Medicines/finished pharmaceutical products

Reference Number: 
HA573

Date of prequalification: 
09 September 2015
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: 
HDPE Container 60x1
Applicant: 
Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India
FPP Manufacturing Site: 

Macleods Pharmaceuticals Ltd, Block No. N2, Village Theda, P.O. Lodhi Majra, Tehsil Baddi, District Solan, Himachal Pradesh, 174 101, 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
(Ritonavir) Shanghai Desano Chemical Pharmaceutical Co Ltd, 417 Binhai Road, Laogang Town, Pudong New Area, Shanghai, 201 302, China (People's Republic of)

API WHO Public Inspection Reports: