Antibiotice S.A.
ルーマニアの製薬メーカーであり、ナイスタチン API の世界的なサプライヤーです。
Antibiotice S.A. はヤシでナイスタチン API、ジェネリック医薬品、OTC 医薬品を製造しています。 1955 年に設立された同社は、世界の主要なナイスタチン生産者の 1 つであり、ヨーロッパ、アフリカ、アジアの医薬品販売業者やヘルスケア バイヤーに輸出しています。
- Type
- Manufacturer
- Location
- Iași, Romania
- Founded
- 1955
- Website
- antibiotice.ro
- Categories
- 医療およびヘルスケア用品
- Markets
- ルーマニア, モルドバ, ウクライナ, トルコ
Verified facts
- lei-active (green), checked 2026-08-07 GLEIF global LEI register (golden copy)
- sanctions-clear (green), checked 2026-08-03 OpenSanctions
- vat-valid (green), checked 2026-08-03 VIES
- web-presence-since (green), checked 2026-08-03 Internet Archive (Wayback)
- debarment-clear (green), checked 2026-08-03 OpenSanctions
- media-mention (green), checked 2026-06-05 news.ro
- corporate-mail-on-domain (green), checked 2026-08-03 Mail server of the company domain
- gmp-certified (green), checked 2023-03-01 EudraGMDP, EU register of GMP certificates (EMA)
Claimed certifications
- Good Manufacturing Practice
- ISO 9001, Quality Management IAF CertSearch
- ISO 14001, Environmental 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)