Simtra Deutschland GmbH
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
- Kantstrasse 2, Halle/Westfalen, 33790, Germany (DEU)
- Operations here
- analysisapi manufacturelabelmanufacturepackparticle size reductionsterilize
- FDA identifiers
- FEI 3002806419 · DUNS 344276063
Recent inspection flagged official action
FDA classified an inspection here as OAI (official action indicated) within the last two years — the strongest public warning signal a facility gets. This plant is listed on labels for 9 drugs. A supply problem here can ripple to all of them.
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- OAIDrug Quality Assurance2025-09-26
- NAIDrug Quality Assurance2023-05-03
- VAIDrug Quality Assurance2020-01-29
- NAIDrug Quality Assurance2019-09-03
- VAIDrug Quality Assurance2018-06-14
- VAIDrug Quality Assurance2017-06-27
- VAIDrug Quality Assurance2016-03-18
- NAIDrug Quality Assurance2014-07-01
- NAIDrug Quality Assurance2013-07-20
- NAIDrug Quality Assurance2011-08-26
- NAIDrug Quality Assurance2010-07-22
Drugs this plant is listed as making
9 distinct drugs across 13 products name this site in their FDA label.
- (daunorubicin and cytarabine) liposomeJazz Pharmaceuticals, Inc.
- cyclophosphamideBluePoint Laboratories
- LurbinectedinJazz Pharmaceuticals, Inc.
- MecaserminEton Pharmaceuticals, Inc.
- mesnaBamboo US Bidco LCC
- PralatrexateFresenius Kabi USA, LLC
- TrabectedinJanssen Products, LP
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.