Medicines/finished pharmaceutical products

Reference Number: 
HA650

Date of prequalification: 
19 June 2018
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Lopinavir/Ritonavir
Therapeutic area: 
HIV/AIDS
Dosage form & strength: 
Tablet, Film-coated 100mg/25mg
Storage condition: 
Do not store above 30°C, protect from light
Shelf life (months): 
24
Packaging: 
Bottle, HDPE 120
Applicant: 
Hetero Labs Ltd, 7-2-A2 Hetero Corporate Industrial Estates, Sanathnagar, Hyderabad, Telangana, 500 018, India
FPP Manufacturing Site: 

Hetero Labs Ltd, Unit III, Plot No 22-110 IDA, Jeedimetla, Hyderabad, Telangana, 500 055, India

API Manufacturing Site: 

(Lopinavir) Hetero Labs Ltd, Unit 1, Survey No 10 IDA, Gaddapothoram Village, Kazipally, Jinnaram (M), Sangareddy District, Telangana, 502319, India
(Ritonavir) Hetero Drugs Limited, Unit 9, Plot 1, Hetero Infrastructure SEZ - Ltd, N Narasapuram Village, Nakkapalli Mandal, Visakhapatnam District, Andhra Pradesh, 531 081, India

API WHO Public Inspection Reports: