Product Details
WHO Product ID
HP025
Status
Prequalified
INN, dosage form and strength
Daclatasvir (dihydrochloride)/Sofosbuvir Tablet, Film-coated 60mg/400mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Hepatitis B and C
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Film-coated
Applicant organization
Mylan Laboratories Limited
Plot No.564/A/22, Road No. 92, Jubilee Hills
Hyderabad,
Telangana
500096
India
Packaging details and storage conditions
Packaging Type
Bottle (blue), HDPE
Configuration
28x1
Shelf life (months)
36
Storage conditions
Do not store above 30°C, store in the original container
API Manufacturing Site(s)
By Organization
By Active Ingredient
Mylan Laboratories Ltd
Unit 8, G Chodavaram, Poosapatirega Mandal, Vizianagaram District
Andhra Pradesh
535 204
India
Daclatasvir (dihydrochloride), Sofosbuvir
FPP Manufacturing Site(s)
Mylan Laboratories Ltd
F4 & F12 Malegaon MIDC, Nashik District
Sinnar,
Maharashtra
422 113
India