Is Takeda Pharmaceuticals U.S.A., Inc. FDA approved?

Takeda Pharmaceuticals U.S.A., Inc. holds 7 FDA-registered establishments across 4 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 Takeda Pharmaceuticals U.S.A., Inc.'s drugs manufactured?

At registered sites in Germany, Ireland, Japan, the United States. The FDA register lists Oranienburg; Singen (Hohentwiel); Bray; Dublin; Hikari; Yodogawa-Ku, and 1 more. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging.

What drugs does Takeda Pharmaceuticals U.S.A., Inc. make?

226 products are listed under Takeda Pharmaceuticals U.S.A., Inc. in the openFDA NDC Directory, most often as tablet, film coated; kit; tablet. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Are any Takeda Pharmaceuticals U.S.A., Inc. products in shortage?

13 presentations are currently listed in the FDA drug shortage database under Takeda Pharmaceuticals U.S.A., Inc., covering Lisdexamfetamine Dimesylate Capsule, Lisdexamfetamine Dimesylate Tablet, Chewable.

Takeda Pharmaceuticals U.S.A., Inc.

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

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Registered sites: 7
Active NDC listings: 226
Labeller names: 9
Live patents: 237
Exclusivities: 7
Shortage listings: 20
Countries: 4
Base: Germany

Authorisation

Registered operations

Analytical testing7Active ingredient (API) manufacture3Labelling4Finished drug manufacture6Packaging6

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Takeda GmbH	Lehnitzstr. 70-98, Oranienburg, Brandenburg 16515, Germany (DEU)	Analytical testing, Labelling, Finished drug manufacture, Packaging	3002807809313270015
Takeda GmbH	Robert-Bosch-Str. 8, Singen (Hohentwiel), Baden-Wurttemberg 78224, Germany (DEU)	Analytical testing, Labelling, Finished drug manufacture, Packaging	3002806542313270016
Takeda Ireland LimitedRegistrant: TAKEDA PHARMACEUTICAL COMPANY LIMITED	Bray South Business Park Killarney Road, Bray, Kilruddery A98 CD36, Ireland (IRL)	Analytical testing, Labelling, Finished drug manufacture, Packaging	3002870748988980314
Takeda Ireland LimitedRegistrant: TAKEDA PHARMACEUTICAL COMPANY LIMITED	Grange Castle Business Park, Nangor Road, Dublin, Co. Dublin D22 XR57, Ireland (IRL)	Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging	3006687027986017670
Takeda Pharmaceutical Company LimitedRegistrant: TAKEDA PHARMACEUTICAL COMPANY LIMITED	4720, Takeda, Mitsui, Hikari, Yamaguchi 743-0011, Japan (JPN)	Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture, Packaging	3004664162695132431
Takeda Pharmaceutical Company LimitedRegistrant: TAKEDA PHARMACEUTICAL COMPANY LIMITED	2-17-85, Jusohonmachi,, Yodogawa-Ku, Osaka 532-0024, Japan (JPN)	Analytical testing, Finished drug manufacture, Packaging	3002808311695132274
Takeda Pharmaceuticals U.S.A., Inc.	9450 Winnetka Ave N, Brooklyn Park, Minnesota (MN) 55445, United States (USA)	Analytical testing, Active ingredient (API) manufacture	3013514239080273072

Alert

Drug shortage listings

Drug	Presentation	Status	Availability	Posted / updated
Lisdexamfetamine Dimesylate CapsulePsychiatry	Vyvanse, Capsule, 50 mg (NDC 59417-105-10)	Current	Available	14 Jul 202315 Sept 2026
Lisdexamfetamine Dimesylate CapsulePsychiatry	Vyvanse, Capsule, 10 mg (NDC 59417-101-10)	Current	Available	14 Jul 202315 Sept 2026
Lisdexamfetamine Dimesylate CapsulePsychiatry	Vyvanse, Capsule, 60 mg (NDC 59417-106-10)	Current	Available	14 Jul 202315 Sept 2026
Lisdexamfetamine Dimesylate CapsulePsychiatry	Vyvanse, Capsule, 70 mg (NDC 59417-107-10)	Current	Available	14 Jul 202315 Sept 2026
Lisdexamfetamine Dimesylate CapsulePsychiatry	Vyvanse, Capsule, 40 mg (NDC 59417-104-10)	Current	Available	14 Jul 202315 Sept 2026
Lisdexamfetamine Dimesylate CapsulePsychiatry	Vyvanse, Capsule, 30 mg (NDC 59417-103-10)	Current	Available	14 Jul 202315 Sept 2026
Lisdexamfetamine Dimesylate CapsulePsychiatry	Vyvanse, Capsule, 20 mg (NDC 59417-102-10)	Current	Available	14 Jul 202315 Sept 2026
Lisdexamfetamine Dimesylate Tablet, ChewablePsychiatry	Vyvanse, Tablet, Chewable, 50 mg (NDC 59417-119-01)	Current	Available	14 Jul 202315 Sept 2026
Lisdexamfetamine Dimesylate Tablet, ChewablePsychiatry	Vyvanse, Tablet, Chewable, 10 mg (NDC 59417-115-01)	Current	Available	14 Jul 202315 Sept 2026
Lisdexamfetamine Dimesylate Tablet, ChewablePsychiatry	Vyvanse, Tablet, Chewable, 60 mg (NDC 59417-120-01)	Current	Available	14 Jul 202315 Sept 2026
Lisdexamfetamine Dimesylate Tablet, ChewablePsychiatry	Vyvanse, Tablet, Chewable, 30 mg (NDC 59417-117-01)	Current	Available	14 Jul 202315 Sept 2026
Lisdexamfetamine Dimesylate Tablet, ChewablePsychiatry	Vyvanse, Tablet, Chewable, 20 mg (NDC 59417-116-01)	Current	Available	14 Jul 202315 Sept 2026
Lisdexamfetamine Dimesylate Tablet, ChewablePsychiatry	Vyvanse, Tablet, Chewable, 40 mg (NDC 59417-118-01)	Current	Available	14 Jul 202315 Sept 2026
Mesalamine Capsule, Extended ReleaseGastroenterology	Pentasa, Capsule, Extended Release, 250 mg (NDC 54092-189-81)	To Be Discontinued	-	16 Sept 202616 Sept 2026
Mesalamine Capsule, Extended ReleaseGastroenterology	Pentasa, Capsule, Extended Release, 500 mg (NDC 54092-191-12)	To Be Discontinued	-	16 Sept 202616 Sept 2026
Ramelteon TabletPsychiatry	Rozerem, Tablet, 8 mg (NDC 64764-805-10)	To Be Discontinued	-	19 Mar 202619 Mar 2026
Ramelteon TabletPsychiatry	Rozerem, Tablet, 8 mg (NDC 64764-805-30)	To Be Discontinued	-	19 Mar 202619 Mar 2026
Carbamazepine Capsule, Extended ReleaseNeurology	Carbatrol, Capsule, Extended Release, 100 mg (NDC 54092-171-12)	To Be Discontinued	-	19 Dec 202519 Dec 2025
Carbamazepine Capsule, Extended ReleaseNeurology	Carbatrol, Capsule, Extended Release, 200 mg (NDC 54092-172-12)	To Be Discontinued	-	19 Dec 202519 Dec 2025
Carbamazepine Capsule, Extended ReleaseNeurology	Carbatrol, Capsule, Extended Release, 300 mg (NDC 54092-173-12)	To Be Discontinued	-	19 Dec 202519 Dec 2025

Catalogue

Drug listings by form and route

226

226 active NDC listings: 109 human prescription drug, 71 drug for further processing, 43 plasma derivative, 3 bulk ingredient. By marketing category: NDA 94, DRUG FOR FURTHER PROCESSING 71, BLA 57, BULK INGREDIENT 3, NDA AUTHORIZED GENERIC 1.

Dosage form	NDCs
tablet, film coated	51
kit	49
tablet	32
capsule	15
capsule, extended release	13
injection, powder, lyophilized, for suspension	11
injection, solution	10
tablet, chewable	9
injection, powder, lyophilized, for solution	6
tablet, delayed release	4
tablet, extended release	4
tablet, orally disintegrating, delayed release	4
capsule, delayed release	3
powder	3
solution	3

Route	NDCs
oral	84
subcutaneous	17
intravenous	10

Labeller name on the listing	NDCs
takeda pharmaceuticals america, inc.	151
takeda gmbh	22
takeda pharmaceutical company limited	14
takeda pharmaceutical co ltd	13
takeda ireland ltd.	9
takeda pharmaceutical company ltd	8
takeda ireland limited	4
takeda pharmaceuticals america, inc.	3
takeda pharmaceuticals co ltd	2

Exclusivity

Patents and exclusivities

237

Patent	Product	Covers	Expiry
11197822	EOHILIAbudesonide	product	Nov 2026
11413296	EOHILIAbudesonide	product	Nov 2026
8497258	EOHILIAbudesonide	use	Nov 2026
8679545	EOHILIAbudesonide	product	Nov 2026
8975243	EOHILIAbudesonide	use	Nov 2026
9119863	EOHILIAbudesonide	use	Nov 2026
7144884*PED	TRINTELLIXvortioxetine hydrobromide	use	Dec 2026
9029533	ICLUSIGponatinib hydrochloride	use	Dec 2026
9101660	ACTOPLUS METmetformin hydrochloride; pioglitazone hydrochloride	product	Jan 2027
8114874	ICLUSIGponatinib hydrochloride	substance, product	Jan 2027
7700128	DUETACTglimepiride; pioglitazone hydrochloride	product	Jan 2027
7790755*PED	DEXILANTdexlansoprazole	use	Feb 2027
8105626*PED	DEXILANTdexlansoprazole	use	Mar 2027
11458134	TRINTELLIXvortioxetine hydrobromide	product	Jun 2027
8969355	TRINTELLIXvortioxetine hydrobromide	use	Jun 2027
9125908	TRINTELLIXvortioxetine hydrobromide	use	Jun 2027
9125909	TRINTELLIXvortioxetine hydrobromide	use	Jun 2027
9125910	TRINTELLIXvortioxetine hydrobromide	use	Jun 2027
9227946	TRINTELLIXvortioxetine hydrobromide	use	Jun 2027
9861630	TRINTELLIXvortioxetine hydrobromide	use	Jun 2027
7687662	NINLAROixazomib citrate	substance, product	Aug 2027
8003819	NINLAROixazomib citrate	substance, product	Aug 2027
8530694	NINLAROixazomib citrate	substance, product	Aug 2027
8871745	NINLAROixazomib citrate	use	Aug 2027
11458134*PED	TRINTELLIXvortioxetine hydrobromide	use	Dec 2027
8969355*PED	TRINTELLIXvortioxetine hydrobromide	use	Dec 2027
9125908*PED	TRINTELLIXvortioxetine hydrobromide	use	Dec 2027
9125909*PED	TRINTELLIXvortioxetine hydrobromide	use	Dec 2027
9125910*PED	TRINTELLIXvortioxetine hydrobromide	use	Dec 2027
9227946*PED	TRINTELLIXvortioxetine hydrobromide	use	Dec 2027
9861630*PED	TRINTELLIXvortioxetine hydrobromide	use	Dec 2027
8871273	DEXILANT, DEXILANT SOLUTABdexlansoprazole	product	Jan 2028
8212033	FRUZAQLAfruquintinib	use	May 2028
8071130	DUETACTglimepiride; pioglitazone hydrochloride	product	Jun 2028
7807689	KAZANO, NESINA, OSENIalogliptin benzoate; alogliptin benzoate; metformin hydrochloride; alogliptin benzoate; pioglitazone hydrochloride	substance, product	Jun 2028
8871273*PED	DEXILANT SOLUTABdexlansoprazole	use	Jul 2028
7964647	COLCRYScolchicine	use	Oct 2028
7964648	COLCRYScolchicine	use	Oct 2028
7981938	COLCRYScolchicine	use	Oct 2028
8093296	COLCRYScolchicine	use	Oct 2028
8093297	COLCRYScolchicine	use	Oct 2028
8093298	COLCRYScolchicine	use	Oct 2028
8097655	COLCRYScolchicine	use	Oct 2028
8415395	COLCRYScolchicine	use	Oct 2028
8415396	COLCRYScolchicine	use	Oct 2028
11357859	EOHILIAbudesonide	use	Nov 2028
10293052	EOHILIAbudesonide	product	Nov 2028
7619004	COLCRYScolchicine	use	Dec 2028
7935731	COLCRYScolchicine	use	Dec 2028
9320714	ACTOPLUS METmetformin hydrochloride; pioglitazone hydrochloride	product	Feb 2029
7601758	COLCRYScolchicine	use	Feb 2029
7820681	COLCRYScolchicine	use	Feb 2029
7906519	COLCRYScolchicine	use	Feb 2029
7915269	COLCRYScolchicine	use	Feb 2029
8440721	COLCRYScolchicine	use	Feb 2029
8440722	COLCRYScolchicine	use	Feb 2029
9241910	DEXILANT SOLUTABdexlansoprazole	product	Mar 2029
9273077	ALUNBRIGbrigatinib	use	May 2029
8900638	KAZANOalogliptin benzoate; metformin hydrochloride	product	May 2029
8637079	OSENIalogliptin benzoate; pioglitazone hydrochloride	product	Jun 2029

Product	Exclusivity	Until
ALUNBRIGBRIGATINIB	ODE-300 Orphan drug	May 2027
EOHILIABUDESONIDE	ODE-466 Orphan drug	Feb 2031
EXKIVITYMOBOCERTINIB SUCCINATE	ODE-374 Orphan drug	Sept 2028
FRUZAQLAFRUQUINTINIB	NCE New chemical entity	Nov 2028
ICLUSIGPONATINIB HYDROCHLORIDE	ODE-472 Orphan drug	Mar 2031
LIVTENCITYMARIBAVIR	ODE-388 Orphan drug	Nov 2028
TRINTELLIXVORTIOXETINE HYDROBROMIDE	PED Paediatric	Feb 2027

Catalogue

Marketed products

226

Showing 150 of 226.

Brand	Generic name	Form / route	NDC
ADVATE	Antihemophilic Factor (Recombinant)	kit	0944-3045BLA
ADVATE	Antihemophilic Factor (Recombinant)	kit	0944-3046BLA
ADVATE	Antihemophilic Factor (Recombinant)	kit	0944-3047BLA
ADVATE	Antihemophilic Factor (Recombinant)	kit	0944-3051BLA
ADVATE	Antihemophilic Factor (Recombinant)	kit	0944-3052BLA
ADVATE	Antihemophilic Factor (Recombinant)	kit	0944-3053BLA
ADVATE	Antihemophilic Factor (Recombinant)	kit	0944-3054BLA
ADZYNMA	Apadamtase Alfa	kit	64764-140BLA
ADZYNMA	Apadamtase Alfa	kit	64764-145BLA
Actoplus Met	pioglitazone and metformin hydrochloride	tablet, film coated, oral	64764-158NDA
Actos	pioglitazone	tablet, oral	64764-151NDA
Actos	pioglitazone	tablet, oral	64764-301NDA
Actos	pioglitazone	tablet, oral	64764-451NDA
Adderall XR	Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate	capsule, extended release, oral	54092-381NDA
Adderall XR	Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate	capsule, extended release, oral	54092-383NDA
Adderall XR	Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate	capsule, extended release, oral	54092-385NDA
Adderall XR	Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate	capsule, extended release, oral	54092-387NDA
Adderall XR	Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate	capsule, extended release, oral	54092-389NDA
Adderall XR	Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate	capsule, extended release, oral	54092-391NDA
Agrylin	anagrelide hydrochloride	capsule, oral	54092-063NDA
-	Alogliptin Benzoate and Pioglitazone Hydrochloride	tablet, film coated	47234-7102DRUG FOR FURTHER PROCESSING
-	Alogliptin Benzoate and Pioglitazone Hydrochloride	tablet, film coated	47234-7104DRUG FOR FURTHER PROCESSING
-	Alogliptin Benzoate and Pioglitazone Hydrochloride	tablet, film coated	47234-7105DRUG FOR FURTHER PROCESSING
-	Alogliptin Benzoate and Pioglitazone Hydrochloride	tablet, film coated	47234-7106DRUG FOR FURTHER PROCESSING
Alunbrig	brigatinib	tablet, film coated, oral	63020-090NDA
Alunbrig	brigatinib	tablet, film coated, oral	63020-113NDA
Alunbrig	brigatinib	tablet, film coated, oral	63020-180NDA
Alunbrig	brigatinib	kit	63020-198NDA
Amitiza	lubiprostone	capsule, gelatin coated, oral	64764-080NDA
Amitiza	lubiprostone	capsule, gelatin coated, oral	64764-240NDA
Aralast NP	Alpha-1-Proteinase Inhibitor (Human)	kit	0944-2814BLA
Aralast NP	Alpha-1-Proteinase Inhibitor (Human)	kit	0944-2815BLA
-	Azilsartan kamedoxomil	tablet	11532-2002DRUG FOR FURTHER PROCESSING
-	Azilsartan kamedoxomil	tablet	11532-2003DRUG FOR FURTHER PROCESSING
-	Azilsartan medoxomil	tablet	66332-2002DRUG FOR FURTHER PROCESSING
-	Azilsartan medoxomil	tablet	66332-2003DRUG FOR FURTHER PROCESSING
-	Azilsartan medoxomil and CHLORTHALIDONE	tablet	66332-6002DRUG FOR FURTHER PROCESSING
-	Azilsartan medoxomil and CHLORTHALIDONE	tablet	66332-6003DRUG FOR FURTHER PROCESSING
-	Bictegravir sodium, Emtricitabine, and Tenofovir Alafenamide Fumarate	tablet	47234-2501DRUG FOR FURTHER PROCESSING
CEPROTIN	Protein C Concentrate Human	kit	0944-4177BLA
CEPROTIN	Protein C Concentrate Human	kit	0944-4179BLA
CUVITRU	Immune Globulin Subcutaneous (Human)	injection, solution, subcutaneous	0944-2850BLA
Carbatrol	carbamazepine	capsule, extended release, oral	54092-171NDA
Carbatrol	carbamazepine	capsule, extended release, oral	54092-172NDA
Carbatrol	carbamazepine	capsule, extended release, oral	54092-173NDA
Cinryze	HUMAN C1-ESTERASE INHIBITOR	injection, powder, lyophilized, for solution, intravenous	42227-081BLA
Cinryze	HUMAN C1-ESTERASE INHIBITOR	kit	42227-083BLA
-	Colchicine	tablet, film coated	47234-0119DRUG FOR FURTHER PROCESSING
Dexilant	dexlansoprazole	capsule, delayed release, oral	64764-171NDA
Dexilant	dexlansoprazole	capsule, delayed release, oral	64764-175NDA
Duetact	pioglitazone and glimepiride	tablet, oral	64764-302NDA
Duetact	pioglitazone and glimepiride	tablet, oral	64764-304NDA
ELAPRASE	idursulfase	solution, concentrate, intravenous	54092-700BLA
ENTYVIO	vedolizumab	injection, solution, subcutaneous	64764-107BLA
ENTYVIO Pen	vedolizumab	injection, solution, subcutaneous	64764-108BLA
Entyvio	vedolizumab	injection, powder, lyophilized, for solution, intravenous	64764-300BLA
Eohilia	Budesonide	suspension, oral	64764-105NDA
FEIBA	anti-inhibitor coagulant complex	kit	64193-424BLA
FEIBA	anti-inhibitor coagulant complex	kit	64193-425BLA
FEIBA	anti-inhibitor coagulant complex	kit	64193-426BLA
FLEXBUMIN	Albumin Human	solution, intravenous	0944-0493BLA
Firazyr	icatibant acetate	injection, solution, subcutaneous	54092-702NDA
Flexbumin	Albumin Human	injection, solution, intravenous	0944-0495BLA
Fosrenol	lanthanum carbonate	tablet, chewable, oral	54092-252NDA
Fosrenol	lanthanum carbonate	tablet, chewable, oral	54092-253NDA
Fosrenol	lanthanum carbonate	tablet, chewable, oral	54092-254NDA
Fosrenol	lanthanum carbonate	powder, oral	54092-256NDA
Fosrenol	lanthanum carbonate	powder, oral	54092-257NDA
Fruzaqla	fruquintinib	capsule, oral	63020-210NDA
Fruzaqla	fruquintinib	capsule, oral	63020-225NDA
GAMMAGARD Liquid	Immune Globulin Infusion (Human)	injection, solution, intravenous, subcutaneous	0944-2700BLA
GAMMAGARD Liquid ERC	Immune Globulin Infusion (Human)	injection, solution, intravenous, subcutaneous	0944-2705BLA
GAMMAGARD S/D	Immune Globulin Intravenous (Human)	kit	0944-2656BLA
GAMMAGARD S/D	Immune Globulin Intravenous (Human)	kit	0944-2658BLA
GLASSIA	ALPHA.1-PROTEINASE INHIBITOR HUMAN	injection, solution, intravenous	0944-2884BLA
Gattex	teduglutide	injection, powder, lyophilized, for solution, subcutaneous	68875-0101NDA
Gattex	teduglutide	kit	68875-0102NDA
Gattex	teduglutide	kit	68875-0103NDA
HEMOFIL M	antihemophilic factor human	kit	0944-3940BLA
HEMOFIL M	antihemophilic factor human	kit	0944-3942BLA
HEMOFIL M	antihemophilic factor human	kit	0944-3944BLA
HEMOFIL M	antihemophilic factor human	kit	0944-3946BLA
HYQVIA	Immune Globulin Infusion (Human), 10% with Recombinant Human Hyaluronidase	kit	0944-2510BLA
HYQVIA	Immune Globulin Infusion (Human), 10% with Recombinant Human Hyaluronidase	kit	0944-2511BLA
HYQVIA	Immune Globulin Infusion (Human), 10% with Recombinant Human Hyaluronidase	kit	0944-2512BLA
HYQVIA	Immune Globulin Infusion (Human), 10% with Recombinant Human Hyaluronidase	kit	0944-2513BLA
HYQVIA	Immune Globulin Infusion (Human), 10% with Recombinant Human Hyaluronidase	kit	0944-2514BLA
Iclusig	ponatinib hydrochloride	tablet, film coated, oral	63020-533NDA
Iclusig	ponatinib hydrochloride	tablet, film coated, oral	63020-534NDA
Iclusig	ponatinib hydrochloride	tablet, film coated, oral	63020-535NDA
Iclusig	ponatinib hydrochloride	tablet, film coated, oral	63020-536NDA
Intuniv	guanfacine	tablet, extended release, oral	54092-513NDA
Intuniv	guanfacine	tablet, extended release, oral	54092-515NDA
Intuniv	guanfacine	tablet, extended release, oral	54092-517NDA
Intuniv	guanfacine	tablet, extended release, oral	54092-519NDA
KAZANO	alogliptin and metformin hydrochloride	tablet, film coated, oral	64764-335NDA
KAZANO	alogliptin and metformin hydrochloride	tablet, film coated, oral	64764-337NDA
Kalbitor	Ecallantide	injection, solution, subcutaneous	47783-101BLA
Lialda	mesalamine	tablet, delayed release, oral	54092-476NDA
Livtencity	MARIBAVIR	tablet, coated, oral	64764-800NDA
MIMRYLO	rusfertide	kit, subcutaneous	63020-715NDA
MIMRYLO	rusfertide	kit, subcutaneous	63020-725NDA
MIMRYLO	rusfertide	kit, subcutaneous	63020-735NDA
MIMRYLO	rusfertide	kit, subcutaneous	63020-745NDA
MIMRYLO	rusfertide	kit, subcutaneous	63020-765NDA
MOTEGRITY	PRUCALOPRIDE	tablet, film coated, oral	54092-546NDA
MOTEGRITY	PRUCALOPRIDE	tablet, film coated, oral	54092-547NDA
MYDAYIS	DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATE	capsule, extended release, oral	54092-468NDA
MYDAYIS	DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATE	capsule, extended release, oral	54092-471NDA
MYDAYIS	DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATE	capsule, extended release, oral	54092-474NDA
MYDAYIS	DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATE	capsule, extended release, oral	54092-477NDA
Mesalamine	MESALAMINE	tablet, delayed release, oral	54092-100NDA AUTHORIZED GENERIC
NINLARO	ixazomib	capsule, oral	63020-230NDA
NINLARO	ixazomib	capsule, oral	63020-390NDA
NINLARO	ixazomib	capsule, oral	63020-400NDA
Nesina	alogliptin	tablet, film coated, oral	64764-125NDA
Nesina	alogliptin	tablet, film coated, oral	64764-250NDA
Nesina	alogliptin	tablet, film coated, oral	64764-625NDA
OBIZUR	Antihemophilic Factor (Recombinant), Porcine Sequence	kit	0944-5001BLA
OSENI	alogliptin and pioglitazone	tablet, film coated, oral	64764-123NDA
OSENI	alogliptin and pioglitazone	tablet, film coated, oral	64764-251NDA
OSENI	alogliptin and pioglitazone	tablet, film coated, oral	64764-253NDA
OSENI	alogliptin and pioglitazone	tablet, film coated, oral	64764-254NDA
-	PANTOPRAZOLE SODIUM	tablet, delayed release	47234-0841DRUG FOR FURTHER PROCESSING
-	PANTOPRAZOLE SODIUM	tablet, delayed release	47234-0843DRUG FOR FURTHER PROCESSING
-	PANTOPRAZOLE SODIUM	injection, powder, for solution	47234-0923DRUG FOR FURTHER PROCESSING
Pentasa	mesalamine	capsule, oral	54092-189NDA
Pentasa	mesalamine	capsule, oral	54092-191NDA
Prevacid	lansoprazole	capsule, delayed release, oral	64764-046NDA
Prevacid SoluTab	lansoprazole	tablet, orally disintegrating, delayed release, oral	64764-543NDA
Prevacid SoluTab	lansoprazole	tablet, orally disintegrating, delayed release, oral	64764-544NDA
RECOMBINATE	antihemophilic factor recombinant	kit	0944-2841BLA
RECOMBINATE	antihemophilic factor recombinant	kit	0944-2842BLA
RECOMBINATE	antihemophilic factor recombinant	kit	0944-2843BLA
RECOMBINATE	antihemophilic factor recombinant	kit	0944-2844BLA
RECOMBINATE	antihemophilic factor recombinant	kit	0944-2845BLA
RIXUBIS	COAGULATION FACTOR IX (RECOMBINANT)	kit	0944-3026BLA
RIXUBIS	COAGULATION FACTOR IX (RECOMBINANT)	kit	0944-3028BLA
RIXUBIS	COAGULATION FACTOR IX (RECOMBINANT)	kit	0944-3030BLA
RIXUBIS	COAGULATION FACTOR IX (RECOMBINANT)	kit	0944-3032BLA
RIXUBIS	COAGULATION FACTOR IX (RECOMBINANT)	kit	0944-3034BLA
Rozerem	ramelteon	tablet, film coated, oral	64764-805NDA
TAKHZYRO	lanadelumab-flyo	injection, solution, subcutaneous	47783-644BLA
TAKHZYRO	lanadelumab-flyo	solution, subcutaneous	47783-645BLA
TAKHZYRO	lanadelumab-flyo	solution, subcutaneous	47783-646BLA
-	TENOFOVIR DISOPROXIL FUMARATE	tablet, coated	47234-0401DRUG FOR FURTHER PROCESSING
Trintellix	vortioxetine	tablet, film coated, oral	64764-720NDA
Trintellix	vortioxetine	tablet, film coated, oral	64764-730NDA
Trintellix	vortioxetine	tablet, film coated, oral	64764-750NDA
ULORIC	febuxostat	tablet, oral	64764-677NDA

Neighbours

Registered in the same town

Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.Dublin, IRL
Astellas Pharma US, Inc.DUBLIN, IRL
Allergan, Inc.Dublin, IRL
BRACCO DIAGNOSTICS INCSingen (Hohentwiel), DEU
West Pharmaceutical Services, Inc.Dublin, IRL
Alexion Pharmaceuticals, Inc.Dublin, IRL
LEO Pharma A/SDublin, IRL
STERIS CorporationBrooklyn Park, MN
LIEBEL-FLARSHEIM COMPANY LLC.Dublin, IRL
Clarochem Ireland LimitedDublin, IRL
HELSINN BIREX PHARMACEUTICALS LIMITEDDublin, IRL

Compare

Comparable companies in Germany

Ferring Pharmaceuticals Inc.9 sites · 17 NDC
Octapharma Pharmazeutika Produktionsgesellschaft m.b.H.5 sites · 0 NDC
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Vetter Pharma Fertigung GmbH & Co. KG4 sites · 1 NDC
Wacker Biotech GmbH4 sites · 1 NDC
Boehringer Ingelheim Biopharmaceuticals China Ltd3 sites · 127 NDC
Beiersdorf AG3 sites · 107 NDC
Evonik Operations GmbH11 sites · 18 NDC
Merz Pharma GmbH & Co. KGaA3 sites · 17 NDC
Bavarian Nordic A/S3 sites · 10 NDC

Enquiry

Common questions

Is Takeda Pharmaceuticals U.S.A., Inc. FDA approved?: Takeda Pharmaceuticals U.S.A., Inc. holds 7 FDA-registered establishments across 4 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 Takeda Pharmaceuticals U.S.A., Inc.'s drugs manufactured?: At registered sites in Germany, Ireland, Japan, the United States. The FDA register lists Oranienburg; Singen (Hohentwiel); Bray; Dublin; Hikari; Yodogawa-Ku, and 1 more. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging.
What drugs does Takeda Pharmaceuticals U.S.A., Inc. make?: 226 products are listed under Takeda Pharmaceuticals U.S.A., Inc. in the openFDA NDC Directory, most often as tablet, film coated; kit; tablet. The full breakdown by dosage form and route is above. A listing count is not a sales figure.
Are any Takeda Pharmaceuticals U.S.A., Inc. products in shortage?: 13 presentations are currently listed in the FDA drug shortage database under Takeda Pharmaceuticals U.S.A., Inc., covering Lisdexamfetamine Dimesylate Capsule, Lisdexamfetamine Dimesylate Tablet, Chewable.

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.