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    Solus BioTech

    South Korea

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

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    Solus BioTech

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    DDL Conference
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 37029

    Submission : 2022-05-04

    Status : Active

    Type : IV

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

    South Korea

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

    DDL Conference
    Not Confirmed
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    Doosan Corporation

    South Korea

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

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    DDL Conference
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 19653

    Submission : 2006-07-04

    Status : Active

    Type : IV

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

    Vav Life Science

    India

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

    DDL Conference
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    Vav Life Science

    India

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

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    DDL Conference
    Not Confirmed
    USDMF CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2024-03-21

    Valid Till : 2026-08-02

    Written Confirmation Number : WC-479

    Address of the Firm :

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    04

    Vav Life Science

    India

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

    DDL Conference
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    Vav Life Science

    India

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

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    DDL Conference
    Not Confirmed
    USDMF CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2024-03-21

    Valid Till : 2026-08-02

    Written Confirmation Number : WC-479

    Address of the Firm :

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    05

    Vav Life Science

    India

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

    DDL Conference
    Not Confirmed
    arrow

    Vav Life Science

    India

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

    arrow
    DDL Conference
    Not Confirmed
    USDMF CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2024-03-21

    Valid Till : 2026-08-02

    Written Confirmation Number : WC-479

    Address of the Firm :

    NDC KDMF VMF Others AUDIT arrow-down
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    06

    Vav Life Science

    India

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

    DDL Conference
    Not Confirmed
    arrow

    Vav Life Science

    India

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

    arrow
    DDL Conference
    Not Confirmed
    USDMF CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2024-03-21

    Valid Till : 2026-08-02

    Written Confirmation Number : WC-479

    Address of the Firm :

    NDC KDMF VMF Others AUDIT arrow-down
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    07

    Vav Life Science

    India

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

    DDL Conference
    Not Confirmed
    arrow

    Vav Life Science

    India

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

    arrow
    DDL Conference
    Not Confirmed
    USDMF CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2024-03-21

    Valid Till : 2026-08-02

    Written Confirmation Number : WC-479

    Address of the Firm :

    NDC KDMF VMF Others AUDIT arrow-down
    blank

    Portfolio PDF

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    08

    Vav Life Science

    India

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

    DDL Conference
    Not Confirmed
    arrow

    Vav Life Science

    India

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

    arrow
    DDL Conference
    Not Confirmed
    USDMF CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2024-03-21

    Valid Till : 2026-08-02

    Written Confirmation Number : WC-479

    Address of the Firm :

    NDC KDMF VMF Others AUDIT arrow-down
    blank

    Portfolio PDF

    Product Web Link

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    09

    Vav Life Science

    India

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

    DDL Conference
    Not Confirmed
    arrow

    Vav Life Science

    India

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

    arrow
    DDL Conference
    Not Confirmed
    USDMF CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2024-03-21

    Valid Till : 2026-02-08

    Written Confirmation Number : WC-0479

    Address of the Firm :

    NDC KDMF VMF Others AUDIT arrow-down
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    10

    Vav Life Science

    India

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

    DDL Conference
    Not Confirmed
    arrow

    Vav Life Science

    India

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

    arrow
    DDL Conference
    Not Confirmed
    USDMF CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2024-03-21

    Valid Till : 2026-02-08

    Written Confirmation Number : WC-0479

    Address of the Firm :

    NDC KDMF VMF Others AUDIT arrow-down
    blank

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

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    USDMF

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    01

    Doosan Biotech Business Div

    South Korea

    USDMF

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    DDL Conference
    Not Confirmed

    01

    Doosan Biotech Business Div

    South Korea
    arrow
    DDL Conference
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 19653

    Submission : 2006-07-04

    Status : Active

    Type : IV

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    02

    Croda Korea Ltd

    South Korea

    USDMF

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    DDL Conference
    Not Confirmed

    02

    Croda Korea Ltd

    South Korea
    arrow
    DDL Conference
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 37029

    Submission : 2022-05-04

    Status : Active

    Type : IV

    blank

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    FINISHED DOSAGE FORMULATIONS

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    FDA Listed Dossiers

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    01

    Dosage Form : AEROSOL, METERED

    LECITHIN
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    Saudi International Expo
    Not Confirmed

