Is BTGEN Co., Ltd. FDA approved?

BTGEN 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 BTGEN Co., Ltd.'s drugs manufactured?

The FDA register lists 21990. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging.

BTGEN 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

Authorisation

Registered operations

Analytical testing1Active ingredient (API) manufacture1Labelling1Finished drug manufacture1Packaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
BTGEN Co., Ltd.	45, Jisikgiban-ro, Yeonsu-gu, Incheon, 21990, Korea, South (KOR)	Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging	3025416433689844428

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Enquiry

Common questions

Is BTGEN Co., Ltd. FDA approved?: BTGEN 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 BTGEN Co., Ltd.'s drugs manufactured?: The FDA register lists 21990. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging.

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.