Rottendorf Pharma 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
- Ostenfelder Strasse 51-61, Ennigerloh, 59320, Germany (DEU)
- Operations here
- analysislabelmanufacturepack
- FDA identifiers
- FEI 3003732290 · DUNS 315974691
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2024-03-14
- VAIDrug Quality Assurance2021-05-06
- VAIDrug Quality Assurance2019-02-21
- VAIDrug Quality Assurance2017-02-03
- NAIDrug Quality Assurance2014-03-14
- VAIDrug Quality Assurance2012-03-30
Drugs this plant is listed as making
5 distinct drugs across 13 products name this site in their FDA label.
- cabozantinibExelixis, Inc.
- EmpagliflozinBoehringer Ingelheim Pharmaceuticals, Inc.
- empagliflozin and linagliptinBoehringer Ingelheim Pharmaceuticals, Inc.
- TacrolimusVeloxis Pharmaceuticals, Inc
- telmisartan and hydrochlorothiazideBoehringer Ingelheim 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.