Is Kolon Biotech INC FDA approved?

Kolon Biotech INC 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 Kolon Biotech INC's drugs manufactured?

The FDA register lists Chungcheongbuk-do 27465. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging.

Kolon Biotech INC

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
Kolon Biotech, Inc.Registrant: Kolon Biotech INC	54-1, Gieopdosi 1-ro, Daesowon-myeon, Chungju-si, Chungcheongbuk-do 27465, Korea, South (KOR)	Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging	3019016602695108528

Neighbours

Registered in the same town

OUTIN FUTURES CORP.Chungcheongbuk-do 27465, KOR

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Enquiry

Common questions

Is Kolon Biotech INC FDA approved?: Kolon Biotech INC 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 Kolon Biotech INC's drugs manufactured?: The FDA register lists Chungcheongbuk-do 27465. 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.