Product Details
WHO Product ID
HA705
Status
Prequalified
INN, dosage form and strength
Amphotericin B Powder for concentration for dispersion for infusion 50mg
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
HIV/AIDS
Type
Finished Pharmaceutical Product
Dosage form
Powder for concentration for dispersion for infusion
Applicant organization
Gilead Sciences Ireland UC
IDA Business & Technology Park, County Cork
Carrigtohill,
Ireland
Packaging details and storage conditions
Packaging Type
Vial, Type I glass
Configuration
10x1
Shelf life (months)
48
Storage conditions
Do not store above 25°C. Avoid excursions above 30°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
Xellia Pharmaceuticals ApS
Dalslandsgade 11, DK-2300
Copenhagen S,
Denmark
Amphotericin B
FPP Manufacturing Site(s)
Curia New Mexico, LLC
4272 Balloon Park Road
Albuquerque,
NM 87109
United States
Gilead Sciences Inc.
650 Cliffside Drive
San Dimas,
CA 91773
United States
Gilead Sciences Ireland UC
IDA Business & Technology Park, County Cork
Carrigtohill,
Ireland
Gilead Sciences, Inc.
1800 Wheeler Avenue, La Verne
California,
91750
United States
Jubilant HollisterStier LLC
3525 North Regal Street, Spokane
Washington,
99207
United States