Medicines/finished pharmaceutical products

Reference Number: 
HA536

Date of prequalification: 
18 February 2013
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Lamivudine
Therapeutic area: 
HIV/AIDS
Dosage form & strength: 
Tablet, Film-coated 30mg
Storage condition: 
Do not store above 30°C, protect from moisture, protect from light
Shelf life (months): 
48
Packaging: 
Blister Alu/PVC/PVdC: 10x6; Bottle, HDPE, PP cap: 60x1, 100x1, 500x1, 1000x1
Applicant: 
Micro Labs Ltd, 31 Race Course Road, Bangalore, Karnataka, 560 001, India
FPP Manufacturing Site: 

Micro Labs Ltd, Plot No. S-155 to S-159 & N1, Phase III & Phase IV, Verna Industrial Estate, Verna, Goa, 403 722, India

API Manufacturing Site: 

(Lamivudine) Hetero Labs Ltd, Unit 1, Survey No 10 IDA, Gaddapothoram Village, Kazipally, Jinnaram (M), Sangareddy District, Telangana, 502319, India
(Lamivudine) 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: