Medicines/finished pharmaceutical products

Reference Number: 
HP004

Date of prequalification: 
05 September 2017
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Sofosbuvir
Therapeutic area: 
Hepatitis
Dosage form & strength: 
Tablet, Film-coated 400mg
Storage condition: 
Do not store above 30°C
Shelf life (months): 
24
Packaging: 
Blister, Alu-PVC/PE/PVdC 14x2; Bottle,HDPE 28x1;84x1
Applicant: 
Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India
FPP Manufacturing Site: 

Cipla, Unit 2, Plot A-42 MIDC Industrial Area, Patalganga, Raigad District, Maharashtra, 410 220, India

API Manufacturing Site: 

(Sofosbuvir) Cipla Ltd, Plot D-22 MIDC Industrial Area, Kurkumbh Village, Taluka-Daund, Pune District, Maharashtra, 413 802, India

API WHO Public Inspection Reports: