Product Details
WHO Product ID
HA699
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
Sun Pharmaceutical Industries Limited
Sun House, 201 B/1, Western Express Highway, Goregaon (East)
Mumbai,
400063
India
Packaging details and storage conditions
Packaging Type
Bottle, HDPE
Configuration
30x1, 90x1
Shelf life (months)
30
Storage conditions
Do not store above 30°C, protect from moisture
Packaging Type
Bottle, HDPE
Configuration
180x1
Shelf life (months)
24
Storage conditions
Do not store above 30°C, protect from moisture
API Manufacturing Site(s)
By Organization
By Active Ingredient
Hetero Labs Limited
Unit IX, Plot 2, Hetero Infrastructure SEZ - Ltd, N Narasapuram Village, Nakkapalli Mandal, Anakapalli District
Andhra Pradesh
531 081
India
Lamivudine, Tenofovir disoproxil fumarate
Hetero Labs Limited
Unit 3, Survey No.120, 128, 150 (PART), 150/1, 150/2 &158/1, N.Narasapuram, Nakkapally (M), Anakapalli
Andhra Pradesh
531 081
India
Lamivudine
Hetero Labs Ltd
Unit 1, Survey No 10 IDA, Gaddapothoram Village, Jinnaram (M), Sangareddy District
Telangana
502319
India
Lamivudine, Tenofovir disoproxil fumarate
Laurus Labs Limited
Unit-4, Plot No.25, 25A to 25K, APSEZ De-Notified Area, Lalamkoduru Village, Rambilli Mandal
Anakapalli,
Andhra Pradesh
531011
India
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)
Laurus Labs Limited
Unit 3, Plot No 18, Jawaharlal Nehru Pharma City, Parawada
Anakapalli,
Andhra Pradesh
531 021
India
Lamivudine, Tenofovir disoproxil fumarate
Shanghai Desano Chemical Pharmaceutical Co. Ltd.
417 Binhai Road, Laogang Town, Pudong New Area
Shanghai
201302
China
Lamivudine
Sun Pharmaceutical Industries Limited
Plot No. Z-15, Industrial Area, Dahej SEZ, Bharuch
Vagra,
Gujarat
392130
India
Dolutegravir (sodium)
Sun Pharmaceutical Industries Limited
Village Toansa, P.O. Rail Majra, Dist. S.B.S. Nagar (Nawanshahar)
Punjab
144 533
India
Tenofovir disoproxil fumarate
FPP Manufacturing Site(s)
Sun Pharmaceutical Industries Limited
Village Ganguwala, District Sirmour
Paonta Sahib,
Himachal Pradesh
173 025
India