Product Details
WHO Product ID
HA433
Status
Prequalified
INN, dosage form and strength
Lamivudine/Nevirapine/Zidovudine Tablet, Dispersible 30mg/50mg/60mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
HIV/AIDS
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Dispersible
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
60x1
Shelf life (months)
60
Storage conditions
Do not store above 30°C, store in dry condition
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
Nevirapine
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
Zidovudine
Mylan Laboratories Ltd
Unit 1, Survey 10, Gaddapotharam, Sangareddy
Kazipally Industrial Area,
Telangana
502 319
India
Lamivudine
Shanghai Desano Chemical Pharmaceutical Co. Ltd.
417 Binhai Road, Laogang Town, Pudong New Area
Shanghai
201302
China
Lamivudine, Nevirapine, Zidovudine
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
F4 & F12 Malegaon MIDC, Nashik District
Sinnar,
Maharashtra
422 113
India
Mylan Laboratories Ltd
Plot No H-12 & H13 MIDC Waluj Industrial Area
Aurangabad,
Maharashtra
431 136
India