Medicines/finished pharmaceutical products

Reference Number: 
TB341

Date of prequalification: 
19 June 2018
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Moxifloxacin (hydrochloride)
Therapeutic area: 
Tuberculosis
Dosage form & strength: 
Tablet, Film-coated 400mg
Storage condition: 
Do not store above 30°C, protect from moisture, protect from light
Shelf life (months): 
48
Packaging: 
Bottle; HDPE 30x1, 500x1; Blister;Alu/PVC/PVdC 5x3, 7x5, 10x3,10x10
Applicant: 
MSN Laboratories Private Limited, “MSN House”, Plot No: C – 24, Industrial Estate, Sanath Nagar, Hyderabad, Telangana, 500 018, India
FPP Manufacturing Site: 

MSN Laboratories Private Limited, Formulations Division, Unit-II, Survey Nos. 1277, 1319 to 1324, Nandigama (Village & Mandal), Rangareddy (District), Telangana, 509228, India

API Manufacturing Site: 

(Moxifloxacin (hydrochloride)) MSN Pharmachem Pvt Ltd, Plot No 212, A, B, C, D, IDA Phase II, Pashamylaram, Patancheru (M), Medak District, 502 307, India

API WHO Public Inspection Reports: