Drug factory · FDA FEI 3000998501

Carbogen Amcis Ag

Hauptstrasse 171, Bubendorf, Switzerland

Switzerland: 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.

5 drug inspections on record since 2011: 2 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
BedaquilineMakes the active ingredient Janssen Products LP 59676-701, 59676-702
MaribavirMakes the active ingredient and tests it Takeda Pharmaceuticals America, Inc. 64764-800
Tisotumab VedotinTests it Seagen Inc. 51144-003

FDA inspection history

EndedResultProgramProblems noted
Nov 14, 2025Problems found, fixed voluntarilyDrug Quality Assurance—
Dec 16, 2022Problems found, fixed voluntarilyDrug Quality Assurance—
Sep 8, 2017No problems foundDrug Quality Assurance—
Mar 14, 2014Problems found, fixed voluntarilyDrug Quality Assurance—
Sep 29, 2011No problems foundDrug Quality Assurance—

Registered with FDA for: analysis; api manufacture.