Product Details
WHO Product ID
HP022
Status
Prequalified
INN, dosage form and strength
Daclatasvir (dihydrochloride) Tablet, Film-coated 60mg
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
Cipla Ltd
Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel
Mumbai,
Maharashtra
400 013
India
Packaging details and storage conditions
Packaging Type
Bottle, HDPE
Configuration
28x1
Shelf life (months)
24
Storage conditions
Do not store above 30°C
Packaging Type
Blister, Alu/PVC/PE/PVDC
Configuration
2x14
Shelf life (months)
24
Storage conditions
Do not store above 30°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
Cipla Ltd
Unit 1, Plot A-33, & A-2 MIDC Industrial Area, Raigad District
Patalganga,
Maharashtra
410 220
India
Daclatasvir (dihydrochloride)
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)
Cipla Limited
Unit 2, Plot A-42 MIDC, Patalganga, Raigad District
Maharashtra
410 220
India