Suppliers / Mallinckrodt

Mallinckrodt

Ireland Updated 9 July 2026

Mallinckrodt is an API manufacturer based in Ireland. It holds 3 valid CEPs across a filed portfolio of 5 molecules. Its filings concentrate with US FDA, Health Canada and ARCSA (EC). Its GMP standing is certified by MFDS (Korea).

0
active US DMFs
3
valid CEPs
3
registered plants
98
filings across 12 regulators

Registered plants

Site FDA FEI
Madison, United Arab Emirates Not on file
Hazelwood, United States Not on file
St Louis, United States Not on file

What they file, and where

Molecule Regulators Docs
Acetaminophen SFDA (Saudi Arabia) 1
Calcium Stearate EDQM 1
Leuprolide SFDA (Saudi Arabia) 1
Magnesium Stearate EDQM 1
Stearic Acid EDQM 1

Also appears on these molecule pages

Acetaminophen API Leuprolide API Paracetamol API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA 56 None
Health Canada 12 None
ARCSA (EC) 10 None
ISP (CL) 6 None
EDA (EG) 5 None
INFARMED (PT) 2 None
MFDS (Korea) None 2

Questions about Mallinckrodt

Does Mallinckrodt hold a US DMF or a CEP?
Mallinckrodt holds 3 valid CEPs. 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.
Where does Mallinckrodt manufacture?
3 registered sites are on record, in United Arab Emirates and United States (Madison, Hazelwood and St Louis). Every site is listed on this page with the register it came from.
What does Mallinckrodt make?
5 molecules are on record against Mallinckrodt, including Acetaminophen, Calcium Stearate, Leuprolide and Magnesium Stearate. Each links through to that molecule's full manufacturer list.
Which regulators recognise Mallinckrodt's GMP?
Current GMP certificates are on record from MFDS (Korea). 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

  • 86 active litigation matters are on record.

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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