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
- Nonnenwald 2, Penzberg, D-82377, Germany (DEU)
- Operations here
- analysisapi manufacture
- FDA identifiers
- FEI 3002806560 · DUNS 323105205
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIBlood and Blood Products2025-08-01
- VAIDrug Quality Assurance2025-05-22
- VAIDrug Quality Assurance2020-09-16
- VAIDrug Quality Assurance2016-04-29
- VAIDrug Quality Assurance2014-05-16
- VAIDrug Quality Assurance2012-10-16
- VAIDrug Quality Assurance2010-06-25
Drugs this plant is listed as making
21 distinct drugs across 48 products name this site in their FDA label.
- atezolizumabGenentech, Inc.
- atezolizumab and hyaluronidase-tqjsGenentech, Inc.
- bevacizumabGenentech, Inc.
- CrovalimabGenentech, Inc.
- dornase alfaGenentech, Inc.
- emicizumabGenentech, Inc.
- FaricimabGenentech, Inc.
- GlofitamabGenentech, Inc.
- Methoxy polyethylene glycol-epoetin betaVifor (International) Inc.
- obinutuzumabGenentech, Inc.
- ocrelizumabGenentech, Inc.
- ocrelizumab and hyaluronidaseGenentech, Inc.
- omalizumabGenentech, Inc.
- PertuzumabGenentech, Inc.
- pertuzumab, trastuzumab, and hyaluronidase-zzxfGenentech, Inc.
- polatuzumab vedotinGenentech, 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.