Prescription drug

Where is Mitotane made?

2 companies sell it under their own name. Their labels name 2 factories in the United States and Italy.

United States 1Italy 1
United States: 1Italy: 1

Companies and their factories

Company on the labelFactoryWhereLast FDA inspection
Esteve Pharmaceuticals, S.a. Lysodren500 mg · NDC 68118-080 ISP Chemicals LLCMakes the active ingredient Columbus, OH, United StatesProblems found, fixed voluntarilyJan 2024
Latina Pharma S.P.AMakes it, tests it, packages it and labels it Sermoneta, ItalyProblems found, fixed voluntarilyJan 2024
HRA Pharma Rare Diseases Lysodren500 mg · NDC 76336-080 ISP Chemicals LLCMakes the active ingredient Columbus, OH, United StatesProblems found, fixed voluntarilyJan 2024
Latina Pharma S.P.AMakes it, tests it, packages it and labels it Sermoneta, ItalyProblems found, fixed voluntarilyJan 2024