Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
01 1Pfanstiehl
02 1Roche Diagnostics GmbH
03 1SIGMA TAU
04 1Shanghai Hegeng Industrial Co. Ltd
01 1China
02 1Germany
03 2U.S.A
01 1Active
02 2Inactive
03 1Blank
01 1Withdrawn by Holder
02 3Blank
01 4Blank
01 4Blank
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 : 33700
Submission : 2019-03-22
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7786
Submission : 1988-11-18
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8650
Submission : 1990-07-03
Status : Inactive
Type : II
Certificate Number : R1-CEP 1997-098 - Rev 02
Issue Date : 2010-12-01
Type : Chemical
Substance Number : 1215
Status : Withdrawn by Holder
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