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

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SUPPLIERS

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01

SPI Pharma

U.S.A

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

  • fda
  • EDQM
  • WHO-GMP

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

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Digital Content Digital Content
USDMF arrow-down Click Us! arrow-down
CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
SPI Pharma

02

Gangwal Healthcare

India

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

  • fda
  • EDQM
  • WHO-GMP

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

Flag India
Digital Content Digital Content
USDMF arrow-down CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
Gangwal Healthcare CB

03

Pfanstiehl

U.S.A

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

  • 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
USDMF arrow-down CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
Pfanstiehl

04

SPI Pharma

U.S.A

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

  • fda
  • EDQM
  • WHO-GMP

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

Flag U.S.A
Digital Content Digital Content
USDMF arrow-down CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
SPI Pharma

05

SPI Pharma

U.S.A

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

  • fda
  • EDQM
  • WHO-GMP

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

Flag U.S.A
Digital Content Digital Content
USDMF arrow-down CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
SPI Pharma

06

SPI Pharma

U.S.A

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

  • fda
  • EDQM
  • WHO-GMP

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

Flag U.S.A
Digital Content Digital Content
USDMF arrow-down CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
SPI Pharma

07

BASF

Germany

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

AGGSpend
Not Confirmed
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BASF

Germany

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

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AGGSpend
Not Confirmed
USDMF arrow-down 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

AGGSpend
Not Confirmed
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Shandong Tianli Pharmaceutical Co ...

China

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

arrow
AGGSpend
Not Confirmed
USDMF arrow-down CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
blank

09

Qingdao Bright Moon Seaweed Group

China

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

AGGSpend
Not Confirmed
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Qingdao Bright Moon Seaweed Group

China

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

arrow
AGGSpend
Not Confirmed
USDMF arrow-down CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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10

Anmol Chemicals

India

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

AGGSpend
Not Confirmed
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Anmol Chemicals

India

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

arrow
AGGSpend
Not Confirmed
USDMF arrow-down CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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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 : 16037

Submission : 2002-07-03

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 : 28402

Submission : 2014-06-18

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 : 24099

Submission : 2010-08-27

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 : 17044

Submission : 2003-12-22

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.

Flag U.S.A
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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ACS Fall 2025
Not Confirmed

07

Freund Corp

U.S.A
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ACS Fall 2025
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

arrow
ACS Fall 2025
Not Confirmed

08

ACS Fall 2025
Not Confirmed

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 18143

Submission : 2005-03-08

Status : Active

Type : IV

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09

Roquette Freres

France

USDMF

arrow
ACS Fall 2025
Not Confirmed

09

ACS Fall 2025
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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CEP/COS

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01

ACS Fall 2025
Not Confirmed
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ACS Fall 2025
Not Confirmed

Certificate Number : R1-CEP 2000-040 - Rev 02

Status : Valid

Issue Date : 2019-09-12

Type : Chemical

Substance Number : 559

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02

ACS Fall 2025
Not Confirmed
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ACS Fall 2025
Not Confirmed

Certificate Number : R1-CEP 2000-039 - Rev 01

Status : Valid

Issue Date : 2019-09-12

Type : Chemical

Substance Number : 559

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CARGILL S.R.L. Castelmassa IT

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Virtual Booth Virtual Booth
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CEP 2005-019 - Rev 03
Valid
Chemical
2025-06-24
559
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03

CARGILL S.R.L. Castelmassa IT

Country
ACS Fall 2025
Not Confirmed
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CARGILL S.R.L. Castelmassa IT

Country
arrow
ACS Fall 2025
Not Confirmed

Certificate Number : CEP 2005-019 - Rev 03

Status : Valid

Issue Date : 2025-06-24

Type : Chemical

Substance Number : 559

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EU WC

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01

ACS Fall 2025
Not Confirmed
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ACS Fall 2025
Not Confirmed

Omeprazole Sodium Sterile (Sterile dry powder of omeprazole sodium 35% in mannitol qs) IH

Date of Issue : 2022-08-12

Valid Till : 2025-07-06

Written Confirmation Number : WC-0378

Address of the Firm : Plot No. 100, 118G, Sec-56, Phase-IV, HSIIDC, Kundli, Sonipat, Haryana, INDIA Ku...

