Medicines/finished pharmaceutical products

Reference Number: 
HA486

Date of prequalification: 
03 November 2011
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Zidovudine
Therapeutic area: 
HIV/AIDS
Dosage form & strength: 
Solution, Oral 10mg
Storage condition: 
Do not store above 25°C
Shelf life (months): 
24
Packaging: 
Bottle HDPE (with induction sealing wad and CR cap): 240ml;
Applicant: 
Hetero Labs Ltd, Unit III, Survey No 51, Plot No 22-110 IDA, Jeedimetla, Hyderabad, Telangana, 500 055, India
FPP Manufacturing Site: 

Hetero Labs Ltd, Unit III, Survey No 51, Plot No 22-110 IDA, Jeedimetla, Hyderabad, Telangana, 500 055, 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)
(Zidovudine) Hetero Labs Ltd, Unit 9, Plot 2 Hetero Infrastructure Ltd - SEZ, N Narasapuram Village, Nakkapally Mandal, Visakhapatnam District, Andhra Pradesh, 531 081, India
(Zidovudine) Hetero Labs Ltd, Unit 1, Survey No 10 IDA, Gaddapothoram Village, Kazipally, Jinnaram (M), Medak District, Telangana, India

API WHO Public Inspection Reports: