PharmaZell 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
- Rosenheimer Strasse 43, Raubling, Bavaria 83064, Germany (DEU)
- Operations here
- api manufacture
- FDA identifiers
- FEI 3003725792 · DUNS 506639652
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2022-06-30
- VAIDrug Quality Assurance2017-09-22
- VAIDrug Quality Assurance2014-12-12
- NAIDrug Quality Assurance2011-12-08
Drugs this plant is listed as making
3 distinct drugs across 5 products name this site in their FDA label.
- AcetylcysteineGlenmark Pharmaceuticals Inc., USA
- mesalamineTakeda Pharmaceuticals America, 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.