    Dosage Form : AEROSOL, METERED

    USA
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    Saudi International Expo
    Not Confirmed

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    LECITHIN

    Route : INHALATION

    CAS : 8002-43-5

    UNII : NA

    Potency Amount : 0.00025

    Potency Unit : %

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    02

    Dosage Form : INJECTION

    LECITHIN
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    Saudi International Expo
    Not Confirmed

    Dosage Form : INJECTION

    USA
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    Saudi International Expo
    Not Confirmed

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    LECITHIN

    Route : INTRAMUSCULAR

    CAS : 8002-43-5

    UNII : NA

    Potency Amount : 1.92

    Potency Unit : %

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    03

    Dosage Form : POWDER, FOR INJECTION SOLUTION

    LECITHIN
    arrow
    Saudi International Expo
    Not Confirmed

    Dosage Form : POWDER, FOR INJECTION SOLUTION

    USA
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    Saudi International Expo
    Not Confirmed

    • fda
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    LECITHIN

    Route : INTRAMUSCULAR

    CAS : 8002-43-5

    UNII : NA

    Potency Amount : 0

    Potency Unit : NA

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    04

    Dosage Form : BAR, CHEWABLE

    LECITHIN
    arrow
    Saudi International Expo
    Not Confirmed

    Dosage Form : BAR, CHEWABLE

    USA
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    Saudi International Expo
    Not Confirmed

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    LECITHIN

    Route : ORAL

    CAS : 8002-43-5

    UNII : NA

    Potency Amount : 0

    Potency Unit : NA

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    05

    Dosage Form : CAPSULE

    LECITHIN
    arrow
    Saudi International Expo
    Not Confirmed

    Dosage Form : CAPSULE

    USA
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    Saudi International Expo
    Not Confirmed

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    LECITHIN

    Route : ORAL

    CAS : 8002-43-5

    UNII : NA

    Potency Amount : 15

    Potency Unit : MG

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    06

    Dosage Form : CAPSULE, COATED, SOFT GELATIN

    LECITHIN
    arrow
    Saudi International Expo
    Not Confirmed

    Dosage Form : CAPSULE, COATED, SOFT GELATIN

    USA
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    Saudi International Expo
    Not Confirmed

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    LECITHIN

    Route : ORAL

    CAS : 8002-43-5

    UNII : NA

    Potency Amount : 1

    Potency Unit : MG

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    07

    Dosage Form : CAPSULE, SOFT GELATIN

    LECITHIN
    arrow
    Saudi International Expo
    Not Confirmed

    Dosage Form : CAPSULE, SOFT GELATIN

    USA
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    Saudi International Expo
    Not Confirmed

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    LECITHIN

    Route : ORAL

    CAS : 8002-43-5

    UNII : NA

    Potency Amount : 1.8

    Potency Unit : MG

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    08

    Dosage Form : CAPSULE, SOFT GELATIN LIQUID-F...

    LECITHIN
    arrow
    Saudi International Expo
    Not Confirmed

    Dosage Form : CAPSULE, SOFT GELATIN LIQUID-F...

    USA
    arrow
    Saudi International Expo
    Not Confirmed

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    LECITHIN

    Route : ORAL

    CAS : 8002-43-5

    UNII : NA

    Potency Amount : 325

    Potency Unit : MG

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    09

    Dosage Form : CAPSULE, SUSTAINED ACTION

    LECITHIN
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    Saudi International Expo
    Not Confirmed

    Dosage Form : CAPSULE, SUSTAINED ACTION

    USA
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    Saudi International Expo
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    LECITHIN

    Route : ORAL

    CAS : 8002-43-5

    UNII : NA

    Potency Amount : 0

    Potency Unit : NA

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    10

    Dosage Form : POWDER, FOR SUSPENSION

    LECITHIN
    arrow
    Saudi International Expo
    Not Confirmed

    Dosage Form : POWDER, FOR SUSPENSION

    USA
    arrow
    Saudi International Expo
    Not Confirmed

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    • EDQM
    • WHO-GMP
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    LECITHIN

    Route : ORAL

    CAS : 8002-43-5

    UNII : NA

    Potency Amount : 167

    Potency Unit : MG/5ML

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