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.
Core services & business areas
Active pharmaceutical ingredients supplied
Substances BASF PLC 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
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
6 FDA enforcement records linked to this company.
- 4832025-05-29
Establish reliability of supplier's C of A
- recall — Class II2020-12-23
Cross contamination: the excipient was found to be contaminated with theophylline.
- 4832017-11-17
Investigations of discrepancies, failures
- 4832017-11-17
Control procedures to monitor and validate performance
- 4832017-11-17
Equipment Design, Size and Location
- 4832017-11-17
Scientifically sound laboratory controls
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