Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
01 1Pfanstiehl
02 2AVT (Shanghai)
03 1BioSpectra
04 2CordenPharma
05 1Hubei Gedian Humanwell Pharmaceutical
06 1Suzhou Yacoo Science
07 1Blank
01 5Active
02 1Inactive
03 3Blank
01 9Blank
01 9Blank
01 9Blank
01 9Blank
01 112869-114
02 142533-114
03 167430-350
04 6Blank
01 9Blank
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 : 39484
Submission : 2024-01-31
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37604
Submission : 2022-11-25
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38022
Submission : 2023-04-11
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40518
Submission : 2024-12-24
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37932
Submission : 2023-06-06
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24380
Submission : 2011-02-22
Status : Inactive
Type : IV
NDC Package Code : 42533-114
Start Marketing Date : 2009-11-16
End Marketing Date : 2027-12-31
Dosage Form (Strength) : POWDER (23kg/23kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 12869-114
Start Marketing Date : 2009-11-16
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (23kg/23kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
NDC Package Code : 67430-350
Start Marketing Date : 2023-07-28
End Marketing Date : 2027-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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