Medicines/finished pharmaceutical products

Reference Number: 
HA555

Date of prequalification: 
13 January 2015
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Lamivudine/Zidovudine
Therapeutic area: 
HIV/AIDS
Dosage form & strength: 
Tablet, Film-coated 30mg/60mg
Storage condition: 
Do not store above 30°C, protect from light
Shelf life (months): 
48
Packaging: 
Blister Alu/PVC/PVdC: 10x1; Bottle HDPE: 60x1, 100x1, 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: 

(Zidovudine) Shanghai Desano Chemical Pharmaceutical Co Ltd, 417 Binhai Road, Laogang Town, Pudong New Area, Shanghai, 201 302, China (People's Republic of)
(Lamivudine) Shanghai Desano Chemical Pharmaceutical Co Ltd, 417 Binhai Road, Laogang Town, Pudong New Area, Shanghai, 201 302, China (People's Republic of)
(Lamivudine) Hetero Drugs Limited, Unit 9, Plot 2, Hetero Infrastructure SEZ - Ltd, N Narasapuram Village, Nakkapalli Mandal, Visakhapatnam District, Andhra Pradesh, 531 081, India
(Zidovudine) Mylan Laboratories Limited, Unit 2, Survey No. 10/42, Gaddapotharam, Kazipally Industrial Area, Medak District, Telangana, 502 319, India
(Zidovudine) Mylan Laboratories Ltd, Unit 8, G Chodavaram, Poosapatirega Mandal, Vizianagaram District, Andhra Pradesh, 535 204, India
(Zidovudine) Mylan Laboratories Ltd, Unit 1, Survey 10/42, Gaddapotharam, Kazipally Industrial Area, Sangareddy, Telangana, 502 319, India
(Zidovudine) Mylan Laboratories Ltd, Unit 9, Road No 12, Plot No. 5, Jawaharlal Nehru Pharma City, Parawada (M), Visakhapatnam District, Andhra Pradesh, 531 021, India
(Zidovudine) Hetero Drugs Limited, Unit 9, Plot 2, Hetero Infrastructure SEZ - Ltd, N Narasapuram Village, Nakkapalli Mandal, Visakhapatnam District, Andhra Pradesh, 531 081, India
(Lamivudine) Hetero Labs Ltd, Unit 1, Survey No 10 IDA, Gaddapothoram Village, Kazipally, Jinnaram (M), Sangareddy District, Telangana, 502319, India