Drug factory · FDA FEI 3007164129

Roche Singapore Technical Operations Pte. Ltd.

10 Tuas Bay Link, Singapore, Singapore

Singapore: 1

Problems found, fixed voluntarily at FDA's last inspection, Nov 14, 2025.

Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.

6 drug inspections on record since 2012: 2 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
BevacizumabMakes the active ingredient and tests it Genentech, Inc. 50242-060, 50242-061
Hyaluronidase (human Recombinant) and Pertuzumab and TrastuzumabMakes the active ingredient and tests it Genentech, Inc. 50242-245, 50242-260
Hyaluronidase (human Recombinant) and TrastuzumabMakes the active ingredient and tests it Genentech, Inc. 50242-077
RanibizumabMakes the active ingredient and tests it Genentech, Inc. 50242-078, 50242-080, 50242-082
TrastuzumabMakes the active ingredient and tests it Genentech, Inc. 50242-132
Trastuzumab EmtansineTests it Genentech, Inc. 50242-087, 50242-088

FDA inspection history

EndedResultProgramProblems noted
Nov 14, 2025Problems found, fixed voluntarilyDrug Quality Assurance—
Oct 18, 2019No problems foundDrug Quality Assurance—
May 18, 2018No problems foundDrug Quality Assurance—
Aug 26, 2016Problems found, fixed voluntarilyDrug Quality Assurance—
Jun 24, 2014Problems found, fixed voluntarilyDrug Quality Assurance—
May 3, 2012Problems found, fixed voluntarilyDrug Quality Assurance—

Registered with FDA for: analysis; api manufacture.