AstraZeneca PLC

Registered sites: 15
Drug products: 150
Live patents: 343
Countries: 5
Base: United States

Authorisation

Registered operations

What the FDA has registered these sites to do. This is the regulatory record, not a marketing claim.

Analytical testingActive ingredient (API) manufactureLabellingFinished drug manufacturePackagingparticle size reductionRelabellingRepackaging

Sites

Facilities

Site	Location	Operations	FEI
AstraZeneca Dunkerque Production	DunkerqueFrance	Analytical testing, Labelling, Finished drug manufacture, Packaging	3003063819
MedImmune UK Limited	LiverpoolUnited Kingdom	Analytical testing, Active ingredient (API) manufacture	3004066112
AstraZeneca UK Ltd	MacclesfieldUnited Kingdom	Analytical testing, Labelling, Finished drug manufacture, Packaging	3002850317
AstraZeneca Nijmegen B.V.	NijmegenNetherlands	Analytical testing, Labelling, Finished drug manufacture, Packaging	3003000472
AstraZeneca AB	SodertaljeSweden	Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging, Relabelling	3002806411
AstraZeneca AB	SodertaljeSweden	Analytical testing, Labelling, Finished drug manufacture, Packaging	3003342394
AstraZeneca Pharmaceuticals LP	Bensalem, PAUnited States	Finished drug manufacture	3014292925
IPR Pharmaceuticals, Inc	Canovanas, PRUnited States	Analytical testing, Finished drug manufacture, Relabelling, Repackaging	3003009422
AstraZeneca Pharmaceuticals LP	Coppell, TXUnited States	Analytical testing, Active ingredient (API) manufacture	3010199915
AstraZeneca Pharmaceuticals LP	Frederick, MDUnited States	Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture, Packaging	3002617771
AstraZeneca Pharmaceuticals LP	Mount Vernon, INUnited States	Analytical testing, Labelling, Finished drug manufacture, Packaging	1825662
AstraZeneca Pharmaceuticals LP	Newark, DEUnited States	Analytical testing, Labelling, Finished drug manufacture, Packaging	2517100
AstraZeneca Pharmaceuticals LP	Philadelphia, PAUnited States	Analytical testing, Labelling, Finished drug manufacture, Packaging	3004829714
AstraZeneca Pharmaceuticals LP	Redwood City, CAUnited States	Analytical testing, Active ingredient (API) manufacture, particle size reduction	3011389428
AstraZeneca Pharmaceuticals LP	Shepherdsville, KYUnited States	Finished drug manufacture	3014798309

Exclusivity

Patents

343

Unexpired Orange Book patents where this company is the application holder.

Product	Active ingredient	Expiry
AIRSUPRA	ALBUTEROL SULFATE; BUDESONIDE	May 2030
BAXFENDY	BAXDROSTAT	Feb 2033
BEVESPI AEROSPHERE	FORMOTEROL FUMARATE; GLYCOPYRROLATE	May 2030
BEVESPI AEROSPHERE	FORMOTEROL FUMARATE; GLYCOPYRROLATE	Mar 2031
BREZTRI AEROSPHERE	BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE	May 2030
BREZTRI AEROSPHERE	BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE	Mar 2031
BREZTRI AEROSPHERE	BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE	Oct 2038
BRILINTA	TICAGRELOR	Apr 2030
BRILINTA	TICAGRELOR	Oct 2030
BRILINTA	TICAGRELOR	Jan 2036
BRILINTA	TICAGRELOR	Jul 2036
BYDUREON	EXENATIDE SYNTHETIC	Feb 2027
BYDUREON	EXENATIDE SYNTHETIC	Jun 2027
BYDUREON	EXENATIDE SYNTHETIC	Dec 2027
BYDUREON	EXENATIDE SYNTHETIC	Mar 2028
BYDUREON	EXENATIDE SYNTHETIC	Sept 2028
BYDUREON BCISE	EXENATIDE SYNTHETIC	Feb 2027
BYDUREON BCISE	EXENATIDE SYNTHETIC	Jun 2027
BYDUREON BCISE	EXENATIDE SYNTHETIC	Dec 2027
BYDUREON BCISE	EXENATIDE SYNTHETIC	Mar 2028
BYDUREON BCISE	EXENATIDE SYNTHETIC	Sept 2028
BYDUREON BCISE	EXENATIDE SYNTHETIC	Oct 2030
BYDUREON BCISE	EXENATIDE SYNTHETIC	Apr 2031
BYDUREON PEN	EXENATIDE SYNTHETIC	Feb 2027
BYDUREON PEN	EXENATIDE SYNTHETIC	Jun 2027
BYDUREON PEN	EXENATIDE SYNTHETIC	Dec 2027
BYDUREON PEN	EXENATIDE SYNTHETIC	Mar 2028
BYDUREON PEN	EXENATIDE SYNTHETIC	Sept 2028
CALQUENCE	ACALABRUTINIB	Nov 2026
CALQUENCE	ACALABRUTINIB MALEATE	Jul 2032
CALQUENCE	ACALABRUTINIB	Jan 2035
CALQUENCE	ACALABRUTINIB MALEATE	Aug 2035
CALQUENCE	ACALABRUTINIB	Jul 2036
EPANOVA	OMEGA-3-CARBOXYLIC ACIDS	Dec 2026
EPANOVA	OMEGA-3-CARBOXYLIC ACIDS	Jan 2033
FARXIGA	DAPAGLIFLOZIN	Feb 2027
FARXIGA	DAPAGLIFLOZIN	Jun 2027
FARXIGA	DAPAGLIFLOZIN	Dec 2027
FARXIGA	DAPAGLIFLOZIN	Mar 2028
FARXIGA	DAPAGLIFLOZIN	Aug 2028
FARXIGA	DAPAGLIFLOZIN	Sept 2028
FARXIGA	DAPAGLIFLOZIN	Feb 2029
FARXIGA	DAPAGLIFLOZIN	Dec 2029
FARXIGA	DAPAGLIFLOZIN	May 2030
FARXIGA	DAPAGLIFLOZIN	Jun 2030
FARXIGA	DAPAGLIFLOZIN	Jul 2030
FARXIGA	DAPAGLIFLOZIN	Nov 2030
FARXIGA	DAPAGLIFLOZIN	Jul 2039
FARXIGA	DAPAGLIFLOZIN	Jan 2040
FARXIGA	DAPAGLIFLOZIN	Mar 2040
FARXIGA	DAPAGLIFLOZIN	Sept 2040
FARXIGA	DAPAGLIFLOZIN	Apr 2041
FARXIGA	DAPAGLIFLOZIN	Oct 2041
KOSELUGO	SELUMETINIB SULFATE	Dec 2026
KOSELUGO	SELUMETINIB SULFATE	Mar 2028
KOSELUGO	SELUMETINIB SULFATE	Mar 2029
LOKELMA	SODIUM ZIRCONIUM CYCLOSILICATE	Feb 2032
LOKELMA	SODIUM ZIRCONIUM CYCLOSILICATE	Apr 2032
LOKELMA	SODIUM ZIRCONIUM CYCLOSILICATE	Oct 2033
LOKELMA	SODIUM ZIRCONIUM CYCLOSILICATE	Oct 2035

Catalogue

Marketed products

150

Showing 150 of 150.

Brand	Generic name	Form	Category
AIRSUPRA	Albuterol sulfate and budesonide	AEROSOL, METERED	NDA
ANDEXXA	andexanet alfa	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	BLA
-	Albuterol Sulfate Micronised Conditioned	POWDER	BULK INGREDIENT
-	Anastrozole	TABLET	DRUG FOR FURTHER PROCESSING
BAXFENDY	baxdrostat	TABLET, FILM COATED	NDA
BAXFENDY	baxdrostat	TABLET, FILM COATED	NDA
BEVESPI AEROSPHERE	Glycopyrrolate and formoterol fumarate	AEROSOL, METERED	NDA
BREZTRI	budesonide, glycopyrrolate, and formoterol fumarate	AEROSOL, METERED	NDA
BREZTRI	budesonide, glycopyrrolate, and formoterol fumarate	AEROSOL, METERED	NDA
BRILINTA	Ticagrelor	TABLET	NDA
BRILINTA	Ticagrelor	TABLET	NDA
-	Benralizumab	INJECTION, SOLUTION	DRUG FOR FURTHER PROCESSING
-	Budesonide Micronised Co-Suspension APN	POWDER	BULK INGREDIENT
-	Budesonide Micronized	POWDER	BULK INGREDIENT
Budesonide and Formoterol Fumarate Dihydrate	Budesonide and Formoterol Fumarate Dihydrate	AEROSOL	NDA AUTHORIZED GENERIC
Budesonide and Formoterol Fumarate Dihydrate	Budesonide and Formoterol Fumarate Dihydrate	AEROSOL	NDA AUTHORIZED GENERIC
Byetta	exenatide	INJECTION	NDA
Byetta	exenatide	INJECTION	NDA
CALQUENCE	Acalabrutinib	CAPSULE, GELATIN COATED	NDA
CALQUENCE	acalabrutinib	TABLET, FILM COATED	NDA
CALQUENCE	acalabrutinib	TABLET, FILM COATED	NDA
Crestor	Rosuvastatin	TABLET, FILM COATED	NDA
Crestor	Rosuvastatin	TABLET, FILM COATED	NDA
Crestor	Rosuvastatin	TABLET, FILM COATED	NDA
Crestor	Rosuvastatin	TABLET, FILM COATED	NDA
-	DAPAGLIFLOZIN	TABLET, FILM COATED	DRUG FOR FURTHER PROCESSING
-	DAPAGLIFLOZIN	TABLET, FILM COATED	DRUG FOR FURTHER PROCESSING
-	DAPAGLIFLOZIN	TABLET, FILM COATED	DRUG FOR FURTHER PROCESSING
-	DAPAGLIFLOZIN	TABLET, FILM COATED	DRUG FOR FURTHER PROCESSING
Daliresp	roflumilast	TABLET	NDA
Daliresp	roflumilast	TABLET	NDA
-	Durvalumab	INJECTION, SOLUTION	DRUG FOR FURTHER PROCESSING
-	Durvalumab	INJECTION, SOLUTION	DRUG FOR FURTHER PROCESSING
FARXIGA	DAPAGLIFLOZIN	TABLET, FILM COATED	NDA
FARXIGA	DAPAGLIFLOZIN	TABLET, FILM COATED	NDA
FASENRA	Benralizumab	INJECTION, SOLUTION	BLA
FASENRA	Benralizumab	INJECTION, SOLUTION	BLA
FASENRA	Benralizumab	INJECTION, SOLUTION	BLA
FASLODEX	Fulvestrant	INJECTION	NDA
-	Goserelin acetate	IMPLANT	DRUG FOR FURTHER PROCESSING
IMFINZI	Durvalumab	INJECTION, SOLUTION	BLA
IMFINZI	Durvalumab	INJECTION, SOLUTION	BLA
IMJUDO	tremelimumab	INJECTION, SOLUTION	BLA
IMJUDO	tremelimumab	INJECTION, SOLUTION	BLA
IRESSA	Gefitinib	TABLET, COATED	NDA
KOSELUGO	SELUMETINIB	CAPSULE	NDA
KOSELUGO	SELUMETINIB	CAPSULE	NDA
KOSELUGO	SELUMETINIB	GRANULE	NDA
KOSELUGO	SELUMETINIB	GRANULE	NDA
LOKELMA	sodium zirconium cyclosilicate	POWDER, FOR SUSPENSION	NDA
LOKELMA	sodium zirconium cyclosilicate	POWDER, FOR SUSPENSION	NDA
Lynparza	olaparib	TABLET, FILM COATED	NDA
Lynparza	olaparib	TABLET, FILM COATED	NDA
Lynparza	olaparib	TABLET, FILM COATED	NDA
Lynparza	olaparib	TABLET, FILM COATED	NDA
-	Metoprolol succinate	TABLET, EXTENDED RELEASE	DRUG FOR FURTHER PROCESSING
-	Metoprolol succinate	TABLET, EXTENDED RELEASE	DRUG FOR FURTHER PROCESSING
-	Metoprolol succinate	TABLET, EXTENDED RELEASE	DRUG FOR FURTHER PROCESSING
-	Metoprolol succinate	TABLET, EXTENDED RELEASE	DRUG FOR FURTHER PROCESSING
-	Micronized Glycopyrronium Bromide	POWDER	BULK INGREDIENT
-	Micronized Glycopyrronium Bromide	POWDER	BULK INGREDIENT
-	Micronized Glycopyrronium Bromide	POWDER	BULK INGREDIENT
-	Monalizumab	LIQUID	BULK INGREDIENT
NEXIUM	Esomeprazole magnesium	GRANULE, DELAYED RELEASE	NDA
NEXIUM	Esomeprazole magnesium	GRANULE, DELAYED RELEASE	NDA
NEXIUM	Esomeprazole magnesium	GRANULE, DELAYED RELEASE	NDA
NEXIUM	Esomeprazole magnesium	GRANULE, DELAYED RELEASE	NDA
NEXIUM	Esomeprazole magnesium	GRANULE, DELAYED RELEASE	NDA
NEXIUM	Esomeprazole magnesium	CAPSULE, DELAYED RELEASE	NDA
NEXIUM	Esomeprazole magnesium	CAPSULE, DELAYED RELEASE	NDA
-	Omeprazole magnesium	CAPSULE, DELAYED RELEASE	DRUG FOR FURTHER PROCESSING
-	Omeprazole magnesium	CAPSULE, DELAYED RELEASE	DRUG FOR FURTHER PROCESSING
-	Omeprazole magnesium	CAPSULE, DELAYED RELEASE	DRUG FOR FURTHER PROCESSING
-	Omeprazole magnesium	TABLET, DELAYED RELEASE	DRUG FOR FURTHER PROCESSING
-	Osimertinib	TABLET, FILM COATED	DRUG FOR FURTHER PROCESSING
-	Osimertinib	TABLET, FILM COATED	DRUG FOR FURTHER PROCESSING
-	Osimertinib	TABLET, FILM COATED	DRUG FOR FURTHER PROCESSING
-	Osimertinib	TABLET, FILM COATED	DRUG FOR FURTHER PROCESSING
PULMICORT RESPULES	Budesonide	SUSPENSION	NDA
PULMICORT RESPULES	Budesonide	SUSPENSION	NDA
PULMICORT RESPULES	Budesonide	SUSPENSION	NDA
SAPHNELO	Anifrolumab-fnia	INJECTION, SOLUTION	BLA
SAPHNELO	Anifrolumab-fnia	INJECTION, SOLUTION	BLA
SEROQUEL	quetiapine	TABLET, FILM COATED	NDA
SEROQUEL	quetiapine	TABLET, FILM COATED	NDA
SEROQUEL	quetiapine	TABLET, FILM COATED	NDA
SEROQUEL	quetiapine	TABLET, FILM COATED	NDA
SEROQUEL	quetiapine	TABLET, FILM COATED	NDA
SEROQUEL	quetiapine	TABLET, FILM COATED	NDA
SEROQUEL XR	quetiapine	TABLET, EXTENDED RELEASE	NDA
SEROQUEL XR	quetiapine	TABLET, EXTENDED RELEASE	NDA
SEROQUEL XR	quetiapine	TABLET, EXTENDED RELEASE	NDA
SEROQUEL XR	quetiapine	TABLET, EXTENDED RELEASE	NDA
SYMBICORT	Budesonide and Formoterol Fumarate Dihydrate	AEROSOL	NDA
SYMBICORT	Budesonide and Formoterol Fumarate Dihydrate	AEROSOL	NDA
-	Selumetinib	CAPSULE	DRUG FOR FURTHER PROCESSING
-	Selumetinib	CAPSULE	DRUG FOR FURTHER PROCESSING
-	Sodium Zirconium Cyclosilicate	POWDER, FOR SUSPENSION	BULK INGREDIENT
SymlinPen	pramlintide acetate	INJECTION	NDA
SymlinPen	pramlintide acetate	INJECTION	NDA
TAGRISSO	osimertinib	TABLET, FILM COATED	NDA
TAGRISSO	osimertinib	TABLET, FILM COATED	NDA
TAGRISSO	osimertinib	TABLET, FILM COATED	NDA
TAGRISSO	osimertinib	TABLET, FILM COATED	NDA
TRUQAP	capivasertib	TABLET, FILM COATED	NDA
TRUQAP	capivasertib	TABLET, FILM COATED	NDA
-	Ticagrelor	TABLET, FILM COATED	DRUG FOR FURTHER PROCESSING
-	Ticagrelor	TABLET, FILM COATED	DRUG FOR FURTHER PROCESSING
-	Tozorakimab	LIQUID	BULK INGREDIENT
WAINUA	EPLONTERSEN	INJECTION, SOLUTION	NDA
WAINUA	EPLONTERSEN	INJECTION, SOLUTION	NDA
XIGDUO XR	dapagliflozin and metformin hydrochloride	TABLET, FILM COATED, EXTENDED RELEASE	NDA
XIGDUO XR	dapagliflozin and metformin hydrochloride	TABLET, FILM COATED, EXTENDED RELEASE	NDA
XIGDUO XR	dapagliflozin and metformin hydrochloride	TABLET, FILM COATED, EXTENDED RELEASE	NDA
XIGDUO XR	dapagliflozin and metformin hydrochloride	TABLET, FILM COATED, EXTENDED RELEASE	NDA
XIGDUO XR	dapagliflozin and metformin hydrochloride	TABLET, FILM COATED, EXTENDED RELEASE	NDA
-	acalabrutinib	TABLET, FILM COATED	DRUG FOR FURTHER PROCESSING
-	acalabrutinib	TABLET, FILM COATED	DRUG FOR FURTHER PROCESSING
-	anifrolumab	SOLUTION	BULK INGREDIENT
-	baxdrostat	TABLET, FILM COATED	DRUG FOR FURTHER PROCESSING
-	baxdrostat	TABLET, FILM COATED	DRUG FOR FURTHER PROCESSING
-	benralizumab	LIQUID	BULK INGREDIENT
-	candesartan cilexetil	TABLET	DRUG FOR FURTHER PROCESSING
-	candesartan cilexetil	TABLET	DRUG FOR FURTHER PROCESSING
-	candesartan cilexetil	TABLET	DRUG FOR FURTHER PROCESSING
-	candesartan cilexetil	TABLET	DRUG FOR FURTHER PROCESSING
-	candesartan cilexetil hydrochlorothiazide	TABLET	DRUG FOR FURTHER PROCESSING
-	candesartan cilexetil hydrochlorothiazide	TABLET	DRUG FOR FURTHER PROCESSING
-	candesartan cilexetil hydrochlorothiazide	TABLET	DRUG FOR FURTHER PROCESSING
-	capivasertib	TABLET, FILM COATED	DRUG FOR FURTHER PROCESSING
-	capivasertib	TABLET, FILM COATED	DRUG FOR FURTHER PROCESSING
-	dapagliflozin and metformin hydrochloride	TABLET, FILM COATED, EXTENDED RELEASE	DRUG FOR FURTHER PROCESSING
-	dapagliflozin and metformin hydrochloride	TABLET, FILM COATED, EXTENDED RELEASE	DRUG FOR FURTHER PROCESSING
-	dapagliflozin and metformin hydrochloride	TABLET, FILM COATED, EXTENDED RELEASE	DRUG FOR FURTHER PROCESSING
-	dapagliflozin and metformin hydrochloride	TABLET, FILM COATED, EXTENDED RELEASE	DRUG FOR FURTHER PROCESSING
-	dapagliflozin and metformin hydrochloride	TABLET, FILM COATED, EXTENDED RELEASE	DRUG FOR FURTHER PROCESSING
-	durvalumab	LIQUID	BULK INGREDIENT
-	esomeprazole magnesium	CAPSULE	DRUG FOR FURTHER PROCESSING
-	esomeprazole magnesium	CAPSULE	DRUG FOR FURTHER PROCESSING
-	goserelin implant	IMPLANT	DRUG FOR FURTHER PROCESSING
-	olaparib	TABLET, FILM COATED	DRUG FOR FURTHER PROCESSING
-	olaparib	TABLET, FILM COATED	DRUG FOR FURTHER PROCESSING
-	omeprazole magnesium	TABLET, DELAYED RELEASE	DRUG FOR FURTHER PROCESSING
-	palivizumab	LIQUID	BULK INGREDIENT
-	quetiapine	TABLET, EXTENDED RELEASE	DRUG FOR FURTHER PROCESSING
-	quetiapine	TABLET, EXTENDED RELEASE	DRUG FOR FURTHER PROCESSING
-	quetiapine	TABLET, EXTENDED RELEASE	DRUG FOR FURTHER PROCESSING
-	quetiapine	TABLET, EXTENDED RELEASE	DRUG FOR FURTHER PROCESSING
-	quetiapine	TABLET, EXTENDED RELEASE	DRUG FOR FURTHER PROCESSING
-	ticagrelor	POWDER	BULK INGREDIENT

Provenance

Facility and operations data from the FDA Drug Establishments Current Registration Site. Product data from the openFDA National Drug Code Directory. Patent and exclusivity data from the FDA Orange Book. Shortage data from the FDA drug shortage database. Contact details the FDA publishes for registered establishments are deliberately not reproduced here. This entry is compiled from public records and has not been claimed by the company.