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List of Drug Master Files (DMF) of Excipients submissions by Pfanstiehl to the U.S. FDA. Original Data : FDA Website

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01 A, A TREHALOSE DIHYDRATE, HIGH PURITY, LOW ENDOTOXIN, LOW GLUCOSE, NF, EP, JP, CHP (T-104-4-LG) (1)

02 A, A TREHALOSE DIHYDRATE, INHALATION GRADE, HIGH PURITY, LOW ENDOTOXIN-LOW METALS (HPLE-LM), NF, EP, JP, CHP (T-104-4-IG) (1)

03 A, A-TREHALOSE DIHYDRATE, HIGH PURITY, LOW ENDOTOXIN, LOW METALS, NF, EP, BP, JP, CHP (T-104-4) (1)

04 D-GALACTOSE, PLANT DERIVED HIGH PURITY LOW ENDOTOXIN / LOW METAL, NF, EP (G-126-3) (1)

05 D-MANNITOL (PLANT DERIVED) HIGH PURITY / LOW ENDOTOXIN-LOW METALS USP/EP/JP/CHP (M-109-7) (1)

06 L-ARGININE HYDROCHLORIDE, HIGH PURITY, LOW ENDOTOXIN, LOW METALS, USP, EP, JP, CHP (1)

07 L-ARGININE, HIGH PURITY, LOW ENDOTOXIN, LOW METALS, USP, EP, JP, CHP (1)

08 L-HISTIDINE HYDROCHLORIDE MONOHYDRATE, HIGH PURITY, LOW ENDOTOXIN, LOW METALS, BP, EP, JP, CHP (H-117) (1)

09 L-HISTIDINE, HIGH PURITY, LOW ENDOTOXIN, LOW METALS, USP, EP, BP, JP, CHP (1)

10 L-METHIONINE, HIGH PURITY, LOW ENDOTOXIN, LOW METALS, USP, EP, BP, JP, CHP (1)

11 MALTOSE MONOHYDRATE, HIGH PURITY, LOW ENDOTOXIN, LOW METALS, NF, JP, CHP (1)

12 SODIUM SUCCINATE, HEXAHYDRATE, HIGH PURITY, LOW ENDOTOXIN, LOW METALS, NF, JPE (D-161) (1)

13 SUCROSE NF, EP, JP, ChP HIGH PURITY, LOW ENDOTOXIN, BEET DERIVED (S-124-2-MC) (1)

14 SUCROSE, NF, EP, JP, CHP HIGH PURITY, LOW ENDOTOXIN - CANE DERIVED (1)

15 TRIS BASE, HIGH PURITY, LOW ENDOTOXIN, LOW METALS, USP, EP, BP, CHP (T-153) (1)

16 TRIS HYDROCHLORIDE, HIGH PURITY, LOW ENDOTOXIN, LOW METALS (T-154) (1)

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01 PFANSTIEHL INC (16)

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01 U.S.A (16)

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01 Active (16)

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