Suppliers / Mallinckrodt

Mallinckrodt

United States Updated 9 July 2026

Mallinckrodt is an API manufacturer based in United States. 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

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

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Open risk flags

  • 86 active litigation matters are on record.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates