Jubilant DraxImage Inc., dba Jubilant Radiopharma
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
- 16751 Trans Canada Highway, Kirkland, Quebec H9H 4J4, Canada (CAN)
- Operations here
- analysislabelmanufacturepack
- FDA identifiers
- FEI 3009003838 · DUNS 243604761
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2024-04-23
- VAIDrug Quality Assurance2022-06-10
- NAIDrug Quality Assurance2017-09-08
- VAIDrug Quality Assurance2015-12-17
- VAIDrug Quality Assurance2013-09-17
Drugs this plant is listed as making
7 distinct drugs across 8 products name this site in their FDA label.
- Kit for the Preparation of Technetium Tc 99m Exametazime for Leukocyte LabelingJubilant DraxImage Inc., dba Jubilant Radiopharma
- Kit for the preparation of Technetium Tc 99m PentetateJubilant DraxImage Inc., dba Jubilant Radiopharma
- Rubidium Rb 82Jubilant DraxImage Inc., dba Jubilant Radiopharma
- Sodium Iodide I 131Jubilant DraxImage Inc., dba Jubilant Radiopharma
- Technetium Tc 99m MedronateJubilant DraxImage Inc., dba Jubilant Radiopharma
- Technetium Tc 99m MertiatideJubilant DraxImage Inc., dba Jubilant Radiopharma
- Technetium Tc 99m Sulfur Colloid KitJubilant DraxImage Inc., dba Jubilant Radiopharma
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.