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 : 19538
Submission : 2006-06-20
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 : 37676
Submission : 2022-11-11
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36348
Submission : 2021-11-03
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18881
Submission : 2005-10-15
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16697
Submission : 2003-07-09
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11797
Submission : 1995-10-27
Status : Inactive
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14975
Submission : 2000-07-31
Status : Inactive
Type : IV
NDC Package Code : 51552-1530
Start Marketing Date : 2016-12-28
End Marketing Date : 2025-11-08
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
NDC Package Code : 51552-1414
Start Marketing Date : 2012-04-01
End Marketing Date : 2027-04-15
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
NDC Package Code : 51552-1527
Start Marketing Date : 2016-09-15
End Marketing Date : 2027-07-07
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
FINISHED DOSAGE FORMULATIONS
EXCIPIENTS BY APPLICATIONS
MARKET PLACE
Reply
21 May 2025
Reply
14 Apr 2025
Reply
16 Jun 2023
Reply
28 Jun 2022
Reply
22 Feb 2022
Reply
07 Sep 2021
Reply
24 Jun 2021
Reply
03 Sep 2020
Reply
16 Nov 2018
REF. STANDARDS & IMPURITIES