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    01 1Atorvastatin

    02 1CAS 147118-36-3

    03 1CAS 461432-22-4

    04 1Empagliflozin

    05 1Gelatin

    06 1Imiquimod

    07 1Procaine

    08 1Xylazine Hydrochloride

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    01

    Atorvastatin

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

    American Thoracic Society
    Not Confirmed
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    Atorvastatin

    China

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

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    American Thoracic Society
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2017-158 - Rev 04

    Issue Date : 2023-11-17

    Type : Chemical

    Substance Number : 2191

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 229MF10192

    Registrant's Address : Chem&APIs Zone, Linhai, Zhejiang, China.

    Initial Date of Registration : 2017-11-01

    Latest Date of Registration :

    EU-WC NDC KDMF VMF Others AUDIT
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    02

    CAS 147118-36-3

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

    American Thoracic Society
    Not Confirmed
    arrow

    CAS 147118-36-3

    China

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

    arrow
    American Thoracic Society
    Not Confirmed
    • fda
    • EDQM
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    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 39218

    Submission : 2023-12-28

    Status : Active

    Type : II

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

    CAS 461432-22-4

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

    American Thoracic Society
    Not Confirmed
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    CAS 461432-22-4

    China

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

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    American Thoracic Society
    Not Confirmed
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 39284

    Submission : 2023-12-30

    Status : Active

    Type : II

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

    Empagliflozin

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

    STLE Annual Meeting
    Not Confirmed
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    Empagliflozin

    China

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

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    STLE Annual Meeting
    Not Confirmed
    • fda
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 38905

    Submission : 2023-09-27

    Status : Active

    Type : II

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

    L-1/ATV-1/(4R-cis)-1,1-DIMETHYLETHY...

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

    American Thoracic Society
    Not Confirmed
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    L-1/ATV-1/(4R-cis)-1,1-DIMETHYLETHY...

    China

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

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    American Thoracic Society
    Not Confirmed
    • fda
    • EDQM
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    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 38753

    Submission : 2023-08-29

    Status : Active

    Type : II

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

    Pulmonary surfactant

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

    American Thoracic Society
    Not Confirmed
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    Pulmonary surfactant

    Germany

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

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    American Thoracic Society
    Not Confirmed
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    ✖

    Certificate Number : R1-CEP 2009-110 - Rev 00

    Issue Date : 2016-01-22

    Type : TSE

    Substance Number :

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT
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    07

    Gelatin

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

    American Thoracic Society
    Not Confirmed
    arrow

    Gelatin

    Belgium

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

    arrow
    American Thoracic Society
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF CEP/COS Inactive-api
    ✖

    Certificate Number : R0-CEP 2000-386 - Rev 00

    Issue Date : 2002-01-25

    Type : Chemical and TSE

    Substance Number : 330

    Status : Withdrawn by Holder

     JDMF EU-WC NDC KDMF VMF Others AUDIT
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    08

    FOR NATURAL LATEX SHEETING-

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

    American Thoracic Society
    Not Confirmed
    arrow

    FOR NATURAL LATEX SHEETING-

    U.S.A

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

    arrow
    American Thoracic Society
    Not Confirmed
    • fda
    • EDQM
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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 4511

    Submission : 1982-04-20

    Status : Inactive

    Type : II

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

    Imiquimod

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

    American Thoracic Society
    Not Confirmed
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    Imiquimod

    Egypt

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

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    American Thoracic Society
    Not Confirmed
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    ✖

    Registrant Name : Dong-A ST Co., Ltd.

    Registration Date : 2023-02-15

    Registration Number : 20230215-209-J-1446

    Manufacturer Name : Orgapharm

    Manufacturer Address : Zone Industrielle, Rue du Moulin De La Canne, Pithiviers, 45300, France

     VMF Others AUDIT
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    10

    Procaine

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

    American Thoracic Society
    Not Confirmed
    arrow

    Procaine

    China

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

    arrow
    American Thoracic Society
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    VMF Number : 6069

    Submission : 2014-05-01

    Status : Active

    Type : II

     Others AUDIT
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