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
- Mullerstr. 178, Berlin, 13353, Germany (DEU)
- Operations here
- analysisapi manufacturelabelmanufacturepacksterilize
- FDA identifiers
- FEI 3002808086 · DUNS 315097875
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2024-06-06
- VAIDrug Quality Assurance2021-08-27
- VAIDrug Quality Assurance2019-09-24
- NAIDrug Quality Assurance2017-01-24
- VAIDrug Quality Assurance2014-05-13
- NAIBioresearch Monitoring2014-04-17
- VAIDrug Quality Assurance2012-09-18
- NAIDrug Quality Assurance2010-11-19
- NAIBioresearch Monitoring2010-11-16
Drugs this plant is listed as making
7 distinct drugs across 8 products name this site in their FDA label.
- drospirenone and ethinyl estradiolBayer HealthCare Pharmaceuticals Inc.
- Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calciumSandoz Inc
- estradiol valerate and estradiol valerate/dienogestBayer HealthCare Pharmaceuticals Inc.
- gadobutrolBayer HealthCare Pharmaceuticals Inc.
- interferon beta-1bBayer HealthCare Pharmaceuticals Inc.
- iopromideBayer HealthCare 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.