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 9DFE Pharma
03 2Kerry
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01 9Germany
02 3U.S.A
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01 9Active
02 3Inactive
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01 12Blank
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
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DMF Number : 41447
Submission : 2025-03-06
Status : Active
Type : IV
GDUFA
DMF Review : N/A
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DMF Number : 21014
Submission : 2007-11-02
Status : Active
Type : IV
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DMF Review : N/A
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DMF Number : 15909
Submission : 2001-12-21
Status : Active
Type : IV
GDUFA
DMF Review : N/A
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DMF Number : 18730
Submission : 2005-09-06
Status : Active
Type : IV
GDUFA
DMF Review : N/A
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DMF Number : 14644
Submission : 1999-12-23
Status : Active
Type : IV
GDUFA
DMF Review : N/A
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DMF Number : 16285
Submission : 2002-12-02
Status : Active
Type : IV
GDUFA
DMF Review : N/A
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DMF Number : 13102
Submission : 1998-07-29
Status : Active
Type : IV
GDUFA
DMF Review : N/A
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DMF Number : 16284
Submission : 2002-12-02
Status : Active
Type : IV
GDUFA
DMF Review : N/A
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DMF Number : 15916
Submission : 2002-03-29
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 16066
Submission : 2002-07-10
Status : Inactive
Type : IV
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