GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16037
Submission : 2002-07-03
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41204
Submission : 2025-01-15
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
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17044
Submission : 2003-12-22
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24099
Submission : 2010-08-27
Status : Active
Type : IV
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 : 41483
Submission : 2025-03-21
Status : Active
Type : IV

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 : 20960
Submission : 2007-10-11
Status : Active
Type : IV

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39035
Submission : 2023-10-27
Status : Active
Type : II

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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24099
Submission : 2010-08-27
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17044
Submission : 2003-12-22
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16037
Submission : 2002-07-03
Status : Active
Type : IV
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 : 41204
Submission : 2025-01-15
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
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 : 14891
Submission : 2000-05-16
Status : Active
Type : IV

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18143
Submission : 2005-03-08
Status : Active
Type : IV

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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.

Certificate Number : R1-CEP 2000-040 - Rev 02
Status : Valid
Issue Date : 2019-09-12
Type : Chemical
Substance Number : 559

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.

Certificate Number : R1-CEP 2000-039 - Rev 01
Status : Valid
Issue Date : 2019-09-12
Type : Chemical
Substance Number : 559

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Mannitol, For Use In The Manufacture Of Parenter...
Certificate Number : CEP 2005-019 - Rev 03
Status : Valid
Issue Date : 2025-06-24
Type : Chemical
Substance Number : 559

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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] 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

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

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

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FINISHED DOSAGE FORMULATIONS
Drug : MYOZYME
Dosage Form : INJECTABLE; IV (INFUSION)
Application Number : 125141
Country : US
Patented : No
Drug : PLAVIX
Dosage Form : TABLET; ORAL
Application Number : 20839
Country : US
Patented : No
LEUPROLIDE ACETATE; NORETHINDRONE ACETATE
Drug : LUPANETA PACK
Dosage Form : INJECTABLE, TABLET; INTRAMUSCULAR, ORAL
Application Number : 203696
Country : US
Patented : No
Drug : DALVANCE
Dosage Form : POWDER; INTRAVENOUS
Application Number : 21883
Country : US
Patented : Yes
Drug : SAPHRIS
Dosage Form : TABLET; SUBLINGUAL
Application Number : 22117
Country : US
Patented : Yes
Drug : DILACOR XR
Dosage Form : CAPSULE, EXTENDED RELEASE; ORAL
Application Number : 20092
Country : US
Patented : No
CARBIDOPA; ENTACAPONE; LEVODOPA
Drug : STALEVO 100
Dosage Form : TABLET; ORAL
Application Number : 21485
Country : US
Patented : No
CARBIDOPA; ENTACAPONE; LEVODOPA
Drug : STALEVO 50
Dosage Form : TABLET; ORAL
Application Number : 21485
Country : US
Patented : No
Drug : COMTAN
Dosage Form : TABLET; ORAL
Application Number : 20796
Country : US
Patented : No
CARBIDOPA; ENTACAPONE; LEVODOPA
Drug : STALEVO 125
Dosage Form : TABLET; ORAL
Application Number : 21485
Country : US
Patented : No
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]MANNITOL
Route : ORAL
CAS :
UNII : 3OWL53L36A
Potency Amount : 32.58
Potency Unit : MG

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MANNITOL
Route : ORAL
CAS :
UNII : 3OWL53L36A
Potency Amount : 174.78
Potency Unit : MG

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MANNITOL
Route : ORAL
CAS :
UNII : 3OWL53L36A
Potency Amount : 174.76
Potency Unit : MG

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MANNITOL
Route : BUCCAL
CAS : 69-65-8
UNII : 3OWL53L36A
Potency Amount : 37.11
Potency Unit : MG

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MANNITOL
Route : BUCCAL
CAS : 69-65-8
UNII : 3OWL53L36A
Potency Amount : 97.69
Potency Unit : MG

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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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MANNITOL
Route : IM - IV
CAS : 69-65-8
UNII : 3OWL53L36A
Potency Amount : 2.5
Potency Unit : %

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MANNITOL
Route : IM - IV
CAS : 69-65-8
UNII : 3OWL53L36A
Potency Amount : 30
Potency Unit : %

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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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Virtual Booth
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Corporate PDF
MANNITOL
Route : IM - SC
CAS : 69-65-8
UNII : 3OWL53L36A
Potency Amount : 0
Potency Unit : NA

Portfolio PDF
Product Web Link
Virtual Booth
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Website
Corporate PDF
EXCIPIENTS BY APPLICATIONS
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REF. STANDARDS & IMPURITIES