WHO Product ID
HA794
Status
Prequalified
INN, dosage form and strength
Dolutegravir (sodium) Tablet, Film-coated 50mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
HIV/AIDS
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Film-coated
Applicant organization
RV Lifesciences Limited
Plot No. H-19, MIDC, Waluj
Chhatrapati Sambhajinagar,
Maharashtra
431133
India
Packaging details and storage conditions
Packaging Type
Bottle, HDPE
Configuration
30x1
Shelf life (months)
36
Storage conditions
Do not store above 30°C, avoid excursions above 30°C
Packaging Type
Blister, Alu/Alu
Configuration
10x3
Shelf life (months)
36
Storage conditions
Do not store above 30°C, avoid excursions above 30°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
Mangalam Drugs and Organics Limited
Unit-2, G.I.D.C, Plot no. 1203
Vapi,
Gujarat
396 195
India
Dolutegravir (sodium)
FPP Manufacturing Site(s)
RV Lifesciences Limited
Plot No. H-19, MIDC, Waluj
Chhatrapati Sambhajinagar,
Maharashtra
431133
India