Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
01 1Pfanstiehl
02 4Corbion
03 4FUJIFILM Wako Pure Chemical
04 1Galactic
05 1Luoyang Longmen Pharmaceutical
06 3Musashino Chemical Laboratory
07 1Roquette
08 4Showa Kako
09 1Taihei Chemical Industry
01 1Belgium
02 1China
03 1France
04 12Japan
05 4Netherlands
06 1U.S.A
01 4Active
02 16Blank
01 1Valid
02 2Withdrawn by Holder
03 17Blank
01 1218MF10454
02 1218MF10464
03 1218MF10598
04 1218MF10599
05 1218MF10600
06 1218MF10630
07 1218MF10633
08 1218MF10691
09 1218MF10692
10 1218MF10693
11 1219MF10185
12 1219MF10186
13 1222MF10244
14 1223MF10062
15 1224MF10179
16 1228MF10227
17 4Blank
01 20Blank
Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7658
Submission : 1988-09-06
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-03-28
Pay. Date : 2017-03-17
DMF Number : 20598
Submission : 2007-06-11
Status : Active
Type : II
Certificate Number : R1-CEP 1999-038 - Rev 01
Issue Date : 2014-10-06
Type : Chemical
Substance Number : 2033
Status : Valid
Registration Number : 218MF10464
Registrant's Address : P. O. BOX21, Gorinchem, The Netherlands
Initial Date of Registration : 2006-04-27
Latest Date of Registration : --
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-09-26
Pay. Date : 2016-07-25
DMF Number : 30736
Submission : 2016-07-20
Status : Active
Type : II
Certificate Number : R0-CEP 2015-372 - Rev 00
Issue Date : 2017-11-17
Type : Chemical
Substance Number : 2033
Status : Withdrawn by Holder
Certificate Number : R0-CEP 2006-048 - Rev 00
Issue Date : 2007-06-08
Type : Chemical
Substance Number : 2033
Status : Withdrawn by Holder
Registration Number : 219MF10185
Registrant's Address : P. O. BOX21, Gorinchem, The Netherlands
Initial Date of Registration : 2007-06-01
Latest Date of Registration : --
Registration Number : 219MF10186
Registrant's Address : P. O. BOX21, Gorinchem, The Netherlands
Initial Date of Registration : 2007-06-01
Latest Date of Registration : --
Registration Number : 224MF10179
Registrant's Address : 1-8-2 Marunouchi, Chiyoda-ku, Tokyo
Initial Date of Registration : 2012-08-17
Latest Date of Registration : --
Registration Number : 222MF10244
Registrant's Address : P. O. BOX21, Gorinchem, The Netherlands
Initial Date of Registration : 2010-10-21
Latest Date of Registration : --
Registration Number : 223MF10062
Registrant's Address : 18-23 Yoshinocho, Suita City, Osaka Prefecture
Initial Date of Registration : 2011-05-12
Latest Date of Registration : --
Registration Number : 228MF10227
Registrant's Address : Osaka Prefecture, Osaka City, Chuo Ward, Higashi-Koraibashi 1-16
Initial Date of Registration : 2016-12-14
Latest Date of Registration : --
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