Medicines/finished pharmaceutical products

Reference Number: 
HA634 (a)

Date of prequalification: 
14 October 2014
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Dolutegravir (Sodium)
Therapeutic area: 
HIV/AIDS
Dosage form & strength: 
Tablet, Film-coated 50mg
Shelf life (months): 
60
Packaging: 
Bottle HDPE: 30x1
Applicant: 
ViiV Healthcare BV, Huis ter Heideweg 62, 3705 LZ Zeist, Netherlands
FPP Manufacturing Site: 

GlaxoSmithKline LLC, 1011, North Arendall Avenue, Zebulon, North Carolina, 27597, United States of America
Glaxo Operations UK Limited, Priory Street, Ware, Hertfordshire, SG12 0DJ, United Kingdom of Great Britain and Northern Ireland
Glaxo Wellcome SA, Avenue de Extremadura 3, Aranda de Duero, Burgos, Spain
GlaxoSmithKline Pharmaceuticals S. A. ul., Grunwaldzka 189, 60-332 Poznan, Poland

FPP WHO Public Inspection Reports: 
API Manufacturing Site: 

(Dolutegravir (sodium)) Catalent Micron Technologies Inc., Crossways Boulevard, Crossways, Dartford, Kent, DA26QY, United Kingdom of Great Britain and Northern Ireland
(Dolutegravir (sodium)) S.A. Ajinomoto OmniChem n.v., OmniChem Division, Cooppallaan 91, B-9230 Wetteren, Belgium
(Dolutegravir (sodium)) Shanghai Desano Chemical Pharmaceutical Co Ltd, 417 Binhai Road, Laogang Town, Pudong New Area, Shanghai, 201 302, China (People's Republic of)
(Dolutegravir (sodium)) Glaxo Operations UK Limited, Priory Street, Ware, Hertfordshire, SG12 0DJ, United Kingdom of Great Britain and Northern Ireland
(Dolutegravir (sodium)) Fujimoto Chemicals Co Ltd, Senboku Plant, 1-24, Rinkai-cho, Izumiotsu, Osaka, 595-0075, Japan
(Dolutegravir (sodium)) Glaxo Wellcome Manufacturing Pte Ltd, 1 Pioneer Sector 1, Jurong, 628 413, Singapore
(Dolutegravir (sodium)) Shionogi Pharma Chemicals Co Ltd, 224-20, Hiraishiebisuno, Kawauchi-cho, Tokushima, Tokushima, 771-0132, Japan

API WHO Public Inspection Reports: