Medicines/finished pharmaceutical products

Reference Number: 
HA705 (a)

Date of prequalification: 
19 June 2018
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Amphotericin B
Therapeutic area: 
HIV/AIDS
Dosage form & strength: 
Powder for concentration for dispersion for infusion 50mg
Storage condition: 
Do not store above 25°C. Avoid excursions above 30°C
Shelf life (months): 
48
Packaging: 
Vial, Type I glass 10x1
Applicant: 
Gilead Sciences Ireland UC, IDA Business & Technology Park, Carrigtohill, County Cork, Ireland
FPP Manufacturing Site: 

Gilead Sciences Inc., 650 Cliffside Drive, San Dimas, CA 91773, United States of America
Jubilant HollisterStier LLC, 3525 North Regal Street, Spokane, Washington, 99207, United States of America
Oso Biopharmaceuticals Manufacturing, LLC, 4272 Balloon Park Road, Albuquerque, NM 87109, United States of America
Gilead Sciences Ireland UC, IDA Business & Technology Park, Carrigtohill, County Cork, Ireland

FPP WHO Public Inspection Reports: 
API Manufacturing Site: 

(Amphotericin B) Xellia Pharmaceuticals ApS, Dalslandsgade 11, DK-2300, Copenhagen S, Denmark

API WHO Public Inspection Reports: