Medicines/finished pharmaceutical products

Reference Number: 
TB332

Date of prequalification: 
17 July 2018
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Rifampicin
Therapeutic area: 
Tuberculosis
Dosage form & strength: 
Capsules, hard 300mg
Storage condition: 
Do not store above 25°C, store in dry condition, protect from light
Shelf life (months): 
24
Packaging: 
Blister,Alu/PVC 10x10; Strip,Alu/Alu 10x10; Self-sealing bag,LDPE 100x1, LDPE bag packed in Al/PET/LDPE bag, packed in HDPE jar
Applicant: 
Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India
FPP Manufacturing Site: 

Macleods Pharmaceuticals Ltd, Unit 2, Plot No 25-27, Survey No 366, Premier Industrial Estate, Kachigam, Daman, 396 210, India

API Manufacturing Site: 

(Rifampicin) Sandoz Pvt Ltd, Plot L-, Additional Phase MIDC, Mahad, Raigad District, Maharashtra, 402 301, India
(Rifampicin) Shenyang Antibiotic Manufacturer, Jianshebei 3 Road, Hushitai Town, Xinchengzi District, Shenyang, Liaoning, 110 122, China (People's Republic of)
(Rifampicin) Lupin Ltd, T-142, MIDC, Tarapur, Via Boisar, Thane District, Maharashtra, 401 506, India