Bayer AG
Overview
Bayer AG is a global enterprise with core competencies in the Life Science fields of healthcare and agriculture. As a leading pharmaceutical company, Bayer develops and manufactures a wide range of healthcare products. Nexavar, an anticancer drug, is developed under Bayer's pharmaceuticals division.
Therapeutic areas
Active pharmaceutical ingredients supplied
Substances Bayer AG 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
Bayer AG holds 28 active (64 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.
- MOLIDUSTAT SODIUM (MICRONIZED) DRUG SUBSTANCEActive2020-09-10
- AZELAIC ACID (A)Active2014-06-26
- RIVAROXABAN COATED TABLETS, 10 MGActive2008-07-23
- RIVAROXABAN (MICRONIZED) DRUG SUBSTANCEActive2008-07-23
- EOB-DTPAActive2007-05-14
- NORGESTRELActive2004-04-16
- ILOPROSTActive2004-02-18
- TESTOSTERONE UNDECANOATEActive2003-08-15
- TESTOSTERONE UNDECANOATE 750 MG I.M.Active2003-08-15
- TESTOSTERONEActive2000-10-02
- ETHINYLESTRADIOL-BETA-CYCLODEXTRIN-CLATHRATEActive2000-07-25
- DIENOGESTActive1999-02-26
- GADOBUTROLActive1998-07-07
- DROSPIRENONEActive1996-09-09
- CIPROFLOXACIN HYDRATED DRUG SUBSTANCEActive1993-07-13
Showing 15 of 64 Drug Master Files.
FDA compliance signals
19 FDA enforcement records linked to this company.
- 4832020-07-27
Written record of investigation incomplete
- 4832020-07-27
Scientifically sound laboratory controls
- 4832020-07-27
Prevention of cross contamination, mix-ups
- 4832020-07-27
Written procedures fail to include
- 4832020-07-27
Control procedures to monitor and validate performance
- 4832019-09-24
Cleaning System
- 4832019-09-24
Written procedures not established/followed
- 4832019-09-24
Top/Middle/Bottom container sampling
- 4832019-03-22
Prepared for each batch, include complete information
- 4832019-03-22
Control procedures to monitor and validate performance
- 4832019-03-22
Following/documenting laboratory controls
- 4832019-03-22
Labels and labeling stored separately
- 4832019-03-22
Written procedures fail to include
- 4832019-03-22
Identification of containers, lines, equipment
- warning_letter2017-11-14
FDA Warning Letter (drug product)
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