Medicines/finished pharmaceutical products

Reference Number: 
HA644

Date of prequalification: 
26 October 2016
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Lamivudine
Therapeutic area: 
HIV/AIDS
Dosage form & strength: 
Tablet, Film-coated 150mg
Storage condition: 
Do not store above 30°C
Shelf life (months): 
48
Packaging: 
Blister Alu/PVC/PVDC 10x1; Bottle HDPE 60x1
Applicant: 
Micro Labs Ltd, 27 Race Course Road, Bangalore, Karnataka, 560 001, India
FPP Manufacturing Site: 

Micro Labs Ltd, Phase III and Phase IV, Plot No S-155 to S-159 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), Medak District, Andhra Pradesh, India
(Lamivudine) Hetero Labs Ltd, Unit 9, Plot 2 Hetero Infrastructure Ltd - SEZ, N Narasapuram Village, Nakkapally Mandal, Visakhapatnam District, Andhra Pradesh, 531 081, India

API WHO Public Inspection Reports: