Register entry

GlaxoSmithKline Biologicals SA

Data as of · How to read this entry

Registered sites
19
Active NDC listings
126
Labeller names
3
Live patents
63
Exclusivities
5
Shortage listings
3
Countries
9
Base
United Kingdom
Authorisation

Registered operations

Analytical testing19Active ingredient (API) manufacture6Labelling13Finished drug manufacture15Packaging15particle size reduction3sterilize8
Sites

Registered establishments

19
EstablishmentAddressRegistered forFEI / DUNS
GlaxoSmithKline Biologicals SARue de l'Institut 89, Rixensart, B-1330, Belgium (BEL)Analytical testing, Labelling, Finished drug manufacture, Packaging, sterilize3002875226372748392
GlaxoSmithKline Biologicals SAAvenue Fleming 20, Wavre, 1300, Belgium (BEL)Analytical testing, Labelling, Finished drug manufacture, Packaging, sterilize3003973577376996273
ID Biomedical Corporation of QuebecRegistrant: GlaxoSmithKline Biologicals SA2323 du Parc Technologique Blvd., Ste-Foy, Quebec G1P 4R8, Canada (CAN)Analytical testing, Labelling, Finished drug manufacture, Packaging, sterilize3004835647243368284
SmithKline Beecham Pharma GmbH & Co. KG (dba GlaxoSmithKline Biologicals)Registrant: GlaxoSmithKline Biologicals SAZirkusstrabe 40, Dresden, Sachsen D-01069, Germany (DEU)Analytical testing, Finished drug manufacture, Packaging, sterilize3004835618344031009
GSK Vaccines GmbHRegistrant: GlaxoSmithKline Biologicals SAEmil-von-Behring-Str. 76, Marburg, 35041, Germany (DEU)Analytical testing, Finished drug manufacture, Packaging3001314775314891029
Glaxo Wellcome S.A.Registrant: GlaxoSmithKline plcAvda. Extremadura, 3, Aranda De Duero, 09400, Spain (ESP)Analytical testing, Labelling, Finished drug manufacture, Packaging3004195227462027152
Glaxo Wellcome ProductionRegistrant: GlaxoSmithKline plcZone Industrielle No. 2, 23 Rue Lavoisier, Evreux, Eure 27000, France (FRA)Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging, particle size reduction3002807436383861593
GlaxoSmithKline BiologicalsRegistrant: GlaxoSmithKline Biologicals SA637 Rue des Aulnois, Saint-Amand Les Eaux, 59230, France (FRA)Analytical testing, Labelling, Finished drug manufacture, Packaging3014752610393016621
Glaxo Operations UK LtdRegistrant: GlaxoSmithKline plcHarmire Road, Barnard Castle, County Durham DL12 8DT, United Kingdom (GBR)Analytical testing, Labelling, Finished drug manufacture, Packaging, sterilize3002807078228472833
Glaxo Operations UK LtdRegistrant: GlaxoSmithKline plcCobden Street, Montrose, Angus DD10 8EA, United Kingdom (GBR)Analytical testing, Active ingredient (API) manufacture3003215057424738227
Glaxo Operations UK LtdRegistrant: GlaxoSmithKline plcGunnels Wood Road, Stevenage, Hertfordshire SG1 2NY, United Kingdom (GBR)Analytical testing3009763376218783633
Glaxo Operations UK LtdRegistrant: GlaxoSmithKline plcPriory Street, Ware, Hertfordshire SG12 0DJ, United Kingdom (GBR)Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging, particle size reduction3003262904517226676
GlaxoSmithKline Vaccines SrlRegistrant: GlaxoSmithKline Biologicals SALOCALITA' BELLARIA, SOVICILLE (ROSIA ), 53018, Italy (ITA)Analytical testing, Labelling, Finished drug manufacture, Packaging3006738517445558679
GlaxoSmithKline Manufacturing SpARegistrant: GlaxoSmithKline plcStrada Provinciale 343 Asolana 90, Torrile, San Polo, Parma 43056, Italy (ITA)Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging, sterilize3002807114338471078
GSK Vaccines S.r.l.Registrant: GlaxoSmithKline Biologicals SAVia Fiorentina 1, Siena, SI 53100, Italy (ITA)Analytical testing3007780504442017901
Glaxo Wellcome Manufacturing Pte. LtdRegistrant: GlaxoSmithKline plc1, Pioneer Sector 1, Jurong, 628413, Singapore (SGP)Analytical testing, Active ingredient (API) manufacture, particle size reduction3002807079595295577
GlaxoSmithKline LLCRegistrant: GlaxoSmithKline plc893 River Road, Building 40, Conshohocken, Pennsylvania (PA) 19428, United States (USA)Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging, sterilize3004055938929301406
Corixa CorporationRegistrant: GlaxoSmithKline Biologicals SA325 North Bridge Street, Marietta, Pennsylvania (PA) 17547, United States (USA)Analytical testing, Labelling, Finished drug manufacture, Packaging, sterilize3007726770011553920
GlaxoSmithKline LLCRegistrant: GlaxoSmithKline plc1011 North Arendell Ave, Zebulon, North Carolina (NC) 27597, United States (USA)Analytical testing, Labelling, Finished drug manufacture, Packaging1033964149372109
Alert

Drug shortage listings

3
DrugPresentationStatusAvailabilityPosted / updated
Fluticasone Propionate and Salmeterol Xinafoate Aerosol, MeteredPulmonary/AllergyAdvair HFA, Aerosol, Metered, 115 ug; 21 ug (NDC 0173-0716-22)To Be Discontinued-27 Jul 202627 Jul 2026
Fluticasone Propionate and Salmeterol Xinafoate Aerosol, MeteredPulmonary/AllergyAdvair HFA, Aerosol, Metered, 230 ug; 21 ug (NDC 0173-0717-22)To Be Discontinued-27 Jul 202627 Jul 2026
Fluticasone Propionate and Salmeterol Xinafoate Aerosol, MeteredPulmonary/AllergyAdvair HFA, Aerosol, Metered, 45 ug; 21 ug (NDC 0173-0715-22)To Be Discontinued-27 Jul 202627 Jul 2026
Catalogue

Drug listings by form and route

126

126 active NDC listings: 81 human prescription drug, 25 vaccine, 13 drug for further processing, 7 bulk ingredient. By marketing category: NDA 72, BLA 33, DRUG FOR FURTHER PROCESSING 13, BULK INGREDIENT 7, UNAPPROVED DRUG OTHER 1.

Dosage formNDCs
tablet, film coated26
kit18
powder13
tablet, film coated, extended release10
tablet9
injection, suspension8
liquid7
injection, solution6
suspension5
aerosol, metered4
injection4
tablet, orally disintegrating4
tablet, for suspension3
injection, powder, for solution2
injection, powder, lyophilized, for solution2
RouteNDCs
oral45
respiratory (inhalation)18
intramuscular14
subcutaneous8
intravenous4
Labeller name on the listingNDCs
glaxosmithkline llc97
glaxosmithkline biologicals sa25
glaxosmithkline manufacturing spa4
Exclusivity

Patents and exclusivities

63
PatentProductCoversExpiry
8071579ZEJULAniraparib tosylateuseAug 2027
8143241ZEJULAniraparib tosylateuseAug 2027
8637512LAMICTAL XRlamotrigineproductJan 2029
8389524BLUJEPAgepotidacin mesylatesubstance, productFeb 2029
8436185ZEJULAniraparib tosylatesubstanceApr 2029
8188085BREXAFEMMEibrexafungerp citratesubstance, productAug 2030
8071623ZEJULAniraparib tosylatesubstance, productMar 2031
8859562ZEJULAniraparib tosylateuseAug 2031
8486941OJJAARAmomelotinib dihydrochloridesubstance, productJan 2035
10174074BREXAFEMMEibrexafungerp citratesubstance, productJan 2035
10370406BREXAFEMMEibrexafungerp citrateuseJan 2035
10927142BREXAFEMMEibrexafungerp citratesubstanceJan 2035
9809559OJJAARAmomelotinib dihydrochlorideuseJun 2035
RE48285OJJAARAmomelotinib dihydrochloridesubstance, productJun 2035
10702521BLUJEPAgepotidacin mesylateuseAug 2035
11229646BLUJEPAgepotidacin mesylateuseAug 2035
12226403UTEBZItebipenem pivoxil hydrobromideproductDec 2037
10889587UTEBZItebipenem pivoxil hydrobromidesubstance, productFeb 2038
11091459ZEJULAniraparib tosylateproductMar 2038
11673877ZEJULAniraparib tosylateproductMar 2038
11730725ZEJULAniraparib tosylateproductJan 2039
11534433BREXAFEMMEibrexafungerp citrateuseJun 2039
12576089OJJAARAmomelotinib dihydrochlorideuseAug 2039
11963962OJJAARAmomelotinib dihydrochlorideuseDec 2040
12528809BLUJEPAgepotidacin mesylatesubstance, productDec 2042
ProductExclusivityUntil
BLUJEPAGEPOTIDACIN MESYLATEGAIN Qualified infectious disease product (GAIN)Mar 2035
BREXAFEMMEIBREXAFUNGERP CITRATEGAIN Qualified infectious disease product (GAIN)Jun 2031
OJJAARAMOMELOTINIB DIHYDROCHLORIDEODE-441 Orphan drugSept 2030
UTEBZITEBIPENEM PIVOXIL HYDROBROMIDEGAIN Qualified infectious disease product (GAIN)Jun 2036
ZEJULANIRAPARIB TOSYLATEODE-295 Orphan drugApr 2027
Catalogue

Marketed products

126
BrandGeneric nameForm / routeNDC
ADVAIR DISKUSfluticasone propionate and salmeterolpowder, respiratory (inhalation)0173-0695NDA
ADVAIR DISKUSfluticasone propionate and salmeterolpowder, respiratory (inhalation)0173-0696NDA
ADVAIR DISKUSfluticasone propionate and salmeterolpowder, respiratory (inhalation)0173-0697NDA
ADVAIR HFAfluticasone propionate and salmeterol xinafoateaerosol, metered, respiratory (inhalation)0173-0715NDA
ADVAIR HFAfluticasone propionate and salmeterol xinafoateaerosol, metered, respiratory (inhalation)0173-0716NDA
ADVAIR HFAfluticasone propionate and salmeterol xinafoateaerosol, metered, respiratory (inhalation)0173-0717NDA
AS03AS03injection, solution, intramuscular58160-855UNAPPROVED DRUG OTHER
Anoro Elliptaumeclidinium bromide and vilanterol trifenatatepowder, respiratory (inhalation)0173-0869NDA
ArepanrixInfluenza A H5 Monovalent Vaccinekit58160-742BLA
ArexvyRespiratory Syncytial Virus Vaccine Recombinant, Adjuvantedkit58160-848BLA
ArexvyRespiratory Syncytial Virus Vaccine Recombinant, Adjuvantedkit58160-882BLA
ArexvyRespiratory Syncytial Virus Vaccine Recombinant, Adjuvantedkit58160-894BLA
Arnuity Elliptafluticasone furoatepowder, respiratory (inhalation)0173-0874NDA
Arnuity Elliptafluticasone furoatepowder, respiratory (inhalation)0173-0876NDA
Arnuity Elliptafluticasone furoatepowder, respiratory (inhalation)0173-0888NDA
BENLYSTAbelimumabsolution, subcutaneous49401-088BLA
BENLYSTAbelimumabinjection, powder, lyophilized, for solution, intravenous49401-101BLA
BENLYSTAbelimumabinjection, powder, lyophilized, for solution, intravenous49401-102BLA
BOOSTRIXTetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbedsuspension, intramuscular58160-842BLA
BexseroNEISSERIA MENINGITIDIS SEROGROUP B NHBA FUSION PROTEIN ANTIGEN, NEISSERIA MENINGITIDIS SEROGROUP B FHBP FUSION PROTEIN ANTIGEN and NEISSERIA MENINGITIDIS SEROGROUP B NADA PROTEIN ANTIGENinjection, suspension, intramuscular58160-976BLA
Blenrepbelantamab mafodotininjection, powder, for solution, intravenous0173-0913BLA
Blujepagepotidacintablet, film coated, oral0173-0922NDA
Breo Elliptafluticasone furoate and vilanterol trifenatatepowder, respiratory (inhalation)0173-0859NDA
Breo Elliptafluticasone furoate and vilanterol trifenatatepowder, respiratory (inhalation)0173-0882NDA
Breo Elliptafluticasone furoate and vilanterol trifenatatepowder, respiratory (inhalation)0173-0916NDA
-Depemokimabliquid58437-029BULK INGREDIENT
-Dolutegravir and Lamivudinetablet, film coated58437-027DRUG FOR FURTHER PROCESSING
ENGERIX-BHepatitis B Vaccine (Recombinant)injection, suspension, intramuscular58160-820BLA
ENGERIX-BHepatitis B Vaccine (Recombinant)injection, suspension, intramuscular58160-821BLA
Exdensurdepemokimabinjection, solution, subcutaneous0173-0927BLA
FLUARIX 2026/2027influenza virus vaccinesuspension, intramuscular58160-725BLA
HAVRIXHepatitis A Vaccineinjection, suspension, intramuscular58160-825BLA
HAVRIXHepatitis A Vaccineinjection, suspension, intramuscular58160-826BLA
HiberixHaemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)kit58160-726BLA
HiberixHaemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)kit58160-818BLA
IMITREXsumatriptaninjection, subcutaneous0173-0478NDA
IMITREXsumatriptaninjection, subcutaneous0173-0479NDA
IMITREXsumatriptantablet, film coated, oral0173-0735NDA
IMITREXsumatriptantablet, film coated, oral0173-0736NDA
