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

    ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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    Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

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    Rusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.

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    Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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    Fishfa Biogenics: Renowned Manufacturer, & Exporter of Tacrolimus & Mupirocin API.

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    INACTIVE PHARMA INGREDIENTS

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    SUPPLIERS

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    SPI Pharma

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    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 16037

    Submission : 2002-07-03

    Status : Active

    Type : IV

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    Gangwal Healthcare

    India

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    DMF Review : N/A

    Rev. Date :

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    DMF Number : 41204

    Submission : 2025-01-15

    Status : Active

    Type : IV

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    Gangwal Healthcare CB

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    Pfanstiehl

    U.S.A

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

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    GDUFA

    DMF Review : N/A

    Rev. Date :

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    DMF Number : 32464

    Submission : 2018-02-15

    Status : Active

    Type : IV

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    SPI Pharma

    U.S.A

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    Booth #8.Q31
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 17044

    Submission : 2003-12-22

    Status : Active

    Type : IV

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

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    05

    SPI Pharma

    U.S.A

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    CPhI India
    Booth #8.Q31
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    Virtual BoothSPI Pharma has been solving formulation challenges using superior functional materials.

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 24099

    Submission : 2010-08-27

    Status : Active

    Type : IV

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    SPI Pharma

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    SPI Pharma

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    CPhI India
    Booth #8.Q31
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 28402

    Submission : 2014-06-18

    Status : Active

    Type : IV

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    Qingdao Bright Moon Seaweed Group

    China

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

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    Qingdao Bright Moon Seaweed Group

    China

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

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    Tides Europe
    Not Confirmed
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 41483

    Submission : 2025-03-21

    Status : Active

    Type : IV

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

    Shandong Tianli Pharmaceutical Co ...

    China

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

    Tides Europe
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    Shandong Tianli Pharmaceutical Co ...

    China

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

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    Tides Europe
    Not Confirmed
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 39035

    Submission : 2023-10-27

    Status : Active

    Type : II

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    09

    BASF

    Germany

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

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    BASF

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 20960

    Submission : 2007-10-11

    Status : Active

    Type : IV

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

    Hubei Gedian Humanwell Pharmaceuti...

    China

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

    Tides Europe
    Not Confirmed
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    Hubei Gedian Humanwell Pharmaceuti...

    China

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

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    Tides Europe
    Not Confirmed
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 41812

    Submission : 2025-07-25

    Status : Active

    Type : IV

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

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    01

    Agno Pharma Jiangsu

    U.S.A
    Neuroscience
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    Agno Pharma Jiangsu

    U.S.A
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    Neuroscience
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    MANNITOL

    NDC Package Code : 57821-013

    Start Marketing Date : 2022-12-01

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    Hunan Jiudian Pharmaceutical Co.,Lt...

    China
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    Hunan Jiudian Pharmaceutical Co.,Lt...

    China
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    MANNITOL

    NDC Package Code : 49574-527

    Start Marketing Date : 2019-04-01

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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    03

    Roquette Freres SA

    France
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    Roquette Freres SA

    France
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    Neuroscience
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    MANNITOL

    NDC Package Code : 50516-002

    Start Marketing Date : 2014-05-07

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    FINISHED DOSAGE FORMULATIONS

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    FDA Listed Dossiers

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    01

    Dosage Form : TABLET (IMMED./COMP. RELEASE),...

    MANNITOL
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    Florida Innovation
    Not Confirmed

    Dosage Form : TABLET (IMMED./COMP. RELEASE),...

    USA
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    Florida Innovation
    Not Confirmed

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    MANNITOL

    Route : ORAL

    CAS :

    UNII : 3OWL53L36A

    Potency Amount : 32.58

    Potency Unit : MG

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    02

    Dosage Form : TABLET, ORALLY DISINTEGRATING

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    Dosage Form : TABLET, ORALLY DISINTEGRATING

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    MANNITOL

    Route : ORAL

    CAS :

    UNII : 3OWL53L36A

    Potency Amount : 174.78

    Potency Unit : MG

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    03

    Dosage Form : TABLET, ORALLY DISINTEGRATING

    MANNITOL
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    Florida Innovation
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    Dosage Form : TABLET, ORALLY DISINTEGRATING

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    Florida Innovation
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    MANNITOL

    Route : ORAL

    CAS :

    UNII : 3OWL53L36A

    Potency Amount : 174.76

    Potency Unit : MG

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    04

    Dosage Form : GUM, CHEWING

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    Not Confirmed

    Dosage Form : GUM, CHEWING

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    Florida Innovation
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    MANNITOL

    Route : BUCCAL

    CAS : 69-65-8

    UNII : 3OWL53L36A

    Potency Amount : 37.11

    Potency Unit : MG

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    05

    Dosage Form : TABLET

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    Dosage Form : TABLET

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    Florida Innovation
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    MANNITOL

    Route : BUCCAL

    CAS : 69-65-8

    UNII : 3OWL53L36A

    Potency Amount : 97.69

    Potency Unit : MG

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    06

    Dosage Form : TABLET

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    Dosage Form : TABLET

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    Florida Innovation
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    MANNITOL

    Route : BUCCAL/SUBLINGUAL

    CAS : 69-65-8

    UNII : 3OWL53L36A

    Potency Amount : 52.5

    Potency Unit : MG

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    07

    Dosage Form : INJECTION

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    Dosage Form : INJECTION

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    MANNITOL

    Route : IM - IV

    CAS : 69-65-8

    UNII : 3OWL53L36A

    Potency Amount : 2.5

    Potency Unit : %

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    08

    Dosage Form : POWDER, FOR INJECTION SOLUTION

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    Not Confirmed

    Dosage Form : POWDER, FOR INJECTION SOLUTION

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    MANNITOL

    Route : IM - IV

    CAS : 69-65-8

    UNII : 3OWL53L36A

    Potency Amount : 30

    Potency Unit : %

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    09

    Dosage Form : INJECTION

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    Dosage Form : INJECTION

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    MANNITOL

    Route : IM - IV - SC

    CAS : 69-65-8

    UNII : 3OWL53L36A

    Potency Amount : 0

    Potency Unit : NA

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    10

    Dosage Form : INJECTION

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    Not Confirmed

    Dosage Form : INJECTION

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    Florida Innovation
    Not Confirmed

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    MANNITOL

    Route : IM - SC

    CAS : 69-65-8

    UNII : 3OWL53L36A

    Potency Amount : 0

    Potency Unit : NA

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