Medicines/finished pharmaceutical products

Reference Number: 
HA537

Date of prequalification: 
14 June 2013
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Zidovudine
Therapeutic area: 
HIV/AIDS
Dosage form & strength: 
Tablet, Film-coated 60mg
Storage condition: 
Do not store above 30°C, protect from moisture
Shelf life (months): 
48
Packaging: 
Blister Alu/PVC/PVdC: 10x1; Bottle HDPE: 60x1, 100x1, 500x1, 1000x1
Applicant: 
Micro Labs Ltd, 27 Race Course Road, Bangalore, Karnataka, 560 001, India
FPP Manufacturing Site: 

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

API Manufacturing Site: 

(Zidovudine) Hetero Drugs Limited, Unit 9, Plot 2, Hetero Infrastructure SEZ - Ltd, N Narasapuram Village, Nakkapalli Mandal, Visakhapatnam District, Andhra Pradesh, 531 081, India
(Zidovudine) Shanghai Desano Chemical Pharmaceutical Co Ltd, 417 Binhai Road, Laogang Town, Pudong New Area, Shanghai, 201 302, China (People's Republic of)
(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 1, Survey 10/42, Gaddapotharam, Kazipally Industrial Area, Sangareddy, 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 9, Road No 12, Plot No. 5, Jawaharlal Nehru Pharma City, Parawada (M), Visakhapatnam District, Andhra Pradesh, 531 021, India