Medicines/finished pharmaceutical products

Reference Number: 
HA733 (a)

Date of prequalification: 
11 June 2019
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Darunavir
Therapeutic area: 
HIV/AIDS
Dosage form & strength: 
Tablet, Film-coated 600mg
Storage condition: 
Do not store above 25°C, protect from moisture
Shelf life (months): 
24
Packaging: 
Bottle, HDPE 30 (1x30); 60 (2x30), 90 (3x30), 180 (6x30)
Applicant: 
Krka, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
FPP Manufacturing Site: 

Krka, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann - Straβe 5, 27472 Cuxhaven, Germany
Prestige Promotion Verkaufsförderung & Werbeservice GmbH, Lindigstraße 6, 63801 Kleinostheim, Germany (Additional secondary packaging)
RAFARM S A, Thesi Pousi-Xatzi Agiou Louka, Paiania Attiki TK 19002, TΘ 37, Greece

FPP WHO Public Inspection Reports: 
API Manufacturing Site: 

Laurus Labs Ltd, Plot No 21, Jawaharlal Nehru Pharma City, Parawada, Visakhapatnam District, Andhra Pradesh, 531 021, India