Product Details
WHO Product ID
HA707
Status
Prequalified
INN, dosage form and strength
Dolutegravir (sodium)/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 50mg/300mg/300mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
HIV/AIDS
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Film-coated
Applicant organization
Laurus Labs Limited
2nd Floor, Serene Chambers, Road No. 7, Banjara Hills
Hyderabad,
Telangana
500 034
India
Packaging details and storage conditions
Packaging Type
Bottle, HDPE
Configuration
30x1, 90x1, 180 x1
Shelf life (months)
36
Storage conditions
Do not store above 30°C, store in the original container
API Manufacturing Site(s)
By Organization
By Active Ingredient
Laurus Labs Limited
Unit 1, Plot No 21, Jawaharlal Nehru Pharma City, Anakapalli District
Parawada,
Andhra Pradesh
531 021
India
Dolutegravir (sodium), Tenofovir disoproxil fumarate
Laurus Labs Limited
Unit 3, Plot No 18, Jawaharlal Nehru Pharma City, Parawada
Anakapalli,
Andhra Pradesh
531 021
India
Lamivudine, Tenofovir disoproxil fumarate
FPP Manufacturing Site(s)
Laurus Labs Limited
Unit-II, Plot No:19, 20 & 21, Western Sector, APSEZ, Gurajapalem Village, Rambilli Mandal
Anakapalli,
Andhra Pradesh
531011
India