Drug factory · FDA FEI 3004015296

Yuhan Chemical Inc.

45 Jiwon-ro, Danwon-gu, Ansan-si, South Korea

South Korea: 1

Problems found, fixed voluntarily at FDA's last inspection, Feb 28, 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: 1 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
Cobicistat and DarunavirMakes the active ingredient Janssen Products LP 59676-575, 59676-578
Darunavir, Cobicistat, Emtricitabine, and Tenofovir AlafenamideMakes the active ingredient Janssen Products LP 59676-800
LazertinibMakes the active ingredient Janssen Biotech, Inc. 57894-080, 57894-240
Piperacillin and TazobactamMakes the active ingredient Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. 0206-8860, 0206-8861, 0206-8862

FDA inspection history

EndedResultProgramProblems noted
Feb 28, 2025Problems found, fixed voluntarilyDrug Quality Assurance—
Jan 17, 2020Problems found, fixed voluntarilyDrug Quality Assurance—
Sep 22, 2017Problems found, fixed voluntarilyDrug Quality Assurance—
Dec 4, 2015Problems found, fixed voluntarilyDrug Quality Assurance—
Jun 27, 2014No problems foundDrug Quality Assurance—
Nov 8, 2012Problems found, fixed voluntarilyDrug Quality Assurance—

Registered with FDA for: analysis; api manufacture.