Is Baxalta US Inc. FDA approved?

Baxalta US Inc. holds 15 FDA-registered establishments across 6 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 Baxalta US Inc.'s drugs manufactured?

At registered sites in Austria, Belgium, Switzerland, Italy, Singapore, the United States. The FDA register lists Orth an der Donau; WIEN; Wien; Lessines; NEUCH�TEL; Cittaducale (Santa Rufina), and 6 more. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging.

Baxalta US Inc.

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

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Registered sites: 15
Active NDC listings: 0
Live patents: 0
Countries: 6
Base: Austria

Authorisation

Registered operations

Analytical testing12Active ingredient (API) manufacture10Labelling4Finished drug manufacture11Packaging5

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Takeda Manufacturing Austria AGRegistrant: Baxalta US Inc.	Uferstra�e 15, Orth an der Donau, 2304, Austria (AUT)	Analytical testing	3003046565300466733
Takeda Manufacturing Austria AGRegistrant: Baxalta US Inc.	Industriestra�e 72, WIEN, 1221, Austria (AUT)	Active ingredient (API) manufacture, Finished drug manufacture	3002669612300434671
Takeda Manufacturing Austria AGRegistrant: Baxalta US Inc.	Industriestra�e 131, WIEN, 1221, Austria (AUT)	Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging	3002807133300434675
Takeda Manufacturing Austria AGRegistrant: Baxalta US Inc.	Pasettistrasse 76, Wien, 1200, Austria (AUT)	Finished drug manufacture	3003608831300434678
Takeda Manufacturing Austria AGRegistrant: Baxalta US Inc.	Benatzkygasse 2-6, Wien, 1221, Austria (AUT)	Analytical testing, Active ingredient (API) manufacture	3003608834300434676
Takeda Manufacturing Austria AGRegistrant: Baxalta US Inc.	Industriestrasse 20, Wien, 1221, Austria (AUT)	Analytical testing	3004073331300434674
Baxalta Belgium Manufacturing SARegistrant: Baxalta US Inc.	Boulevard Ren� Branquart 80, Lessines, 7860, Belgium (BEL)	Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging	3002806503370634700
Baxalta Manufacturing S�rlRegistrant: Baxalta US Inc.	Route de Pierre-�-Bot 111, NEUCH�TEL, 2000, Switzerland (CHE)	Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture	3002689389482124943
Takeda Manufacturing Italia SPARegistrant: Baxalta US Inc.	VIALE DELLA CHIMICA 5, Cittaducale (Santa Rufina), 02015, Italy (ITA)	Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture	3007244131629957643
Takeda Manufacturing Singapore Pte. Ltd.Registrant: Baxalta US Inc.	2A Woodlands Industrial Park D, Singapore, 737779, Singapore (SGP)	Analytical testing, Active ingredient (API) manufacture	3009153654659910011
BAXALTA US INC.Registrant: Baxalta US Inc.	4501 COLORADO BLVD, LOS ANGELES, California (CA) 90039-1103, United States (USA)	Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture	2011021085206634
BAXALTA US INC.Registrant: Baxalta US Inc.	25212 W IL ROUTE 120, ROUND LAKE, Illinois (IL) 60073-9610, United States (USA)	Analytical testing, Labelling, Finished drug manufacture, Packaging	3012385969105875392
Baxalta US Inc.	505 Shire Pkwy, Social Circle, Georgia (GA) 30025-4723, United States (USA)	Analytical testing, Finished drug manufacture, Packaging	3013980449079887650
Baxalta US Inc.	1700 RANCHO CONEJO BLVD, THOUSAND OAKS, California (CA) 91320-1424, United States (USA)	Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging	1000519965009471603
Baxalta US Inc.	15903 Strathern St, Van Nuys, California (CA) 91406, United States (USA)	Active ingredient (API) manufacture, Finished drug manufacture	3002772556076220016

Neighbours

Registered in the same town

Merck & Co., Inc.Singapore, SGP; Wien, AUT · 6 sites
Baxter Healthcare CorporationLessines, BEL; Round Lake, IL · 2 sites
SanofiSingapore, SGP · 2 sites
Pfizer IncOrth an der Donau, AUT; Singapore, SGP · 2 sites
Amgen, IncSingapore, SGP; Thousand Oaks, CA · 2 sites
Cardinal Health 418, Inc.Van Nuys, CA
Novartis Pharmaceuticals CorporationSingapore, SGP
Charles River Laboratories, Inc.Singapore, SGP
Lonza Biologics IncSingapore, SGP
Pharmalogic Holdings Corp.Los Angeles, CA
AbbVie Inc.Singapore, SGP
Sotera Health LLCLos Angeles, CA

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Enquiry

Common questions

Is Baxalta US Inc. FDA approved?: Baxalta US Inc. holds 15 FDA-registered establishments across 6 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 Baxalta US Inc.'s drugs manufactured?: At registered sites in Austria, Belgium, Switzerland, Italy, Singapore, the United States. The FDA register lists Orth an der Donau; WIEN; Wien; Lessines; NEUCH�TEL; Cittaducale (Santa Rufina), and 6 more. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging.

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.