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
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 : 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
FINISHED DOSAGE FORMULATIONS
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
MARKET PLACE
Reply
10 Jul 2025
Reply
19 Jun 2025
Reply
14 Jun 2025
Reply
03 Feb 2025
Reply
03 Dec 2024
Reply
17 Oct 2024
Reply
10 Jun 2024
Reply
09 Dec 2023
Reply
29 May 2023
Reply
04 Nov 2022
REF. STANDARDS & IMPURITIES