Medicines/finished pharmaceutical products

Reference Number: 
TB263

Date of prequalification: 
11 July 2016
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Moxifloxacin (hydrochloride)
Therapeutic area: 
Tuberculosis
Dosage form & strength: 
Tablet, coated 400mg
Storage condition: 
Do not store above 30°C, protect from light
Shelf life (months): 
36
Packaging: 
Blister, PVC/PE/PVdC-Alu 10x10; Blister, Alu/Alu 10x10; Bottle, HDPE 30x1, 100x1
Applicant: 
Micro Labs Ltd, 31 Race Course Road, Bangalore, Karnataka, 560 001, India
FPP Manufacturing Site: 

Micro Labs Ltd, Unit 3, 92 Sipcot Industrial Complex, Hosur, Tamil Nadu, 635 126, 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: