Sumitomo Chemical Company, Limited
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
- 6-4-1, Kojimatanokuchi, Kurashiki, Okayama 711-0903, Japan (JPN)
- Operations here
- api manufacture
- FDA identifiers
- FEI 3003973514 · DUNS 711530345
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- NAIDrug Quality Assurance2023-11-02
- VAIDrug Quality Assurance2016-07-15
- NAIDrug Quality Assurance2011-08-25
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.