Antibiotice
United Arab Emirates 635 employees 2 duplicate records merged Updated 9 July 2026
Antibiotice is an API and finished-dose manufacturer based in United Arab Emirates. It holds one active US drug master file. Its filings concentrate with EDE (AE), DPM (TN) and DAV (Vietnam). Its most recent recorded inspection, by US FDA, closed on 14 October 2022 as VAI.
2
registered plants
1 with an FDA FEI number
56
filings
across 7 regulators
These figures were checked against the regulators' own files on 25 July 2026
Inspections
5 of 5 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.
Inspection history
- 14 October 2022 VAI US FDA
- 11 October 2019 VAI US FDA
- 14 March 2017 VAI US FDA
- 22 January 2013 NAI US FDA
- 9 November 2010 VAI US FDA
NAI means no action indicated, VAI means voluntary action indicated, and OAI means
official action indicated.
Registered plants
| Site | FDA FEI |
| Iasi, United Arab Emirates | Not on file |
| Romania, Romania | 3003489017 |
What they file, and where
| Molecule | Regulators | Docs |
| Nystatin | SFDA (Saudi Arabia), US FDA | 3 |
Also appears on these molecule pages
Filings and GMP by regulator
| Regulator | Filings | GMP certificates |
| EDE (AE) | 17 | None |
| DPM (TN) | 10 | None |
| DAV (Vietnam) | 10 | None |
| MPA (SE) | 9 | None |
| EMA | 5 | None |
| EEC_EAEU | 3 | None |
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Open risk flags
- The most recent inspection outcome was VAI, on 14 October 2022.
Sources on this page
- FDA
- Drug master files, establishment registration, inspection classifications
- EDQM
- Certificates of suitability