Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
01 1Pfanstiehl
02 1Roquette
03 1Shanpar
01 1France
02 1India
03 1U.S.A
01 2Active
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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
DMF Review : Reviewed
Rev. Date : 2021-09-14
Pay. Date : 2021-09-09
DMF Number : 9147
Submission : 1991-05-31
Status : Active
Type : II
NDC Package Code : 67430-150
Start Marketing Date : 2017-01-23
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34499
Submission : 2020-01-15
Status : Active
Type : II
NDC Package Code : 50516-004
Start Marketing Date : 2020-08-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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