Suppliers / Ipsen Pharma Biotech

Ipsen Pharma Biotech

France Updated 9 July 2026

Ipsen Pharma Biotech is a finished-dose manufacturer based in France. It appears in 30 regulatory filings across 7 regulators, without an active US DMF or CEP on file. Its filings concentrate with NPRA (MY), EDE (AE) and MINSA (CR). Its GMP standing is certified by ANSM (FR), ANVISA (Brazil) and EMA, among 5 authorities. Its most recent recorded inspection, by US FDA, closed on 29 March 2024 as VAI.

0
active US DMFs
0
valid CEPs
4
registered plants 1 with an FDA FEI number
30
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
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

  • 29 March 2024 VAI US FDA
  • 6 November 2020 VAI US FDA
  • 11 June 2018 VAI US FDA
  • 12 July 2016 VAI US FDA
  • 24 June 2014 VAI US FDA

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

Registered plants

Site FDA FEI
SIGNES, United Arab Emirates Not on file
SIGNES, France Not on file
France, France 3003749112
Marseille Cedex 14, France Not on file

Filings and GMP by regulator

Regulator Filings GMP certificates
NPRA (MY) 12 None
EDE (AE) 8 None
MINSA (CR) 3 None
ARCSA (EC) 2 None
INVIMA (CO) 2 None
DIGEMAPS (DO) 2 None
ANSM (FR) None 10
ANVISA (Brazil) None 3
EMA None 2
MFDS (Korea) None 2
US FDA None 1

Scale

Year Revenue Exports Destinations
2024 $504.5M 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 We do not publish the identity of any buyer.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 Ipsen Pharma Biotech

Does Ipsen Pharma Biotech hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Ipsen Pharma Biotech. It does have 30 filings with 7 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Ipsen Pharma Biotech FDA-registered?
One site operated by Ipsen Pharma 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 Ipsen Pharma Biotech's last inspection go?
The most recent inspection on record closed on 29 March 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 5 inspections are on file.
Where does Ipsen Pharma Biotech manufacture?
4 registered sites are on record, in United Arab Emirates and France (Signes, France and Marseille Cedex 14 among others). Every site is listed on this page with the register it came from.
Which regulators recognise Ipsen Pharma Biotech's GMP?
Current GMP certificates are on record from ANSM (FR), ANVISA (Brazil), EMA, MFDS (Korea) and US FDA. 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 29 March 2024.

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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