Suppliers / Haleon Ireland Dungarvan

Haleon Ireland Dungarvan

Ireland Updated 9 July 2026

Haleon Ireland Dungarvan is a finished-dose manufacturer based in Ireland. It appears in 165 regulatory filings across 13 regulators, without an active US DMF or CEP on file. Its filings concentrate with NPRA (MY), FAMHP (BE) and EDE (AE). Its GMP standing is certified by ANVISA (Brazil), EMA and US FDA, among 4 authorities. Its most recent recorded inspection, by US FDA, closed on 23 August 2024 as VAI.

0
active US DMFs
0
valid CEPs
4
registered plants 1 with an FDA FEI number
165
filings across 13 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

  • 23 August 2024 VAI US FDA
  • 10 June 2016 NAI US FDA
  • 13 September 2013 NAI US FDA
  • 22 September 2011 NAI US FDA

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

Registered plants

Site FDA FEI
Dungarvan, United Arab Emirates Not on file
DUNGARVAN, Ireland Not on file
Ireland, Ireland 3003721894
Co. Waterford, Ireland Not on file

Filings and GMP by regulator

Regulator Filings GMP certificates
NPRA (MY) 109 None
FAMHP (BE) 10 None
EDE (AE) 10 None
AEMPS (ES) 10 None
AIFA (IT) 10 None
EMA 4 2
ANVISA (Brazil) None 2
US FDA None 1
NCELS (KZ) None 1

Questions about Haleon Ireland Dungarvan

Does Haleon Ireland Dungarvan hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Haleon Ireland Dungarvan. It does have 165 filings with 13 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Haleon Ireland Dungarvan FDA-registered?
One site operated by Haleon Ireland Dungarvan 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 Haleon Ireland Dungarvan's last inspection go?
The most recent inspection on record closed on 23 August 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 4 inspections are on file.
Where does Haleon Ireland Dungarvan manufacture?
4 registered sites are on record, in United Arab Emirates and Ireland (Dungarvan, Dungarvan and Ireland among others). Every site is listed on this page with the register it came from.
Which regulators recognise Haleon Ireland Dungarvan's GMP?
Current GMP certificates are on record from ANVISA (Brazil), EMA, US FDA and NCELS (KZ). 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 23 August 2024.

Comparable suppliers

Abbvie Ireland Nl also in Ireland Amgen Technology (Ireland) Unlimited also in Ireland Chanelle Pharmaceuticals Manufacturing also in Ireland Fournier Laboratories Ireland also in Ireland Helsinn Birex Pharmaceuticals also in Ireland

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