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    01 1Aluminium Monostearate

    02 1Calcium Carbonate Excipient

    03 1Calcium Hydroxide

    04 1Calcium Stearate

    05 1Calcium Stearate API

    06 1Calsil

    07 1Dextrose

    08 1Kaolin Excipient

    09 1Magnesium Hydroxide Excipient

    10 1Magnesium Stearate

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    01

    Calcium Carbonate Excipient

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

    STLE Annual Meeting
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    Calcium Carbonate Excipient

    India

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

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    STLE Annual Meeting
    Not Confirmed
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 37646

    Submission : 2022-11-05

    Status : Active

    Type : IV

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    02

    Calcium Stearate

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

    STLE Annual Meeting
    Not Confirmed
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    Calcium Stearate

    India

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

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    STLE Annual Meeting
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 35106

    Submission : 2020-08-26

    Status : Active

    Type : IV

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

    Calcium Stearate API

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

    STLE Annual Meeting
    Not Confirmed
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    Calcium Stearate API

    India

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

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    STLE Annual Meeting
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 35102

    Submission : 2020-08-26

    Status : Active

    Type : IV

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

    Calsil

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

    STLE Annual Meeting
    Not Confirmed
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    Calsil

    India

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

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    STLE Annual Meeting
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 35100

    Submission : 2020-08-26

    Status : Active

    Type : IV

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

    Kaolin Excipient

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

    STLE Annual Meeting
    Not Confirmed
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    Kaolin Excipient

    India

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

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    STLE Annual Meeting
    Not Confirmed
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 35101

    Submission : 2020-08-26

    Status : Active

    Type : IV

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

    Magnesium Stearate

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

    STLE Annual Meeting
    Not Confirmed
    arrow

    Magnesium Stearate

    India

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

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    STLE Annual Meeting
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 29612

    Submission : 2015-06-25

    Status : Active

    Type : IV

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

    Stearic Acid

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

    STLE Annual Meeting
    Not Confirmed
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    Stearic Acid

    India

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

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    STLE Annual Meeting
    Not Confirmed
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    • EDQM
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 37656

    Submission : 2022-11-05

    Status : Active

    Type : IV

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

    Talc

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

    STLE Annual Meeting
    Not Confirmed
    arrow

    Talc

    India

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

    arrow
    STLE Annual Meeting
    Not Confirmed
    • fda
    • EDQM
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 35103

    Submission : 2020-08-26

    Status : Active

    Type : IV

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

    Zinc Oxide Excipient

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

    STLE Annual Meeting
    Not Confirmed
    arrow

    Zinc Oxide Excipient

    India

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

    arrow
    STLE Annual Meeting
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 35104

    Submission : 2020-08-26

    Status : Active

    Type : IV

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

    Zinc Stearate

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

    STLE Annual Meeting
    Not Confirmed
    arrow

    Zinc Stearate

    India

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

    arrow
    STLE Annual Meeting
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Flag India
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    Digital Content Digital Content
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 35105

    Submission : 2020-08-26

    Status : Active

    Type : IV

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

    Product
    Web Link

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    #PipelineProspector

    Market
    Place