Hisamitsu Pharmaceutical Co., 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
- Japan
- Registered address
- 408, Tashirodaikammachi, Tosu, Saga 841-0017, Japan (JPN)
- Operations here
- manufacture
- FDA identifiers
- FEI 1000266995 · DUNS 690539713
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2025-07-04
- VAIDrug Quality Assurance2019-05-31
- VAIDrug Quality Assurance2017-09-15
- VAIDrug Quality Assurance2014-04-11
- VAIDrug Quality Assurance2012-02-17
- NAIDrug Quality Assurance2009-04-01
- NAIPostmarket Surv. and Epidemiology2009-04-01
Drugs this plant is listed as making
1 distinct drugs across 3 products name this site in their FDA label.
- AsenapineNoven Therapeutics, 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.