IMITREXsumatriptantablet, film coated, oral0173-0737NDA
IMITREXsumatriptaninjection, subcutaneous0173-0739NDA
INFANRIXDiphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbedsuspension, intramuscular58160-810BLA
Incruse Elliptaumeclidiniumaerosol, powder, oral0173-0873NDA
Jemperlidostarlimabinjection, intravenous0173-0898BLA
Jesduvroqdaprodustattablet, film coated, oral0173-0897NDA
Jesduvroqdaprodustattablet, film coated, oral0173-0903NDA
Jesduvroqdaprodustattablet, film coated, oral0173-0906NDA
Jesduvroqdaprodustattablet, film coated, oral0173-0911NDA
Jesduvroqdaprodustattablet, film coated, oral0173-0914NDA
KINRIXDiphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccineinjection, suspension, intramuscular58160-812BLA
Krintafeltafenoquine succinatetablet, film coated, oral0173-0889NDA
LAMICTALlamotriginetablet, for suspension, oral0173-0526NDA
LAMICTALlamotriginetablet, for suspension, oral0173-0527NDA
LAMICTALlamotriginekit0173-0594NDA
LAMICTALlamotriginetablet, oral0173-0633NDA
LAMICTALlamotriginetablet, oral0173-0642NDA
LAMICTALlamotriginetablet, oral0173-0643NDA
LAMICTALlamotriginetablet, oral0173-0644NDA
LAMICTALlamotriginetablet, for suspension, oral0173-0699NDA
LAMICTALlamotriginekit0173-0817NDA
LAMICTAL ODTlamotriginetablet, orally disintegrating, oral0173-0772NDA
LAMICTAL ODTlamotriginetablet, orally disintegrating, oral0173-0774NDA
LAMICTAL ODTlamotriginetablet, orally disintegrating, oral0173-0776NDA
LAMICTAL ODTlamotriginetablet, orally disintegrating, oral0173-0777NDA
LAMICTAL ODTlamotriginekit0173-0778NDA
LAMICTAL ODTlamotriginekit0173-0779NDA
LAMICTAL ODTlamotriginekit0173-0780NDA
LAMICTAL XRlamotriginetablet, film coated, extended release, oral0173-0754NDA
LAMICTAL XRlamotriginetablet, film coated, extended release, oral0173-0755NDA
LAMICTAL XRlamotriginetablet, film coated, extended release, oral0173-0756NDA
LAMICTAL XRlamotriginetablet, film coated, extended release, oral0173-0757NDA
LAMICTAL XRlamotriginekit0173-0758NDA
LAMICTAL XRlamotriginekit0173-0759NDA
LAMICTAL XRlamotriginekit0173-0760NDA
LAMICTAL XRlamotriginetablet, film coated, extended release, oral0173-0761NDA
LAMICTAL XRlamotriginetablet, film coated, extended release, oral0173-0781NDA
MALARONEatovaquone and proguanil hydrochloridetablet, film coated, oral0173-0675NDA
MALARONEatovaquone and proguanil hydrochloridetablet, film coated, oral0173-0676NDA
MEPRONatovaquonesuspension, oral0173-0547NDA
MEPRONatovaquonesuspension, oral0173-0665NDA
MenveoMeningococcal (Groups A, C, Y and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccineinjection, solution, intramuscular58160-827BLA
MenveoMeningococcal (Groups A, C, Y and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccinekit58160-955BLA
Nucalamepolizumabinjection, powder, for solution, subcutaneous0173-0881BLA
Nucalamepolizumabinjection, solution, subcutaneous0173-0892BLA
Nucalamepolizumabinjection, solution, subcutaneous0173-0904BLA
OjjaaraMomelotinibtablet, oral81864-101NDA
OjjaaraMomelotinibtablet, oral81864-102NDA
OjjaaraMomelotinibtablet, oral81864-103NDA
PEDIARIXDiphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combinedinjection, suspension, intramuscular58160-811BLA
PENMENVYMeningococcal (Groups A, B, C, W and Y)kit58160-757BLA
PriorixMeasels, Mumps, and Rubella Vaccine, Livekit58160-824BLA
RELENZAzanamivirpowder, respiratory (inhalation)0173-0681NDA
