Product Details
WHO Product ID
HA696
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
Hetero Labs Ltd
Hetero Corporate, 7-2-A2, Industrial Estates, Sanath Nagar, Ranga Reddy District
Hyderabad,
Telangana
500 018
India
Packaging details and storage conditions
Packaging Type
Container, HDPE
Configuration
30x1, 60x1, 90x1, 100x1, 180x1, 750x1
Shelf life (months)
48
Storage conditions
Do not store above 30°C, store in the original container
API Manufacturing Site(s)
By Organization
By Active Ingredient
Acebright (India) Pharma Pvt Ltd
77D & 116/117 KIADB Industrial Area, Jigani
Bangalore,
Karnataka
560 105
India
Tenofovir disoproxil fumarate
Hetero Labs Limited
Unit IX, Plot 2, Hetero Infrastructure SEZ - Ltd, N Narasapuram Village, Nakkapalli Mandal, Anakapalli District
Andhra Pradesh
531 081
India
Dolutegravir (sodium), Lamivudine, Tenofovir disoproxil fumarate
Hetero Labs Ltd
Unit 1, Survey No 10 IDA, Gaddapothoram Village, Jinnaram (M), Sangareddy District
Telangana
502319
India
Dolutegravir (sodium), Lamivudine, Tenofovir disoproxil fumarate
Laurus Labs Limited
Unit 1, Plot No 21, Jawaharlal Nehru Pharma City, Anakapalli District
Parawada,
Andhra Pradesh
531 021
India
Dolutegravir (sodium)
Shanghai Desano Chemical Pharmaceutical Co. Ltd.
417 Binhai Road, Laogang Town, Pudong New Area
Shanghai
201 302
China
Lamivudine
FPP Manufacturing Site(s)
Hetero Labs Ltd
Unit III, Plot No 22-110 IDA, Jeedimetla
Hyderabad,
Telangana
500 055
India
Hetero Labs Ltd
Unit 5, Survey No 439, 440, 441 & 458 TSIIC Formulation SEZ, Polepally Village, Jadcherla (M), Mahaboob Nagar District
Telangana
509 301
India