Suppliers / Loba biotech

Loba biotech

Austria Updated 9 July 2026

Loba biotech is an API manufacturer based in Austria. It holds one active US drug master file and 2 valid CEPs. Its GMP standing is certified by EMA. Its most recent recorded inspection, by US FDA, closed on 13 October 2022 as VAI.

1
active US DMFs
2
valid CEPs
2
registered plants 1 with an FDA FEI number
0
filings across 0 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
5 of 5 confirmed
EU GMP
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026. EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Inspection history

  • 13 October 2022 VAI US FDA
  • 17 August 2018 VAI US FDA
  • 24 June 2016 VAI US FDA
  • 30 January 2014 NAI US FDA
  • 23 September 2010 NAI US FDA

NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.

Registered plants

Site FDA FEI
Fischamend, Austria Not on file
Austria, Austria 3002807485

What they file, and where

Molecule Regulators Docs
Naphazoline EDQM, US FDA 3

Also appears on these molecule pages

Naphazoline API

Filings and GMP by regulator

Regulator Filings GMP certificates
EMA None 2

Questions about Loba biotech

Does Loba biotech hold a US DMF or a CEP?
Loba biotech holds 1 active US drug master file and 2 valid CEPs. 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 Loba biotech FDA-registered?
One site operated by Loba biotech 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 Loba biotech's last inspection go?
The most recent inspection on record closed on 13 October 2022 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 5 inspections are on file.
Where does Loba biotech manufacture?
2 registered sites are on record, in Austria (Fischamend and Austria). Every site is listed on this page with the register it came from.
What does Loba biotech make?
1 molecule is on record against Loba biotech, including Naphazoline. Each links through to that molecule's full manufacturer list.
Which regulators recognise Loba biotech's GMP?
Current GMP certificates are on record from EMA. GMP recognition covers the manufacturing site, separately from any filing on the substance itself.

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 13 October 2022.

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Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates