit
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2021-03-29

    Pay. Date : 2021-03-24

    DMF Number : 8975

    Submission : 1991-02-01

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 306MF10038

    Registrant's Address : Calle Dulcinea, s/n 28805 Alcala De Henares Madrid Spain

    Initial Date of Registration : 2024-03-06

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 53069-0380

    Start Marketing Date : 1999-01-01

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Sandoz Korea Co., Ltd.

    Registration Date : 2005-09-15

    Registration Number : 20050915-74-A-170-12

    Manufacturer Name : Quimica Sintecica SA

    Manufacturer Address : C/Dulcinea s/n 28805 Alcala de Henares Madridm spain

     VMF Others AUDIT arrow-down
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    07

    Guanfacine

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Guanfacine

    Spain

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

    arrow
    PEGS Boston Summit
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-08-01

    Pay. Date : 2014-07-29

    DMF Number : 8661

    Submission : 1990-07-12

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 227MF10293

    Registrant's Address : Calle Dulcinea, s/n 28805 Alcala De Henares Madrid Spain

    Initial Date of Registration : 2015-12-24

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 53069-1150

    Start Marketing Date : 2024-09-24

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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    08

    Indapamide

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Indapamide

    Spain

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

    arrow
    PEGS Boston Summit
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 9064

    Submission : 1991-03-25

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2021-159 - Rev 01

    Issue Date : 2024-11-28

    Type : Chemical

    Substance Number : 1108

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 53069-0710

    Start Marketing Date : 1999-01-01

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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    09

    Itraconazole

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

    PEGS Boston Summit
    Not Confirmed
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    Itraconazole

    Spain

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

    arrow
    PEGS Boston Summit
    Not Confirmed
    • fda
    • EDQM
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-10-31

    Pay. Date : 2013-10-07

    DMF Number : 13012

    Submission : 1998-05-28

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2016-006 - Rev 00

    Issue Date : 2021-04-16

    Type : Chemical

    Substance Number : 1335

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 53069-0450

    Start Marketing Date : 2000-01-01

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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    10

    Lansoprazole

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

    PEGS Boston Summit
    Not Confirmed
    arrow

    Lansoprazole

    Spain

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

    arrow
    PEGS Boston Summit
    Not Confirmed
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    USDMF CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2015-123 - Rev 02

    Issue Date : 2024-05-29

    Type : Chemical

    Substance Number : 2219

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 230MF10154

    Registrant's Address : Calle Dulcinea, s/n 28805 Alcala De Henares Madrid Spain

    Initial Date of Registration : 2018-11-14

    Latest Date of Registration :

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    Contact Quimica Sintetica and get a quotation

    Quimica Sintetica is a supplier offers 113 products (APIs, Excipients or Intermediates).

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