Roche Singapore Technical Operations Pte. Ltd.
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
- Singapore
- Registered address
- 10 Tuas Bay Link, Singapore, 637394, Singapore (SGP)
- Operations here
- analysisapi manufacture
- FDA identifiers
- FEI 3007164129 · DUNS 937189173
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2025-11-14
- NAIDrug Quality Assurance2019-10-18
- NAIDrug Quality Assurance2018-05-18
- VAIDrug Quality Assurance2016-08-26
- VAIDrug Quality Assurance2014-06-24
- VAIDrug Quality Assurance2012-05-03
Drugs this plant is listed as making
7 distinct drugs across 11 products name this site in their FDA label.
- Ado-Trastuzumab EmtansineGenentech, Inc.
- bevacizumabGenentech, Inc.
- pertuzumab, trastuzumab, and hyaluronidase-zzxfGenentech, Inc.
- RanibizumabGenentech, 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.