Kowa Company, 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
- 2-18-57, Hatooka, Kita-ku, Nagoya, AICHI 462-0024, Japan (JPN)
- Operations here
- analysismanufacture
- FDA identifiers
- FEI 3007065180 · DUNS 717190628
FDA inspection history
Outcomes of closed FDA inspections at this site, every FDA program area; the official-action banner above considers Drug Quality Assurance inspections only.
- NAIDrug Quality Assurance2023-09-01
- VAIDrug Quality Assurance2016-12-09
- VAIDrug Quality Assurance2011-10-21
Drugs this plant is listed as making
1 distinct drugs across 3 products name this site for a manufacturing step (any MANUFACTURE-type role, API included). Counts are per distinct generic name (case-insensitive).
- pitavastatin calciumKowa Pharmaceuticals America, 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.