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    Looking for Lactose Monohydrate pharmaceutical excipients? Find information on Lactose Monohydrate's applications, manufacturers, suppliers, etc. on PharmaCompass.

    Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.

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    Global Pharma Healthcare: Setting the global benchmark in quality, innovation, and care

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    Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.

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    Phyton is a World Leader in Plant Cell Fermentation Technology and Commercial Manufacturing.

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    Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.

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    INACTIVE PHARMA INGREDIENTS

    FINISHED DOSAGE FORMULATIONS

    EXCIPIENTS BY APPLICATIONS

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    SUPPLIERS

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    01

    Gangwal Healthcare

    India

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

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    BIO Partnering at JPM
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 32957

    Submission : 2018-07-18

    Status : Active

    Type : IV

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

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    02

    International Ingredients & Excipi...

    India

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

    BIO Partnering at JPM
    Not Confirmed
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    International Ingredients & Excipi...

    India

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

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    BIO Partnering at JPM
    Not Confirmed
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 37688

    Submission : 2022-11-12

    Status : Active

    Type : IV

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

    Meggle

    Germany

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

    BIO Partnering at JPM
    Not Confirmed
    arrow

    Meggle

    Germany

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

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    BIO Partnering at JPM
    Not Confirmed
    USDMF arrow-down
    ✖

    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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    04

    Meggle

    Germany

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

    BIO Partnering at JPM
    Not Confirmed
    arrow

    Meggle

    Germany

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

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    BIO Partnering at JPM
    Not Confirmed
    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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    05

    Lactose India Limited

    India

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

    BIO Partnering at JPM
    Not Confirmed
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    Lactose India Limited

    India

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

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    BIO Partnering at JPM
    Not Confirmed
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 38990

    Submission : 2023-10-16

    Status : Active

    Type : IV

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

    Dawning Pharmaceuticals

    China

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

    BIO Partnering at JPM
    Not Confirmed
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    Dawning Pharmaceuticals

    China

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

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    BIO Partnering at JPM
    Not Confirmed
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 37267

    Submission : 2022-09-15

    Status : Active

    Type : IV

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

    Kerry

    U.S.A

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

    BIO Partnering at JPM
    Not Confirmed
    arrow

    Kerry

    U.S.A

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

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    BIO Partnering at JPM
    Not Confirmed
    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 21598

    Submission : 2008-05-07

    Status : Inactive

    Type : IV

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

    Kerry

    U.S.A

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

    BIO Partnering at JPM
    Not Confirmed
    arrow

    Kerry

    U.S.A

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

    arrow
    BIO Partnering at JPM
    Not Confirmed
    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 24141

    Submission : 2010-09-14

    Status : Inactive

    Type : IV

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

    Fagron Group

    Netherlands

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

    BIO Partnering at JPM
    Not Confirmed
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    Fagron Group

    Netherlands

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

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    BIO Partnering at JPM
    Not Confirmed
    USDMF CEP/COS JDMF EU-WC NDC arrow-down
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    NDC Package Code : 51552-0136

    Start Marketing Date : 1998-04-01

    End Marketing Date : 2026-02-12

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

    Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING

     KDMF VMF Others AUDIT
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    FINISHED DOSAGE FORMULATIONS

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    FDA Listed Dossiers

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    01

    Dosage Form : INJECTION

    LACTOSE MONOHYDRATE
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    Dosage Form : INJECTION

    USA
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    LACTOSE MONOHYDRATE

    Route : IM - IV

    CAS :

    UNII : EWQ57Q8I5X

    Potency Amount : 2.5

    Potency Unit : %

    blank

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    02

    Dosage Form : POWDER, FOR INJECTION SOLUTION

    LACTOSE MONOHYDRATE
    arrow
    Biotech Showcase
    Not Confirmed

    Dosage Form : POWDER, FOR INJECTION SOLUTION

    USA
    arrow
    Biotech Showcase
    Not Confirmed

    • fda
    • EDQM
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    LACTOSE MONOHYDRATE

    Route : IM - IV

    CAS :

    UNII : EWQ57Q8I5X

    Potency Amount : 2.5

    Potency Unit : %

    blank

    Portfolio PDF

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    03

    Dosage Form : POWDER, FOR INJECTION SOLUTION...

    LACTOSE MONOHYDRATE
    arrow
    Biotech Showcase
    Not Confirmed

    Dosage Form : POWDER, FOR INJECTION SOLUTION...

    USA
    arrow
    Biotech Showcase
    Not Confirmed

    • fda
    • EDQM
    • WHO-GMP
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    LACTOSE MONOHYDRATE

    Route : INTRAMUSCULAR

    CAS :

    UNII : EWQ57Q8I5X

    Potency Amount : 1.05

    Potency Unit : %

    blank

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    04

    Dosage Form : INJECTION

    LACTOSE MONOHYDRATE
    arrow
    Biotech Showcase
    Not Confirmed

    Dosage Form : INJECTION

    USA
    arrow
    Biotech Showcase
    Not Confirmed

    • fda
    • EDQM
    • WHO-GMP
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    LACTOSE MONOHYDRATE

    Route : INTRAVENOUS

    CAS :

    UNII : EWQ57Q8I5X

    Potency Amount : 25

    Potency Unit : %

    blank

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    05

    Dosage Form : POWDER, FOR INJECTION SOLUTION

    LACTOSE MONOHYDRATE
    arrow
    Biotech Showcase
    Not Confirmed

    Dosage Form : POWDER, FOR INJECTION SOLUTION

    USA
    arrow
    Biotech Showcase
    Not Confirmed

    • fda
    • EDQM
    • WHO-GMP
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    LACTOSE MONOHYDRATE

    Route : INTRAVENOUS

    CAS :

    UNII : EWQ57Q8I5X

    Potency Amount : 75

    Potency Unit : %

    blank

    Portfolio PDF

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    06

    Dosage Form : POWDER, FOR INJECTION SOLUTION

    LACTOSE MONOHYDRATE
    arrow
    Biotech Showcase
    Not Confirmed

    Dosage Form : POWDER, FOR INJECTION SOLUTION

    USA
    arrow
    Biotech Showcase
    Not Confirmed

    • fda
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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    LACTOSE MONOHYDRATE

    Route : IV(INFUSION)

    CAS :

    UNII : EWQ57Q8I5X

    Potency Amount : 20

    Potency Unit : %

    blank

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    07

    Dosage Form : CAPSULE

    LACTOSE MONOHYDRATE
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    Biotech Showcase
    Not Confirmed

    Dosage Form : CAPSULE

    USA
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    Biotech Showcase
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    LACTOSE MONOHYDRATE

    Route : ORAL

    CAS :

    UNII : EWQ57Q8I5X

    Potency Amount : 430.42

    Potency Unit : MG

    blank

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    08

    Dosage Form : CAPSULE, HARD GELATIN

    LACTOSE MONOHYDRATE
    arrow
    Biotech Showcase
    Not Confirmed

    Dosage Form : CAPSULE, HARD GELATIN

    USA
    arrow
    Biotech Showcase
    Not Confirmed

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    LACTOSE MONOHYDRATE

    Route : ORAL

    CAS :

    UNII : EWQ57Q8I5X

    Potency Amount : 141

    Potency Unit : MG

    blank

    Portfolio PDF

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    09

    Dosage Form : CAPSULE, SUSTAINED ACTION

    LACTOSE MONOHYDRATE
    arrow
    Biotech Showcase
    Not Confirmed

    Dosage Form : CAPSULE, SUSTAINED ACTION

    USA
    arrow
    Biotech Showcase
    Not Confirmed

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    LACTOSE MONOHYDRATE

    Route : ORAL

    CAS :

    UNII : EWQ57Q8I5X

    Potency Amount : 147.6

    Potency Unit : MG

    blank

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    10

    Dosage Form : GRANULE, FOR SUSPENSION

    LACTOSE MONOHYDRATE
    arrow
    Biotech Showcase
    Not Confirmed

    Dosage Form : GRANULE, FOR SUSPENSION

    USA
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    Biotech Showcase
    Not Confirmed

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    LACTOSE MONOHYDRATE

    Route : ORAL

    CAS :

    UNII : EWQ57Q8I5X

    Potency Amount : 0

    Potency Unit : NA

    blank

    Portfolio PDF

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    Corporate PDF

    Only 10 entries up to this point, click to access all click full view read-more
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    EXCIPIENTS BY APPLICATIONS

    Click here to find the perfect excipient manufacturers by their capabilities

    Fillers Diluents Binders

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    01

    Gangwal Healthcare

    India
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    Virtual BoothGangwal Healthcare is powered by innovation, driving health, wellness & healing.

    Dosage Form : Tablet

    Grade : Oral

    Category : Fillers, Diluents & Binders

    Brand Name : Starlose®

    Application : Fillers, Diluents & Binders

    Excipient Details : Starlose P40 (Starch & Lactose Monohydrate) is used as a diluent in oral dosage forms such as tablets.

    Pharmacopoeia Ref : DMF, EXCiPAT, KOSHER, HALAL, W...

    Technical Specs : NA

    Ingredient(s) : Lactose Monohydrate

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    Gangwal Healthcare Starlose®

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    Gangwal Healthcare

    India
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    Virtual BoothGangwal Healthcare is powered by innovation, driving health, wellness & healing.

    Dosage Form : Tablet

    Grade : Oral

    Category : Fillers, Diluents & Binders

    Brand Name : Microlose™

    Application : Fillers, Diluents & Binders

    Excipient Details : Microlose (Lactose Monohydrate & Microcrystalline Cellulose) is used as a diluent in oral dosage forms such as tablets.

    Pharmacopoeia Ref : DMF, EXCiPAT, KOSHER, HALAL, W...

    Technical Specs : Lactose Monohydrate – 40%, Microcrystalline cellulose – 60%

    Ingredient(s) : Lactose Monohydrate

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    Gangwal Healthcare Microlose™

    Excipients Web Link

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    03

    Pluviaendo

    Turkey
    Biotech Showcase
    Not Confirmed
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    04

    DFE Pharma

    Germany
    Biotech Showcase
    Not Confirmed
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    05

    DFE Pharma

    Germany
    Biotech Showcase
    Not Confirmed
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    06

    Kerry

    U.S.A
    Biotech Showcase
    Not Confirmed
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    07

    Kerry

    U.S.A
    Biotech Showcase
    Not Confirmed
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    08

    Kerry

    U.S.A
    Biotech Showcase
    Not Confirmed
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    09

    Kerry

    U.S.A
    Biotech Showcase
    Not Confirmed
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    Granulation

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