Suppliers / Alkermes

Alkermes

Ireland ALKS Updated 9 July 2026

Alkermes is an API and finished-dose manufacturer based in Ireland. It holds one active US drug master file across a filed portfolio of 2 molecules. Its filings concentrate with US FDA, ARCSA (EC) and INVIMA (CO). Its GMP standing is certified by ANVISA (Brazil), MINPROMTORG (RU) and US FDA, among 5 authorities. Its most recent recorded inspection, by US FDA, closed on 19 October 2023 as VAI.

1
active US DMFs
0
valid CEPs
3
registered plants 1 with an FDA FEI number
18
filings across 5 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
8 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

  • 19 October 2023 VAI US FDA
  • 14 August 2017 NAI US FDA
  • 17 April 2015 NAI US FDA
  • 15 August 2014 NAI US FDA
  • 23 April 2014 NAI US FDA
  • 23 September 2013 NAI US FDA
  • 28 June 2013 VAI US FDA
  • 29 June 2012 NAI US FDA

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

Registered plants

Site FDA FEI
WILMINGTON, United States Not on file
WILMINGTON, United States Not on file
Wilmington, United States 1000142940

What they file, and where

Molecule Regulators Docs
Sirolimus US FDA 1
Ｍｅｄｉｓｏｒｂ７５２５Ｄｌｊｎ１ PMDA (Japan) 1

Also appears on these molecule pages

Naltrexone finished dose Olanzapine finished dose Risperidone finished dose Sirolimus API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA 10 1
ARCSA (EC) 3 None
INVIMA (CO) 2 None
DIGEMAPS (DO) 2 None
NCELS (KZ) 1 None
ANVISA (Brazil) None 1
MINPROMTORG (RU) None 1
MHRA (UK) None 1
EAEU_EEC None 1

Scale

Year Revenue Exports Destinations
2025 $1.5B Not reported Not reported
2024 $1.6B Not reported Not reported
2023 $1.7B Not reported Not reported

Export figures are customs aggregates. We do not publish the identity of any buyer.

Questions about Alkermes

Does Alkermes hold a US DMF or a CEP?
Alkermes holds 1 active US drug master file. 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 Alkermes FDA-registered?
One site operated by Alkermes 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 Alkermes's last inspection go?
The most recent inspection on record closed on 19 October 2023 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file.
Where does Alkermes manufacture?
3 registered sites are on record, in United States (Wilmington and Wilmington among others). Every site is listed on this page with the register it came from.
What does Alkermes make?
2 molecules are on record against Alkermes, including Sirolimus and Ｍｅｄｉｓｏｒｂ７５２５Ｄｌｊｎ１. Each links through to that molecule's full manufacturer list.
Which regulators recognise Alkermes's GMP?
Current GMP certificates are on record from ANVISA (Brazil), MINPROMTORG (RU), US FDA, MHRA (UK) and EEC (Eurasian Economic Union). 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. Alkermes comes back tiered against every other supplier able to file there.

Start for free
No sales call.

Open risk flags

  • 61 active litigation matters are on record.
  • The most recent inspection outcome was VAI, on 19 October 2023.

Comparable suppliers

Biocon shares 1 molecule Apotex shares 1 molecule BrightGene Bio-Medical shares 1 molecule Concord Biotech shares 1 molecule Livzon Group Fuzhou Fuxing Pharmaceutical shares 1 molecule

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