Medicines/finished pharmaceutical products

Reference Number: 
HA632

Date of prequalification: 
21 April 2017
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Atazanavir (sulfate)/Ritonavir
Therapeutic area: 
HIV/AIDS
Dosage form & strength: 
Tablet, Film-coated 300mg/100mg
Storage condition: 
Do not store above 30°C
Shelf life (months): 
24
Packaging: 
Bottle HDPE 30x1; Blister Alu/Alu 10x3
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: 

(Atazanavir (sulfate)) Cipla Ltd, Plot D-7 MIDC Industrial Area, Kurkumbh Village, Taluka-Daund, Pune District, Maharashtra, 413 802, India
(Ritonavir) Shanghai Desano Chemical Pharmaceutical Co Ltd, 417 Binhai Road, Laogang Town, Pudong New Area, Shanghai, 201 302, China (People's Republic of)