Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
01 1Pfanstiehl
02 9DFE Pharma
03 1Fagron Group
04 2Kerry
01 9Active
02 3Inactive
03 1Blank
01 13Blank
01 13Blank
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01 13Blank
01 151552-0618
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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.
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GDUFA
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DMF Number : 41447
Submission : 2025-03-06
Status : Active
Type : IV
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DMF Number : 13102
Submission : 1998-07-29
Status : Active
Type : IV
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DMF Number : 14644
Submission : 1999-12-23
Status : Active
Type : IV
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DMF Number : 15909
Submission : 2001-12-21
Status : Active
Type : IV
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DMF Number : 15916
Submission : 2002-03-29
Status : Active
Type : IV
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DMF Number : 16284
Submission : 2002-12-02
Status : Active
Type : IV
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DMF Number : 16285
Submission : 2002-12-02
Status : Active
Type : IV
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DMF Number : 21599
Submission : 2008-05-06
Status : Inactive
Type : IV
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DMF Number : 21601
Submission : 2008-05-06
Status : Inactive
Type : IV
GDUFA
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DMF Number : 16066
Submission : 2002-07-10
Status : Inactive
Type : IV
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