Product Details
WHO Product ID
HP033
Status
Prequalified
INN, dosage form and strength
Daclatasvir (dihydrochloride) Tablet, Film-coated 30 mg
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
Zydus Lifesciences Limited
“Zydus Corporate Park”, Scheme no. 63, survey no. 536, Khoraj (Gandhinagar), Near. Vaishnodevi circle,
Ahmedabad,
Gujarat
382441
India
Packaging details and storage conditions
Packaging Type
Blister, Alu/Alu
Configuration
10x3, 10x10
Shelf life (months)
24
Storage conditions
Do not store above 30°C
Packaging Type
Bottle, HDPE
Configuration
28x1
Shelf life (months)
24
Storage conditions
Do not store above 30°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
Laurus Labs Limited
Unit 1, Plot No 21, Jawaharlal Nehru Pharma City, Anakapalli District
Parawada,
Andhra Pradesh
531 021
India
Daclatasvir (dihydrochloride)
FPP Manufacturing Site(s)
Zydus Lifesciences Limited
Kundaim Industrial Estate, Plot No.203-213, Kundaim
Goa
403115
India