Is KBI Biopharma, Inc. FDA approved?

KBI Biopharma, Inc. holds 4 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 KBI Biopharma, Inc.'s drugs manufactured?

At registered sites in Switzerland, the United States. The FDA register lists Plan-les-Ouates; Boulder, CO; Durham, NC. Registered operations: analytical testing, active ingredient (API) manufacture, finished drug manufacture.

KBI Biopharma, Inc.

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

Request a quote Claim this profile

Registered sites: 4
Active NDC listings: 0
Live patents: 0
Countries: 2
Base: United States

Authorisation

Registered operations

Analytical testing4Active ingredient (API) manufacture3Finished drug manufacture3

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
KBI Biopharma SARegistrant: KBI Biopharma, Inc.	Route de la Galaise 36, Plan-les-Ouates, Ginevra 1228, Switzerland (CHE)	Analytical testing	3022997121480487319
KBI Biopharma, Inc.	2500 Central Ave., Boulder, Colorado (CO) 80301, United States (USA)	Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture	3011326133079582679
KBI Biopharma, Inc.	1101 Hamlin Rd., Durham, North Carolina (NC) 27704, United States (USA)	Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture	3004638264034248380
KBI Biopharma, Inc.	47 National Dr, Durham, North Carolina (NC) 27703, United States (USA)	Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture	3017660941118524705

Neighbours

Registered in the same town

Almac Clinical Services, LLCDurham, NC · 3 sites
Merck & Co., Inc.Durham, NC · 2 sites
PETNET Solutions, Inc.DURHAM, NC
SGS North America Inc.Plan-les-Ouates, CHE
Novo Nordisk Inc.Durham, NC
Eli Lilly and CompanyDurham, NC
AGC Biologics, Inc.Boulder, CO
BRACCO DIAGNOSTICS INCPlan-les-Ouates, CHE
Encube Ethicals LimitedDurham, NC
Oxford Biomedica (UK) LimitedDurham, NC
United Therapeutics CorporationDurham, NC
Aurolife Pharma LLCDurham, NC

Compare

Comparable companies in United States

Hikma Pharmaceuticals USA Inc.4 sites · 763 NDC
Church & Dwight Co., Inc.4 sites · 157 NDC
Sterling Pharmaceutical Services, LLC4 sites · 104 NDC
Bausch & Lomb Ireland Limited4 sites · 92 NDC
Grifols Therapeutics LLC4 sites · 53 NDC
Gilead Sciences, Inc.4 sites · 51 NDC
Nice-Pak Products, LLC4 sites · 48 NDC
HOVIONE FARMACIENCIA, S.A.4 sites · 47 NDC
Pacific Medical Industries Ltd4 sites · 41 NDC
United Therapeutics Corporation4 sites · 40 NDC

Enquiry

Common questions

Is KBI Biopharma, Inc. FDA approved?: KBI Biopharma, Inc. holds 4 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 KBI Biopharma, Inc.'s drugs manufactured?: At registered sites in Switzerland, the United States. The FDA register lists Plan-les-Ouates; Boulder, CO; Durham, NC. Registered operations: analytical testing, active ingredient (API) manufacture, finished drug manufacture.

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.