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
- Kaiser-Wilhelm-Allee 101-103, Leverkusen, NW 51368, Germany (DEU)
- Operations here
- analysisapi manufacturelabelmanufacturepackparticle size reduction
- FDA identifiers
- FEI 3002806462 · DUNS 314947622
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2023-09-07
- NAIDrug Quality Assurance2022-05-13
- VAIDrug Quality Assurance2020-07-27
- OAIDrug Quality Assurance2019-03-22
- OAIDrug Quality Assurance2017-01-20
- NAIDrug Quality Assurance2016-06-03
- VAIDrug Quality Assurance2014-11-14
- VAIDrug Quality Assurance2012-07-09
- VAIDrug Quality Assurance2010-02-23
Drugs this plant is listed as making
9 distinct drugs across 17 products name this site in their FDA label.
- ciprofloxacinBayer HealthCare Pharmaceuticals Inc.
- ciprofloxacin hydrochlorideBayer HealthCare Pharmaceuticals Inc.
- finerenoneBayer HealthCare Pharmaceuticals Inc.
- praziquantelBayer HealthCare Pharmaceuticals Inc.
- regorafenibBayer HealthCare Pharmaceuticals Inc.
- RivaroxabanJanssen Pharmaceuticals, Inc.
- sorafenibBayer 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.