Is Prestige Biologics Co., Ltd. FDA approved?

Prestige Biologics Co., Ltd. holds 2 FDA-registered establishments 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 Prestige Biologics Co., Ltd.'s drugs manufactured?

The FDA register lists Chungcheongbuk-do 28161; Chungcheongbuk-do 28220. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging.

Prestige Biologics Co., Ltd.

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

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Registered sites: 2
Active NDC listings: 0
Live patents: 0
Countries: 1
Base: South Korea

Authorisation

Registered operations

Analytical testing2Active ingredient (API) manufacture1Labelling1Finished drug manufacture1Packaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Prestige Biologics Co., LtdRegistrant: Prestige Biologics Co., Ltd.	197 Osongsaengmyeong 1-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do 28161, Korea, South (KOR)	Analytical testing, Labelling, Finished drug manufacture, Packaging	3022076803694466328
Prestige Biologics Co., Ltd.	56 Osongsaengmyeong 8-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do 28220, Korea, South (KOR)	Analytical testing, Active ingredient (API) manufacture	3046540791696554793

Neighbours

Registered in the same town

Medytox Inc.Chungcheongbuk-do 28161, KOR

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Enquiry

Common questions

Is Prestige Biologics Co., Ltd. FDA approved?: Prestige Biologics Co., Ltd. holds 2 FDA-registered establishments 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 Prestige Biologics Co., Ltd.'s drugs manufactured?: The FDA register lists Chungcheongbuk-do 28161; Chungcheongbuk-do 28220. 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.