Medicines/finished pharmaceutical products

Reference Number: 
TB268 (a)

Date of prequalification: 
28 February 2013
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Rifampicin
Therapeutic area: 
Tuberculosis
Dosage form & strength: 
Capsules, hard 150mg
Storage condition: 
Do not store above 25°C
Shelf life (months): 
48
Packaging: 
Blister Alu/PVC:10x2, 10x100
Applicant: 
Antibiotice SA, 1 Valea Lupului Street, Iasi, Romania
FPP Manufacturing Site: 

Antibiotice SA, 1 Valea Lupului Street, Iasi, Romania

FPP WHO Public Inspection Reports: 
API Manufacturing Site: 

(Rifampicin) Lupin Ltd, T-142, MIDC, Tarapur, Via Boisar, Thane District, Maharashtra, 401 506, India
(Rifampicin) Sandoz Pvt Ltd, Plot L-, Additional Phase MIDC, Mahad, Raigad District, Maharashtra, 402 301, India