Suppliers / Laboratoires Besins International

Laboratoires Besins International

France Updated 9 July 2026

Laboratoires Besins International is a finished-dose manufacturer based in France. It appears in 93 regulatory filings across 11 regulators, without an active US DMF or CEP on file. Its filings concentrate with EMA, AIFA (IT) and INFARMED (PT). Its GMP standing is certified by ANSM (FR), EMA and NAFDAC (NG), among 4 authorities. Its most recent recorded inspection, by US FDA, closed on 20 April 2022 as VAI.

0
active US DMFs
0
valid CEPs
3
registered plants 1 with an FDA FEI number
93
filings across 11 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
4 of 4 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

  • 20 April 2022 VAI US FDA
  • 13 March 2019 VAI US FDA
  • 12 March 2015 VAI US FDA
  • 8 March 2013 VAI US FDA

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

Registered plants

Site FDA FEI
Montrouge, France Not on file
Paris, France Not on file
France, France 3002844244

Filings and GMP by regulator

Regulator Filings GMP certificates
EMA 40 4
AIFA (IT) 22 None
INFARMED (PT) 10 None
MPA (SE) 7 None
SFDA (Saudi Arabia) 3 None
URPL (PL) 3 None
ANSM (FR) None 18
NAFDAC (NG) None 1
EAEU_EEC None 1

Scale

Year Revenue Exports Destinations
2024 $31.5M 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 We do not publish the identity of any buyer.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 Laboratoires Besins International

Does Laboratoires Besins International hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Laboratoires Besins International. It does have 93 filings with 11 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Laboratoires Besins International FDA-registered?
One site operated by Laboratoires Besins International 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 Laboratoires Besins International's last inspection go?
The most recent inspection on record closed on 20 April 2022 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 4 inspections are on file.
Where does Laboratoires Besins International manufacture?
3 registered sites are on record, in France (Montrouge, Paris and France). Every site is listed on this page with the register it came from.
Which regulators recognise Laboratoires Besins International's GMP?
Current GMP certificates are on record from ANSM (FR), EMA, NAFDAC (NG) 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 20 April 2022.

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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
EudraGMDP and national regulators
GMP certificates
Company filings
Revenue as reported