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).

Core services & business areas

Active pharmaceutical ingredients supplied

Substances PFANSTIEHL INC is evidenced to supply (US FDA Drug Master File or EU CEP). Open any ingredient to see its full supplier landscape, CAS number and patent status.

API / Drug Master Files

PFANSTIEHL INC holds 11 active (17 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.

• D-GALACTOSE, PLANT DERIVED, HIGH PURITY, LOW ENDOTOXIN, LOW METALS, NF, EP, BP (G-126-3)Active2026-06-19
• L-ARGININE, HIGH PURITY, LOW ENDOTOXIN, LOW METALS, USP, EP, BP, JP, CHP (A-170)Active2026-06-02
• 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

Showing 15 of 17 Drug Master Files.

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.