Suppliers / Leo Laboratories

Leo Laboratories

Ireland 4 employees 2 duplicate records merged Updated 9 July 2026

The public registers hold a second record for Leo Laboratories. The fuller profile, with 2 active US DMFs and 11 valid CEPs, is at Leo Pharma. Figures on this page cover only this record.

Leo Laboratories is a finished-dose manufacturer based in Ireland. It appears in 123 regulatory filings across 11 regulators, without an active US DMF or CEP on file. Its filings concentrate with MHRA (UK), EMA and MINSA (CR). Its GMP standing is certified by EMA, MFDS (Korea) and ANVISA (Brazil), among 4 authorities. Its most recent recorded inspection, by US FDA, closed on 24 June 2022 as VAI.

0
active US DMFs
0
valid CEPs
4
registered plants 1 with an FDA FEI number
123
filings across 11 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

  • 24 June 2022 VAI US FDA
  • 3 November 2017 NAI US FDA
  • 14 March 2014 NAI US FDA
  • 9 September 2011 NAI US FDA
  • 8 December 2008 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, United Arab Emirates Not on file
DUBLIN, Ireland Not on file
Ireland, Ireland 3002807468
Dublin 12, Ireland Not on file

Filings and GMP by regulator

Regulator Filings GMP certificates
MHRA (UK) 62 None
EMA 22 3
MINSA (CR) 11 None
DIGEMAPS (DO) 8 None
ARCSA (EC) 7 None
DMP (NO) 4 None
MFDS (Korea) None 2
ANVISA (Brazil) None 2
NAFDAC (NG) None 1

Questions about Leo Laboratories

Does Leo Laboratories hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Leo Laboratories. It does have 123 filings with 11 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Leo Laboratories FDA-registered?
One site operated by Leo Laboratories 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 Leo Laboratories's last inspection go?
The most recent inspection on record closed on 24 June 2022 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 5 inspections are on file.
Where does Leo Laboratories manufacture?
4 registered sites are on record, in United Arab Emirates and Ireland (Dublin, Dublin and Ireland among others). Every site is listed on this page with the register it came from.
Which regulators recognise Leo Laboratories's GMP?
Current GMP certificates are on record from EMA, MFDS (Korea), ANVISA (Brazil) and NAFDAC (NG). 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.

Comparing suppliers?

Choose your molecules and target markets. Leo Laboratories comes back tiered against every other supplier able to file there.

Start for free
No sales call.

Open risk flags

  • The most recent inspection outcome was VAI, on 24 June 2022.

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 Haleon Ireland Dungarvan 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