Otsuka 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
- KAGASUNO463-10, KAWAUCHICHO, Tokushima, TOKUSHIMA 771-0130, Japan (JPN)
- Operations here
- analysismanufacture
- FDA identifiers
- FEI 3002809299 · DUNS 695314484
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- NAIDrug Quality Assurance2025-05-16
- NAIDrug Quality Assurance2019-10-10
- VAIDrug Quality Assurance2017-12-08
- VAIDrug Quality Assurance2016-04-15
- VAIDrug Quality Assurance2014-09-18
- VAIDrug Quality Assurance2012-08-02
Drugs this plant is listed as making
1 distinct drugs across 7 products name this site in their FDA label.
- tolvaptanOtsuka America Pharmaceutical, 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.