Is Celltrion Branchburg, LLC FDA approved?

Celltrion Branchburg, 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 Celltrion Branchburg, LLC's drugs manufactured?

The FDA register lists Branchburg, NJ. Registered operations: analytical testing, active ingredient (API) manufacture.

What drugs does Celltrion Branchburg, LLC make?

2 products are listed under Celltrion Branchburg, LLC in the openFDA NDC Directory, most often as liquid; solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Celltrion Branchburg, LLC

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

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Registered sites: 1
Active NDC listings: 2
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
Celltrion Branchburg, LLC	33 ImClone Drive, Branchburg, New Jersey (NJ) 08876, United States (USA)	Analytical testing, Active ingredient (API) manufacture	3002889358798223376

Catalogue

Drug listings by form and route

2 active NDC listings: 2 bulk ingredient. By marketing category: BULK INGREDIENT 2.

Dosage form	NDCs
liquid	1
solution	1

Route	NDCs

Labeller name on the listing	NDCs
celltrion branchburg, llc	2

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	Cetuximab	liquid	73424-0561BULK INGREDIENT
-	Galcanezumab	solution	73424-0556BULK INGREDIENT

Neighbours

Registered in the same town

Amneal Pharmaceuticals of New York, LLCBranchburg, NJ
ZebraSci, Inc.Branchburg, NJ

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Enquiry

Common questions

Is Celltrion Branchburg, LLC FDA approved?: Celltrion Branchburg, 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 Celltrion Branchburg, LLC's drugs manufactured?: The FDA register lists Branchburg, NJ. Registered operations: analytical testing, active ingredient (API) manufacture.
What drugs does Celltrion Branchburg, LLC make?: 2 products are listed under Celltrion Branchburg, LLC in the openFDA NDC Directory, most often as liquid; 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.