BASF PLC

Overview

BASF PLC is an active pharmaceutical ingredient (API) supplier with 5 active FDA Type II Drug Master Files, covering IBUPROFEN; IBUPROFEN DC 85; POLOXALENE USP; POLYETHYLENE GLYCOL 3350; SODIUM IBUPROFEN DIHYDRATE.

API / Drug Master Files

BASF PLC holds 5 active (11 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.

• SODIUM IBUPROFEN DIHYDRATEActive2008-04-30
• IBUPROFEN DC 85Active2007-04-09
• POLOXALENE USPActive2005-05-27
• POLYETHYLENE GLYCOL 3350Active2003-11-07
• IBUPROFENActive1990-09-10
• RIBOFLAVIN (BULK DRUG SUBSTANCE)Inactive2005-10-10
• GLUCOPONA(R) 600 UPInactive2003-12-01
• UVINUL N539 SGInactive1992-11-19
• ACETAMINOPHENInactive1988-05-05
• BIS-2-ETHYLHEXYL PHTHALATEInactive1988-01-29
• BTS 54 524Inactive1985-09-30

FDA compliance signals

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