Medicines/finished pharmaceutical products

Reference Number: 
HA054 *

Date of prequalification: 
20 March 2002
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Zidovudine
Therapeutic area: 
HIV/AIDS
Dosage form & strength: 
Solution, Oral 50mg/5mL
Storage condition: 
Do not store above 30°C
Shelf life (months): 
36
Packaging: 
Bottle PET Amber Transparent + Plastic Syringe: 100x1
Applicant: 
Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India
FPP Manufacturing Site: 

Cipla Ltd, Unit I, Plot No 9, 10 & 15 Indore Special Economic Zone, Phase II, Pithampur, Dhar District, Madhya Pradesh, 454 775, India

API Manufacturing Site: 

(Zidovudine) Hetero Labs Ltd, Unit 1, Survey No 10 IDA, Gaddapothoram Village, Kazipally, Jinnaram (M), Sangareddy District, Telangana, 502 319, 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) Hetero Labs Ltd, Unit 9, Plot 2 Hetero Infrastructure Ltd - SEZ, N Narasapuram Village, Nakkapalli Mandal, Visakhapatnam District, Andhra Pradesh, 531 081, India

API WHO Public Inspection Reports: