Samsung Biologics Co., 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
- Korea, South
- Registered address
- 300, Songdo bio-daero, Yeonsu-gu, Incheon, 21987, Korea, South (KOR)
- Operations here
- analysisapi manufacturelabelmanufacturepack
- FDA identifiers
- FEI 3010479596 · DUNS 557810567
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2023-09-01
- VAIBlood and Blood Products2023-02-28
- VAIDrug Quality Assurance2019-11-01
- VAIDrug Quality Assurance2018-06-26
Drugs this plant is listed as making
6 distinct drugs across 7 products name this site in their FDA label.
- Anifrolumab-fniaAstraZeneca Pharmaceuticals LP
- DaratumumabJanssen Biotech, Inc.
- denosumabCordavis Limited
- perflutrenLantheus Medical Imaging, Inc.
- rituximab-pvvrPfizer Laboratories Div Pfizer Inc
- ublituximabTG Therapeutics, 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.