Suppliers / Astellas Ireland

Astellas Ireland

Ireland 3 duplicate records merged Updated 9 July 2026

Astellas Ireland is an API and finished-dose manufacturer based in Ireland. It holds 2 active US drug master files across a filed portfolio of 2 molecules. Its filings concentrate with URPL (PL), AIFA (IT) and US FDA. Its GMP standing is certified by ZLG (DE), US FDA and EMA, among 5 authorities. Its most recent recorded inspection, by US FDA, closed on 6 June 2025 as VAI.

2
active US DMFs
0
valid CEPs
12
registered plants 3 with an FDA FEI number
803
filings across 34 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
3 of 3 confirmed
Inspections
5 of 8 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

  • 6 June 2025 VAI US FDA
  • 6 June 2025 VAI US FDA
  • 18 April 2024 NAI US FDA
  • 27 October 2023 VAI US FDA
  • 14 August 2023 OAI US FDA
  • 2 September 2022 VAI US FDA
  • 17 June 2022 VAI US FDA
  • 17 January 2020 VAI US FDA

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

Registered plants

Site FDA FEI
Killorglin, United Arab Emirates Not on file
Wallisellen, Switzerland Not on file
Hassia, Germany Not on file
Offenbach Am Main, Germany Not on file
Munich, Germany Not on file
ADDLESTONE, United Kingdom Not on file

6 further sites are on record.

What they file, and where

Molecule Regulators Docs
Famotidine US FDA 1
Tacrolimus US FDA 1

Also appears on these molecule pages

Adenosine finished dose Enzalutamide finished dose Famotidine API Isavuconazonium finished dose Mirabegron finished dose Regadenoson finished dose Solifenacin finished dose Tacrolimus API Tamsulosin finished dose Triamcinolone finished dose

Filings and GMP by regulator

Regulator Filings GMP certificates
URPL (PL) 77 None
AIFA (IT) 71 None
US FDA 68 4
MHRA (UK) 61 None
INFARMED (PT) 57 None
Health Canada 57 None
ZLG (DE) None 6
EMA None 3
MFDS (Korea) None 2
ANVISA (Brazil) None 2

Scale

Year Revenue Exports Destinations
2023 $445.6M 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 We do not publish the identity of any buyer.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 Astellas Ireland

Does Astellas Ireland hold a US DMF or a CEP?
Astellas Ireland holds 2 active US drug master files. A drug master file is a submission to the FDA describing how an ingredient is made; a CEP is the EDQM's certificate that the substance meets its European Pharmacopoeia monograph. Both are filings rather than approvals.
Is Astellas Ireland FDA-registered?
3 sites operated by Astellas Ireland carry an FDA establishment identifier (FEI), which means they are registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Astellas Ireland's last inspection go?
The most recent inspection on record closed on 6 June 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file, of which 1 closed as OAI.
Where does Astellas Ireland manufacture?
12 registered sites are on record, in United Arab Emirates, Switzerland, Germany and United Kingdom (Killorglin, Wallisellen and Hassia among others). Every site is listed on this page with the register it came from.
What does Astellas Ireland make?
2 molecules are on record against Astellas Ireland, including Famotidine and Tacrolimus. Each links through to that molecule's full manufacturer list.
Which regulators recognise Astellas Ireland's GMP?
Current GMP certificates are on record from ZLG (DE), US FDA, 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

  • 20 active litigation matters are on record.
  • The most recent inspection outcome was VAI, on 6 June 2025.

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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