Suppliers / Helsinn Birex Pharmaceuticals

Helsinn Birex Pharmaceuticals

Ireland Updated 9 July 2026

Helsinn Birex Pharmaceuticals is a finished-dose manufacturer based in Ireland. It appears in 86 regulatory filings across 15 regulators, without an active US DMF or CEP on file. Its filings concentrate with AIFA (IT), AEMPS (ES) and EMA. Its GMP standing is certified by EMA, MFDS (Korea) and ANVISA (Brazil). Its most recent recorded inspection, by US FDA, closed on 15 July 2022 as VAI.

0
active US DMFs
0
valid CEPs
5
registered plants 1 with an FDA FEI number
86
filings across 15 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

  • 15 July 2022 VAI US FDA
  • 25 October 2019 VAI US FDA
  • 3 June 2016 NAI US FDA
  • 21 February 2014 NAI US FDA
  • 27 May 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
Dublin 15, United Arab Emirates Not on file
Dublin, United Arab Emirates Not on file
Ireland, Ireland 3003724414
DUBLIN, Ireland Not on file
Dublin 15, Ireland Not on file

Filings and GMP by regulator

Regulator Filings GMP certificates
AIFA (IT) 20 None
AEMPS (ES) 14 None
EMA 12 2
FAMHP (BE) 10 None
INFARMED (PT) 9 None
MPA (SE) 7 None
MFDS (Korea) None 2
ANVISA (Brazil) None 2

Questions about Helsinn Birex Pharmaceuticals

Does Helsinn Birex Pharmaceuticals hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Helsinn Birex Pharmaceuticals. It does have 86 filings with 15 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Helsinn Birex Pharmaceuticals FDA-registered?
One site operated by Helsinn Birex Pharmaceuticals 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 Helsinn Birex Pharmaceuticals's last inspection go?
The most recent inspection on record closed on 15 July 2022 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 5 inspections are on file.
Where does Helsinn Birex Pharmaceuticals manufacture?
5 registered sites are on record, in United Arab Emirates and Ireland (Dublin 15, Dublin and Ireland among others). Every site is listed on this page with the register it came from.
Which regulators recognise Helsinn Birex Pharmaceuticals's GMP?
Current GMP certificates are on record from EMA, MFDS (Korea) and ANVISA (Brazil). 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 15 July 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