Actelion Pharmaceuticals Ltd
Overview
Actelion Pharmaceuticals Ltd is a pharmaceutical company focused on innovative treatments for pulmonary arterial hypertension and other rare diseases. It operates as part of Johnson & Johnson, one of the world's largest healthcare companies.
Therapeutic areas
API / Drug Master Files
Actelion Pharmaceuticals Ltd holds 3 active (3 total) FDA Type II Drug Master Files — identifying it as an active-substance / API supplier. Type II DMFs are filed with the FDA to support the use of an active pharmaceutical ingredient in drug applications.
- NITROFURANTOIN MONOHYDRATEActive2023-05-10
- NITROFURANTOIN MACROCRYSTALSActive2023-05-10
- SUGAMMADEX SODIUMActive2022-09-16
FDA compliance signals
2 FDA enforcement records linked to this company.
- 4832024-10-28
Failure to comply with REMS Elements to Assure Safe Use (ETASU) B
- 4832024-10-28
Failure to comply with REMS Implementation System
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