RotarixRotavirus Vaccine, Live, Oralsolution, oral58160-740BLA
SEREVENT DISKUSsalmeterol xinafoatepowder, metered, oral, respiratory (inhalation)0173-0521NDA
ShingrixZoster Vaccine Recombinant, Adjuvantedkit58160-823BLA
ShingrixZoster Vaccine Recombinant, Adjuvantedinjection, solution, intramuscular58160-849BLA
TWINRIXHepatitis A and Hepatitis B (Recombinant) Vaccineinjection, suspension, intramuscular58160-815BLA
Trelegy Elliptafluticasone furoate, umeclidinium bromide and vilanterol trifenatatepowder, respiratory (inhalation)0173-0887NDA
Trelegy Elliptafluticasone furoate, umeclidinium bromide and vilanterol trifenatatepowder, respiratory (inhalation)0173-0893NDA
VALTREXvalacyclovir hydrochloridetablet, film coated, oral0173-0565NDA
VALTREXvalacyclovir hydrochloridetablet, film coated, oral0173-0933NDA
VENTOLIN HFAalbuterol sulfateaerosol, metered, respiratory (inhalation)0173-0682NDA
WELLBUTRIN SRbupropion hydrochloridetablet, film coated, oral0173-0135NDA
WELLBUTRIN SRbupropion hydrochloridetablet, film coated, oral0173-0722NDA
WELLBUTRIN SRbupropion hydrochloridetablet, film coated, oral0173-0947NDA
ZEJULAniraparibtablet, film coated, oral0173-0909NDA
ZEJULAniraparibtablet, film coated, oral0173-0912NDA
ZEJULAniraparibtablet, film coated, oral0173-0915NDA
-belantamab mafodotinliquid12064-026BULK INGREDIENT
-belimumabliquid49401-000BULK INGREDIENT
-doxorubicin hydrochlorideinjection, suspension, liposomal12064-019DRUG FOR FURTHER PROCESSING
-lamotriginetablet, film coated, extended release58437-019DRUG FOR FURTHER PROCESSING
-lamotriginetablet, film coated, extended release58437-020DRUG FOR FURTHER PROCESSING
-lamotriginetablet, film coated, extended release58437-021DRUG FOR FURTHER PROCESSING
-lamotriginetablet, film coated, extended release58437-022DRUG FOR FURTHER PROCESSING
-lamotriginetablet58437-023DRUG FOR FURTHER PROCESSING
-lamotriginetablet58437-024DRUG FOR FURTHER PROCESSING
-mepolizumabliquid49401-012BULK INGREDIENT
-mepolizumabliquid58437-004BULK INGREDIENT
-mepolizumabliquid58437-009BULK INGREDIENT
-raxibacumabliquid49401-080BULK INGREDIENT
-sumatriptantablet, film coated58437-016DRUG FOR FURTHER PROCESSING
-sumatriptantablet, film coated58437-017DRUG FOR FURTHER PROCESSING
-sumatriptantablet, film coated58437-018DRUG FOR FURTHER PROCESSING
-trametinibtablet, film coated12064-021DRUG FOR FURTHER PROCESSING
-trametinibtablet, film coated12064-022DRUG FOR FURTHER PROCESSING
Neighbours

Registered in the same town

5
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Enquiry

Common questions

Is GlaxoSmithKline Biologicals SA FDA approved?
GlaxoSmithKline Biologicals SA holds 19 FDA-registered establishments across 9 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 GlaxoSmithKline Biologicals SA's drugs manufactured?
At registered sites in Belgium, Canada, Germany, Spain, France, the United Kingdom and 3 other countries. The FDA register lists Rixensart; Wavre; Ste-Foy; Dresden; Marburg; Aranda De Duero, and 13 more. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging, particle size reduction, sterilize.
What drugs does GlaxoSmithKline Biologicals SA make?
126 products are listed under GlaxoSmithKline Biologicals SA in the openFDA NDC Directory, most often as tablet, film coated; kit; powder. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

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.