Medicines/finished pharmaceutical products

Reference Number: 
HA640 (a)

Date of prequalification: 
17 November 2014
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Rifabutin
Therapeutic area: 
HIV/AIDS
Dosage form & strength: 
Capsules, hard 150mg
Storage condition: 
Do not store above 25°C. Avoid excursions above 30°C. Protect from light and moisture
Shelf life (months): 
24
Packaging: 
Bottle HDPE: 100x1
Applicant: 
Lupin Ltd, Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai, Maharashtra, 400055, India
FPP Manufacturing Site: 

Lupin Ltd, Rifa & Non-Rifa Facilities, Block No 1 & 2, A-28/1 MIDC Industrial Area, Chikalthana, Aurangabad, 431 210, India

API Manufacturing Site: 

(Rifabutin) Lupin Ltd, T-142, MIDC, Tarapur, Via Boisar, Thane District, Maharashtra, 401 506, India