Simafex
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
- France
- Registered address
- 16, avenue des Fours à Chaux, Marans, 17230, France (FRA)
- Operations here
- api manufacture
- FDA identifiers
- FEI 1000238384 · DUNS 381108273
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2025-01-31
- VAIDrug Quality Assurance2021-06-25
- VAIDrug Quality Assurance2016-05-27
- NAIDrug Quality Assurance2013-02-15
- VAIDrug Quality Assurance2011-07-13
Drugs this plant is listed as making
2 distinct drugs across 4 products name this site in their FDA label.
- ethiodized oilGuerbet LLC
- gadoterate meglumineGuerbet LLC
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.