Suppliers / Fareva Unterach

Fareva Unterach

Austria Updated 9 July 2026

Fareva Unterach is a finished-dose manufacturer based in Austria. It appears in 242 regulatory filings across 9 regulators, without an active US DMF or CEP on file. Its filings concentrate with EDE (AE), UZPHARM (UZ) and MINSA (CR). Its GMP standing is certified by NCELS (KZ), ANVISA (Brazil) and EMA. Its most recent recorded inspection, by US FDA, closed on 2 June 2022 as VAI.

0
active US DMFs
0
valid CEPs
4
registered plants 1 with an FDA FEI number
242
filings across 9 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
7 of 7 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

  • 2 June 2022 VAI US FDA
  • 10 July 2019 VAI US FDA
  • 8 May 2019 VAI US FDA
  • 18 December 2014 NAI US FDA
  • 23 October 2012 OAI US FDA
  • 25 July 2011 VAI US FDA
  • 12 March 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
Unterach, United Arab Emirates Not on file
UNTERACH AM ATTERSEE, Austria Not on file
Austria, Austria 3002829723
Oberoesterreich, Austria Not on file

Filings and GMP by regulator

Regulator Filings GMP certificates
EDE (AE) 202 None
UZPHARM (UZ) 12 None
MINSA (CR) 10 None
FDA (GH) 8 None
NAFDAC (NG) 3 None
NCELS (KZ) 2 2
ANVISA (Brazil) None 1
EMA None 1

Questions about Fareva Unterach

Does Fareva Unterach hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Fareva Unterach. It does have 242 filings with 9 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Fareva Unterach FDA-registered?
One site operated by Fareva Unterach 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 Fareva Unterach's last inspection go?
The most recent inspection on record closed on 2 June 2022 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 7 inspections are on file, of which 1 closed as OAI.
Where does Fareva Unterach manufacture?
4 registered sites are on record, in United Arab Emirates and Austria (Unterach, Unterach AM Attersee and Austria among others). Every site is listed on this page with the register it came from.
Which regulators recognise Fareva Unterach's GMP?
Current GMP certificates are on record from NCELS (KZ), ANVISA (Brazil) and 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 2 June 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