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01 1A, A-TREHALOSE DIHYDRATE, API
02 1AMMONIUM LACTATE
03 1D-MANNOSE, HIGH PURITY, LOW ENDOTOXIN LOW METALS (M-164-2)
04 1METHOTREXATE, HIGH PURITY LOW ENDOTOXIN, LOW METALS, USP, EP, BP, JP, ChP (M-166-1)
05 1PODOPHYLLOTOXIN (P-126)
06 1SODIUM DL-LACTATE SOLUTION 60%, USP (S-110, S110-M)
07 1SODIUM GLUCONATE, USP (S-108)
08 1STREPTOZOTOCIN (S-119)
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33548
Submission : 2019-02-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12612
Submission : 1997-08-05
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39988
Submission : 2024-06-05
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25758
Submission : 2012-02-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7658
Submission : 1988-09-06
Status : Active
Type : II
KEY PRODUCTS
Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
