Is Samsung Bioepis Co., Ltd. FDA approved?

Samsung Bioepis Co., Ltd. holds 1 FDA-registered establishment in South Korea. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.

Where are Samsung Bioepis Co., Ltd.'s registered sites?

The FDA register lists 21987. Registered operations: analytical testing.

Samsung Bioepis Co., Ltd.

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 1
Active NDC listings: 0
Live patents: 0
Countries: 1
Base: South Korea

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Samsung Bioepis Co., Ltd.	76, Songdogyoyuk -ro, Yeonsu-gu, Incheon, 21987, Korea, South (KOR)	Analytical testing	3010031951557822226

Neighbours

Registered in the same town

Samsung Biologics Co., Ltd.21987, KOR

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Enquiry

Common questions

Is Samsung Bioepis Co., Ltd. FDA approved?: Samsung Bioepis Co., Ltd. holds 1 FDA-registered establishment in South Korea. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
Where are Samsung Bioepis Co., Ltd.'s registered sites?: The FDA register lists 21987. Registered operations: analytical testing.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.