Product Details
WHO Product ID
HP024
Status
Prequalified
INN, dosage form and strength
Sofosbuvir/Velpatasvir Tablet, Film-coated 400mg/100mg
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
Hepatitis B and C
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Film-coated
Applicant organization
Gilead Sciences Ireland UC
IDA Business & Technology Park, Co. Cork
Carrigtohill,
Ireland
Packaging details and storage conditions
Packaging Type
Bottle, HDPE
Configuration
28x1
Shelf life (months)
48
Storage conditions
Do not store above 25°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
AMPAC Fine Chemicals
Highway 50 & Hazel Avenue
Rancho Cordova,
95670
United States of America
Sofosbuvir
Cambrex Charles City
1205 11th Street
Charles City,
Iowa
50616
United States of America
Sofosbuvir
Fabbrica Italiana Sintetici S.p.A. (F.I.S.)
Viale Milano 26, Alte di Montecchio Maggiore
Vicenza,
36075
Italy
Sofosbuvir, Velpatasvir
Gilead Alberta, ULC
1021 Hayter Road, Alberta
Edmonton,
T6S 1A1
Canada
Velpatasvir
ST Pharm Co Ltd
Sihwa Site, 231, Hyeomnyeok-ro, Siheung-si
15086
Republic of Korea
Sofosbuvir
Yuhan Chemical, Inc
45 Jiwon-ro, Ansan-si
Danwon-gu,
15619
Republic of Korea
Velpatasvir
Yuhan Chemical, Inc
162 Cheongwonsandan 8-gil, Hwaseong-si
Mado-myeon,
18543
Republic of Korea
Velpatasvir
FPP Manufacturing Site(s)
Gilead Sciences Ireland UC
IDA Business & Technology Park, Co. Cork
Carrigtohill,
Ireland
Microchem Laboratories Ireland Ltd
Dungarvan
Clogherane,
Ireland
Patheon Inc
2100 Syntex Court
Mississauga,
Ontario
L5N 7K9
Canada