Bayer Aktiengesellschaft
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
- Max-Dohrn-Str. 8, Berlin, 10589, Germany (DEU)
- Operations here
- analysispackparticle size reduction
- FDA identifiers
- FEI 3002808063 · DUNS 342872971
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2023-06-16
- VAIDrug Quality Assurance2020-07-02
- NAIDrug Quality Assurance2017-09-15
- NAIDrug Quality Assurance2014-03-27
- NAIDrug Quality Assurance2011-07-14
Drugs this plant is listed as making
8 distinct drugs across 11 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.
- finerenoneBayer 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.