Product Details
WHO Product ID
HA286
Status
Prequalified
INN, dosage form and strength
Lamivudine/Zidovudine Tablet, Film-coated 150mg/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
Village Ganguwala, District Sirmour
Paonta Sahib,
Himachal Pradesh
173 025
India
Packaging details and storage conditions
Packaging Type
Bottle, HDPE
Configuration
60x1
Shelf life (months)
36
Storage conditions
Do not store above 30°C, protect from moisture
Packaging Type
Blister, Alu/PVC/PVdC
Configuration
10x6
Shelf life (months)
36
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, Zidovudine
Shanghai Desano Chemical Pharmaceutical Co Ltd
417 Binhai Road, Laogang Town, Pudong New Area
Shanghai
201302
China
Lamivudine, Zidovudine
FPP Manufacturing Site(s)
Sun Pharmaceutical Industries Limited
Village Ganguwala, District Sirmour
Paonta Sahib,
Himachal Pradesh
173 025
India