Jetpharma SA
A single plant registered with the FDA to make drugs for the US market. Below is where it is and the drugs whose FDA labels list this site as performing a manufacturing step β so if this plant has a problem, these are the products that could be affected.
- Country
- Switzerland
- Registered address
- Via Sottobisio 42ac, Balerna, TI 6828, Switzerland (CHE)
- Operations here
- api manufactureparticle size reduction
- FDA identifiers
- FEI 3002807359 Β· DUNS 481885861
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- NAIDrug Quality Assurance2023-06-23
- VAIDrug Quality Assurance2020-02-07
- VAIDrug Quality Assurance2017-12-01
- VAIDrug Quality Assurance2016-01-29
- NAIDrug Quality Assurance2013-05-08
- NAIDrug Quality Assurance2011-02-16
Drugs this plant is listed as making
5 distinct drugs across 8 products name this site in their FDA label.
- bosentanActelion Pharmaceuticals US, Inc.
- macitentanActelion Pharmaceuticals US, Inc.
- macitentan and tadalafilActelion Pharmaceuticals US, Inc.
- MaribavirTakeda Pharmaceuticals America, Inc.
- PonesimodJanssen Pharmaceuticals, Inc
Sources:the establishment's name, address, and country from FDA's Drug Establishments Current Registration Site (DECRS); the drug-to-facility links from DailyMed SPL drug labels, matched by the facility's DUNS number; inspection outcomes from the FDA Data Dashboard, matched by FEI; shortage status from FDA's drug shortage database. More on how this is built. Educational only.