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    Looking for Sodium Stearyl Fumarate pharmaceutical excipients? Find information on Sodium Stearyl Fumarate's applications, manufacturers, suppliers, etc. on PharmaCompass.

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    INACTIVE PHARMA INGREDIENTS

    FINISHED DOSAGE FORMULATIONS

    EXCIPIENTS BY APPLICATIONS

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    REF. STANDARDS & IMPURITIES

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    01

    Gangwal Healthcare

    India

    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 : 37309

    Submission : 2022-07-12

    Status : Active

    Type : IV

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
    Gangwal Healthcare CB

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    02

    Standard Chem. & Pharm. Co., Ltd

    China

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

    CST
    Not Confirmed
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    Standard Chem. & Pharm. Co., Ltd

    China

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

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    CST
    Not Confirmed
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 18189

    Submission : 2005-03-14

    Status : Active

    Type : IV

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    03

    FMCCorporation - ICG

    U.S.A

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

    CST
    Not Confirmed
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    FMCCorporation - ICG

    U.S.A

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

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    CST
    Not Confirmed
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    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 25408

    Submission : 2011-10-13

    Status : Active

    Type : IV

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    04

    Maruti Chemicals

    India

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

    CST
    Not Confirmed
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    Maruti Chemicals

    India

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

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    CST
    Not Confirmed
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 33435

    Submission : 2018-12-24

    Status : Active

    Type : IV

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    05

    Prachin Chemical

    India

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

    CST
    Not Confirmed
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    Prachin Chemical

    India

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

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    CST
    Not Confirmed
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 39364

    Submission : 2024-01-12

    Status : Active

    Type : IV

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    06

    Alcedo Pharmachem

    India

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

    CST
    Not Confirmed
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    Alcedo Pharmachem

    India

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

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    CST
    Not Confirmed
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    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 36276

    Submission : 2021-10-04

    Status : Active

    Type : IV

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    07

    Jiangxi Alpha Hi-tech Pharmaceutic...

    China

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

    CST
    Not Confirmed
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    Jiangxi Alpha Hi-tech Pharmaceutic...

    China

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

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    CST
    Not Confirmed
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 38822

    Submission : 2023-11-27

    Status : Active

    Type : IV

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    08

    Rank Organics

    India

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

    CST
    Not Confirmed
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    Rank Organics

    India

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

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    CST
    Not Confirmed
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 32792

    Submission : 2018-04-16

    Status : Active

    Type : IV

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    09

    Fujian Freemind Pharm

    China

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

    CST
    Not Confirmed
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    Fujian Freemind Pharm

    China

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

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    CST
    Not Confirmed
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 36998

    Submission : 2023-03-28

    Status : Active

    Type : IV

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    10

    Anhui Sunhere Pharmaceutical Excip...

    China

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

    CST
    Not Confirmed
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    Anhui Sunhere Pharmaceutical Excip...

    China

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

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    CST
    Not Confirmed
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 36480

    Submission : 2021-12-29

    Status : Active

    Type : IV

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

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    Gangwal Healthcare Private Ltd

    India
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 37309

    Submission : 2022-07-12

    Status : Active

    Type : IV

    Gangwal Healthcare CB

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    02

    American Thoracic Society
    Not Confirmed

    02

    Alcedo Pharmachem Private Ltd

    India
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    American Thoracic Society
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 36276

    Submission : 2021-10-04

    Status : Active

    Type : IV

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    03

    American Thoracic Society
    Not Confirmed

    03

    Anhui Sunhere Pharmaceutical Excipie...

    China
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    American Thoracic Society
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 36480

    Submission : 2021-12-29

    Status : Active

    Type : IV

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    04

    Corden Pharma Chenove

    Germany

    USDMF

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    Not Confirmed

    04

    Corden Pharma Chenove

    Germany
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    American Thoracic Society
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 25991

    Submission : 2012-04-20

    Status : Active

    Type : IV

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    05

    American Thoracic Society
    Not Confirmed

    05

    International Flavors And Fragrances...

