WHO Product ID
HA721
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 - Abridged
Therapeutic area
HIV/AIDS
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Film-coated
Applicant organization
Mylan Laboratories Ltd.
Plot No.564/A/22, Road No. 92, Jubilee Hills
Hyderabad,
Telangana
500096
India
Packaging details and storage conditions
Packaging Type
Bottle, Blue HDPE
Configuration
30x1
Shelf life (months)
24
Storage conditions
Do not store above 30°C
Packaging Type
Bottle White, HDPE
Configuration
30x1
Shelf life (months)
36
Storage conditions
Do not store above 30°C
Packaging Type
Bottle, Blue HDPE
Configuration
90x1
Shelf life (months)
36
Storage conditions
Do not store above 30°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
Tianish Laboratories Private Limited
Unit 2, Survey 10 and 42, Kazipally Industrial Area, Gaddapotharam, Sangareddy District
Hyderabad,
Telangana
502 319
India
Lamivudine
Tianish Laboratories Private Limited
Unit 10, Plot No. 86, SEZ, Jawaharlal Nehru Pharma City, Parawada Mandal, Anakapalli District
Visakhapatnam,
Andhra Pradesh
531019
India
Efavirenz, Tenofovir disoproxil fumarate
Tianish Laboratories Private Limited
Unit 8, Gaitula Chodavaram, Poosapatirega Mandal, Vizianagaram
Andhra Pradesh
535 204
India
Efavirenz
Tianish Laboratories Private Limited
Unit 1, Survey 10, Kazipally Industrial Area Gaddapotharam, Sangareddy District
Hyderabad,
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
Mylan Laboratories Ltd
Plot No H-12 & H13 MIDC Waluj Industrial Area
Chhatrapati Sambhajinagar,
Maharashtra
431 136
India
