Medicines/finished pharmaceutical products

Reference Number: 
HP016

Date of prequalification: 
15 May 2019
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Daclatasvir (dihydrochloride)
Therapeutic area: 
Hepatitis
Dosage form & strength: 
Tablet, Film-coated 60mg
Storage condition: 
Do not store above 30°C
Shelf life (months): 
24
Packaging: 
Bottle, HDPE 28x1
Applicant: 
Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India
FPP Manufacturing Site: 

Mylan Laboratories Ltd, F4 & F12 Malegaon MIDC, Sinnar, Nashik District, Maharashtra, 422 113, India

API Manufacturing Site: 

(Daclatasvir dihydrochloride) Mylan Laboratories Ltd, Unit 8, G Chodavaram, Poosapatirega Mandal, Vizianagaram District, Andhra Pradesh, 535 204, India