bene pharmaChem GmbH & Co. KG
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
- Bayerwaldstr. 7-9, Geretsried, Bavaria 82538, Germany (DEU)
- Operations here
- api manufacture
- FDA identifiers
- FEI 3006803926 · DUNS 332479380
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2018-11-08
- NAIDrug Quality Assurance2014-05-21
- VAIDrug Quality Assurance2011-07-08
- VAIDrug Quality Assurance2008-10-23
Drugs this plant is listed as making
1 distinct drugs across 1 products name this site in their FDA label.
- Pentosan Polysulfate SodiumJanssen 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.