KAKEN Pharmaceutical Co., 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
- Japan
- Registered address
- 301 Gensuke, Fujieda-shi, Shizuoka 426-8646, Japan (JPN)
- Operations here
- analysisapi manufacturelabelmanufacturepack
- FDA identifiers
- FEI 3002807376 · DUNS 706296951
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- NAIDrug Quality Assurance2023-09-01
- VAIDrug Quality Assurance2018-06-22
- VAIDrug Quality Assurance2014-03-28
- NAIDrug Quality Assurance2012-11-14
Drugs this plant is listed as making
1 distinct drugs across 1 products name this site in their FDA label.
- efinaconazoleBausch Health US LLC
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.