Suppliers / Laboratoire Unither

Laboratoire Unither

France Updated 9 July 2026

Laboratoire Unither is a finished-dose manufacturer based in France. It appears in 22 regulatory filings across 5 regulators, without an active US DMF or CEP on file. Its filings concentrate with EDE (AE), NPRA (MY) and MINSA (CR). Its GMP standing is certified by ANSM (FR), EMA and EAEU_EEC. Its most recent recorded inspection, by US FDA, closed on 22 October 2021 as VAI.

0
active US DMFs
0
valid CEPs
9
registered plants 1 with an FDA FEI number
22
filings across 5 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

  • 22 October 2021 VAI US FDA
  • 21 June 2018 VAI US FDA
  • 15 September 2015 VAI US FDA
  • 19 September 2013 VAI US FDA
  • 16 May 2011 VAI US FDA

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

Registered plants

Site FDA FEI
Amiens, United Arab Emirates Not on file
80084 Amiens, United Arab Emirates Not on file
Amiens Cedex 2, United Arab Emirates Not on file
Coutances Cedex, United Arab Emirates Not on file
Coutances, United Arab Emirates Not on file
Amiens, France Not on file

3 further sites are on record.

Filings and GMP by regulator

Regulator Filings GMP certificates
EDE (AE) 8 None
NPRA (MY) 6 None
MINSA (CR) 5 None
DIGEMAPS (DO) 2 None
ARCSA (EC) 1 None
ANSM (FR) None 10
EMA None 2
EAEU_EEC None 1

Scale

Year Revenue Exports Destinations
2024 $311.6M Not reported Not reported

Export figures are customs aggregates. We do not publish the identity of any buyer. Revenue shown in US dollars, converted from the reported currency.

Questions about Laboratoire Unither

Does Laboratoire Unither hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Laboratoire Unither. It does have 22 filings with 5 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Laboratoire Unither FDA-registered?
One site operated by Laboratoire Unither 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 Laboratoire Unither's last inspection go?
The most recent inspection on record closed on 22 October 2021 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 5 inspections are on file.
Where does Laboratoire Unither manufacture?
9 registered sites are on record, in United Arab Emirates and France (Amiens, 80084 Amiens and Amiens Cedex 2 among others). Every site is listed on this page with the register it came from.
Which regulators recognise Laboratoire Unither's GMP?
Current GMP certificates are on record from ANSM (FR), EMA and EEC (Eurasian Economic Union). 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 22 October 2021.

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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
Company filings
Revenue as reported