Medicines/finished pharmaceutical products

Reference Number: 
HA666

Date of prequalification: 
21 December 2016
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Lamivudine/Tenofovir disoproxil fumarate
Therapeutic area: 
HIV/AIDS
Dosage form & strength: 
Tablet, Film-coated 300mg/300mg
Storage condition: 
Do not store above 30°C
Shelf life (months): 
24
Packaging: 
Bottle,HDPE 30x1; Blister,Alu/Alu 10x1
Applicant: 
Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India
FPP Manufacturing Site: 

Cipla, Unit 2, Plot A-42 MIDC Industrial Area, Patalganga, Raigad District, Maharashtra, 410 220, India

API Manufacturing Site: 

(Lamivudine) Hetero Labs Ltd, Unit 1, Survey No 10 IDA, Gaddapothoram Village, Kazipally, Jinnaram (M), Medak District, Telangana, India
(Lamivudine) Hetero Labs Limited, Unit 3, Survey No.120, 128, 150 (PART), 150/1, 150/2 &158/1, N.Narasapuram, Nakkapally (M), Visakhapatnam, Andhra Pradesh, India
(Lamivudine) Hetero Labs Ltd, Unit 9, Plot 2 Hetero Infrastructure Ltd - SEZ, N Narasapuram Village, Nakkapally 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