Medicines/finished pharmaceutical products

Reference Number: 
HP002

Date of prequalification: 
07 February 2018
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: 
Bottle;HDPE 14x1;28x1; Blister;Alu/Alu 10x10
Applicant: 
Hetero Labs Ltd, 7-2-A2 Hetero Corporate Industrial Estates, Sanathnagar, Hyderabad, Telangana, 500 018, India
FPP Manufacturing Site: 

Hetero Labs Ltd, Unit 5, Survey No 439, 440, 441 & 458 TSIIC Formulation SEZ, Polepally Village, Jadcherla (M), Mahaboob Nagar District, Telangana, 509 301, India

API Manufacturing Site: 

(Sofosbuvir) Hetero Labs Ltd, Unit 1, Survey No 10 IDA, Gaddapothoram Village, Kazipally, Jinnaram (M), Sangareddy District, Telangana, 502110, India

API WHO Public Inspection Reports: