Astellas Pharma 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
- 160-2, Akahama, Takahagi, Ibaraki 318-0004, Japan (JPN)
- Operations here
- analysisapi manufacture
- FDA identifiers
- FEI 3002808523 · DUNS 695087171
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2025-06-06
- NAIDrug Quality Assurance2018-12-13
- NAIDrug Quality Assurance2014-06-27
- VAIDrug Quality Assurance2009-10-15
Drugs this plant is listed as making
1 distinct drugs across 3 products name this site in their FDA label.
- mirabegronAstellas Pharma US, 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.