Aesica Pharmaceuticals 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
- Galileistr. 6, Zwickau, 08056, Germany (DEU)
- Operations here
- analysismanufacture
- FDA identifiers
- FEI 3002948883 · DUNS 341970412
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2023-08-31
- NAIDrug Quality Assurance2019-08-30
- VAIDrug Quality Assurance2016-12-02
- VAIDrug Quality Assurance2014-06-20
- VAIDrug Quality Assurance2011-11-08
Drugs this plant is listed as making
1 distinct drugs across 1 products name this site in their FDA label.
- Carglumic AcidRecordati Rare Diseases
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.