Product Details
WHO Product ID
HA720
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
Lupin Ltd.
Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East)
Mumbai,
Maharashtra
400 055
India
Packaging details and storage conditions
Packaging Type
Bottle, HDPE
Configuration
30x1, with one silica gel sachet
Shelf life (months)
36
Storage conditions
Do not store above 30°C, avoid excursions above 30°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
Hetero Drugs Limited
Unit IX, Plot No.1, Hetero Infrastructure SEZ - Ltd, N Narasapuram Village, Nakkapalli Mandal, Anakapalli District
Andhra Pradesh
531 081
India
Ritonavir
Hetero Labs Limited
Unit IX, Plot 2, Hetero Infrastructure SEZ - Ltd, N Narasapuram Village, Nakkapalli Mandal, Anakapalli District
Andhra Pradesh
531 081
India
Ritonavir
Laurus Labs Limited
Unit 1, Plot No 21, Jawaharlal Nehru Pharma City, Anakapalli District
Parawada,
Andhra Pradesh
531 021
India
Atazanavir (sulfate)
Laurus Labs Limited
Unit 3, Plot No 18, Jawaharlal Nehru Pharma City, Parawada
Anakapalli,
Andhra Pradesh
531 021
India
Atazanavir (sulfate)
FPP Manufacturing Site(s)
Lupin Limited
Unit 1, Plot No. 6A1, 6A2, Sector-17, Special Economic Zone, MIHAN
Nagpur,
Maharashtra
441 108
India