BioChem Labor für biologische und chemische Analytik 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
- Daimlerstr. 5b, Karlsruhe, 76185, Germany (DEU)
- Operations here
- analysis
- FDA identifiers
- FEI 3004058183 · DUNS 318354230
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- NAIDrug Quality Assurance2022-03-23
- VAIDrug Quality Assurance2017-11-07
- NAIDrug Quality Assurance2016-01-19
- NAIDrug Quality Assurance2013-06-06
Drugs this plant is listed as making
8 distinct drugs across 29 products name this site in their FDA label.
- birch triterpenesAmryt Pharmaceuticals DAC
- gadobenate dimeglumineBracco Diagnostics Inc
- gadoteridolBracco Diagnostics Inc
- Iomeprol InjectionBracco Diagnostics Inc
- IopamidolBracco Diagnostics Inc
- MotixafortideGamida Cell Inc.
- oteseconazoleMycovia 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.