Product Details
WHO Product ID
HA483
Status
Prequalified
INN, dosage form and strength
Zidovudine Tablet, Film-coated 300mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
HIV/AIDS
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Film-coated
Applicant organization
Micro Labs Limited
31 Race Course Road
Bangalore,
Karnataka
560 001
India
Packaging details and storage conditions
Packaging Type
Blister, PVDC/PVC/Alu; Bottle, HDPE
Configuration
10x1; 30x1; 60x1; 90x1
Shelf life (months)
36
Storage conditions
Do not store above 30°C, protect from light
Packaging Type
Bottle, HDPE
Configuration
60x1
Shelf life (months)
48
Storage conditions
Do not store above 30°C, protect from light
Packaging Type
Bottle, HDPE
Configuration
90x1
Shelf life (months)
36
Storage conditions
Do not store above 30°C, protect from light
Packaging Type
Bottle, HDPE
Configuration
30x1
Shelf life (months)
36
Storage conditions
Do not store above 30°C, protect from light
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
Mylan Laboratories Ltd
Unit 9, Road No 12, Plot No. 5, Jawaharlal Nehru Pharma City, Tadi Village, Parawada (M), Anakapalli District
Andhra Pradesh
531019
India
Zidovudine
FPP Manufacturing Site(s)
Micro Labs Limited
Plot No. S-155 to S-159 & N1, Phase III & Phase IV, Verna Industrial Estate
Verna,
Goa
403 722
India