Is Samsung Biologics Co., Ltd. FDA approved?

Samsung Biologics Co., Ltd. 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 Samsung Biologics Co., Ltd.'s drugs manufactured?

At registered sites in South Korea, the United States. The FDA register lists 21987; Rockville, MD. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging.

What drugs does Samsung Biologics Co., Ltd. make?

57 products are listed under Samsung Biologics Co., Ltd. in the openFDA NDC Directory, most often as liquid; solution; injection, solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Samsung Biologics Co., Ltd.

Data as of 28 Sept 2026 · How to read this entry

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Registered sites: 2
Active NDC listings: 57
Labeller names: 3
Live patents: 0
Countries: 2
Base: United States

Authorisation

Registered operations

Analytical testing2Active ingredient (API) manufacture2Labelling1Finished drug manufacture1Packaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Samsung Biologics Co., Ltd.	300, Songdo bio-daero, Yeonsu-gu, Incheon, 21987, Korea, South (KOR)	Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging	3010479596557810567
Human Genome Sciences, Inc.Registrant: Samsung Biologics Co., Ltd.	9910 Belward Campus Drive, Rockville, Maryland (MD) 20850, United States (USA)	Analytical testing, Active ingredient (API) manufacture	3003782237034062104

Catalogue

Drug listings by form and route

57 active NDC listings: 37 bulk ingredient, 20 drug for further processing. By marketing category: BULK INGREDIENT 37, DRUG FOR FURTHER PROCESSING 20.

Dosage form	NDCs
liquid	37
solution	9
injection, solution	4
injection	3
injection, powder, lyophilized, for solution	3
injection, suspension	1

Route	NDCs

Labeller name on the listing	NDCs
samsung biologics co., ltd.	43
samsung biologics co. ltd	13
samsung biologics co., ltd.	1

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	Adalimumab	liquid	71124-0023BULK INGREDIENT
-	Adalimumab	liquid	71124-0027BULK INGREDIENT
-	Durvalumab	liquid	71124-0030BULK INGREDIENT
-	Emicizumab	solution	71124-0009DRUG FOR FURTHER PROCESSING
-	Emicizumab	solution	71124-0010DRUG FOR FURTHER PROCESSING
-	Emicizumab	solution	71124-0011DRUG FOR FURTHER PROCESSING
-	Emicizumab	solution	71124-0012DRUG FOR FURTHER PROCESSING
-	Infliximab	injection, powder, lyophilized, for solution	71124-0004DRUG FOR FURTHER PROCESSING
-	Infliximab	liquid	71124-0008BULK INGREDIENT
-	Ipilimumab	liquid	71124-0001BULK INGREDIENT
-	Nivolumab	liquid	71124-0002BULK INGREDIENT
-	Perflutren	injection, suspension	71124-0016DRUG FOR FURTHER PROCESSING
-	Rilonacept	liquid	71124-0037BULK INGREDIENT
-	Rituximab	liquid	71124-0003BULK INGREDIENT
-	THROMBIN ALFA	liquid	71124-0014BULK INGREDIENT
-	Telavancin	injection, powder, lyophilized, for solution	71124-0005DRUG FOR FURTHER PROCESSING
-	adalimumab	injection	71124-0059DRUG FOR FURTHER PROCESSING
-	aflibercept-yszy	liquid	71124-0032BULK INGREDIENT
-	amivantamab	liquid	71124-0056BULK INGREDIENT
-	bamlanivimab	liquid	71124-0017BULK INGREDIENT
-	belatacept	liquid	71124-0040BULK INGREDIENT
-	belimumab	liquid	71124-0025BULK INGREDIENT
-	belimumab	liquid	71124-0062BULK INGREDIENT
-	bevacizumab	injection	71124-0039DRUG FOR FURTHER PROCESSING
-	bevacizumab-bvzr	liquid	71124-0029BULK INGREDIENT
-	bimekizumab	liquid	71124-0055BULK INGREDIENT
-	cosibelimab	liquid	71124-0047BULK INGREDIENT
-	cosibelimab	injection	71124-0048DRUG FOR FURTHER PROCESSING
-	daratumumab	liquid	71124-0007BULK INGREDIENT
-	denosumab	injection, solution	71124-0035DRUG FOR FURTHER PROCESSING
-	denosumab	liquid	71124-0038BULK INGREDIENT
-	donanemab	liquid	71124-0045BULK INGREDIENT
-	eculizumab	injection, solution	71124-0034DRUG FOR FURTHER PROCESSING
-	emicizumab	injection, solution	71124-0054DRUG FOR FURTHER PROCESSING
-	emicizumab	injection, solution	71124-0057DRUG FOR FURTHER PROCESSING
-	etesevimab	liquid	71124-0018BULK INGREDIENT
-	ibalizumab	solution	71124-0024DRUG FOR FURTHER PROCESSING
-	ibalizumab	liquid	71124-0050BULK INGREDIENT
-	infliximab	injection, powder, lyophilized, for solution	71124-0031DRUG FOR FURTHER PROCESSING
-	infliximab	liquid	71124-0060BULK INGREDIENT
-	ipilimumab	solution	71124-0020DRUG FOR FURTHER PROCESSING
-	ipilimumab	solution	71124-0021DRUG FOR FURTHER PROCESSING
-	ipilimumab	solution	71124-0022DRUG FOR FURTHER PROCESSING
-	lebrikizumab	liquid	71124-0028BULK INGREDIENT
-	mepolizumab	liquid	71124-0063BULK INGREDIENT
-	mirvetuximab	liquid	71124-0052BULK INGREDIENT
-	nirsevimab	liquid	71124-0033BULK INGREDIENT
-	rituximab	liquid	71124-0053BULK INGREDIENT
-	rozanolixizumab	liquid	71124-0049BULK INGREDIENT
-	sacituzumab	liquid	71124-0015BULK INGREDIENT
-	sotatercept	liquid	71124-0061BULK INGREDIENT
-	tildrakizumab	liquid	71124-0013BULK INGREDIENT
-	tocilizumab	liquid	71124-0019BULK INGREDIENT
-	trastuzumab	liquid	71124-0042BULK INGREDIENT
-	trastuzumab	liquid	71124-0046BULK INGREDIENT
-	ublituximab	solution	71124-0026DRUG FOR FURTHER PROCESSING
-	ublituximab	liquid	71124-0041BULK INGREDIENT

Neighbours

Registered in the same town

Sigma-Aldrich CorporationRockville, MD
Bora Pharmaceutical Laboratories Inc.Rockville, MD
Aurinia Pharma U.S., Inc.Rockville, MD
Supernus Pharmaceuticals IncRockville, MD

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Enquiry

Common questions

Is Samsung Biologics Co., Ltd. FDA approved?: Samsung Biologics Co., Ltd. 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 Samsung Biologics Co., Ltd.'s drugs manufactured?: At registered sites in South Korea, the United States. The FDA register lists 21987; Rockville, MD. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging.
What drugs does Samsung Biologics Co., Ltd. make?: 57 products are listed under Samsung Biologics Co., Ltd. in the openFDA NDC Directory, most often as liquid; solution; injection, solution. 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.