WHO Product ID
HA467
Status
Prequalified
INN, dosage form and strength
Ritonavir Tablet, Film-coated 100mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
HIV/AIDS
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Film-coated
Applicant organization
Mylan Laboratories Ltd.
Plot No.564/A/22, Road No. 92, Jubilee Hills
Hyderabad,
Telangana
500096
India
Packaging details and storage conditions
Packaging Type
Alu/Alu blister
Configuration
10x1
Shelf life (months)
24
Storage conditions
Do not store above 30°C
Packaging Type
Bottle, HDPE
Configuration
30x1; 120x1
Shelf life (months)
24
Storage conditions
Do not store above 30°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
Tianish Laboratories Private Limited
Unit 8, G. Chodavaram, Poosapatirega Mandal, Vizianagaram District
Andhra Pradesh
535 204
India
Ritonavir
FPP Manufacturing Site(s)
Mylan Laboratories Ltd
Plot No 11, 12 & 13, Indore Special Economic Zone, Pharma Zone, Phase II, Sector III, District Dhar
Pithampur,
Madhya Pradesh
454 775
India
Mylan Laboratories Ltd
F4 & F12 Malegaon MIDC, Nashik District
Sinnar,
Maharashtra
422 113
India