    U.S.A
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    American Thoracic Society
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 25408

    Submission : 2011-10-13

    Status : Active

    Type : IV

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    06

    American Thoracic Society
    Not Confirmed

    06

    Fujian Freemind Pharm Co Ltd

    China
    arrow
    American Thoracic Society
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 36998

    Submission : 2023-03-28

    Status : Active

    Type : IV

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    07

    Maruti Chemicals

    India

    USDMF

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    American Thoracic Society
    Not Confirmed

    07

    Maruti Chemicals

    India
    arrow
    American Thoracic Society
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 33435

    Submission : 2018-12-24

    Status : Active

    Type : IV

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    08

    American Thoracic Society
    Not Confirmed

    08

    Nitika Pharmaceutical Specialities P...

    India
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    American Thoracic Society
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 26686

    Submission : 2012-04-08

    Status : Active

    Type : IV

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    09

    American Thoracic Society
    Not Confirmed

    09

    Rank Organics Chemical Pvt Ltd

    India
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    American Thoracic Society
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 20643

    Submission : 2007-06-15

    Status : Inactive

    Type : IV

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    10

    American Thoracic Society
    Not Confirmed

    10

    Rank Organics Chemical Pvt Ltd

    India
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    American Thoracic Society
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 32792

    Submission : 2018-04-16

    Status : Active

    Type : IV

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    CEP/COS

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    JRS Pharma GmbH & Co. KG. Rosenberg...

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    Sodium stearyl fumarate

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    R1-CEP 2006-313 - Rev 01
    Valid
    Chemical
    2018-03-26
    1567
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    01

    JRS Pharma GmbH & Co. KG. Rosenberg...

    Germany
    American Thoracic Society
    Not Confirmed
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    JRS Pharma GmbH & Co. KG. Rosenberg...

    Germany
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    Sodium Stearyl Fumarate

    Certificate Number : R1-CEP 2006-313 - Rev 01

    Status : Valid

    Issue Date : 2018-03-26

    Type : Chemical

    Substance Number : 1567

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    RANK ORGANICS CHEMICAL PVT. LTD. Bo...

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      Sodium stearyl fumarate

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      CEP 2023-052 - Rev 00
      Valid
      Chemical
      2024-06-12
      1567
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      02

      RANK ORGANICS CHEMICAL PVT. LTD. Bo...

      India
      American Thoracic Society
      Not Confirmed
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      RANK ORGANICS CHEMICAL PVT. LTD. Bo...

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      Sodium Stearyl Fumarate

      Certificate Number : CEP 2023-052 - Rev 00

      Status : Valid

      Issue Date : 2024-06-12

      Type : Chemical

      Substance Number : 1567

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      SYN-TECH CHEM. & PHARM. CO., LTD. T...

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      Sodium stearyl fumarate

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      CEP 2011-269 - Rev 02
      Valid
      Chemical
      2023-10-23
      1567
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      SYN-TECH CHEM. & PHARM. CO., LTD. T...

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      SYN-TECH CHEM. & PHARM. CO., LTD. T...

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      American Thoracic Society
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      Sodium Stearyl Fumarate

      Certificate Number : CEP 2011-269 - Rev 02

      Status : Valid

      Issue Date : 2023-10-23

      Type : Chemical

      Substance Number : 1567

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      NDC API

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      Fagron Inc

      Netherlands
      STLE Annual Meeting
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      Fagron Inc

      Netherlands
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      SODIUM STEARYL FUMARATE

      NDC Package Code : 51552-1491

      Start Marketing Date : 2016-09-15

      End Marketing Date : 2025-08-31

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

      Marketing Category : BULK INGREDIENT FOR HUMAN P...

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      FINISHED DOSAGE FORMULATIONS

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      FDA Listed Dossiers

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      01

      Dosage Form : CAPSULE

      SODIUM STEARYL FUMARATE
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      Cophex
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      Dosage Form : CAPSULE

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      Cophex
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      SODIUM STEARYL FUMARATE

      Route : ORAL

      CAS : 4070808

      UNII : 7CV7WJK4UI

      Potency Amount : 15

      Potency Unit : MG

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      Dosage Form : CAPSULE, DELAYED ACTION

      SODIUM STEARYL FUMARATE
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      Cophex
      Not Confirmed

