Bayer AG
A single plant registered with the FDA to make drugs for the US market. Below is where it is and the drugs whose FDA labels list this site as performing a manufacturing step — so if this plant has a problem, these are the products that could be affected.
- Country
- Germany
- Registered address
- Ernst-Schering-Str. 14, Bergkamen, 59192, Germany (DEU)
- Operations here
- analysisapi manufacture
- FDA identifiers
- FEI 3002808084 · DUNS 314398484
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2024-11-14
- VAIDrug Quality Assurance2019-10-10
- NAIDrug Quality Assurance2018-06-15
- NAIDrug Quality Assurance2015-11-12
- VAIDrug Quality Assurance2013-05-24
- NAIDrug Quality Assurance2010-02-12
- OAIDrug Quality Assurance2009-03-10
Drugs this plant is listed as making
11 distinct drugs across 20 products name this site in their FDA label.
- drospirenone and ethinyl estradiolBayer HealthCare Pharmaceuticals Inc.
- Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calciumBayer HealthCare Pharmaceuticals Inc.
- estradiol valerate and estradiol valerate/dienogestBayer HealthCare Pharmaceuticals Inc.
- finerenoneBayer HealthCare Pharmaceuticals Inc.
- gadobutrolBayer HealthCare Pharmaceuticals Inc.
- iopromideBayer HealthCare Pharmaceuticals Inc.
- LevonorgestrelBayer HealthCare Pharmaceuticals Inc.
- rivaroxabanJanssen Pharmaceuticals, Inc.
Sources:the establishment's name, address, and country from FDA's Drug Establishments Current Registration Site (DECRS); the drug-to-facility links from DailyMed SPL drug labels, matched by the facility's DUNS number; inspection outcomes from the FDA Data Dashboard, matched by FEI; shortage status from FDA's drug shortage database. More on how this is built. Educational only.