Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
01 2Pfanstiehl
02 1Durect Corporation
03 1Freund Vector Corporation
04 1Hubei Gedian Humanwell Pharmaceutical
05 1JRS Pharma
06 1Mitsubishi Chemical Holdings Corporation
01 1China
02 1Germany
03 1Japan
04 4U.S.A
01 5Active
02 2Inactive
01 7Blank
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 : 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 : 36348
Submission : 2021-11-03
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
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