Medicines/finished pharmaceutical products

Reference Number: 
HP024 (a)

Date of prequalification: 
06 February 2019
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Sofosbuvir/Velpatasvir
Therapeutic area: 
Hepatitis
Dosage form & strength: 
Tablet, Film-coated 400mg/100mg
Storage condition: 
SRA accepted: No special storage conditions; WHO recommended: Do not store above 30°C. Store in the original package in order to protect from moisture. The shelf life at this storage condition is 36 months
Shelf life (months): 
36
Packaging: 
Bottle, HDPE 28x1
Applicant: 
Gilead Sciences Ireland UC, IDA Business & Technology Park, Carrigtohill, County Cork, Ireland
FPP Manufacturing Site: 

Gilead Sciences Ireland UC, IDA Business & Technology Park, Carrigtohill, County Cork, Ireland
Patheon Inc, 2100 Syntex Court, Mississauga, Ontario, L5N 7K9, Canada

FPP WHO Public Inspection Reports: 
API Manufacturing Site: 

(Sofosbuvir) AMPAC Fine Chemicals, Highway 50 & Hazel Avenue, Rancho Cordova, CA, 95670, United States of America
(Sofosbuvir) Cambrex Charles City, 1205 11th Street, Charles City, IA 50616, United States of America
(Sofosbuvir) Fabbrica Italiana Sintetici S.p.A. (F.I.S.), Viale Milano 26, 36075 Alte di Montecchio Maggiore, Vicenza, Italy
(Sofosbuvir) ST Pharm Co Ltd, Sihwa Site, 231, Hyeomnyeok-ro, Siheung-si, Gyeonggi-do, 15086, Republic of Korea
(Velpatasvir) Yuhan Chemical, Inc, 45 Jiwon-ro, Danwon-gu, Ansan-si, Gyeonggi-do, 15619, Republic of Korea
(Velpatasvir) Yuhan Chemical, Inc, 162 Cheongwonsandan 8-gil, Mado-myeon, Hwaseong-si, Gyeonggi-do, 18543, Republic of Korea
(Velpatasvir) Fabbrica Italiana Sintetici S.p.A. (F.I.S.), Viale Milano 26, 36075 Alte di Montecchio Maggiore, Vicenza, Italy
(Velpatasvir) Gilead Alberta, ULC, 1021 Hayter Road, Edmonton, Alberta, T6S 1A1, Canada

API WHO Public Inspection Reports: