WHO Product ID
HA742
Status
Prequalified
INN, dosage form and strength
Atazanavir (sulfate)/Ritonavir Tablet, Film-coated 300mg/100mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
HIV/AIDS
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Film-coated
Applicant organization
Sun Pharmaceutical Industries Limited
Sun House, 201 B/1, Western Express Highway, Goregaon (East)
Mumbai,
400063
India
Packaging details and storage conditions
Packaging Type
Bottle, HDPE
Configuration
30x1, 90x1
Shelf life (months)
36
Storage conditions
Do not store above 30°C. Avoid excursions above 30°C. Protect from moisture
API Manufacturing Site(s)
By Organization
By Active Ingredient
Cdymax (India) Pharma Private Limited
77D & 116/117 KIADB Industrial Area, Jigani
Bangalore,
Karnataka
560 105
India
Atazanavir (sulfate)
Sun Pharmaceutical Industries Limited
Plot No. 24/2, 25, GIDC, Phase IV, Panoli, Bharuch
Gujarat
394 116
India
Atazanavir (sulfate)
Tianish Laboratories Private Limited
Unit 8, G. Chodavaram, Poosapatirega Mandal, Vizianagaram District
Andhra Pradesh
535 204
India
Ritonavir
FPP Manufacturing Site(s)
Sun Pharmaceutical Industries Limited
Village Ganguwala, District Sirmour
Paonta Sahib,
Himachal Pradesh
173 025
India
