Yuhan Chemical Inc.
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
- Korea, South
- Registered address
- 45 Jiwon-ro, Danwon-gu, Ansan-si, Gyeonggi-do 15619, Korea, South (KOR)
- Operations here
- analysisapi manufacture
- FDA identifiers
- FEI 3004015296 · DUNS 687831958
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2025-02-28
- VAIDrug Quality Assurance2020-01-17
- VAIDrug Quality Assurance2017-09-22
- VAIDrug Quality Assurance2015-12-04
- NAIDrug Quality Assurance2014-06-27
- VAIDrug Quality Assurance2012-11-08
Drugs this plant is listed as making
4 distinct drugs across 8 products name this site in their FDA label.
- DARUNAVIR ETHANOLATE and COBICISTATJanssen Products, LP
- Darunavir, Cobicistat, Emtricitabine, and Tenofovir alafenamideJanssen Products LP
- lazertinibJanssen Biotech, Inc.
- TAZOBACTAM SODIUM and PIPERACILLIN SODIUMWyeth Pharmaceuticals LLC, a subsidiary of Pfizer 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.