Is MEDICELL BIO Co., Ltd FDA approved?

MEDICELL BIO 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 MEDICELL BIO Co., Ltd's drugs manufactured?

The FDA register lists Chungcheongnam-do 31254. Registered operations: labelling, finished drug manufacture.

What drugs does MEDICELL BIO Co., Ltd make?

3 products are listed under MEDICELL BIO Co., Ltd in the openFDA NDC Directory, most often as liquid. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

MEDICELL BIO Co., Ltd

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

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Registered sites: 1
Active NDC listings: 3
Live patents: 0
Countries: 1
Base: South Korea

Authorisation

Registered operations

Labelling1Finished drug manufacture1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
MEDICELL BIO Co., Ltd	1772 Chungjeol-ro, Byeongcheon-myeon, Dongnam-gu, Cheonan-si, Chungcheongnam-do 31254, Korea, South (KOR)	Labelling, Finished drug manufacture	3016533086689843703

Catalogue

Drug listings by form and route

3 active NDC listings: 3 human otc drug. By marketing category: UNAPPROVED DRUG OTHER 3.

Dosage form	NDCs
liquid	3

Route	NDCs
topical	3

Labeller name on the listing	NDCs
medicell bio co., ltd.	3

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Kenaf wet wipe	ALLANTOIN	liquid, topical	72944-0001UNAPPROVED DRUG OTHER
Kenaf wet wipe kids	ALLANTOIN	liquid, topical	72944-0002UNAPPROVED DRUG OTHER
Kenaf wet wipe kids	ALLANTOIN	liquid, topical	72944-0004UNAPPROVED DRUG OTHER

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Enquiry

Common questions

Is MEDICELL BIO Co., Ltd FDA approved?: MEDICELL BIO 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 MEDICELL BIO Co., Ltd's drugs manufactured?: The FDA register lists Chungcheongnam-do 31254. Registered operations: labelling, finished drug manufacture.
What drugs does MEDICELL BIO Co., Ltd make?: 3 products are listed under MEDICELL BIO Co., Ltd in the openFDA NDC Directory, most often as liquid. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

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.