Gilead Alberta ULC
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
- Canada
- Registered address
- 1021 Hayter Rd NW, Edmonton, Alberta T6S 1A1, Canada (CAN)
- Operations here
- analysisapi manufacture
- FDA identifiers
- FEI 3001027806 · DUNS 207452996
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- NAIDrug Quality Assurance2023-05-12
- NAIDrug Quality Assurance2017-01-27
- NAIDrug Quality Assurance2014-03-07
- NAIDrug Quality Assurance2012-10-25
- NAIDrug Quality Assurance2011-08-05
- NAIDrug Quality Assurance2009-03-26
Drugs this plant is listed as making
2 distinct drugs across 2 products name this site in their FDA label.
- DARUNAVIR ETHANOLATE and COBICISTATJanssen Products, LP
- Darunavir, Cobicistat, Emtricitabine, and Tenofovir alafenamideJanssen Products LP
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.