Medicines/finished pharmaceutical products

Reference Number: 
HA411 *

Date of prequalification: 
19 February 2009
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Lopinavir/Ritonavir
Therapeutic area: 
HIV/AIDS
Dosage form & strength: 
Tablet, Film-coated 200mg/50mg
Storage condition: 
Do not store above 30°C
Shelf life (months): 
24
Packaging: 
Bottle HDPE: 120x1
Applicant: 
Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India
FPP Manufacturing Site: 

Mylan Laboratories Ltd, F4 & F12 Malegaon MIDC, Sinnar, Nashik District, Maharashtra, 422 113, India

API Manufacturing Site: 

(Lopinavir) Mylan Laboratories Limited, Unit 2, Survey No. 10/42, Gaddapotharam, Kazipally Industrial Area, Medak District, Telangana, 502 319, India
(Lopinavir) Mylan Laboratories Ltd, Unit 1, Survey 10/42, Gaddapotharam, Kazipally Industrial Area, Sangareddy, Telangana, 502 319, India
(Ritonavir) Mylan Laboratories Ltd, Unit 8, G Chodavaram, Poosapatirega Mandal, Vizianagaram District, Andhra Pradesh, 535 204, India