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 2AVT (Shanghai)
03 1BioSpectra
04 1CordenPharma
05 1Hubei Gedian Humanwell Pharmaceutical
06 1Suzhou Yacoo Science
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02 1Inactive
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01 142533-114
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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.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39484
Submission : 2024-01-31
Status : Active
Type : IV
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DMF Number : 37604
Submission : 2022-11-25
Status : Active
Type : IV
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DMF Review : N/A
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DMF Number : 38022
Submission : 2023-04-11
Status : Active
Type : IV
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DMF Review : N/A
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DMF Number : 40518
Submission : 2024-12-24
Status : Active
Type : IV
GDUFA
DMF Review : N/A
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DMF Number : 37932
Submission : 2023-06-06
Status : Active
Type : IV
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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 : 2025-12-31
Dosage Form (Strength) : POWDER (23kg/23kg)
Marketing Category : BULK INGREDIENT
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