ROTOP Pharmaka 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
- Bautzner Landstrasse 400, Dresden, saxony 01328, Germany (DEU)
- Operations here
- analysisapi manufacturelabelmanufacturepack
- FDA identifiers
- FEI 3009075542 · DUNS 314666202
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2021-07-02
- VAIDrug Quality Assurance2018-12-07
Drugs this plant is listed as making
1 distinct drugs across 1 products name this site in their FDA label.
- SuccimerTheragnostics 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.