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
- Matsudani, Itano-cho, Itano-gun, Tokushima 779-0112, Japan (JPN)
- Operations here
- analysismanufacture
- FDA identifiers
- FEI 3003656524 · DUNS 694877866
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- NAIDrug Quality Assurance2025-10-10
- VAIDrug Quality Assurance2019-02-15
- VAIDrug Quality Assurance2016-07-22
- VAIDrug Quality Assurance2014-03-20
- VAIDrug Quality Assurance2011-10-21
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.