Roche Diagnostics 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
- Sandhofer Strasse 116, Mannheim, D-68305, Germany (DEU)
- Operations here
- analysisapi manufacturelabelmanufacturepack
- FDA identifiers
- FEI 3002806559 · DUNS 315028860
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2021-10-29
- NAIDrug Quality Assurance2016-04-22
- VAIDrug Quality Assurance2014-04-04
- VAIDrug Quality Assurance2012-04-26
- NAIDrug Quality Assurance2009-06-19
Drugs this plant is listed as making
18 distinct drugs across 37 products name this site in their FDA label.
- Ado-Trastuzumab EmtansineGenentech, Inc.
- atezolizumabGenentech, Inc.
- atezolizumab and hyaluronidase-tqjsGenentech, Inc.
- CrovalimabGenentech, Inc.
- GlofitamabGenentech, Inc.
- Methoxy polyethylene glycol-epoetin betaVifor (International) Inc.
- obinutuzumabGenentech, Inc.
- ocrelizumabGenentech, Inc.
- ocrelizumab and hyaluronidaseGenentech, Inc.
- PertuzumabGenentech, Inc.
- pertuzumab, trastuzumab, and hyaluronidase-zzxfGenentech, Inc.
- polatuzumab vedotinGenentech, Inc.
- RanibizumabGenentech, Inc.
- rituximabGenentech, Inc.
- rituximab and hyaluronidaseGenentech, Inc.
- tocilizumabGenentech, Inc.
- TrastuzumabGenentech, Inc.
- Trastuzumab and hyaluronidase-oyskGenentech, 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.