Lonza Biologics Tuas 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 — so if this plant has a problem, these are the products that could be affected.
- Country
- Singapore
- Registered address
- 35 Tuas South Avenue 6, Singapore, Singapore 637377, Singapore (SGP)
- Operations here
- analysisapi manufacturelabelmanufacturepack
- FDA identifiers
- FEI 3009725845 · DUNS 936939342
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2023-06-27
- VAIDrug Quality Assurance2019-09-20
- NAIDrug Quality Assurance2017-02-24
- VAIDrug Quality Assurance2015-03-10
- VAIDrug Quality Assurance2012-08-03
Drugs this plant is listed as making
2 distinct drugs across 3 products name this site in their FDA label.
- Ado-Trastuzumab EmtansineGenentech, Inc.
- efgartigimod alfa and hyaluronidase (human recombinant)argenx US
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.