Medicines/finished pharmaceutical products

Reference Number: 
TB337

Date of prequalification: 
15 August 2018
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Capreomycin (sulfate)
Therapeutic area: 
Tuberculosis
Dosage form & strength: 
Powder for solution for injection 500mg
Storage condition: 
Do not store above 30°C, store in dry condition, protect from light
Shelf life (months): 
24
Packaging: 
Vial, 10ml USP type III glass 1x1
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: 

(Capreomycin (sulfate, sterile)) North China Pharmaceutical Huasheng Co Ltd, No 8 Yangzi Road, Shijiazhuang Economic & Technological Development Zone, Shijiazhuang, Hebei, 052 160, China (People's Republic of)

API WHO Public Inspection Reports: