PFANSTIEHL INC

Overview

PFANSTIEHL INC is an active pharmaceutical ingredient (API) supplier with 9 active FDA Type II Drug Master Files, covering A, A-TREHALOSE DIHYDRATE, API; AMMONIUM LACTATE; D-MANNOSE, HIGH PURITY, LOW ENDOTOXIN LOW METALS (M-164-2); METHOTREXATE, HIGH PURITY LOW ENDOTOXIN, LOW METALS, USP, EP, BP, JP, ChP (M-166-1); PODOPHYLLOTOXIN (P-126); SODIUM DL-LACTATE SOLUTION 60%, USP (S-110, S110-M).

API / Drug Master Files

PFANSTIEHL INC holds 9 active (15 total) FDA Type II Drug Master Files — identifying it as an active-substance / API supplier. Type II DMFs are filed with the FDA to support the use of an active pharmaceutical ingredient in drug applications.

• TRIS BASE, HIGH PURITY, LOW ENDOTOXIN, LOW METALS, USP, EP, BP, CHP (T-153)Active2025-09-22
• D-MANNOSE, HIGH PURITY, LOW ENDOTOXIN LOW METALS (M-164-2)Active2024-07-31
• METHOTREXATE, HIGH PURITY LOW ENDOTOXIN, LOW METALS, USP, EP, BP, JP, ChP (M-166-1)Active2024-06-05
• A, A-TREHALOSE DIHYDRATE, APIActive2019-02-28
• PODOPHYLLOTOXIN (P-126)Active2012-02-03
• AMMONIUM LACTATEActive1997-08-05
• SODIUM GLUCONATE, USP (S-108)Active1991-05-31
• SODIUM DL-LACTATE SOLUTION 60%, USP (S-110, S110-M)Active1988-09-06
• STREPTOZOTOCIN (S-119)Active1976-02-17
• D-RIBOSE, HIGH PURITY (LOW ENDOTOXIN) (R-104-1)Inactive2010-08-02
• CYTARABINE USPInactive2003-10-06
• 2-DEOXY-D-GLUCOSE (D-101-1)Inactive2003-07-31
• ADIPIC ACID BIS (N-HYDROXYSUCCINIMIDE) ESTER (A-163-1)Inactive2003-07-25
• MALTOSE HIGH PURITY HYDRATE (LOW ENDOTOXIN)Inactive1996-06-25
• 1-BETA-D-ARABINOFURANOSYL CYTOSINE (CYTARABINE)Inactive1986-04-01

FDA compliance signals

No FDA recalls, Warning Letters, or Form 483 observations are linked to PFANSTIEHL INC in our records. PharmaTek screens the full directory against live FDA enforcement data.