Helsinn Birex Pharmaceuticals Limited
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 — so if this plant has a problem, these are the products that could be affected.
- Country
- Ireland
- Registered address
- Damastown Way Dublin 15, Dublin, D15 X925, Ireland (IRL)
- Operations here
- analysislabelmanufacturepack
- FDA identifiers
- FEI 3003724414 · DUNS 985084409
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2022-07-15
- VAIDrug Quality Assurance2019-10-25
- NAIDrug Quality Assurance2016-06-03
- NAIDrug Quality Assurance2014-02-21
- VAIDrug Quality Assurance2010-05-27
Drugs this plant is listed as making
1 distinct drugs across 1 products name this site in their FDA label.
- palonosetron hydrochlorideCipla USA 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.