Amgen Singapore Manufacturing Pte. Ltd.
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
- Singapore
- Registered address
- 1 Tuas View Drive, Singapore, 637026, Singapore (SGP)
- Operations here
- analysisapi manufacturemanufacture
- FDA identifiers
- FEI 3011255424 Β· DUNS 659221522
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- NAIDrug Quality Assurance2019-10-25
- NAIDrug Quality Assurance2018-05-25
Drugs this plant is listed as making
1 distinct drugs across 1 products name this site in their FDA label.
- eculizumab-aeebAmgen 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.