Is SK BIOTEK FDA approved?

SK BIOTEK holds 2 FDA-registered establishments across 2 countries. 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 SK BIOTEK's drugs manufactured?

At registered sites in Ireland, South Korea. The FDA register lists Swords; 30068. Registered operations: analytical testing, active ingredient (API) manufacture, finished drug manufacture.

What drugs does SK BIOTEK make?

10 products are listed under SK BIOTEK 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.

SK BIOTEK

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

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Registered sites: 2
Active NDC listings: 10
Labeller names: 3
Live patents: 0
Countries: 2
Base: Ireland

Authorisation

Registered operations

Analytical testing1Active ingredient (API) manufacture2Finished drug manufacture1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
SK BIOTEK IRELAND LIMITEDRegistrant: SK BIOTEK	Watery Lane,, Swords, Dublin K67 AY91, Ireland (IRL)	Analytical testing, Active ingredient (API) manufacture	3002806583985691284
SK BIOTEK CO., LTD (Sejong Plant)Registrant: SK BIOTEK	80 Myeonghaksandan-ro, Yeondong-myeon, Sejong-si, 30068, Korea, South (KOR)	Active ingredient (API) manufacture, Finished drug manufacture	3014286622694860983

Catalogue

Drug listings by form and route

10 active NDC listings: 10 bulk ingredient. By marketing category: BULK INGREDIENT 10.

Dosage form	NDCs
powder	10

Route	NDCs

Labeller name on the listing	NDCs
sk biotek ireland limited	7
sk biotek	2
sk biotek ireland limited	1

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	Deferasirox	powder	74436-0323BULK INGREDIENT
-	Deucravacitinib	powder	50193-4323BULK INGREDIENT
-	Maralixibat	powder	50193-0423BULK INGREDIENT
-	apixaban	powder	50193-0893BULK INGREDIENT
-	atazanavir sulfate	powder	50193-3264BULK INGREDIENT
-	cenobamate	powder	74436-0223BULK INGREDIENT
-	dapagliflozin	powder	50193-1427BULK INGREDIENT
-	dasatinib	powder	50193-0524BULK INGREDIENT
-	entecavir monohydrate	powder	50193-1611BULK INGREDIENT
-	saxagliptin	powder	50193-4212BULK INGREDIENT

Neighbours

Registered in the same town

Merck & Co., Inc.SWORDS, IRL

Compare

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Enquiry

Common questions

Is SK BIOTEK FDA approved?: SK BIOTEK holds 2 FDA-registered establishments across 2 countries. 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 SK BIOTEK's drugs manufactured?: At registered sites in Ireland, South Korea. The FDA register lists Swords; 30068. Registered operations: analytical testing, active ingredient (API) manufacture, finished drug manufacture.
What drugs does SK BIOTEK make?: 10 products are listed under SK BIOTEK 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.