Medicines/finished pharmaceutical products

Reference Number: 
HA702

Date of prequalification: 
05 April 2019
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Dolutegravir (Sodium)/Lamivudine/Tenofovir disoproxil fumarate
Therapeutic area: 
HIV/AIDS
Dosage form & strength: 
Tablet, Film-coated 50mg/300mg/300mg
Storage condition: 
Do not store above 30°C
Shelf life (months): 
24
Packaging: 
Bottle, HDPE 30x1, 90x1, 500x1
Applicant: 
Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India
FPP Manufacturing Site: 

Cipla Limited, Unit VII PD II, Plot No. L-139, S-103 & M-62, Verna Industrial Area, Verna, Salcette, Goa, 403 722, India
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

API Manufacturing Site: 

(Dolutegravir (sodium)) Cipla Ltd, Plot D-22 MIDC Industrial Area, Kurkumbh Village, Taluka-Daund, Pune District, Maharashtra, 413 802, India
(Lamivudine) Hetero Drugs Limited, Unit 9, Plot 2, Hetero Infrastructure SEZ - Ltd, N Narasapuram Village, Nakkapalli Mandal, Visakhapatnam District, Andhra Pradesh, 531 081, India
(Tenofovir disoproxil fumarate) Cipla Ltd, Plot D-7 MIDC Industrial Area, Kurkumbh Village, Taluka-Daund, Pune District, Maharashtra, 413 802, India
(Tenofovir disoproxil fumarate) Cipla Ltd, Plot D-22 MIDC Industrial Area, Kurkumbh Village, Taluka-Daund, Pune District, Maharashtra, 413 802, India
(Tenofovir disoproxil fumarate) Cipla Ltd, Plot D-27 MIDC Industrial Area, Kurkumbh Village, Taluka-Daund, Pune District, Maharashtra, 413 802, India

API WHO Public Inspection Reports: