Medicines/finished pharmaceutical products

Reference Number: 
TB214

Date of prequalification: 
16 May 2019
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Streptomycin (sulfate) - Sterile
Therapeutic area: 
Tuberculosis
Dosage form & strength: 
Powder for solution for injection 1000mg
Storage condition: 
Do not store above 30°C. Avoid excursions above 30°C. Protect from light and moisture
Shelf life (months): 
24
Packaging: 
Vial, 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: 

(Streptomycin (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: