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

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USDMF

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01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSPI Pharma has been solving formulation challenges using superior functional materials.

Flag U.S.A
Digital Content Digital Content

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 17044

Submission : 2003-12-22

Status : Active

Type : IV

SPI Pharma

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSPI Pharma has been solving formulation challenges using superior functional materials.

Flag U.S.A
Digital Content Digital Content

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 16037

Submission : 2002-07-03

Status : Active

Type : IV

SPI Pharma

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSPI Pharma has been solving formulation challenges using superior functional materials.

Flag U.S.A
Digital Content Digital Content

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 28402

Submission : 2014-06-18

Status : Active

Type : IV

SPI Pharma

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSPI Pharma has been solving formulation challenges using superior functional materials.

Flag U.S.A
Digital Content Digital Content

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 24099

Submission : 2010-08-27

Status : Active

Type : IV

SPI Pharma

05

  • fda
  • EDQM
  • WHO-GMP

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

Flag India
Digital Content Digital Content

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 41204

Submission : 2025-01-15

Status : Active

Type : IV

Gangwal Healthcare CB

06

  • fda
  • EDQM
  • WHO-GMP

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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Digital Content Digital Content

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 32464

Submission : 2018-02-15

Status : Active

Type : IV

Pfanstiehl

07

Freund Corp

U.S.A

USDMF

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CTAD25
Not Confirmed

07

Freund Corp

U.S.A
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CTAD25
Not Confirmed

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 19954

Submission : 2006-10-30

Status : Active

Type : IV

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08

Roquette Freres

France

USDMF

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CTAD25
Not Confirmed

09

Roquette Freres

France

USDMF

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CTAD25
Not Confirmed

09

CTAD25
Not Confirmed

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 14891

Submission : 2000-05-16

Status : Active

Type : IV

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NDC API

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01

CTAD25
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MANNITOL

NDC Package Code : 57821-013

Start Marketing Date : 2022-12-01

End Marketing Date : 2026-12-31

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

Marketing Category : BULK INGREDIENT

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02

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

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

CTAD25
Not Confirmed
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CTAD25
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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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ISPOR Europe 2025
Not Confirmed

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

USA
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ISPOR Europe 2025
Not Confirmed

Route : ORAL

CAS :

UNII : 3OWL53L36A

Potency Amount : 32.58

Potency Unit : MG

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02

Dosage Form : TABLET, ORALLY DISINTEGRATING

MANNITOL
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ISPOR Europe 2025
Not Confirmed

Dosage Form : TABLET, ORALLY DISINTEGRATING

USA
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ISPOR Europe 2025
Not Confirmed

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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ISPOR Europe 2025
Not Confirmed

Dosage Form : TABLET, ORALLY DISINTEGRATING

USA
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ISPOR Europe 2025
Not Confirmed

Route : ORAL

CAS :

UNII : 3OWL53L36A

Potency Amount : 174.76

Potency Unit : MG

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04

Dosage Form : GUM, CHEWING

MANNITOL
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ISPOR Europe 2025
Not Confirmed

Dosage Form : GUM, CHEWING

USA
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ISPOR Europe 2025
Not Confirmed

Route : BUCCAL

CAS : 69-65-8

UNII : 3OWL53L36A

Potency Amount : 37.11

Potency Unit : MG

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05

Dosage Form : TABLET

MANNITOL
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ISPOR Europe 2025
Not Confirmed

Dosage Form : TABLET

USA
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ISPOR Europe 2025
Not Confirmed

Route : BUCCAL

CAS : 69-65-8

UNII : 3OWL53L36A

Potency Amount : 97.69

Potency Unit : MG

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06

Dosage Form : TABLET

MANNITOL
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ISPOR Europe 2025
Not Confirmed

Dosage Form : TABLET

USA
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ISPOR Europe 2025
Not Confirmed

Route : BUCCAL/SUBLINGUAL

CAS : 69-65-8

UNII : 3OWL53L36A

Potency Amount : 52.5

Potency Unit : MG

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07

Dosage Form : INJECTION

MANNITOL
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ISPOR Europe 2025
Not Confirmed

Dosage Form : INJECTION

USA
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ISPOR Europe 2025
Not Confirmed

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

MANNITOL
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ISPOR Europe 2025
Not Confirmed

Dosage Form : POWDER, FOR INJECTION SOLUTION

USA
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ISPOR Europe 2025
Not Confirmed

Route : IM - IV

CAS : 69-65-8

UNII : 3OWL53L36A

Potency Amount : 30

Potency Unit : %

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09

Dosage Form : INJECTION

MANNITOL
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ISPOR Europe 2025
Not Confirmed

Dosage Form : INJECTION

USA
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ISPOR Europe 2025
Not Confirmed

Route : IM - IV - SC

CAS : 69-65-8

UNII : 3OWL53L36A

Potency Amount : 0

Potency Unit : NA

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10

Dosage Form : INJECTION

MANNITOL
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ISPOR Europe 2025
Not Confirmed

Dosage Form : INJECTION

USA
arrow
ISPOR Europe 2025
Not Confirmed

Route : IM - SC

CAS : 69-65-8

UNII : 3OWL53L36A

Potency Amount : 0

Potency Unit : NA

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EXCIPIENTS BY APPLICATIONS

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