Medicines/finished pharmaceutical products

Reference Number: 
TB349

Date of prequalification: 
31 October 2018
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Moxifloxacin (hydrochloride)
Therapeutic area: 
Tuberculosis
Dosage form & strength: 
Tablet, Dispersible 100mg
Storage condition: 
Do not store above 30°C. Avoid excursions above 30°C. Protect from light and moisture
Shelf life (months): 
24
Packaging: 
Strip, Alu/Alu 10x10; Blister, Alu-PVC/PE/PVdC 10x10, 10x14
Applicant: 
Micro Labs Ltd, 27 Race Course Road, Bangalore, Karnataka, 560 001, India
FPP Manufacturing Site: 

Micro Labs Ltd, Unit 03, 92 Sipcot Industrial Complex, Hosur, Tamil Nadu, 635 126, India
Micro Labs Ltd, ML08, Plot No 15/A, 2nd Phase, Kumbalgodu Industrial Area, Bangalore, 560 074, 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: