GlaxoSmithKline Biologicals SA

Registered sites: 19
Drug products: 126
Live patents: 63
Countries: 9
Base: United Kingdom

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 reductionsterilize

Sites

Facilities

Site	Location	Operations	FEI
GlaxoSmithKline Biologicals SA	RixensartBelgium	Analytical testing, Labelling, Finished drug manufacture, Packaging, sterilize	3002875226
GlaxoSmithKline Biologicals SA	WavreBelgium	Analytical testing, Labelling, Finished drug manufacture, Packaging, sterilize	3003973577
ID Biomedical Corporation of Quebec	Ste-FoyCanada	Analytical testing, Labelling, Finished drug manufacture, Packaging, sterilize	3004835647
SmithKline Beecham Pharma GmbH & Co. KG (dba GlaxoSmithKline Biologicals)	DresdenGermany	Analytical testing, Finished drug manufacture, Packaging, sterilize	3004835618
GSK Vaccines GmbH	MarburgGermany	Analytical testing, Finished drug manufacture, Packaging	3001314775
Glaxo Wellcome S.A.	Aranda De DueroSpain	Analytical testing, Labelling, Finished drug manufacture, Packaging	3004195227
Glaxo Wellcome Production	EvreuxFrance	Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging, particle size reduction	3002807436
GlaxoSmithKline Biologicals	Saint-Amand Les EauxFrance	Analytical testing, Labelling, Finished drug manufacture, Packaging	3014752610
Glaxo Operations UK Ltd	Barnard CastleUnited Kingdom	Analytical testing, Labelling, Finished drug manufacture, Packaging, sterilize	3002807078
Glaxo Operations UK Ltd	MontroseUnited Kingdom	Analytical testing, Active ingredient (API) manufacture	3003215057
Glaxo Operations UK Ltd	StevenageUnited Kingdom	Analytical testing	3009763376
Glaxo Operations UK Ltd	WareUnited Kingdom	Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging, particle size reduction	3003262904
GlaxoSmithKline Vaccines Srl	SOVICILLE (ROSIA )Italy	Analytical testing, Labelling, Finished drug manufacture, Packaging	3006738517
GlaxoSmithKline Manufacturing SpA	San PoloItaly	Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging, sterilize	3002807114
GSK Vaccines S.r.l.	SienaItaly	Analytical testing	3007780504
Glaxo Wellcome Manufacturing Pte. Ltd	JurongSingapore	Analytical testing, Active ingredient (API) manufacture, particle size reduction	3002807079
GlaxoSmithKline LLC	Conshohocken, PAUnited States	Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging, sterilize	3004055938
Corixa Corporation	Marietta, PAUnited States	Analytical testing, Labelling, Finished drug manufacture, Packaging, sterilize	3007726770
GlaxoSmithKline LLC	Zebulon, NCUnited States	Analytical testing, Labelling, Finished drug manufacture, Packaging	1033964

Exclusivity

Patents

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

Product	Active ingredient	Expiry
BLUJEPA	GEPOTIDACIN MESYLATE	Feb 2029
BLUJEPA	GEPOTIDACIN MESYLATE	Aug 2035
BLUJEPA	GEPOTIDACIN MESYLATE	Dec 2042
BREXAFEMME	IBREXAFUNGERP CITRATE	Aug 2030
BREXAFEMME	IBREXAFUNGERP CITRATE	Jan 2035
BREXAFEMME	IBREXAFUNGERP CITRATE	Jun 2039
LAMICTAL XR	LAMOTRIGINE	Jan 2029
OJJAARA	MOMELOTINIB DIHYDROCHLORIDE	Jan 2035
OJJAARA	MOMELOTINIB DIHYDROCHLORIDE	Jun 2035
OJJAARA	MOMELOTINIB DIHYDROCHLORIDE	Aug 2039
OJJAARA	MOMELOTINIB DIHYDROCHLORIDE	Dec 2040
UTEBZI	TEBIPENEM PIVOXIL HYDROBROMIDE	Dec 2037
UTEBZI	TEBIPENEM PIVOXIL HYDROBROMIDE	Feb 2038
ZEJULA	NIRAPARIB TOSYLATE	Aug 2027
ZEJULA	NIRAPARIB TOSYLATE	Apr 2029
ZEJULA	NIRAPARIB TOSYLATE	Mar 2031
ZEJULA	NIRAPARIB TOSYLATE	Aug 2031
ZEJULA	NIRAPARIB TOSYLATE	Mar 2038
ZEJULA	NIRAPARIB TOSYLATE	Jan 2039

Catalogue

Marketed products

126

Showing 126 of 126.

Brand	Generic name	Form	Category
ADVAIR DISKUS	fluticasone propionate and salmeterol	POWDER	NDA
ADVAIR DISKUS	fluticasone propionate and salmeterol	POWDER	NDA
ADVAIR DISKUS	fluticasone propionate and salmeterol	POWDER	NDA
ADVAIR HFA	fluticasone propionate and salmeterol xinafoate	AEROSOL, METERED	NDA
ADVAIR HFA	fluticasone propionate and salmeterol xinafoate	AEROSOL, METERED	NDA
ADVAIR HFA	fluticasone propionate and salmeterol xinafoate	AEROSOL, METERED	NDA
AS03	AS03	INJECTION, SOLUTION	UNAPPROVED DRUG OTHER
Anoro Ellipta	umeclidinium bromide and vilanterol trifenatate	POWDER	NDA
Arepanrix	Influenza A H5 Monovalent Vaccine	KIT	BLA
Arexvy	Respiratory Syncytial Virus Vaccine Recombinant, Adjuvanted	KIT	BLA
Arexvy	Respiratory Syncytial Virus Vaccine Recombinant, Adjuvanted	KIT	BLA
Arexvy	Respiratory Syncytial Virus Vaccine Recombinant, Adjuvanted	KIT	BLA
Arnuity Ellipta	fluticasone furoate	POWDER	NDA
Arnuity Ellipta	fluticasone furoate	POWDER	NDA
Arnuity Ellipta	fluticasone furoate	POWDER	NDA
BENLYSTA	belimumab	SOLUTION	BLA
BENLYSTA	belimumab	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	BLA
BENLYSTA	belimumab	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	BLA
BOOSTRIX	Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed	SUSPENSION	BLA
Bexsero	NEISSERIA MENINGITIDIS SEROGROUP B NHBA FUSION PROTEIN ANTIGEN, NEISSERIA MENINGITIDIS SEROGROUP B FHBP FUSION PROTEIN ANTIGEN and NEISSERIA MENINGITIDIS SEROGROUP B NADA PROTEIN ANTIGEN	INJECTION, SUSPENSION	BLA
Blenrep	belantamab mafodotin	INJECTION, POWDER, FOR SOLUTION	BLA
Blujepa	gepotidacin	TABLET, FILM COATED	NDA
Breo Ellipta	fluticasone furoate and vilanterol trifenatate	POWDER	NDA
Breo Ellipta	fluticasone furoate and vilanterol trifenatate	POWDER	NDA
Breo Ellipta	fluticasone furoate and vilanterol trifenatate	POWDER	NDA
-	Depemokimab	LIQUID	BULK INGREDIENT
-	Dolutegravir and Lamivudine	TABLET, FILM COATED	DRUG FOR FURTHER PROCESSING
ENGERIX-B	Hepatitis B Vaccine (Recombinant)	INJECTION, SUSPENSION	BLA
ENGERIX-B	Hepatitis B Vaccine (Recombinant)	INJECTION, SUSPENSION	BLA
Exdensur	depemokimab	INJECTION, SOLUTION	BLA
FLUARIX 2026/2027	influenza virus vaccine	SUSPENSION	BLA
HAVRIX	Hepatitis A Vaccine	INJECTION, SUSPENSION	BLA
HAVRIX	Hepatitis A Vaccine	INJECTION, SUSPENSION	BLA
Hiberix	Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)	KIT	BLA
Hiberix	Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)	KIT	BLA
IMITREX	sumatriptan	INJECTION	NDA
IMITREX	sumatriptan	INJECTION	NDA
IMITREX	sumatriptan	TABLET, FILM COATED	NDA
IMITREX	sumatriptan	TABLET, FILM COATED	NDA
IMITREX	sumatriptan	TABLET, FILM COATED	NDA
IMITREX	sumatriptan	INJECTION	NDA
INFANRIX	Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed	SUSPENSION	BLA
Incruse Ellipta	umeclidinium	AEROSOL, POWDER	NDA
Jemperli	dostarlimab	INJECTION	BLA
Jesduvroq	daprodustat	TABLET, FILM COATED	NDA
Jesduvroq	daprodustat	TABLET, FILM COATED	NDA
Jesduvroq	daprodustat	TABLET, FILM COATED	NDA
Jesduvroq	daprodustat	TABLET, FILM COATED	NDA
Jesduvroq	daprodustat	TABLET, FILM COATED	NDA
KINRIX	Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine	INJECTION, SUSPENSION	BLA
Krintafel	tafenoquine succinate	TABLET, FILM COATED	NDA
LAMICTAL	lamotrigine	TABLET, FOR SUSPENSION	NDA
LAMICTAL	lamotrigine	TABLET, FOR SUSPENSION	NDA
LAMICTAL	lamotrigine	KIT	NDA
LAMICTAL	lamotrigine	TABLET	NDA
LAMICTAL	lamotrigine	TABLET	NDA
LAMICTAL	lamotrigine	TABLET	NDA
LAMICTAL	lamotrigine	TABLET	NDA
LAMICTAL	lamotrigine	TABLET, FOR SUSPENSION	NDA
LAMICTAL	lamotrigine	KIT	NDA
LAMICTAL ODT	lamotrigine	TABLET, ORALLY DISINTEGRATING	NDA
LAMICTAL ODT	lamotrigine	TABLET, ORALLY DISINTEGRATING	NDA
LAMICTAL ODT	lamotrigine	TABLET, ORALLY DISINTEGRATING	NDA
LAMICTAL ODT	lamotrigine	TABLET, ORALLY DISINTEGRATING	NDA
LAMICTAL ODT	lamotrigine	KIT	NDA
LAMICTAL ODT	lamotrigine	KIT	NDA
LAMICTAL ODT	lamotrigine	KIT	NDA
LAMICTAL XR	lamotrigine	TABLET, FILM COATED, EXTENDED RELEASE	NDA
LAMICTAL XR	lamotrigine	TABLET, FILM COATED, EXTENDED RELEASE	NDA
LAMICTAL XR	lamotrigine	TABLET, FILM COATED, EXTENDED RELEASE	NDA
LAMICTAL XR	lamotrigine	TABLET, FILM COATED, EXTENDED RELEASE	NDA
LAMICTAL XR	lamotrigine	KIT	NDA
LAMICTAL XR	lamotrigine	KIT	NDA
LAMICTAL XR	lamotrigine	KIT	NDA
LAMICTAL XR	lamotrigine	TABLET, FILM COATED, EXTENDED RELEASE	NDA
LAMICTAL XR	lamotrigine	TABLET, FILM COATED, EXTENDED RELEASE	NDA
MALARONE	atovaquone and proguanil hydrochloride	TABLET, FILM COATED	NDA
MALARONE	atovaquone and proguanil hydrochloride	TABLET, FILM COATED	NDA
MEPRON	atovaquone	SUSPENSION	NDA
MEPRON	atovaquone	SUSPENSION	NDA
Menveo	Meningococcal (Groups A, C, Y and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine	INJECTION, SOLUTION	BLA
Menveo	Meningococcal (Groups A, C, Y and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine	KIT	BLA
Nucala	mepolizumab	INJECTION, POWDER, FOR SOLUTION	BLA
Nucala	mepolizumab	INJECTION, SOLUTION	BLA
Nucala	mepolizumab	INJECTION, SOLUTION	BLA
Ojjaara	Momelotinib	TABLET	NDA
Ojjaara	Momelotinib	TABLET	NDA
Ojjaara	Momelotinib	TABLET	NDA
PEDIARIX	Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined	INJECTION, SUSPENSION	BLA
PENMENVY	Meningococcal (Groups A, B, C, W and Y)	KIT	BLA
Priorix	Measels, Mumps, and Rubella Vaccine, Live	KIT	BLA
RELENZA	zanamivir	POWDER	NDA
Rotarix	Rotavirus Vaccine, Live, Oral	SOLUTION	BLA
SEREVENT DISKUS	salmeterol xinafoate	POWDER, METERED	NDA
Shingrix	Zoster Vaccine Recombinant, Adjuvanted	KIT	BLA
Shingrix	Zoster Vaccine Recombinant, Adjuvanted	INJECTION, SOLUTION	BLA
TWINRIX	Hepatitis A and Hepatitis B (Recombinant) Vaccine	INJECTION, SUSPENSION	BLA
Trelegy Ellipta	fluticasone furoate, umeclidinium bromide and vilanterol trifenatate	POWDER	NDA
Trelegy Ellipta	fluticasone furoate, umeclidinium bromide and vilanterol trifenatate	POWDER	NDA
VALTREX	valacyclovir hydrochloride	TABLET, FILM COATED	NDA
VALTREX	valacyclovir hydrochloride	TABLET, FILM COATED	NDA
VENTOLIN HFA	albuterol sulfate	AEROSOL, METERED	NDA
WELLBUTRIN SR	bupropion hydrochloride	TABLET, FILM COATED	NDA
WELLBUTRIN SR	bupropion hydrochloride	TABLET, FILM COATED	NDA
WELLBUTRIN SR	bupropion hydrochloride	TABLET, FILM COATED	NDA
ZEJULA	niraparib	TABLET, FILM COATED	NDA
ZEJULA	niraparib	TABLET, FILM COATED	NDA
ZEJULA	niraparib	TABLET, FILM COATED	NDA
-	belantamab mafodotin	LIQUID	BULK INGREDIENT
-	belimumab	LIQUID	BULK INGREDIENT
-	doxorubicin hydrochloride	INJECTION, SUSPENSION, LIPOSOMAL	DRUG FOR FURTHER PROCESSING
-	lamotrigine	TABLET, FILM COATED, EXTENDED RELEASE	DRUG FOR FURTHER PROCESSING
-	lamotrigine	TABLET, FILM COATED, EXTENDED RELEASE	DRUG FOR FURTHER PROCESSING
-	lamotrigine	TABLET, FILM COATED, EXTENDED RELEASE	DRUG FOR FURTHER PROCESSING
-	lamotrigine	TABLET, FILM COATED, EXTENDED RELEASE	DRUG FOR FURTHER PROCESSING
-	lamotrigine	TABLET	DRUG FOR FURTHER PROCESSING
-	lamotrigine	TABLET	DRUG FOR FURTHER PROCESSING
-	mepolizumab	LIQUID	BULK INGREDIENT
-	mepolizumab	LIQUID	BULK INGREDIENT
-	mepolizumab	LIQUID	BULK INGREDIENT
-	raxibacumab	LIQUID	BULK INGREDIENT
-	sumatriptan	TABLET, FILM COATED	DRUG FOR FURTHER PROCESSING
-	sumatriptan	TABLET, FILM COATED	DRUG FOR FURTHER PROCESSING
-	sumatriptan	TABLET, FILM COATED	DRUG FOR FURTHER PROCESSING
-	trametinib	TABLET, FILM COATED	DRUG FOR FURTHER PROCESSING
-	trametinib	TABLET, FILM COATED	DRUG FOR FURTHER PROCESSING

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.