Is Lotte Biologics USA, LLC FDA approved?

Lotte Biologics USA, LLC holds 1 FDA-registered establishment in the United States. 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 Lotte Biologics USA, LLC's drugs manufactured?

The FDA register lists East Syracuse, NY. Registered operations: analytical testing, active ingredient (API) manufacture.

What drugs does Lotte Biologics USA, LLC make?

4 products are listed under Lotte Biologics USA, LLC in the openFDA NDC Directory, most often as injection; injection, powder, lyophilized, for solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Lotte Biologics USA, LLC

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

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Registered sites: 1
Active NDC listings: 4
Live patents: 0
Countries: 1
Base: United States

Authorisation

Registered operations

Analytical testing1Active ingredient (API) manufacture1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Lotte Biologics USA, LLC	6000 Thompson Road, East Syracuse, New York (NY) 13057, United States (USA)	Analytical testing, Active ingredient (API) manufacture	1317757118777741

Catalogue

Drug listings by form and route

4 active NDC listings: 4 bulk ingredient. By marketing category: BULK INGREDIENT 4.

Dosage form	NDCs
injection	2
injection, powder, lyophilized, for solution	2

Route	NDCs

Labeller name on the listing	NDCs
lotte biologics usa, llc	4

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	BELATACEPT	injection, powder, lyophilized, for solution	83157-0371BULK INGREDIENT
-	Elotuzumab	injection, powder, lyophilized, for solution	83157-2291BULK INGREDIENT
-	IPILIMUMAB	injection	83157-2327BULK INGREDIENT
-	Nivolumab	injection	83157-3772BULK INGREDIENT

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Enquiry

Common questions

Is Lotte Biologics USA, LLC FDA approved?: Lotte Biologics USA, LLC holds 1 FDA-registered establishment in the United States. 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 Lotte Biologics USA, LLC's drugs manufactured?: The FDA register lists East Syracuse, NY. Registered operations: analytical testing, active ingredient (API) manufacture.
What drugs does Lotte Biologics USA, LLC make?: 4 products are listed under Lotte Biologics USA, LLC in the openFDA NDC Directory, most often as injection; injection, powder, lyophilized, for 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.