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
- HIRAISHIEBISUNO224-18, KAWAUCHICHO, Tokushima, TOKUSHIMA 771-0132, Japan (JPN)
- Operations here
- analysisapi manufacturemanufacture
- FDA identifiers
- FEI 3002807834 · DUNS 695733295
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2024-03-22
- VAIDrug Quality Assurance2019-09-10
- VAIDrug Quality Assurance2018-03-23
- VAIDrug Quality Assurance2016-02-12
- VAIDrug Quality Assurance2014-06-26
- VAIDrug Quality Assurance2012-07-09
- VAIDrug Quality Assurance2011-10-27
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.