Product Details
WHO Product ID
HA733
Status
Prequalified
INN, dosage form and strength
Darunavir Tablet, Film-coated 600mg
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
HIV/AIDS
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Film-coated
Applicant organization
Krka, d.d., Novo mesto
Šmarješka cesta 6
Novo mesto,
8501
Slovenia
Packaging details and storage conditions
Packaging Type
Bottle, HDPE
Configuration
30 (1x30); 60 (2x30), 90 (3x30), 180 (6x30)
Shelf life (months)
36
Storage conditions
Do not store above 30°C, protect from moisture
API Manufacturing Site(s)
By Organization
By Active Ingredient
Laurus Labs Limited
Unit 1, Plot No 21, Jawaharlal Nehru Pharma City, Anakapalli District
Parawada,
Andhra Pradesh
531 021
India
Darunavir (ethanolate)
FPP Manufacturing Site(s)
Krka, d.d., Novo mesto
Šmarješka cesta 6
Novo mesto,
8501
Slovenia
Prestige Promotion Verkaufsförderung & Werbeservice GmbH
Lindigstraße 6
Kleinostheim,
63801
Germany
RAFARM S A
Paiania Attiki TK 19002
Thesi Pousi-Xatzi Agiou Louka,
Greece
TAD Pharma GmbH
Heinz-Lohmann - Straβe 5
Cuxhaven,
27472
Germany