Is NEOCHEM KOREA FDA approved?

NEOCHEM KOREA 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.

What drugs does NEOCHEM KOREA make?

1 product is listed under NEOCHEM KOREA in the openFDA NDC Directory, most often as powder. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

NEOCHEM KOREA

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

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

Authorisation

Registered operations

Active ingredient (API) manufacture1Labelling1Packaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
NEOCHEM KOREA	189 Hogupo-ro, Namdong-gu, Incheon, 21644, Korea, South (KOR)	Active ingredient (API) manufacture, Labelling, Packaging	3014221782689516034

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	Zinc Oxide	powder	71961-0001DRUG FOR FURTHER PROCESSING

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Enquiry

Common questions

Is NEOCHEM KOREA FDA approved?: NEOCHEM KOREA 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 NEOCHEM KOREA's drugs manufactured?: The FDA register lists 21644. Registered operations: active ingredient (API) manufacture, labelling, packaging.
What drugs does NEOCHEM KOREA make?: 1 product is listed under NEOCHEM KOREA in the openFDA NDC Directory, most often as powder. 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.