      Dosage Form : CAPSULE, DELAYED ACTION

      USA
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      Cophex
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      SODIUM STEARYL FUMARATE

      Route : ORAL

      CAS : 4070808

      UNII : 7CV7WJK4UI

      Potency Amount : 4.92

      Potency Unit : MG

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      03

      Dosage Form : CAPSULE, EXTENDED RELEASE

      SODIUM STEARYL FUMARATE
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      Cophex
      Not Confirmed

      Dosage Form : CAPSULE, EXTENDED RELEASE

      USA
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      Cophex
      Not Confirmed

      • fda
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      SODIUM STEARYL FUMARATE

      Route : ORAL

      CAS : 4070808

      UNII : 7CV7WJK4UI

      Potency Amount : 7

      Potency Unit : MG

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      04

      Dosage Form : CAPSULE, GELATIN COATED

      SODIUM STEARYL FUMARATE
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      Cophex
      Not Confirmed

      Dosage Form : CAPSULE, GELATIN COATED

      USA
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      Cophex
      Not Confirmed

      • fda
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      SODIUM STEARYL FUMARATE

      Route : ORAL

      CAS : 4070808

      UNII : 7CV7WJK4UI

      Potency Amount : 3

      Potency Unit : MG

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      05

      Dosage Form : CAPSULE, HARD GELATIN

      SODIUM STEARYL FUMARATE
      arrow
      Cophex
      Not Confirmed

      Dosage Form : CAPSULE, HARD GELATIN

      USA
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      Cophex
      Not Confirmed

      • fda
      • EDQM
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      SODIUM STEARYL FUMARATE

      Route : ORAL

      CAS : 4070808

      UNII : 7CV7WJK4UI

      Potency Amount : 2.7

      Potency Unit : MG

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      06

      Dosage Form : POWDER, FOR ORAL SUSPENSION

      SODIUM STEARYL FUMARATE
      arrow
      Cophex
      Not Confirmed

      Dosage Form : POWDER, FOR ORAL SUSPENSION

      USA
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      Cophex
      Not Confirmed

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      • EDQM
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      SODIUM STEARYL FUMARATE

      Route : ORAL

      CAS : 4070808

      UNII : 7CV7WJK4UI

      Potency Amount : 3.74

      Potency Unit : MG/5ML

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      07

      Dosage Form : TABLET

      SODIUM STEARYL FUMARATE
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      Cophex
      Not Confirmed

      Dosage Form : TABLET

      USA
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      Cophex
      Not Confirmed

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      SODIUM STEARYL FUMARATE

      Route : ORAL

      CAS : 4070808

      UNII : 7CV7WJK4UI

      Potency Amount : 29.3

      Potency Unit : MG

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      08

      Dosage Form : TABLET (IMMED./COMP. RELEASE),...

      SODIUM STEARYL FUMARATE
      arrow
      Cophex
      Not Confirmed

      Dosage Form : TABLET (IMMED./COMP. RELEASE),...

      USA
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      Cophex
      Not Confirmed

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      • EDQM
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      SODIUM STEARYL FUMARATE

      Route : ORAL

      CAS : 4070808

      UNII : 7CV7WJK4UI

      Potency Amount : 12

      Potency Unit : MG

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      09

      Dosage Form : TABLET (IMMED./COMP. RELEASE),...

      SODIUM STEARYL FUMARATE
      arrow
      Cophex
      Not Confirmed

      Dosage Form : TABLET (IMMED./COMP. RELEASE),...

      USA
      arrow
      Cophex
      Not Confirmed

      • fda
      • EDQM
      • WHO-GMP
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      SODIUM STEARYL FUMARATE

      Route : ORAL

      CAS : 4070808

      UNII : 7CV7WJK4UI

      Potency Amount : 6.3

      Potency Unit : MG

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      10

      Dosage Form : TABLET, COATED

      SODIUM STEARYL FUMARATE
      arrow
      Cophex
      Not Confirmed

      Dosage Form : TABLET, COATED

      USA
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      Cophex
      Not Confirmed

      • fda
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      SODIUM STEARYL FUMARATE

      Route : ORAL

      CAS : 4070808

      UNII : 7CV7WJK4UI

      Potency Amount : 1.18

      Potency Unit : MG

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