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    Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

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    SPI Pharma has been solving formulation challenges using superior functional materials.

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    Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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    01 1Abiraterone Acetate

    02 1Alfentanil Hydrochloride

    03 1Altanserin

    04 2Apalutamide

    05 1Astemizole

    06 1Azaperone

    07 1Benperidol

    08 1Bromperidol

    09 1Bromperidol Decanoate

    10 2Buprenorphine

    11 2Buprenorphine Hydrochloride

    12 2Canagliflozin

    13 2Carfentanil

    14 1Carisbamate

    15 1Carnidazole

    16 1Ceftobiprole Medocaril

    17 1Cinnarizine

    18 1Cisapride

    19 2Cisapride Monohydrate

    20 2Clazuril

    21 1Dapoxetine Hydrochloride

    22 1Darunavir

    23 1Darunavir Ethanolate

    24 2Domperidone

    25 2Domperidone Maleate

    26 1Draflazine

    27 1Droperidol

    28 2Econazole Nitrate

    29 1Esketamine Hydrochloride

    30 1Etomidate

    31 1Etravirine

    32 1Fentanyl

    33 1Fentanyl Citrate

    34 1Flubendazole

    35 1Flunarizine

    36 2Galantamine Hydrobromide

    37 2Haloperidol

    38 1Haloperidol Decanoate

    39 1Hydromorphone Hydrochloride

    40 1Isoconazole

    41 1Isoconazole Nitrate

    42 3Itraconazole

    43 2Ketoconazole

    44 3Levamisole

    45 1Levocabastine

    46 3Loperamide Hydrochloride

    47 1Lorcainide

    48 1Loviride

    49 1Lubeluzole

    50 2Mebendazole

    51 2Methylphenidate Hydrochloride

    52 2Miconazole

    53 2Miconazole Nitrate

    54 1Nebivolol

    55 2Oxatomide

    56 1Paliperidone

    57 2Paliperidone Palmitate

    58 1Pimozide

    59 2Prucalopride Succinate

    60 1Ridogrel

    61 2Rilpivirine

    62 2Rilpivirine Hydrochloride

    63 3Risperidone

    64 1Ritanserin

    65 1Rivaroxaban

    66 1Simeprevir

    67 1Sufentanil Citrate

    68 2Tapentadol

    69 1Telaprevir

    70 1Terconazole

    71 1Tipifarnib

    72 1Topiramate

    73 1Trabectedin

    74 1Vorozole

    75 8Blank

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    01

    Domperidone

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

    German Wound Congress
    Not Confirmed
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    Domperidone

    U.S.A

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

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    German Wound Congress
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 5402

    Submission : 1984-05-17

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 1996-069 - Rev 10

    Issue Date : 2019-10-22

    Type : Chemical

    Substance Number : 1009

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 218MF10687

    Registrant's Address : Turnhoutseweg 30 B-2340 Beerse Belgium

    Initial Date of Registration : 2006-08-11

    Latest Date of Registration :

    EU-WC NDC KDMF VMF Others AUDIT
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    02

    Levocabastine

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

    German Wound Congress
    Not Confirmed
    arrow

    Levocabastine

    U.S.A

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

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    German Wound Congress
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 5847

    Submission : 1985-04-19

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2002-147 - Rev 03

    Issue Date : 2020-12-09

    Type : Chemical

    Substance Number : 1484

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 228MF10206

    Registrant's Address : Turnhoutseweg 30 B-2340 Beerse Belgium

    Initial Date of Registration : 2016-11-02

    Latest Date of Registration :

    EU-WC NDC KDMF VMF Others AUDIT
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    03

    Miconazole

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

    German Wound Congress
    Not Confirmed
    arrow

    Miconazole

    U.S.A

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

    arrow
    German Wound Congress
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 10912

    Submission : 1994-05-20

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R2-CEP 1995-007 - Rev 03

    Issue Date : 2014-11-14

    Type : Chemical

    Substance Number : 935

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 219MF10165

    Registrant's Address : Turnhoutseweg 30 B-2340 Beerse Belgium

    Initial Date of Registration : 2007-05-21

    Latest Date of Registration :

    EU-WC NDC KDMF VMF Others AUDIT
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    04

    Miconazole Nitrate

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

    German Wound Congress
    Not Confirmed
    arrow

    Miconazole Nitrate

    U.S.A

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

    arrow
    German Wound Congress
    Not Confirmed
    • fda
    • EDQM
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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 10913

    Submission : 1994-05-20

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R2-CEP 1995-008 - Rev 04

    Issue Date : 2023-03-01

    Type : Chemical

    Substance Number : 513

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 219MF10167

    Registrant's Address : Turnhoutseweg 30 B-2340 Beerse Belgium

    Initial Date of Registration : 2007-05-21

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 12578-488

    Start Marketing Date : 2012-04-30

    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

    Haloperidol

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

    German Wound Congress
    Not Confirmed
    arrow

    Haloperidol

    U.S.A

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

    arrow
    German Wound Congress
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 10946

    Submission : 1994-06-13

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 1998-076 - Rev 09

    Issue Date : 2014-06-05

    Type : Chemical

    Substance Number : 616

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 12578-617

    Start Marketing Date : 1989-02-08

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    06

    Haloperidol Decanoate

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

    German Wound Congress
    Not Confirmed
    arrow

    Haloperidol Decanoate

    U.S.A

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

    arrow
    German Wound Congress
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 10954

    Submission : 1994-06-23

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2002-187 - Rev 04

    Issue Date : 2014-06-12

    Type : Chemical

    Substance Number : 1431

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT
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    07

    Itraconazole

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

    German Wound Congress
    Not Confirmed
    arrow

    Itraconazole

    U.S.A

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

    arrow
    German Wound Congress
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 10725

    Submission : 1994-02-18

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 1999-092 - Rev 07

    Issue Date : 2017-02-07

    Type : Chemical

    Substance Number : 1335

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 12578-299

    Start Marketing Date : 1996-05-22

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Korea Janssen Co., Ltd.

    Registration Date : 2005-08-31

    Registration Number : 20050831-56-A-102-03

    Manufacturer Name : Janssen Pharmaceutica NV

    Manufacturer Address : Janssen Pharmaceutica NV Biotech Plant, Lammerdries 55, B-2250 Olen, Belgium

     VMF Others AUDIT
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    08

    Ketoconazole

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

    German Wound Congress
    Not Confirmed
    arrow

    Ketoconazole

    U.S.A

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

    arrow
    German Wound Congress
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 10037

    Submission : 1993-01-15

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R2-CEP 1995-009 - Rev 04

    Issue Date : 2021-03-08

    Type : Chemical

    Substance Number : 921

    Status : Valid

     JDMF EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Hyons Co., Ltd.

    Registration Date : 2012-08-14

    Registration Number : 20120814-167-I-49-02

    Manufacturer Name : Janssen Pharmaceutica NV

    Manufacturer Address : Janssen Pharmaceuticalaan 3, B-2440 Geel

     VMF Others AUDIT
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    09

    Methylphenidate Hydrochloride

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

    German Wound Congress
    Not Confirmed
    arrow

    Methylphenidate Hydrochloride

    U.S.A

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

    arrow
    German Wound Congress
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 30510

    Submission : 2016-05-25

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2009-219 - Rev 04

    Issue Date : 2024-12-23

    Type : Chemical

    Substance Number : 2235

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 65267-115

    Start Marketing Date : 2017-01-31

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Korea Janssen Co., Ltd.

    Registration Date : 2020-07-15

    Registration Number : 20200715-209-J-691

    Manufacturer Name : Janssen Pharmaceuticals, Inc

    Manufacturer Address : 1440 Olympic Drive, Athens, Georgia (GA) 30601, USA

     VMF Others AUDIT
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    10

    Rilpivirine Hydrochloride

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

    German Wound Congress
    Not Confirmed
    arrow

    Rilpivirine Hydrochloride

    U.S.A

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

    arrow
    German Wound Congress
    Not Confirmed
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-02-07

    Pay. Date : 2012-12-26

    DMF Number : 23824

    Submission : 2010-07-19

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 229MF10183

    Registrant's Address : Little Island Industrial Estate, Little Island, Co. Cork, Ireland

    Initial Date of Registration : 2017-10-06

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 65267-501

    Start Marketing Date : 2010-07-19

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Korea Janssen Co., Ltd.

    Registration Date : 2011-10-28

    Registration Number : Su217-14-ND

    Manufacturer Name : Janssen Pharmaceutical Sciences Unlimited Company

    Manufacturer Address : Little Island Industrial EST., Little Island, Co. Cork, Ireland_x000D_

     VMF Others AUDIT
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    Contact Johnson & Johnson Innovative Medicine and get a quotation

    Johnson & Johnson Innovative Medicine is a supplier offers 98 products (APIs, Excipients or Intermediates).

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