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 : 39035
Submission : 2023-10-27
Status : Active
Type : II
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
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 : DILACOR XR
Dosage Form : CAPSULE, EXTENDED RELEASE; ORAL
Application Number : 20092
Country : US
Patented : No
Drug : SAPHRIS
Dosage Form : TABLET; SUBLINGUAL
Application Number : 22117
Country : US
Patented : Yes
Drug : COMTAN
Dosage Form : TABLET; ORAL
Application Number : 20796
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
CARBIDOPA; ENTACAPONE; LEVODOPA
Drug : STALEVO 125
Dosage Form : TABLET; ORAL
Application Number : 21485
Country : US
Patented : No
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 : 69-65-8
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 : 69-65-8
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 : 69-65-8
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 : 69-65-8
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 : 69-65-8
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 : 69-65-8
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 : 69-65-8
UNII : 3OWL53L36A
Potency Amount : 0
Potency Unit : NA
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
EXCIPIENTS BY APPLICATIONS
Application : Fillers, Diluents & Binders
Excipient Details : Mannitol is used as a filler, bulking agent and taste masking agent in ODT formulations such as tablets.
Application : Fillers, Diluents & Binders
Excipient Details : D-Mannitol protects proteins from denaturation & degradation. It is used as a stabilizer in liquid products including biologic injectables & vaccines.
Pharmacopoeia Ref : USP, EP, BP, JP, ChP
Technical Specs : Low Endotoxin, Low Metals
Ingredient(s) : D-Mannitol
MARKET PLACE
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10 Jul 2025
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14 Jun 2025
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03 Feb 2025
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03 Dec 2024
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17 Oct 2024
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10 Jun 2024
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09 Dec 2023
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29 May 2023
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04 Nov 2022
REF. STANDARDS & IMPURITIES