Product Details
WHO Product ID
HA688
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
Mylan Laboratories Limited
Plot No.564/A/22, Road No. 92, Jubilee Hills
Hyderabad,
Telangana
500096
India
Packaging details and storage conditions
Packaging Type
Bottle, HDPE
Configuration
30X1, 90X1, 180X1
Shelf life (months)
36
Storage conditions
Do not store above 30°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
Mylan Laboratories Limited (Unit-10)
Plot No. 86, Ramky Pharma City (India) Ltd, Parawada Mandal, Anakapalli District
Jawaharlal Nehru Pharma City,
Andhra Pradesh
531019
India
Tenofovir disoproxil fumarate
Mylan Laboratories Ltd
Unit 8, G Chodavaram, Poosapatirega Mandal, Vizianagaram District
Andhra Pradesh
535 204
India
Tenofovir disoproxil fumarate
Mylan Laboratories Ltd
Unit 9, Road No 12, Plot No. 5, Jawaharlal Nehru Pharma City, Tadi Village, Parawada (M), Anakapalli District
Andhra Pradesh
531019
India
Dolutegravir (sodium)
Mylan Laboratories Ltd
Unit 1, Survey 10, Gaddapotharam, Sangareddy
Kazipally Industrial Area,
Telangana
502 319
India
Lamivudine
FPP Manufacturing Site(s)
Mylan Laboratories Ltd
Plot No 11, 12 & 13, Indore Special Economic Zone, Pharma Zone, Phase II, Sector III, District Dhar
Pithampur,
Madhya Pradesh
454 775
India