Product Details
WHO Product ID
HA766
Status
Prequalified
INN, dosage form and strength
Efavirenz/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 400mg/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
Desano Pharmaceuticals Private Limited
No. 77D, KIADB Industrial Area, Jigani
Bengaluru,
Karnataka
560105
India
Packaging details and storage conditions
Packaging Type
Bottle, HDPE
Configuration
30x1, 90x1, 180x1
Shelf life (months)
24
Storage conditions
Do not store above 30°C, avoid excursions above 30°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
Shanghai Desano Chemical Pharmaceutical Co Ltd
417 Binhai Road, Laogang Town, Pudong New Area
Shanghai
201302
China
Efavirenz, Lamivudine, Tenofovir disoproxil fumarate
FPP Manufacturing Site(s)
Aizant Drug Research Solutions Pvt. Ltd
Block No. B, Sy. No. 172 & 173, Apparel Park Rd., Dulapally Village, Medchal-Malkhajgiri District
Dundigal-Gandimaisamma Mandal,
Telangana
India