Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
01 1Pfanstiehl
02 1AVT (Shanghai)
03 2Hayashibara
04 1Hubei Gedian Humanwell Pharmaceutical
05 1Blank
01 4Active
02 1Inactive
03 1Blank
01 6Blank
01 6Blank
01 6Blank
01 6Blank
01 173212-108
02 5Blank
01 6Blank
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 : 24122
Submission : 2010-08-30
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31236
Submission : 2016-12-06
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34401
Submission : 2019-12-11
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35711
Submission : 2021-11-03
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17414
Submission : 2004-05-27
Status : Inactive
Type : IV
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
NDC Package Code : 73212-108
Start Marketing Date : 2024-07-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
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