Antibiotice S.A.
Produttore farmaceutico rumeno e fornitore globale di API nistatina.
Antibiotice S.A. produce API nistatina, prodotti farmaceutici generici e medicinali da banco a Iași. Fondata nel 1955, l'azienda è uno dei principali produttori di nistatina al mondo ed esporta verso distributori farmaceutici e acquirenti di prodotti sanitari in Europa, Africa e Asia.
- Type
- brand seeking distribution
- Location
- Iași, Romania
- Founded
- 1955
- Website
- antibiotice.ro
- Categories
- Forniture medicali e sanitarie
- Markets
- Romania, Moldavia, Ucraina, Turchia
Verified facts
- corporate-mail-on-domain (green), checked 2026-08-03 Mail server of the company domain
- sanctions-clear (green), checked 2026-08-03 OpenSanctions
- 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
- workforce-on-record (green), checked 2026-08-16 ANAF, situații financiare depuse (România)
- product-authorised-for-sale (green), checked 2026-08-21 Ministry of Health of Armenia, State Register of Medicinal Products (pharm.am)
- gmp-certified (green), checked 2023-03-01 EudraGMDP, EU register of GMP certificates (EMA)
- certificate-page-on-site (amber), checked 2026-08-30 Company's own certification page
- registry-activity (green), checked 2026-08-19 Oficiul Național al Registrului Comerțului, date deschise (data.gov.ro)
- operating-permit (green), checked 2026-08-19 EudraGMDP manufacturing authorisation register (EMA)
- lei-active (green), checked 2026-08-16 GLEIF global LEI register (golden copy)
- vat-valid (green), checked 2026-08-03 VIES
- leadership-on-record (green), checked 2026-08-19 Oficiul Național al Registrului Comerțului, date deschise (data.gov.ro)
- registered-address (green), checked 2026-08-19 Oficiul Național al Registrului Comerțului, date deschise (data.gov.ro)
- registered-since (green), checked 2026-08-19 Oficiul Național al Registrului Comerțului, date deschise (data.gov.ro)
- registry-active-global (green), checked 2026-08-19 Oficiul Național al Registrului Comerțului, date deschise (data.gov.ro)
- registry-id-verified (green), checked 2026-08-19 Oficiul Național al Registrului Comerțului, date deschise (data.gov.ro)
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)