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
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 (MICRONIZED) DRUG SUBSTANCEActive2008-07-23
- RIVAROXABAN COATED TABLETS, 10 MGActive2008-07-23
- EOB-DTPAActive2007-05-14
- NORGESTRELActive2004-04-16
- ILOPROSTActive2004-02-18
- TESTOSTERONE UNDECANOATE 750 MG I.M.Active2003-08-15
- TESTOSTERONE UNDECANOATEActive2003-08-15
- 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 procedures fail to include
- 4832020-07-27
Prevention of cross contamination, mix-ups
- 4832020-07-27
Scientifically sound laboratory controls
- 4832020-07-27
Written record of investigation incomplete
- 4832020-07-27
Control procedures to monitor and validate performance
- 4832019-09-24
Cleaning System
- 4832019-09-24
Top/Middle/Bottom container sampling
- 4832019-09-24
Written procedures not established/followed
- 4832019-03-22
Identification of containers, lines, equipment
- 4832019-03-22
Following/documenting laboratory controls
- 4832019-03-22
Prepared for each batch, include complete information
- 4832019-03-22
Labels and labeling stored separately
- 4832019-03-22
Written procedures fail to include
- 4832019-03-22
Control procedures to monitor and validate performance
- warning_letter2017-11-14
FDA Warning Letter (drug product)
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