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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01 1Pfanstiehl
02 4Corbion
03 4FUJIFILM Wako Pure Chemical
04 1Galactic
05 1Jiaan Biotech
06 1Luoyang Longmen Pharmaceutical
07 3Musashino Chemical Laboratory
08 1Roquette
09 4Showa Kako
10 1Spectrum Chemical
11 1Taihei Chemical Industry
12 1Tianjin Tianfa Pharmaceutical Import & Export
13 1Wuxi Fortune Pharmaceutical
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01 1Belgium
02 3China
03 1France
04 1India
05 12Japan
06 4Netherlands
07 2U.S.A
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01 4Active
02 20Blank
01 1Valid
02 2Withdrawn by Holder
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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
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01 149452-6830
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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 : 7658
Submission : 1988-09-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35258
Submission : 2020-09-26
Status : Active
Type : II
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Status : Withdrawn by Holder
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 :
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 : 222MF10244
Registrant's Address : P. O. BOX21, Gorinchem, The Netherlands
Initial Date of Registration : 2010-10-21
Latest Date of Registration :
Certificate Number : R0-CEP 2006-048 - Rev 00
Issue Date : 2007-06-08
Type : Chemical
Substance Number : 2033
Status : Withdrawn by Holder
100
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