Medicines/finished pharmaceutical products

Reference Number: 
HA530 (a)

Date of prequalification: 
11 September 2012
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Darunavir
Therapeutic area: 
HIV/AIDS
Dosage form & strength: 
Tablet, Film-coated 150mg
Storage condition: 
Do not store above 30°C
Shelf life (months): 
36
Packaging: 
Bottle HDPE: 240x1
Applicant: 
Janssen Research & Development LLC, Turnhoutseweg 30, Beerse, 2340, Belgium
FPP Manufacturing Site: 

Janssen Ortho LLC, State Road 933 KM 0.1, Mamey Ward, Gurabo, 778, Puerto Rico
Janssen-Cilag SpA, Via C Janssen, Borgo San Michele, Latina, 4010, Italy

FPP WHO Public Inspection Reports: 
API Manufacturing Site: 

(Darunavir (ethanolate)) Cilag AG, Hochstrasse 201, Schaffhausen, 8205, Switzerland
(Darunavir (ethanolate)) Janssen Pharmaceutica NV, Little Island , County Cork, Ireland

API WHO Public Inspection Reports: