Product Details
WHO Product ID
HA486
Status
Prequalified
INN, dosage form and strength
Zidovudine Solution, Oral 10mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
HIV/AIDS
Type
Finished Pharmaceutical Product
Dosage form
Solution, Oral
Applicant organization
Hetero Labs Ltd
Unit III, Plot No 22-110 IDA, Jeedimetla
Hyderabad,
Telangana
500 055
India
Packaging details and storage conditions
Packaging Type
Bottle, HDPE
Configuration
240x1, 1.5mL and 10mL dosing syringes
Shelf life (months)
24
Storage conditions
Do not store above 25°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
Hetero Labs Limited
Unit IX, Plot 2, Hetero Infrastructure SEZ - Ltd, N Narasapuram Village, Nakkapalli Mandal, Anakapalli District
Andhra Pradesh
531 081
India
Zidovudine
Hetero Labs Ltd
Unit 1, Survey No 10 IDA, Gaddapothoram Village, Jinnaram (M), Sangareddy District
Telangana
502319
India
Zidovudine
Shanghai Desano Chemical Pharmaceutical Co Ltd
417 Binhai Road, Laogang Town, Pudong New Area
Shanghai
201302
China
Zidovudine
FPP Manufacturing Site(s)
Hetero Labs Ltd
Unit III, Plot No 22-110 IDA, Jeedimetla
Hyderabad,
Telangana
500 055
India