Product Details
WHO Product ID
HA634
Status
Prequalified
INN, dosage form and strength
Dolutegravir (sodium) Tablet, Film-coated 50mg
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
HIV/AIDS
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Film-coated
Applicant organization
ViiV Healthcare BV
Van Asch van Wijckstraat 55H
Amersfoort,
3811 LP
Netherlands
Packaging details and storage conditions
Packaging Type
Bottle, HDPE
Configuration
30x1
Shelf life (months)
36
Storage conditions
Do not store above 30°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
Catalent Micron Technologies Inc.
Crossways Boulevard, Crossways, Dartford
Kent
DA26QY
United Kingdom of Great Britain and Northern Ireland
Dolutegravir (sodium)
Fujimoto Chemicals Co Ltd
Senboku Plant, 1-24, Rinkai-cho
Izumiotsu,
595-0075
Japan
Dolutegravir (sodium)
Glaxo Operations UK Limited
Priory Street, Hertfordshire
Ware,
SG12 0DJ
United Kingdom of Great Britain and Northern Ireland
Dolutegravir (sodium)
Glaxo Wellcome Manufacturing Pte Ltd
1 Pioneer Sector 1, Jurong
628 413
Singapore
Dolutegravir (sodium)
S.A. Ajinomoto OmniChem n.v.
OmniChem Division, Cooppallaan 91
Wetteren,
B-9230
Belgium
Dolutegravir (sodium)
Shanghai Desano Chemical Pharmaceutical Co., Ltd.
417 Binhai Road, Laogang Town, Pudong New Area
Shanghai
201302
China
Dolutegravir (sodium)
Shionogi Pharma Co. Ltd.
224-20, Hiraishiebisuno, Kawauchi-cho
Tokushima,
771-0132
Japan
Dolutegravir (sodium)
FPP Manufacturing Site(s)
Delpharm Poznań Spółka Akcyjna
ul. Grunwaldzka 189
Poznan,
60-332
Poland
Glaxo Operations UK Limited
Priory Street, Hertfordshire
Ware,
SG12 0DJ
United Kingdom of Great Britain and Northern Ireland
Glaxo Wellcome SA
Avenue de Extremadura 3, Aranda de Duero
Burgos,
Spain
GlaxoSmithKline LLC
1011, North Arendall Avenue, Zebulon
27597
United States of America