Antibiotice S.A.
Romanian pharmaceutical manufacturer and global supplier of nystatin API.
Antibiotice S.A. manufactures nystatin API, generic pharmaceuticals, and OTC medicines in Iași. Founded in 1955, the company is one of the world's main nystatin producers and exports to pharmaceutical distributors and healthcare buyers across Europe, Africa, and Asia.
- Type
- Manufacturer
- Location
- Iași, Romania
- Founded
- 1955
- Website
- antibiotice.ro
- Categories
- Medical & Healthcare Supplies
- Markets
- Romania, Moldova, Ukraine, Turkey
Verified facts
- certificate-page-on-site (amber), checked 2026-08-11 Company's own certification page
- corporate-mail-on-domain (green), checked 2026-08-03 Mail server of the company domain
- 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
- 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)
- 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)
- 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-manufacturer (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)