Is OSSTEM PHARMA CO., LTD. FDA approved?

OSSTEM PHARMA 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 OSSTEM PHARMA CO., LTD.'s drugs manufactured?

The FDA register lists 15420. Registered operations: finished drug manufacture.

What drugs does OSSTEM PHARMA CO., LTD. make?

2 products are listed under OSSTEM PHARMA CO., LTD. in the openFDA NDC Directory, most often as paste, dentifrice. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

OSSTEM PHARMA CO., LTD.

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

Request a quote Claim this profile

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

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
OSSTEM PHARMA CO., LTD.	13 Neunggil-ro 115beon-gil, Danwon-gu, Ansan, 15420, Korea, South (KOR)	Finished drug manufacture	3016445768696467325

Catalogue

Drug listings by form and route

2 active NDC listings: 2 human otc drug. By marketing category: OTC MONOGRAPH DRUG 2.

Dosage form	NDCs
paste, dentifrice	2

Route	NDCs
oral	2

Labeller name on the listing	NDCs
osstem pharma co., ltd	2

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Osstem G Gum Health Care Tooth	Sodium Fluoride	paste, dentifrice, oral	87548-020OTC MONOGRAPH DRUG
Osstem S Sensitivity relief tooth	Potassium Nitrate, Sodium Fluoride	paste, dentifrice, oral	87548-010OTC MONOGRAPH DRUG

Compare

Comparable companies in South Korea

Aekyung Industrial Co., Ltd.1 site · 64 NDC
Amorepacific Group1 site · 53 NDC
I World Pharmaceutical Co., Ltd.1 site · 48 NDC
CELLTRION Inc1 site · 36 NDC
LAON COMMERCE CO LTD1 site · 28 NDC
TAI GUK PHARM. CO., LTD1 site · 28 NDC
Lydia Co Ltd.1 site · 27 NDC
fmg Co.Ltd1 site · 23 NDC
DONG IL PHARMS CO., LTD.1 site · 17 NDC
MISOCOS1 site · 15 NDC

Enquiry

Common questions

Is OSSTEM PHARMA CO., LTD. FDA approved?: OSSTEM PHARMA 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 OSSTEM PHARMA CO., LTD.'s drugs manufactured?: The FDA register lists 15420. Registered operations: finished drug manufacture.
What drugs does OSSTEM PHARMA CO., LTD. make?: 2 products are listed under OSSTEM PHARMA CO., LTD. in the openFDA NDC Directory, most often as paste, dentifrice. 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.