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02

ACS Fall 2025
Not Confirmed
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ACS Fall 2025
Not Confirmed

Pantoprazole Sodium Sterile (sterile dry powder of pantoprazole sodium 38 % in mannitol qs) IH

Date of Issue : 2022-08-12

Valid Till : 2025-07-06

Written Confirmation Number : WC-0378

Address of the Firm : Plot No. 100, 118G, Sec-56, Phase-IV, HSIIDC, Kundli, Sonipat, Haryana, INDIA Ku...

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NDC API

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01

AGGSpend
Not Confirmed
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AGGSpend
Not Confirmed

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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02

AGGSpend
Not Confirmed
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AGGSpend
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

AGGSpend
Not Confirmed
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AGGSpend
Not Confirmed

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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AGGSpend
Not Confirmed

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

USA
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AGGSpend
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
arrow
AGGSpend
Not Confirmed

Dosage Form : TABLET, ORALLY DISINTEGRATING

USA
arrow
AGGSpend
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
arrow
AGGSpend
Not Confirmed

Dosage Form : TABLET, ORALLY DISINTEGRATING

USA
arrow
AGGSpend
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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AGGSpend
Not Confirmed

Dosage Form : GUM, CHEWING

USA
arrow
AGGSpend
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
arrow
AGGSpend
Not Confirmed

Dosage Form : TABLET

USA
arrow
AGGSpend
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
arrow
AGGSpend
Not Confirmed

Dosage Form : TABLET

USA
arrow
AGGSpend
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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AGGSpend
Not Confirmed

Dosage Form : INJECTION

USA
arrow
AGGSpend
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
arrow
AGGSpend
Not Confirmed

Dosage Form : POWDER, FOR INJECTION SOLUTION

USA
arrow
AGGSpend
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
arrow
AGGSpend
Not Confirmed

Dosage Form : INJECTION

USA
arrow
AGGSpend
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
arrow
AGGSpend
Not Confirmed

Dosage Form : INJECTION

USA
arrow
AGGSpend
Not Confirmed

Route : IM - SC

CAS : 69-65-8

UNII : 3OWL53L36A

Potency Amount : 0

Potency Unit : NA

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EXCIPIENTS

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A company that focuses on the manufacturing of tablets, capsules, suspensions, injectables and drops is looking for suppliers of Various Excipients for commercial purposes. The suppliers must support this enquiry with CoA. 1. IP/ BP/ Ph.Eur/ USP/ NF/ JP Grade Aspartame (250 kg) Excipient 2. IP/ BP/ Ph.Eur/ USP/ NF/ JP Grade Calcium Carbonate (2 MT) Granules 3. IP/ BP/ Ph.Eur/ USP/ NF/ JP Grade Calcium Silicate (250 kg) Excipient 4. IP/ BP/ Ph.Eur/ USP/ NF/ JP Grade & Anhydrous Citric Acid (250 kg) Excipient 5. IP/ BP/ Ph.Eur/ USP/ NF/ JP Grade Colloidal Silicone Dioxide (3 MT) Excipient 6. IP/ BP/ Ph.Eur/ USP/ NF/ JP Grade Croscarmellose Sodium (2 MT) Excipient 7. USP & NF Grade Crospovidone (600 kg) Excipient 8. Ph. Eur. Grade Hypromellose (10 MT) Excipient 9. IP/ BP/ Ph.Eur/ USP/ NF/ JP Grade Isopropyl Alcohol (25 MT) Excipient 10. IP/ BP/ Ph.Eur/ USP/ NF/ JP Grade Lactose Monohydrate (15 MT) Excipient 11. IP/ BP/ Ph.Eur/ USP/ NF/ JP Grade Magnesium Stearate (4 MT) Excipient 12. IP/ BP/ Ph.Eur/ USP/ NF/ JP Grade Mannitol (10 MT) Excipient 13. IP/ BP/ Ph.Eur/ USP/ NF/ JP Grade Microcrystalline Cellulose (25 MT) Excipient 14. IP/ BP/ Ph.Eur/ USP/ NF/ JP Grade PEG 4000 (25 MT) Excipient 15. IP/ BP/ Ph.Eur/ USP/ NF/ JP Grade Povidone K30 & K90 (2.5 MT & 1 MT) Excipient 16. IP/ BP/ Ph.Eur/ USP/ NF/ JP Grade Sodium Lauryl Sulfate (400 kg) Excipient 17. IP/ BP/ Ph.Eur/ USP/ NF/ JP Grade Stearic Acid (32 MT) Excipient 18. IP/ BP/ Ph.Eur/ USP/ NF/ JP Grade Sodium Starch Glycolate (4 MT) Excipient
29 May 2023

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29 May 2023

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29 May 2023

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