Product Details
WHO Product ID
HA743
Status
Prequalified
INN, dosage form and strength
Abacavir (sulfate)/Lamivudine Tablet, Film-coated 600mg/300mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
HIV/AIDS
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Film-coated
Applicant organization
Cipla Ltd
Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel
Mumbai,
Maharashtra
400 013
India
Packaging details and storage conditions
Packaging Type
Bottle, HDPE
Configuration
30x1
Shelf life (months)
24
Storage conditions
Do not store above 30°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
Cipla Limited
Plot No. D-7, D-22, D-27, MIDC Industrial area, Kurkumbh village, Taluka Daund District – Pune
Maharashtra
India
Abacavir (sulfate), Lamivudine
Cipla Limited
Plot No. A-33, A-42, A-2, Patalganga Industrial area, District – Raigad
Maharashtra
India
Lamivudine
Mylan Laboratories Ltd
Unit 8, G Chodavaram, Poosapatirega Mandal, Vizianagaram District
Andhra Pradesh
535 204
India
Abacavir (sulfate)
FPP Manufacturing Site(s)
Cipla Ltd
Unit 7, Plot No L-139 to L-147-1, S-103 to S-105, S-107 to S-112 & M-61 to M-63, Verna Industrial Estate, Salcette
Goa
403 722
India
Cipla
Unit 2, Plot A-42 MIDC, Patalganga, Raigad District
Maharashtra
410 220
India