SUPPLIERS
SPI 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 : 16037
Submission : 2002-07-03
Status : Active
Type : IV
Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32464
Submission : 2018-02-15
Status : Active
Type : IV
SPI Pharma has been solving formulation challenges using superior functional materials.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17044
Submission : 2003-12-22
Status : Active
Type : IV
SPI Pharma has been solving formulation challenges using superior functional materials.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24099
Submission : 2010-08-27
Status : Active
Type : IV
SPI Pharma has been solving formulation challenges using superior functional materials.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28402
Submission : 2014-06-18
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39035
Submission : 2023-10-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39456
Submission : 2024-02-06
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19954
Submission : 2006-10-30
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20960
Submission : 2007-10-11
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28717
Submission : 2014-10-03
Status : Active
Type : IV
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USDMF
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CEP/COS
Mannitol, For use in the manufacture of parenteral preparations
Certificate Number : R1-CEP 2005-019 - Rev 02
Status : Valid
Issue Date : 2019-09-04
Type : Chemical
Substance Number : 559
Certificate Number : R1-CEP 2000-040 - Rev 02
Status : Valid
Issue Date : 2019-09-12
Type : Chemical
Substance Number : 559
Certificate Number : R1-CEP 2000-039 - Rev 01
Status : Valid
Issue Date : 2019-09-12
Type : Chemical
Substance Number : 559
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] NDC API
NDC Package Code : 57821-013
Start Marketing Date : 2022-12-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
NDC Package Code : 49574-527
Start Marketing Date : 2019-04-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 50516-002
Start Marketing Date : 2014-05-07
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]LISTED SUPPLIERS
FINISHED DOSAGE FORMULATIONS
FDF DOSSIERS SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Dossiers
MANNITOL
Route : ORAL
CAS :
UNII : 3OWL53L36A
Potency Amount : 32.58
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
MANNITOL
Route : ORAL
CAS :
UNII : 3OWL53L36A
Potency Amount : 174.78
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
MANNITOL
Route : ORAL
CAS :
UNII : 3OWL53L36A
Potency Amount : 174.76
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
MANNITOL
Route : BUCCAL
CAS : 69658
UNII : 3OWL53L36A
Potency Amount : 37.11
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
MANNITOL
Route : BUCCAL
CAS : 69658
UNII : 3OWL53L36A
Potency Amount : 97.69
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
MANNITOL
Route : BUCCAL/SUBLINGUAL
CAS : 69658
UNII : 3OWL53L36A
Potency Amount : 52.5
Potency Unit : MG
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
MANNITOL
Route : IM - IV
CAS : 69658
UNII : 3OWL53L36A
Potency Amount : 2.5
Potency Unit : %
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
MANNITOL
Route : IM - IV
CAS : 69658
UNII : 3OWL53L36A
Potency Amount : 30
Potency Unit : %
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
MANNITOL
Route : IM - IV - SC
CAS : 69658
UNII : 3OWL53L36A
Potency Amount : 0
Potency Unit : NA
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
MANNITOL
Route : IM - SC
CAS : 69658
UNII : 3OWL53L36A
Potency Amount : 0
Potency Unit : NA
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
EXCIPIENTS BY APPLICATIONS
Fillers Diluents Binders
Chewable Orodispersible Aids
Taste Masking
Direct Compression
Parenteral
Disintegrants Superdisintegrants
Co Processed Excipients
Granulation
API Stability Enhancers
Thickeners And Stabilizers
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DATA COMPILATION #PharmaFlow
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REF. STANDARDS & IMPURITIES
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