Suppliers / Antibiotice

Antibiotice

Romania 635 employees 2 duplicate records merged Updated 9 July 2026

Antibiotice is an API and finished-dose manufacturer based in Romania. It holds one active US drug master file. Its filings concentrate with EDE (AE), DAV (Vietnam) and DPM (TN). Its most recent recorded inspection, by US FDA, closed on 14 October 2022 as VAI.

1
active US DMFs
0
valid CEPs
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
Plants
1 of 1 confirmed
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

Nystatin API Pyrazinamide finished dose

Filings and GMP by regulator

Regulator Filings GMP certificates
EDE (AE) 17 None
DAV (Vietnam) 10 None
DPM (TN) 10 None
MPA (SE) 9 None
EMA 5 None
EEC_EAEU 3 None

Questions about Antibiotice

Does Antibiotice hold a US DMF or a CEP?
Antibiotice holds 1 active US drug master file. A drug master file is a submission to the FDA describing how an ingredient is made; a CEP is the EDQM's certificate that the substance meets its European Pharmacopoeia monograph. Both are filings rather than approvals.
Is Antibiotice FDA-registered?
One site operated by Antibiotice carries an FDA establishment identifier (FEI), which means it is registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Antibiotice's last inspection go?
The most recent inspection on record closed on 14 October 2022 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 5 inspections are on file.
Where does Antibiotice manufacture?
2 registered sites are on record, in United Arab Emirates and Romania (Iasi and Romania). Every site is listed on this page with the register it came from.
What does Antibiotice make?
1 molecule is on record against Antibiotice, including Nystatin. Each links through to that molecule's full manufacturer list.
Where does Antibiotice file?
Filings are on record with EDE (AE), DAV (Vietnam), DPM (TN), MPA (SE) and 3 other regulators, 56 in total.

Answered from this company's own record. Where a register holds nothing, the question is not asked rather than answered with a zero. How we count our figures.

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Open risk flags

  • The most recent inspection outcome was VAI, on 14 October 2022.

Comparable suppliers

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Ranked by shared active ingredients where we have them, otherwise by country and comparable credentials.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability