Astellas Pharma Inc
泌尿器科、腫瘍科、移植医療を専門とする世界的な製薬会社…
泌尿器科、腫瘍科、移植医療を専門とする世界的な製薬会社で、15 か国で製造を行っています。
- Type
- Manufacturer
- Location
- Tokyo, Japan
- Founded
- 2005
- Website
- astellas.com
- Categories
- 医療およびヘルスケア用品
- Markets
- 日本, アメリカ合衆国, ドイツ, イギリス, オランダ
Verified facts
- sanctions-clear (green), checked 2026-08-04 OpenSanctions
- debarment-clear (green), checked 2026-08-04 OpenSanctions
- corporate-mail-on-domain (green), checked 2026-08-04 Mail server of the company domain
- domain-registered (green), checked 2026-08-04 Domain registry record
Claimed certifications
- Good Manufacturing Practice
- FDA Registered FDA Establishment Registration
- ISO 9001, Quality Management IAF CertSearch
Import rules for these goods
- Medical devices sold in the EU must carry CE marking under the Medical Device Regulation (EU) 2017/745, with a conformity assessment matched to the device risk class. European Commission (MDR)
- For the US market, the maker must have an FDA device establishment registration and product listing; most instruments also need 510(k) premarket clearance. US FDA (devices)