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

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    01

    Lactose

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

    STLE Annual Meeting
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    Lactose

    Germany

    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 : 14052

    Submission : 1999-03-18

    Status : Active

    Type : IV

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

    Lactose

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

    STLE Annual Meeting
    Not Confirmed
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    Lactose

    Germany

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

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    STLE Annual Meeting
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    • EDQM
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 15483

    Submission : 2001-06-12

    Status : Active

    Type : IV

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    03

    Lactose

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

    STLE Annual Meeting
    Not Confirmed
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    Lactose

    Germany

    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

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    DMF Number : 24839

    Submission : 2011-04-08

    Status : Active

    Type : IV

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    04

    Lactose

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

    STLE Annual Meeting
    Not Confirmed
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    Lactose

    Germany

    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 : 30290

    Submission : 2016-02-11

    Status : Active

    Type : IV

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    05

    Lactose

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

    STLE Annual Meeting
    Not Confirmed
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    Lactose

    Germany

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

    arrow
    STLE Annual Meeting
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    • fda
    • EDQM
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 30436

    Submission : 2016-03-17

    Status : Active

    Type : IV

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

    Lactose

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

    STLE Annual Meeting
    Not Confirmed
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    Lactose

    Germany

    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 : 32723

    Submission : 2018-09-17

    Status : Active

    Type : IV

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

    Lactose

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

    STLE Annual Meeting
    Not Confirmed
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    Lactose

    Germany

    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 : 34567

    Submission : 2020-09-01

    Status : Active

    Type : IV

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

    Lactose Monohydrate

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

    STLE Annual Meeting
    Not Confirmed
    arrow

    Lactose Monohydrate

    Germany

    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 : 20568

    Submission : 2007-05-10

    Status : Active

    Type : IV

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

    Lactose Monohydrate

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

    STLE Annual Meeting
    Not Confirmed
    arrow

    Lactose Monohydrate

    Germany

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

    arrow
    STLE Annual Meeting
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 28498

    Submission : 2014-05-23

    Status : Active

    Type : IV

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