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
- AZAHIGASHIYAMA5006-5, OMAGARI, YOSHINOGARICHO, Kanzaki-gun, Saga 842-0103, Japan (JPN)
- Operations here
- analysisapi manufacture
- FDA identifiers
- FEI 3003808559 · DUNS 695314260
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2025-07-11
- VAIDrug Quality Assurance2019-02-01
- VAIDrug Quality Assurance2016-04-08
- VAIDrug Quality Assurance2014-12-05
- VAIDrug Quality Assurance2012-07-25
- VAIDrug Quality Assurance2011-10-14
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.